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Concussion may not affect IQ in children
data suggest.
In a multicenter study of almost 900 children with concussion or orthopedic injury, differences between groups in full-scale IQ (Cohen’s d = 0.13) and matrix reasoning scores (d = 0.16) were small.
“We draw the inference that IQ scores are unchanged, in the sense that they’re not different from [those of] kids with other types of injuries that don’t involve the brain,” said study author Keith Owen Yeates, PhD, Ronald and Irene Ward Chair in Pediatric Brain Injury and a professor of psychology at the University of Calgary (Alta.).
The study was published in Pediatrics.
A representative sample
The investigators analyzed data from two prospective cohort studies of children who were treated for concussion or mild orthopedic injury at two hospitals in the United States and five in Canada. Participants were aged 8-17 years and were recruited within 24 hours of the index event. Patients in the United States completed IQ and performance validity testing at 3-18 days after injury. Patients in Canada did so at 3 months after injury. The study used the short-form IQ test. The investigators included 866 children in their analysis.
Using linear modeling, Bayesian analysis, and multigroup factor analysis, the researchers found “very small group differences” in full-scale IQ scores between the two groups. Mean IQ was 104.95 for the concussion group and 106.08 for the orthopedic-injury group. Matrix reasoning scores were 52.28 and 53.81 for the concussion and orthopedic-injury groups, respectively.
Vocabulary scores did not differ between the two groups (53.25 for the concussion group and 53.27 for the orthopedic-injury group).
The study population is “pretty representative” from a demographic perspective, although it was predominantly White, said Dr. Yeates. “On the other hand, we did look at socioeconomic status, and that didn’t seem to alter the findings at all.”
The sample size is one of the study’s strengths, said Dr. Yeates. “Having 866 kids is far larger, I think, than just about any other study out there.” Drawing from seven children’s hospitals in North America is another strength. “Previous studies, in addition to having smaller samples, were from a single site and often recruited from a clinic population, not a representative group for a general population of kids with concussion.”
The findings must be interpreted precisely, however. “We don’t have actual preinjury data, so the more precise way of describing the findings is to say they’re not different from kids who are very similar to them demographically, have the same risk factors for injuries, and had a similar experience of a traumatic injury,” said Dr. Yeates. “The IQ scores for both groups are smack dab in the average range.”
Overall, the results are encouraging. “There’s been a lot of bad news in the media and in the science about concussion that worries patients, so it’s nice to be able to provide a little bit of balance,” said Dr. Yeates. “The message I give parents is that most kids recover within 2-4 weeks, and we’re much better now at predicting who’s going to [recover] and who isn’t, and that helps, too, so that we can focus our intervention on kids who are most at risk.”
Some children will have persisting symptoms, but evidence-based treatments are lacking. “I think that’ll be a really important direction for the future,” said Dr. Yeates.
Graduated return
Commenting on the findings, Michael Esser, MD, a pediatric neurologist at Alberta Children’s Hospital, Calgary, and an associate professor in pediatrics at the University of Calgary, said that they can help allay parents’ concerns about concussions. “It can also be of help for clinicians who want to have evidence to reassure families and promote a graduated return to activities. In particular, the study would support the philosophy of a graduated return to school or work, after a brief period of rest, following concussion.” Dr. Esser did not participate in the study.
The research is also noteworthy because it acknowledges that the differences in the design and methodology used in prior studies may explain the apparent disagreement over how concussion may influence cognitive function.
“This is an important message,” said Dr. Esser. “Families struggle with determining the merit of a lot of information due to the myriad of social media comments about concussion and the risk for cognitive impairment. Therefore, it is important that conclusions with a significant implication are evaluated with a variety of approaches.”
The study received funding from the National Institutes of Health and the Canadian Institutes for Health Research. Dr. Yeates disclosed relationships with the American Psychological Association, Guilford Press, and Cambridge University Press. He has received grant funding from the Canadian Institutes of Health Research, the National Institutes of Health, Brain Canada Foundation, and the National Football League Scientific Advisory Board. He also has relationships with the National Institute for Child Health and Human Development, National Institute of Neurologic Disorders and Stroke, National Pediatric Rehabilitation Resource Center, Center for Pediatric Rehabilitation, and Virginia Tech University. Dr. Esser had no relevant relationships to disclose.
A version of this article appeared on Medscape.com.
data suggest.
In a multicenter study of almost 900 children with concussion or orthopedic injury, differences between groups in full-scale IQ (Cohen’s d = 0.13) and matrix reasoning scores (d = 0.16) were small.
“We draw the inference that IQ scores are unchanged, in the sense that they’re not different from [those of] kids with other types of injuries that don’t involve the brain,” said study author Keith Owen Yeates, PhD, Ronald and Irene Ward Chair in Pediatric Brain Injury and a professor of psychology at the University of Calgary (Alta.).
The study was published in Pediatrics.
A representative sample
The investigators analyzed data from two prospective cohort studies of children who were treated for concussion or mild orthopedic injury at two hospitals in the United States and five in Canada. Participants were aged 8-17 years and were recruited within 24 hours of the index event. Patients in the United States completed IQ and performance validity testing at 3-18 days after injury. Patients in Canada did so at 3 months after injury. The study used the short-form IQ test. The investigators included 866 children in their analysis.
Using linear modeling, Bayesian analysis, and multigroup factor analysis, the researchers found “very small group differences” in full-scale IQ scores between the two groups. Mean IQ was 104.95 for the concussion group and 106.08 for the orthopedic-injury group. Matrix reasoning scores were 52.28 and 53.81 for the concussion and orthopedic-injury groups, respectively.
Vocabulary scores did not differ between the two groups (53.25 for the concussion group and 53.27 for the orthopedic-injury group).
The study population is “pretty representative” from a demographic perspective, although it was predominantly White, said Dr. Yeates. “On the other hand, we did look at socioeconomic status, and that didn’t seem to alter the findings at all.”
The sample size is one of the study’s strengths, said Dr. Yeates. “Having 866 kids is far larger, I think, than just about any other study out there.” Drawing from seven children’s hospitals in North America is another strength. “Previous studies, in addition to having smaller samples, were from a single site and often recruited from a clinic population, not a representative group for a general population of kids with concussion.”
The findings must be interpreted precisely, however. “We don’t have actual preinjury data, so the more precise way of describing the findings is to say they’re not different from kids who are very similar to them demographically, have the same risk factors for injuries, and had a similar experience of a traumatic injury,” said Dr. Yeates. “The IQ scores for both groups are smack dab in the average range.”
Overall, the results are encouraging. “There’s been a lot of bad news in the media and in the science about concussion that worries patients, so it’s nice to be able to provide a little bit of balance,” said Dr. Yeates. “The message I give parents is that most kids recover within 2-4 weeks, and we’re much better now at predicting who’s going to [recover] and who isn’t, and that helps, too, so that we can focus our intervention on kids who are most at risk.”
Some children will have persisting symptoms, but evidence-based treatments are lacking. “I think that’ll be a really important direction for the future,” said Dr. Yeates.
Graduated return
Commenting on the findings, Michael Esser, MD, a pediatric neurologist at Alberta Children’s Hospital, Calgary, and an associate professor in pediatrics at the University of Calgary, said that they can help allay parents’ concerns about concussions. “It can also be of help for clinicians who want to have evidence to reassure families and promote a graduated return to activities. In particular, the study would support the philosophy of a graduated return to school or work, after a brief period of rest, following concussion.” Dr. Esser did not participate in the study.
The research is also noteworthy because it acknowledges that the differences in the design and methodology used in prior studies may explain the apparent disagreement over how concussion may influence cognitive function.
“This is an important message,” said Dr. Esser. “Families struggle with determining the merit of a lot of information due to the myriad of social media comments about concussion and the risk for cognitive impairment. Therefore, it is important that conclusions with a significant implication are evaluated with a variety of approaches.”
The study received funding from the National Institutes of Health and the Canadian Institutes for Health Research. Dr. Yeates disclosed relationships with the American Psychological Association, Guilford Press, and Cambridge University Press. He has received grant funding from the Canadian Institutes of Health Research, the National Institutes of Health, Brain Canada Foundation, and the National Football League Scientific Advisory Board. He also has relationships with the National Institute for Child Health and Human Development, National Institute of Neurologic Disorders and Stroke, National Pediatric Rehabilitation Resource Center, Center for Pediatric Rehabilitation, and Virginia Tech University. Dr. Esser had no relevant relationships to disclose.
A version of this article appeared on Medscape.com.
data suggest.
In a multicenter study of almost 900 children with concussion or orthopedic injury, differences between groups in full-scale IQ (Cohen’s d = 0.13) and matrix reasoning scores (d = 0.16) were small.
“We draw the inference that IQ scores are unchanged, in the sense that they’re not different from [those of] kids with other types of injuries that don’t involve the brain,” said study author Keith Owen Yeates, PhD, Ronald and Irene Ward Chair in Pediatric Brain Injury and a professor of psychology at the University of Calgary (Alta.).
The study was published in Pediatrics.
A representative sample
The investigators analyzed data from two prospective cohort studies of children who were treated for concussion or mild orthopedic injury at two hospitals in the United States and five in Canada. Participants were aged 8-17 years and were recruited within 24 hours of the index event. Patients in the United States completed IQ and performance validity testing at 3-18 days after injury. Patients in Canada did so at 3 months after injury. The study used the short-form IQ test. The investigators included 866 children in their analysis.
Using linear modeling, Bayesian analysis, and multigroup factor analysis, the researchers found “very small group differences” in full-scale IQ scores between the two groups. Mean IQ was 104.95 for the concussion group and 106.08 for the orthopedic-injury group. Matrix reasoning scores were 52.28 and 53.81 for the concussion and orthopedic-injury groups, respectively.
Vocabulary scores did not differ between the two groups (53.25 for the concussion group and 53.27 for the orthopedic-injury group).
The study population is “pretty representative” from a demographic perspective, although it was predominantly White, said Dr. Yeates. “On the other hand, we did look at socioeconomic status, and that didn’t seem to alter the findings at all.”
The sample size is one of the study’s strengths, said Dr. Yeates. “Having 866 kids is far larger, I think, than just about any other study out there.” Drawing from seven children’s hospitals in North America is another strength. “Previous studies, in addition to having smaller samples, were from a single site and often recruited from a clinic population, not a representative group for a general population of kids with concussion.”
The findings must be interpreted precisely, however. “We don’t have actual preinjury data, so the more precise way of describing the findings is to say they’re not different from kids who are very similar to them demographically, have the same risk factors for injuries, and had a similar experience of a traumatic injury,” said Dr. Yeates. “The IQ scores for both groups are smack dab in the average range.”
Overall, the results are encouraging. “There’s been a lot of bad news in the media and in the science about concussion that worries patients, so it’s nice to be able to provide a little bit of balance,” said Dr. Yeates. “The message I give parents is that most kids recover within 2-4 weeks, and we’re much better now at predicting who’s going to [recover] and who isn’t, and that helps, too, so that we can focus our intervention on kids who are most at risk.”
Some children will have persisting symptoms, but evidence-based treatments are lacking. “I think that’ll be a really important direction for the future,” said Dr. Yeates.
Graduated return
Commenting on the findings, Michael Esser, MD, a pediatric neurologist at Alberta Children’s Hospital, Calgary, and an associate professor in pediatrics at the University of Calgary, said that they can help allay parents’ concerns about concussions. “It can also be of help for clinicians who want to have evidence to reassure families and promote a graduated return to activities. In particular, the study would support the philosophy of a graduated return to school or work, after a brief period of rest, following concussion.” Dr. Esser did not participate in the study.
The research is also noteworthy because it acknowledges that the differences in the design and methodology used in prior studies may explain the apparent disagreement over how concussion may influence cognitive function.
“This is an important message,” said Dr. Esser. “Families struggle with determining the merit of a lot of information due to the myriad of social media comments about concussion and the risk for cognitive impairment. Therefore, it is important that conclusions with a significant implication are evaluated with a variety of approaches.”
The study received funding from the National Institutes of Health and the Canadian Institutes for Health Research. Dr. Yeates disclosed relationships with the American Psychological Association, Guilford Press, and Cambridge University Press. He has received grant funding from the Canadian Institutes of Health Research, the National Institutes of Health, Brain Canada Foundation, and the National Football League Scientific Advisory Board. He also has relationships with the National Institute for Child Health and Human Development, National Institute of Neurologic Disorders and Stroke, National Pediatric Rehabilitation Resource Center, Center for Pediatric Rehabilitation, and Virginia Tech University. Dr. Esser had no relevant relationships to disclose.
A version of this article appeared on Medscape.com.
FROM PEDIATRICS
Same-session PCI rates ‘surprisingly high’
Stable patients who have a diagnostic cardiac catheterization for multivessel disease or two-vessel proximal left anterior descending disease often have percutaneous coronary intervention (PCI) in the same session, possibly without input from a multidisciplinary heart team, a new study suggests.
The study, a retrospective analysis of more than 8,000 catheterization procedures in New York State during 2018 and 2019, was published in JACC: Cardiovascular Interventions.
Among the stable patients with multivessel disease or left main (LM) disease who had PCI, 78.4% of PCIs were performed in the same session as their diagnostic catheterization procedure, known as ad hoc PCI, a “surprisingly high rate,” the authors wrote.
The 2011 clinical guidelines in place during the study period advised coronary artery bypass graft (CABG) surgery as a class 1 recommendation for LM disease, whereas PCI is a lower-class recommendation (J Am Coll Cardiol. 2011;58:e44-e-122), they noted.
“Ad hoc PCI can be inadvisable when guidelines indicate that patients can realize better outcomes with CABG surgery,” lead study author Edward L. Hannan, PhD, MS, said in an interview. “The issue is that ad hoc PCI eliminates the opportunity for a multidisciplinary heart team to evaluate the patient.”
Dr. Hannan is principal investigator for the cardiac services program at the New York State Department of Health in Albany and distinguished professor emeritus at the University of Albany School of Public Health.
The researchers analyzed data from two mandatory New York State PCI and cardiac surgery registries, the Percutaneous Coronary Interventions Reporting System and the Cardiac Surgery Reporting System. A total of 91,146 patients had an index PCI from Dec. 1, 2017, to Nov. 30, 2019.
The study included patients who had two-vessel disease with proximal left anterior descending (PLAD) disease, three-vessel disease or unprotected LM disease. Exclusion criteria included a previous revascularization, among a host of other factors. The analysis also identified 10,122 patients who had coronary artery bypass graft (CABG) surgery in addition to the 8,196 patients who had PCI.
The percentage for ad hoc PCI ranged from 58.7% for those with unprotected LM disease to 85.4% for patients with two-vessel PLAD. Among the patients who had PCI for three-vessel disease, 76.7% had an ad hoc PCI.
Selected subgroups had lower ad hoc PCI rates. When patients who had a myocardial infarction within 1-7 days were excluded, the ad hoc percentage decreased slightly to 77.2%. PCI patients with diabetes were also less likely to have ad hoc PCI (75.7% vs. 80.4%, P < .0001), as were patients with compromised left ventricular ejection fraction (< 35%; 64.6% vs. 80.5%, P < .0001).
When all revascularizations – PCI plus CABG – were taken into account, the rate of ad hoc PCIs was 35.1%. Rates were 63.9% for patients with two-vessel PLAD disease, 32.4% for those with three-vessel disease, and 11.5% for patients with unprotected LM disease.
One potential disadvantage of ad hoc PCI, the authors noted, is that it doesn’t allow time for a multidisciplinary heart team to evaluate the patient for a different treatment, such as CABG or medical therapy. “This multidisciplinary team can evaluate all the pros and cons of different approaches, such as PCI vs. CABG surgery in this case,” Dr. Hannan said.
The study findings imply a potential overutilization of PCI and a greater likelihood of forgoing a more appropriate intervention, he said, “given that we have chosen for the study groups of patients who in general benefit more with CABG surgery.”
The results also showed variability in ad hoc PCI rates among hospitals and physicians. “They are large enough to suggest that there is a fairly large variation across the state in the use of heart teams,” he said.
For unprotected LM disease, the risk adjusted rate for hospitals of ad hoc PCIs among all PCIs ranged from 25.6% in the lowest quartile to 93.7% in the highest. Physician rates of ad hoc PCIs for the same indication, which were ranked by tertile, ranged from 22% for the lowest to 84.3% for the highest (P < .001).
One strength of the study, Dr. Hannan said, is that it is a large population-based study that excluded groups for whom an ad hoc PCI would be appropriate, such as emergency patients. One limitation is that it did not account for legitimate reasons for ad hoc PCI, including contraindications for CABG surgery and patient refusal of CABG surgery.
In an invited editorial comment, James C. Blankenship, MD, and Krishna Patel, MD, wrote that this study shows that “past criticisms of ad hoc PCI have had seemingly little effect.”
“The article provides a striking example of a difference between guideline-directed practice and real-life practice,” Dr. Blankenship said in an interview. “Guideline recommendations for the heart team approach are well known by interventionalists, so the findings of this study do not reflect ignorance of cardiologists.” Dr. Blankenship, a cardiologist and professor of medicine at the University of New Mexico in Albuquerque, is a coauthor of the 2011 PCI guidelines.
It’s more likely the study findings “reflect unconscious biases and sincere beliefs of patients and interventionalists that PCI rather than CABG is in patients’ best interests,” Dr. Blankenship said.
He noted the variation in practice across hospitals and individuals suggests an opportunity for improvement. “If the guidelines are correct, then perhaps interventionalists should be held accountable for making sure the heart team approach is followed,” he said. “Alternatively, perhaps a modified approach that guarantees patient-centered decision making and is ethically acceptable could be identified.”
The study received funding from the New York State Department of Health. Dr. Hannan and Dr. Blankenship and Dr. Patel have no relevant disclosures.
Stable patients who have a diagnostic cardiac catheterization for multivessel disease or two-vessel proximal left anterior descending disease often have percutaneous coronary intervention (PCI) in the same session, possibly without input from a multidisciplinary heart team, a new study suggests.
The study, a retrospective analysis of more than 8,000 catheterization procedures in New York State during 2018 and 2019, was published in JACC: Cardiovascular Interventions.
Among the stable patients with multivessel disease or left main (LM) disease who had PCI, 78.4% of PCIs were performed in the same session as their diagnostic catheterization procedure, known as ad hoc PCI, a “surprisingly high rate,” the authors wrote.
The 2011 clinical guidelines in place during the study period advised coronary artery bypass graft (CABG) surgery as a class 1 recommendation for LM disease, whereas PCI is a lower-class recommendation (J Am Coll Cardiol. 2011;58:e44-e-122), they noted.
“Ad hoc PCI can be inadvisable when guidelines indicate that patients can realize better outcomes with CABG surgery,” lead study author Edward L. Hannan, PhD, MS, said in an interview. “The issue is that ad hoc PCI eliminates the opportunity for a multidisciplinary heart team to evaluate the patient.”
Dr. Hannan is principal investigator for the cardiac services program at the New York State Department of Health in Albany and distinguished professor emeritus at the University of Albany School of Public Health.
The researchers analyzed data from two mandatory New York State PCI and cardiac surgery registries, the Percutaneous Coronary Interventions Reporting System and the Cardiac Surgery Reporting System. A total of 91,146 patients had an index PCI from Dec. 1, 2017, to Nov. 30, 2019.
The study included patients who had two-vessel disease with proximal left anterior descending (PLAD) disease, three-vessel disease or unprotected LM disease. Exclusion criteria included a previous revascularization, among a host of other factors. The analysis also identified 10,122 patients who had coronary artery bypass graft (CABG) surgery in addition to the 8,196 patients who had PCI.
The percentage for ad hoc PCI ranged from 58.7% for those with unprotected LM disease to 85.4% for patients with two-vessel PLAD. Among the patients who had PCI for three-vessel disease, 76.7% had an ad hoc PCI.
Selected subgroups had lower ad hoc PCI rates. When patients who had a myocardial infarction within 1-7 days were excluded, the ad hoc percentage decreased slightly to 77.2%. PCI patients with diabetes were also less likely to have ad hoc PCI (75.7% vs. 80.4%, P < .0001), as were patients with compromised left ventricular ejection fraction (< 35%; 64.6% vs. 80.5%, P < .0001).
When all revascularizations – PCI plus CABG – were taken into account, the rate of ad hoc PCIs was 35.1%. Rates were 63.9% for patients with two-vessel PLAD disease, 32.4% for those with three-vessel disease, and 11.5% for patients with unprotected LM disease.
One potential disadvantage of ad hoc PCI, the authors noted, is that it doesn’t allow time for a multidisciplinary heart team to evaluate the patient for a different treatment, such as CABG or medical therapy. “This multidisciplinary team can evaluate all the pros and cons of different approaches, such as PCI vs. CABG surgery in this case,” Dr. Hannan said.
The study findings imply a potential overutilization of PCI and a greater likelihood of forgoing a more appropriate intervention, he said, “given that we have chosen for the study groups of patients who in general benefit more with CABG surgery.”
The results also showed variability in ad hoc PCI rates among hospitals and physicians. “They are large enough to suggest that there is a fairly large variation across the state in the use of heart teams,” he said.
For unprotected LM disease, the risk adjusted rate for hospitals of ad hoc PCIs among all PCIs ranged from 25.6% in the lowest quartile to 93.7% in the highest. Physician rates of ad hoc PCIs for the same indication, which were ranked by tertile, ranged from 22% for the lowest to 84.3% for the highest (P < .001).
One strength of the study, Dr. Hannan said, is that it is a large population-based study that excluded groups for whom an ad hoc PCI would be appropriate, such as emergency patients. One limitation is that it did not account for legitimate reasons for ad hoc PCI, including contraindications for CABG surgery and patient refusal of CABG surgery.
In an invited editorial comment, James C. Blankenship, MD, and Krishna Patel, MD, wrote that this study shows that “past criticisms of ad hoc PCI have had seemingly little effect.”
“The article provides a striking example of a difference between guideline-directed practice and real-life practice,” Dr. Blankenship said in an interview. “Guideline recommendations for the heart team approach are well known by interventionalists, so the findings of this study do not reflect ignorance of cardiologists.” Dr. Blankenship, a cardiologist and professor of medicine at the University of New Mexico in Albuquerque, is a coauthor of the 2011 PCI guidelines.
It’s more likely the study findings “reflect unconscious biases and sincere beliefs of patients and interventionalists that PCI rather than CABG is in patients’ best interests,” Dr. Blankenship said.
He noted the variation in practice across hospitals and individuals suggests an opportunity for improvement. “If the guidelines are correct, then perhaps interventionalists should be held accountable for making sure the heart team approach is followed,” he said. “Alternatively, perhaps a modified approach that guarantees patient-centered decision making and is ethically acceptable could be identified.”
The study received funding from the New York State Department of Health. Dr. Hannan and Dr. Blankenship and Dr. Patel have no relevant disclosures.
Stable patients who have a diagnostic cardiac catheterization for multivessel disease or two-vessel proximal left anterior descending disease often have percutaneous coronary intervention (PCI) in the same session, possibly without input from a multidisciplinary heart team, a new study suggests.
The study, a retrospective analysis of more than 8,000 catheterization procedures in New York State during 2018 and 2019, was published in JACC: Cardiovascular Interventions.
Among the stable patients with multivessel disease or left main (LM) disease who had PCI, 78.4% of PCIs were performed in the same session as their diagnostic catheterization procedure, known as ad hoc PCI, a “surprisingly high rate,” the authors wrote.
The 2011 clinical guidelines in place during the study period advised coronary artery bypass graft (CABG) surgery as a class 1 recommendation for LM disease, whereas PCI is a lower-class recommendation (J Am Coll Cardiol. 2011;58:e44-e-122), they noted.
“Ad hoc PCI can be inadvisable when guidelines indicate that patients can realize better outcomes with CABG surgery,” lead study author Edward L. Hannan, PhD, MS, said in an interview. “The issue is that ad hoc PCI eliminates the opportunity for a multidisciplinary heart team to evaluate the patient.”
Dr. Hannan is principal investigator for the cardiac services program at the New York State Department of Health in Albany and distinguished professor emeritus at the University of Albany School of Public Health.
The researchers analyzed data from two mandatory New York State PCI and cardiac surgery registries, the Percutaneous Coronary Interventions Reporting System and the Cardiac Surgery Reporting System. A total of 91,146 patients had an index PCI from Dec. 1, 2017, to Nov. 30, 2019.
The study included patients who had two-vessel disease with proximal left anterior descending (PLAD) disease, three-vessel disease or unprotected LM disease. Exclusion criteria included a previous revascularization, among a host of other factors. The analysis also identified 10,122 patients who had coronary artery bypass graft (CABG) surgery in addition to the 8,196 patients who had PCI.
The percentage for ad hoc PCI ranged from 58.7% for those with unprotected LM disease to 85.4% for patients with two-vessel PLAD. Among the patients who had PCI for three-vessel disease, 76.7% had an ad hoc PCI.
Selected subgroups had lower ad hoc PCI rates. When patients who had a myocardial infarction within 1-7 days were excluded, the ad hoc percentage decreased slightly to 77.2%. PCI patients with diabetes were also less likely to have ad hoc PCI (75.7% vs. 80.4%, P < .0001), as were patients with compromised left ventricular ejection fraction (< 35%; 64.6% vs. 80.5%, P < .0001).
When all revascularizations – PCI plus CABG – were taken into account, the rate of ad hoc PCIs was 35.1%. Rates were 63.9% for patients with two-vessel PLAD disease, 32.4% for those with three-vessel disease, and 11.5% for patients with unprotected LM disease.
One potential disadvantage of ad hoc PCI, the authors noted, is that it doesn’t allow time for a multidisciplinary heart team to evaluate the patient for a different treatment, such as CABG or medical therapy. “This multidisciplinary team can evaluate all the pros and cons of different approaches, such as PCI vs. CABG surgery in this case,” Dr. Hannan said.
The study findings imply a potential overutilization of PCI and a greater likelihood of forgoing a more appropriate intervention, he said, “given that we have chosen for the study groups of patients who in general benefit more with CABG surgery.”
The results also showed variability in ad hoc PCI rates among hospitals and physicians. “They are large enough to suggest that there is a fairly large variation across the state in the use of heart teams,” he said.
For unprotected LM disease, the risk adjusted rate for hospitals of ad hoc PCIs among all PCIs ranged from 25.6% in the lowest quartile to 93.7% in the highest. Physician rates of ad hoc PCIs for the same indication, which were ranked by tertile, ranged from 22% for the lowest to 84.3% for the highest (P < .001).
One strength of the study, Dr. Hannan said, is that it is a large population-based study that excluded groups for whom an ad hoc PCI would be appropriate, such as emergency patients. One limitation is that it did not account for legitimate reasons for ad hoc PCI, including contraindications for CABG surgery and patient refusal of CABG surgery.
In an invited editorial comment, James C. Blankenship, MD, and Krishna Patel, MD, wrote that this study shows that “past criticisms of ad hoc PCI have had seemingly little effect.”
“The article provides a striking example of a difference between guideline-directed practice and real-life practice,” Dr. Blankenship said in an interview. “Guideline recommendations for the heart team approach are well known by interventionalists, so the findings of this study do not reflect ignorance of cardiologists.” Dr. Blankenship, a cardiologist and professor of medicine at the University of New Mexico in Albuquerque, is a coauthor of the 2011 PCI guidelines.
It’s more likely the study findings “reflect unconscious biases and sincere beliefs of patients and interventionalists that PCI rather than CABG is in patients’ best interests,” Dr. Blankenship said.
He noted the variation in practice across hospitals and individuals suggests an opportunity for improvement. “If the guidelines are correct, then perhaps interventionalists should be held accountable for making sure the heart team approach is followed,” he said. “Alternatively, perhaps a modified approach that guarantees patient-centered decision making and is ethically acceptable could be identified.”
The study received funding from the New York State Department of Health. Dr. Hannan and Dr. Blankenship and Dr. Patel have no relevant disclosures.
FROM JACC; CARDIOVASCULAR INTERVENTIONS
Does colchicine have a role in treating excess ASCVD risk in patients with chronic inflammatory conditions?
The recent Food and Drug Administration approval of colchicine 0.5 mg (Lodoco) for use in atherosclerotic cardiovascular disease (ASCVD) prevention will possibly create opportunities to use the drug to treat residual risk for ASCVD in some patients with immune-mediated inflammatory diseases, particularly in rheumatology.
Potential in rheumatology
The 0.5-mg dose is just a shade under the 0.6-mg, twice daily dosing rheumatologists typically prescribe for gout, Christie Bartels, MD, MS, chief of rheumatology at the University of Wisconsin–Madison, said in an interview. Clinicians also use the 0.6-mg dose off-label for pseudogout or calcium pyrophosphate deposition disease (CPPD), Dr. Bartels noted.
The new formulation opens the consideration for using colchicine more in patients with psoriatic arthritis, lupus, and rheumatoid arthritis, she said. “I think we could certainly discuss it, particularly, in secondary prevention patients who already had an event or who are at the highest risk and already on optimal traditional agents,” she said.
She cited previous comments by Paul Ridker, MD, director of the center for cardiovascular disease prevention at Brigham and Women’s Hospital in Boston, and developer of the high-sensitivity C-reactive protein (hsCRP) test for measuring inflammatory markers. “We might not know the answer because Dr. Ridker pointed out he used colchicine 0.5 mg in patients that had a high-sensitivity CRP that was high; we need patients who have had inflammation of unknown origin, so those patients presumably weren’t already on another anti-inflammatory,” she said, noting that hydroxychloroquine, methotrexate, and some biologics provide some protection from cardiovascular risks.
However, a potential role for long-term colchicine 0.5 mg in ASCVD prevention may cause consideration for changing the drug’s role in gout treatment, Dr. Bartels said. “In gout, where we do have an FDA-approved indication for colchicine, we used to use it only for the first 6 months while we were getting patients to goal on allopurinol, which was usually then monotherapy after the first 6 months,” she said. “I think this will likely change how I treat gout patients in that I may also offer to continue both medications [colchicine and allopurinol] if they are tolerating them well.
“And then in patients where I’m using it off-label in CPPD, I might again share with them that in addition to possibly helping their CPPD, there may be this added benefit to reduce inflammation just in discussing the risks and benefits of the medicine.”
However, rheumatologists must be careful in using colchicine beyond the typical 6-month cycle, Dr. Bartels said. “One of the tricky things with colchicine, and part of the reason we did not traditionally continue it specifically past the first 6 months, was that it can cause myopathies or cytopenias, so we still have to counsel patients regarding these risks and monitor that,” she said.
Additionally, colchicine can have drug interactions with statins or calcium channel blockers that can change colchicine levels. “I think the dose here is so low, the 0.5 mg, that it’s probably still safe, but again, it’s something that we have to take a look at in the patient’s whole picture and the rest of their burden of their meds in order to make a decision with them,” Dr. Bartels said.
Possibilities in dermatology
The LoDoCo2 trial one of two major randomized trials that supported approval of colchicine 0.5 mg, reported that treated patients had a 60% lower rate of gout than the placebo group (1.4% vs. 3.4%). Joel Gelfand, MD, MSCE, the James J. Leyden professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, pointed to this in evaluating the dermatologic implications of the drug’s approval. “This may be of particular interest as people with psoriasis have an increased risk of gout,” he said in emailed comments.
Colchicine’s mechanism of action to reduce inflammation parallels that of tumor necrosis factor (TNF) inhibitors used for dermatologic indications, namely by inhibiting leukocyte adhesion to disrupt the downregulation of TNF receptors, Dr. Gelfand said.
“Interestingly, observational data suggests biologics that target TNF such as adalimumab, etanercept, etc., are associated with a reduction in CV events, and in placebo-controlled trials we conducted in psoriasis patients, it reduced key inflammatory mediators of cardiovascular disease, including IL [interleukin]-6,” he said. “Randomized clinical trials to evaluate the ability of TNF inhibitors, which are now available as biosimilars, to prevent cardiovascular events in high-risk patients, should be conducted, and more work is needed to identify which additional immune-targeted treatments may lower CV risk with an acceptable safety profile.”
Colchicine currently has few indications for rare conditions in dermatology, Dr. Gelfand said, including Sweets syndrome, subcorneal pustular dermatosis, and cutaneous vasculitis. “There are some reports to suggest it may help psoriatic disease, but current data are limited and insufficient to recommend its use for psoriasis and/or psoriatic arthritis,” he said.
The approval of colchicine 0.5 mg for ASCVD could be meaningful for people with psoriasis who are also being treated for CV risk factors, Dr. Gelfand said. “Additional considerations such as signs of residual inflammation (elevated hsCRP) and CV imaging findings may be used to further guide shared decision-making for optimal use,” he said.
Another consideration he noted: “This is also a novel 0.5-mg formulation, and thus cost may be an issue.”
Would side effects bar use in gastroenterology?
Colchicine 0.5 mg may not move the needle much for expanding treatment of ASCVD in patients with inflammatory bowel disease (IBD) and potentially other gastrointestinal conditions, Edward Loftus Jr., MD, the Maxine and Jack Zarrow Family professor of gastroenterology specifically for IBD at the Mayo Clinic in Rochester, Minn., told MDEdge in emailed comments. “Given the GI side effect profile [of colchicine], I am not sure I would go there,” he said.
“Hopefully, the prescribers of this low-dose formulation are aware of the gastrointestinal side effects, such as diarrhea and nausea, and educate patients about these side effects so that a proper risk-benefit discussion can ensue,” he said.
Dr. Bartels reporting a previous financial relationship with Pfizer. Dr. Gelfand said he has financial relationships with AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celldex, GlaxoSmithKline, Twill, Lilly, Leo, Moonlake, Janssen Biologics, Novartis, Pfizer, UCB, Neuroderm, and Veolia North America. Dr. Loftus disclosed relationships with AbbVie, Alvotech, Amgen, Arena, Avalo, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene/Receptos, Celltrion Healthcare, Eli Lilly, Fresenius Kabi, Genentech, Gilead, GlaxoSmithKline, Gossamer Bio, Iterative Health, Janssen, KSL Diagnostics, Morphic, Ono, Pfizer, Sun, Surrozen, Takeda, Theravance, and UCB.
The recent Food and Drug Administration approval of colchicine 0.5 mg (Lodoco) for use in atherosclerotic cardiovascular disease (ASCVD) prevention will possibly create opportunities to use the drug to treat residual risk for ASCVD in some patients with immune-mediated inflammatory diseases, particularly in rheumatology.
Potential in rheumatology
The 0.5-mg dose is just a shade under the 0.6-mg, twice daily dosing rheumatologists typically prescribe for gout, Christie Bartels, MD, MS, chief of rheumatology at the University of Wisconsin–Madison, said in an interview. Clinicians also use the 0.6-mg dose off-label for pseudogout or calcium pyrophosphate deposition disease (CPPD), Dr. Bartels noted.
The new formulation opens the consideration for using colchicine more in patients with psoriatic arthritis, lupus, and rheumatoid arthritis, she said. “I think we could certainly discuss it, particularly, in secondary prevention patients who already had an event or who are at the highest risk and already on optimal traditional agents,” she said.
She cited previous comments by Paul Ridker, MD, director of the center for cardiovascular disease prevention at Brigham and Women’s Hospital in Boston, and developer of the high-sensitivity C-reactive protein (hsCRP) test for measuring inflammatory markers. “We might not know the answer because Dr. Ridker pointed out he used colchicine 0.5 mg in patients that had a high-sensitivity CRP that was high; we need patients who have had inflammation of unknown origin, so those patients presumably weren’t already on another anti-inflammatory,” she said, noting that hydroxychloroquine, methotrexate, and some biologics provide some protection from cardiovascular risks.
However, a potential role for long-term colchicine 0.5 mg in ASCVD prevention may cause consideration for changing the drug’s role in gout treatment, Dr. Bartels said. “In gout, where we do have an FDA-approved indication for colchicine, we used to use it only for the first 6 months while we were getting patients to goal on allopurinol, which was usually then monotherapy after the first 6 months,” she said. “I think this will likely change how I treat gout patients in that I may also offer to continue both medications [colchicine and allopurinol] if they are tolerating them well.
“And then in patients where I’m using it off-label in CPPD, I might again share with them that in addition to possibly helping their CPPD, there may be this added benefit to reduce inflammation just in discussing the risks and benefits of the medicine.”
However, rheumatologists must be careful in using colchicine beyond the typical 6-month cycle, Dr. Bartels said. “One of the tricky things with colchicine, and part of the reason we did not traditionally continue it specifically past the first 6 months, was that it can cause myopathies or cytopenias, so we still have to counsel patients regarding these risks and monitor that,” she said.
Additionally, colchicine can have drug interactions with statins or calcium channel blockers that can change colchicine levels. “I think the dose here is so low, the 0.5 mg, that it’s probably still safe, but again, it’s something that we have to take a look at in the patient’s whole picture and the rest of their burden of their meds in order to make a decision with them,” Dr. Bartels said.
Possibilities in dermatology
The LoDoCo2 trial one of two major randomized trials that supported approval of colchicine 0.5 mg, reported that treated patients had a 60% lower rate of gout than the placebo group (1.4% vs. 3.4%). Joel Gelfand, MD, MSCE, the James J. Leyden professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, pointed to this in evaluating the dermatologic implications of the drug’s approval. “This may be of particular interest as people with psoriasis have an increased risk of gout,” he said in emailed comments.
Colchicine’s mechanism of action to reduce inflammation parallels that of tumor necrosis factor (TNF) inhibitors used for dermatologic indications, namely by inhibiting leukocyte adhesion to disrupt the downregulation of TNF receptors, Dr. Gelfand said.
“Interestingly, observational data suggests biologics that target TNF such as adalimumab, etanercept, etc., are associated with a reduction in CV events, and in placebo-controlled trials we conducted in psoriasis patients, it reduced key inflammatory mediators of cardiovascular disease, including IL [interleukin]-6,” he said. “Randomized clinical trials to evaluate the ability of TNF inhibitors, which are now available as biosimilars, to prevent cardiovascular events in high-risk patients, should be conducted, and more work is needed to identify which additional immune-targeted treatments may lower CV risk with an acceptable safety profile.”
Colchicine currently has few indications for rare conditions in dermatology, Dr. Gelfand said, including Sweets syndrome, subcorneal pustular dermatosis, and cutaneous vasculitis. “There are some reports to suggest it may help psoriatic disease, but current data are limited and insufficient to recommend its use for psoriasis and/or psoriatic arthritis,” he said.
The approval of colchicine 0.5 mg for ASCVD could be meaningful for people with psoriasis who are also being treated for CV risk factors, Dr. Gelfand said. “Additional considerations such as signs of residual inflammation (elevated hsCRP) and CV imaging findings may be used to further guide shared decision-making for optimal use,” he said.
Another consideration he noted: “This is also a novel 0.5-mg formulation, and thus cost may be an issue.”
Would side effects bar use in gastroenterology?
Colchicine 0.5 mg may not move the needle much for expanding treatment of ASCVD in patients with inflammatory bowel disease (IBD) and potentially other gastrointestinal conditions, Edward Loftus Jr., MD, the Maxine and Jack Zarrow Family professor of gastroenterology specifically for IBD at the Mayo Clinic in Rochester, Minn., told MDEdge in emailed comments. “Given the GI side effect profile [of colchicine], I am not sure I would go there,” he said.
“Hopefully, the prescribers of this low-dose formulation are aware of the gastrointestinal side effects, such as diarrhea and nausea, and educate patients about these side effects so that a proper risk-benefit discussion can ensue,” he said.
Dr. Bartels reporting a previous financial relationship with Pfizer. Dr. Gelfand said he has financial relationships with AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celldex, GlaxoSmithKline, Twill, Lilly, Leo, Moonlake, Janssen Biologics, Novartis, Pfizer, UCB, Neuroderm, and Veolia North America. Dr. Loftus disclosed relationships with AbbVie, Alvotech, Amgen, Arena, Avalo, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene/Receptos, Celltrion Healthcare, Eli Lilly, Fresenius Kabi, Genentech, Gilead, GlaxoSmithKline, Gossamer Bio, Iterative Health, Janssen, KSL Diagnostics, Morphic, Ono, Pfizer, Sun, Surrozen, Takeda, Theravance, and UCB.
The recent Food and Drug Administration approval of colchicine 0.5 mg (Lodoco) for use in atherosclerotic cardiovascular disease (ASCVD) prevention will possibly create opportunities to use the drug to treat residual risk for ASCVD in some patients with immune-mediated inflammatory diseases, particularly in rheumatology.
Potential in rheumatology
The 0.5-mg dose is just a shade under the 0.6-mg, twice daily dosing rheumatologists typically prescribe for gout, Christie Bartels, MD, MS, chief of rheumatology at the University of Wisconsin–Madison, said in an interview. Clinicians also use the 0.6-mg dose off-label for pseudogout or calcium pyrophosphate deposition disease (CPPD), Dr. Bartels noted.
The new formulation opens the consideration for using colchicine more in patients with psoriatic arthritis, lupus, and rheumatoid arthritis, she said. “I think we could certainly discuss it, particularly, in secondary prevention patients who already had an event or who are at the highest risk and already on optimal traditional agents,” she said.
She cited previous comments by Paul Ridker, MD, director of the center for cardiovascular disease prevention at Brigham and Women’s Hospital in Boston, and developer of the high-sensitivity C-reactive protein (hsCRP) test for measuring inflammatory markers. “We might not know the answer because Dr. Ridker pointed out he used colchicine 0.5 mg in patients that had a high-sensitivity CRP that was high; we need patients who have had inflammation of unknown origin, so those patients presumably weren’t already on another anti-inflammatory,” she said, noting that hydroxychloroquine, methotrexate, and some biologics provide some protection from cardiovascular risks.
However, a potential role for long-term colchicine 0.5 mg in ASCVD prevention may cause consideration for changing the drug’s role in gout treatment, Dr. Bartels said. “In gout, where we do have an FDA-approved indication for colchicine, we used to use it only for the first 6 months while we were getting patients to goal on allopurinol, which was usually then monotherapy after the first 6 months,” she said. “I think this will likely change how I treat gout patients in that I may also offer to continue both medications [colchicine and allopurinol] if they are tolerating them well.
“And then in patients where I’m using it off-label in CPPD, I might again share with them that in addition to possibly helping their CPPD, there may be this added benefit to reduce inflammation just in discussing the risks and benefits of the medicine.”
However, rheumatologists must be careful in using colchicine beyond the typical 6-month cycle, Dr. Bartels said. “One of the tricky things with colchicine, and part of the reason we did not traditionally continue it specifically past the first 6 months, was that it can cause myopathies or cytopenias, so we still have to counsel patients regarding these risks and monitor that,” she said.
Additionally, colchicine can have drug interactions with statins or calcium channel blockers that can change colchicine levels. “I think the dose here is so low, the 0.5 mg, that it’s probably still safe, but again, it’s something that we have to take a look at in the patient’s whole picture and the rest of their burden of their meds in order to make a decision with them,” Dr. Bartels said.
Possibilities in dermatology
The LoDoCo2 trial one of two major randomized trials that supported approval of colchicine 0.5 mg, reported that treated patients had a 60% lower rate of gout than the placebo group (1.4% vs. 3.4%). Joel Gelfand, MD, MSCE, the James J. Leyden professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, pointed to this in evaluating the dermatologic implications of the drug’s approval. “This may be of particular interest as people with psoriasis have an increased risk of gout,” he said in emailed comments.
Colchicine’s mechanism of action to reduce inflammation parallels that of tumor necrosis factor (TNF) inhibitors used for dermatologic indications, namely by inhibiting leukocyte adhesion to disrupt the downregulation of TNF receptors, Dr. Gelfand said.
“Interestingly, observational data suggests biologics that target TNF such as adalimumab, etanercept, etc., are associated with a reduction in CV events, and in placebo-controlled trials we conducted in psoriasis patients, it reduced key inflammatory mediators of cardiovascular disease, including IL [interleukin]-6,” he said. “Randomized clinical trials to evaluate the ability of TNF inhibitors, which are now available as biosimilars, to prevent cardiovascular events in high-risk patients, should be conducted, and more work is needed to identify which additional immune-targeted treatments may lower CV risk with an acceptable safety profile.”
Colchicine currently has few indications for rare conditions in dermatology, Dr. Gelfand said, including Sweets syndrome, subcorneal pustular dermatosis, and cutaneous vasculitis. “There are some reports to suggest it may help psoriatic disease, but current data are limited and insufficient to recommend its use for psoriasis and/or psoriatic arthritis,” he said.
The approval of colchicine 0.5 mg for ASCVD could be meaningful for people with psoriasis who are also being treated for CV risk factors, Dr. Gelfand said. “Additional considerations such as signs of residual inflammation (elevated hsCRP) and CV imaging findings may be used to further guide shared decision-making for optimal use,” he said.
Another consideration he noted: “This is also a novel 0.5-mg formulation, and thus cost may be an issue.”
Would side effects bar use in gastroenterology?
Colchicine 0.5 mg may not move the needle much for expanding treatment of ASCVD in patients with inflammatory bowel disease (IBD) and potentially other gastrointestinal conditions, Edward Loftus Jr., MD, the Maxine and Jack Zarrow Family professor of gastroenterology specifically for IBD at the Mayo Clinic in Rochester, Minn., told MDEdge in emailed comments. “Given the GI side effect profile [of colchicine], I am not sure I would go there,” he said.
“Hopefully, the prescribers of this low-dose formulation are aware of the gastrointestinal side effects, such as diarrhea and nausea, and educate patients about these side effects so that a proper risk-benefit discussion can ensue,” he said.
Dr. Bartels reporting a previous financial relationship with Pfizer. Dr. Gelfand said he has financial relationships with AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celldex, GlaxoSmithKline, Twill, Lilly, Leo, Moonlake, Janssen Biologics, Novartis, Pfizer, UCB, Neuroderm, and Veolia North America. Dr. Loftus disclosed relationships with AbbVie, Alvotech, Amgen, Arena, Avalo, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene/Receptos, Celltrion Healthcare, Eli Lilly, Fresenius Kabi, Genentech, Gilead, GlaxoSmithKline, Gossamer Bio, Iterative Health, Janssen, KSL Diagnostics, Morphic, Ono, Pfizer, Sun, Surrozen, Takeda, Theravance, and UCB.
Ticagrelor, DAPT equal in preventing repeat revascularization
PHOENIX – Post hoc analysis of the randomized TWILIGHT trial comparing ticagrelor alone with ticagrelor plus aspirin in high-risk patients after percutaneous coronary intervention (PCI) shows both regimens were similarly effective in preventing repeat revascularization after 1 year.
In TWILIGHT, the main findings of which were previously published in the New England Journal of Medicine, 7,119 high-risk PCI patients on standard dual antiplatelet therapy (DAPT) of ticagrelor plus aspirin for 3 months were randomized to continuation of DAPT or to ticagrelor plus placebo for 12 months.
The new post hoc analysis included 6,759 patients and shows the rates of clinically driven revascularization were similar between the two groups: 7.1% and 6.6% for the ticagrelor monotherapy and ticagrelor-based DAPT groups, respectively (P = .363).
The findings were presented at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.
Three key findings come from the post hoc analysis, Usman Baber, MD, director of the cardiac catheterization lab and associate professor at the University of Oklahoma Health Sciences Center, Oklahoma City, who presented the findings, said in an interview.
“The first is that, over the 1-year follow-up of our trial, we found that a repeat revascularization event occurred in 6.7% of patients,” he said. “We found that a slight majority of these repeat revascularization events were due to events at the target lesion or target vessel; and we found that most of the repeat revascularization events actually occurred in patients without a concomitant acute coronary syndrome. In other words, these were essentially stable patients when they were getting their repeat revascularization.”
The second major finding was that these high-risk patients who had repeat revascularization were at three times greater risk for major adverse cardiac and cerebrovascular events (MACCE), based on a multivariable adjusted model, Dr. Baber said.
“And then third is that he said.
Repeat revascularization
The goal of the analysis was to focus on clinically driven repeat revascularization as an outcome, Dr. Baber said. The analysis also aimed to understand the association between repeat revascularization and subsequent risk.
Secondary endpoints included target lesion revascularization (TLR); target vessel revascularization (TVR); MACCE, including clinically driven revascularization; and net adverse clinical events (NACE), a composite of MACCE or Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding.
The outcomes of all those endpoints, except for NACE, were similar, Dr. Baber said. “Overall, ticagrelor monotherapy, as expected, reduced rates of bleeding as compared with ticagrelor plus aspirin,” he said. The rates of NACE were 12.2% versus 14.6%, respectively (P = .004). For BARC 2,3, or 5 bleeding, the rates were 3.4% versus 7.1% (P < .001).
The findings validated repeat revascularization as a meaningful endpoint, Dr. Baber said. “Certainly, we don’t elevate repeat revascularization as an endpoint to the same level as death or stroke, but certainly this analysis and some others prior to it highlight the fact that when these patients come back for repeat revascularization, even if they’re stable, they clearly are at elevated risk for future ischemic events,” he said.
One limitation of the analysis is that the data are from a clinical trial, “which renders the findings not as generalizable to the broader patients in a clinical practice,” he said. However, the TWILIGHT data are validated and adjusted for multiple risk factors.
“When patients come in and they have a repeat revascularization, should there be a consideration to placing them on more intensive antithrombotic therapy?” he asked. “Right now, if patients have a repeat revascularization event and they’re stable, guidelines and clinical practice usually calls for continuing clopidogrel, but again our study and others like it indicate these patients are at a higher thrombotic risk, so maybe there’s a rationale for at least a short course of a more potent antiplatelet agent in such patients.”
The post hoc findings confirm those of the primary TWILIGHT trial, Lorenzo Azzalini, MD, PhD, MSc, director of interventional cardiology research at the University of Washington Medical Center, Seattle, said in an interview.
“It’s not surprising to find no difference between the two therapies with regard to unplanned revascularization,” he said. “It’s considered that only stent thrombosis can only actually be mitigated by the drugs being investigated in the trial; all the other ischemic endpoints reflect more chronic ischemia—TLR or known TVR—upon which ticagrelor and aspirin do not play any role.”
However, he added, “I still think this study provides useful information to the community in a period of intense scrutiny on the relative benefits and merits of PCI versus CABG [coronary artery bypass graft], and this study confirms that shortening DAPT to 3 months and then continuing with just ticagrelor does not bring any penalty in terms of ischemic events or repeat revascularization.”
TWILIGHT enrolled high-risk patients, but not “very-high-risk” patients, Dr. Azzalini noted. The enrollment criteria excluded patients on chronic anticoagulation, who had a prior stroke or liver sclerosis, or were on dialysis.
“Future trials should focus more on very-high-risk patients because these are the patients that we deal with on a daily basis in our clinical practice and we need data to inform our decisions,” he said. “I’m not sure I could use the science contained in this study and extrapolate them to patients on dialysis because these patients really have a high risk of restenosis on follow-up.”
Dr. Baber disclosed relationships with Amgen and Abbott. Dr. Azzalini had no relevant disclosures.
PHOENIX – Post hoc analysis of the randomized TWILIGHT trial comparing ticagrelor alone with ticagrelor plus aspirin in high-risk patients after percutaneous coronary intervention (PCI) shows both regimens were similarly effective in preventing repeat revascularization after 1 year.
In TWILIGHT, the main findings of which were previously published in the New England Journal of Medicine, 7,119 high-risk PCI patients on standard dual antiplatelet therapy (DAPT) of ticagrelor plus aspirin for 3 months were randomized to continuation of DAPT or to ticagrelor plus placebo for 12 months.
The new post hoc analysis included 6,759 patients and shows the rates of clinically driven revascularization were similar between the two groups: 7.1% and 6.6% for the ticagrelor monotherapy and ticagrelor-based DAPT groups, respectively (P = .363).
The findings were presented at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.
Three key findings come from the post hoc analysis, Usman Baber, MD, director of the cardiac catheterization lab and associate professor at the University of Oklahoma Health Sciences Center, Oklahoma City, who presented the findings, said in an interview.
“The first is that, over the 1-year follow-up of our trial, we found that a repeat revascularization event occurred in 6.7% of patients,” he said. “We found that a slight majority of these repeat revascularization events were due to events at the target lesion or target vessel; and we found that most of the repeat revascularization events actually occurred in patients without a concomitant acute coronary syndrome. In other words, these were essentially stable patients when they were getting their repeat revascularization.”
The second major finding was that these high-risk patients who had repeat revascularization were at three times greater risk for major adverse cardiac and cerebrovascular events (MACCE), based on a multivariable adjusted model, Dr. Baber said.
“And then third is that he said.
Repeat revascularization
The goal of the analysis was to focus on clinically driven repeat revascularization as an outcome, Dr. Baber said. The analysis also aimed to understand the association between repeat revascularization and subsequent risk.
Secondary endpoints included target lesion revascularization (TLR); target vessel revascularization (TVR); MACCE, including clinically driven revascularization; and net adverse clinical events (NACE), a composite of MACCE or Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding.
The outcomes of all those endpoints, except for NACE, were similar, Dr. Baber said. “Overall, ticagrelor monotherapy, as expected, reduced rates of bleeding as compared with ticagrelor plus aspirin,” he said. The rates of NACE were 12.2% versus 14.6%, respectively (P = .004). For BARC 2,3, or 5 bleeding, the rates were 3.4% versus 7.1% (P < .001).
The findings validated repeat revascularization as a meaningful endpoint, Dr. Baber said. “Certainly, we don’t elevate repeat revascularization as an endpoint to the same level as death or stroke, but certainly this analysis and some others prior to it highlight the fact that when these patients come back for repeat revascularization, even if they’re stable, they clearly are at elevated risk for future ischemic events,” he said.
One limitation of the analysis is that the data are from a clinical trial, “which renders the findings not as generalizable to the broader patients in a clinical practice,” he said. However, the TWILIGHT data are validated and adjusted for multiple risk factors.
“When patients come in and they have a repeat revascularization, should there be a consideration to placing them on more intensive antithrombotic therapy?” he asked. “Right now, if patients have a repeat revascularization event and they’re stable, guidelines and clinical practice usually calls for continuing clopidogrel, but again our study and others like it indicate these patients are at a higher thrombotic risk, so maybe there’s a rationale for at least a short course of a more potent antiplatelet agent in such patients.”
The post hoc findings confirm those of the primary TWILIGHT trial, Lorenzo Azzalini, MD, PhD, MSc, director of interventional cardiology research at the University of Washington Medical Center, Seattle, said in an interview.
“It’s not surprising to find no difference between the two therapies with regard to unplanned revascularization,” he said. “It’s considered that only stent thrombosis can only actually be mitigated by the drugs being investigated in the trial; all the other ischemic endpoints reflect more chronic ischemia—TLR or known TVR—upon which ticagrelor and aspirin do not play any role.”
However, he added, “I still think this study provides useful information to the community in a period of intense scrutiny on the relative benefits and merits of PCI versus CABG [coronary artery bypass graft], and this study confirms that shortening DAPT to 3 months and then continuing with just ticagrelor does not bring any penalty in terms of ischemic events or repeat revascularization.”
TWILIGHT enrolled high-risk patients, but not “very-high-risk” patients, Dr. Azzalini noted. The enrollment criteria excluded patients on chronic anticoagulation, who had a prior stroke or liver sclerosis, or were on dialysis.
“Future trials should focus more on very-high-risk patients because these are the patients that we deal with on a daily basis in our clinical practice and we need data to inform our decisions,” he said. “I’m not sure I could use the science contained in this study and extrapolate them to patients on dialysis because these patients really have a high risk of restenosis on follow-up.”
Dr. Baber disclosed relationships with Amgen and Abbott. Dr. Azzalini had no relevant disclosures.
PHOENIX – Post hoc analysis of the randomized TWILIGHT trial comparing ticagrelor alone with ticagrelor plus aspirin in high-risk patients after percutaneous coronary intervention (PCI) shows both regimens were similarly effective in preventing repeat revascularization after 1 year.
In TWILIGHT, the main findings of which were previously published in the New England Journal of Medicine, 7,119 high-risk PCI patients on standard dual antiplatelet therapy (DAPT) of ticagrelor plus aspirin for 3 months were randomized to continuation of DAPT or to ticagrelor plus placebo for 12 months.
The new post hoc analysis included 6,759 patients and shows the rates of clinically driven revascularization were similar between the two groups: 7.1% and 6.6% for the ticagrelor monotherapy and ticagrelor-based DAPT groups, respectively (P = .363).
The findings were presented at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.
Three key findings come from the post hoc analysis, Usman Baber, MD, director of the cardiac catheterization lab and associate professor at the University of Oklahoma Health Sciences Center, Oklahoma City, who presented the findings, said in an interview.
“The first is that, over the 1-year follow-up of our trial, we found that a repeat revascularization event occurred in 6.7% of patients,” he said. “We found that a slight majority of these repeat revascularization events were due to events at the target lesion or target vessel; and we found that most of the repeat revascularization events actually occurred in patients without a concomitant acute coronary syndrome. In other words, these were essentially stable patients when they were getting their repeat revascularization.”
The second major finding was that these high-risk patients who had repeat revascularization were at three times greater risk for major adverse cardiac and cerebrovascular events (MACCE), based on a multivariable adjusted model, Dr. Baber said.
“And then third is that he said.
Repeat revascularization
The goal of the analysis was to focus on clinically driven repeat revascularization as an outcome, Dr. Baber said. The analysis also aimed to understand the association between repeat revascularization and subsequent risk.
Secondary endpoints included target lesion revascularization (TLR); target vessel revascularization (TVR); MACCE, including clinically driven revascularization; and net adverse clinical events (NACE), a composite of MACCE or Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding.
The outcomes of all those endpoints, except for NACE, were similar, Dr. Baber said. “Overall, ticagrelor monotherapy, as expected, reduced rates of bleeding as compared with ticagrelor plus aspirin,” he said. The rates of NACE were 12.2% versus 14.6%, respectively (P = .004). For BARC 2,3, or 5 bleeding, the rates were 3.4% versus 7.1% (P < .001).
The findings validated repeat revascularization as a meaningful endpoint, Dr. Baber said. “Certainly, we don’t elevate repeat revascularization as an endpoint to the same level as death or stroke, but certainly this analysis and some others prior to it highlight the fact that when these patients come back for repeat revascularization, even if they’re stable, they clearly are at elevated risk for future ischemic events,” he said.
One limitation of the analysis is that the data are from a clinical trial, “which renders the findings not as generalizable to the broader patients in a clinical practice,” he said. However, the TWILIGHT data are validated and adjusted for multiple risk factors.
“When patients come in and they have a repeat revascularization, should there be a consideration to placing them on more intensive antithrombotic therapy?” he asked. “Right now, if patients have a repeat revascularization event and they’re stable, guidelines and clinical practice usually calls for continuing clopidogrel, but again our study and others like it indicate these patients are at a higher thrombotic risk, so maybe there’s a rationale for at least a short course of a more potent antiplatelet agent in such patients.”
The post hoc findings confirm those of the primary TWILIGHT trial, Lorenzo Azzalini, MD, PhD, MSc, director of interventional cardiology research at the University of Washington Medical Center, Seattle, said in an interview.
“It’s not surprising to find no difference between the two therapies with regard to unplanned revascularization,” he said. “It’s considered that only stent thrombosis can only actually be mitigated by the drugs being investigated in the trial; all the other ischemic endpoints reflect more chronic ischemia—TLR or known TVR—upon which ticagrelor and aspirin do not play any role.”
However, he added, “I still think this study provides useful information to the community in a period of intense scrutiny on the relative benefits and merits of PCI versus CABG [coronary artery bypass graft], and this study confirms that shortening DAPT to 3 months and then continuing with just ticagrelor does not bring any penalty in terms of ischemic events or repeat revascularization.”
TWILIGHT enrolled high-risk patients, but not “very-high-risk” patients, Dr. Azzalini noted. The enrollment criteria excluded patients on chronic anticoagulation, who had a prior stroke or liver sclerosis, or were on dialysis.
“Future trials should focus more on very-high-risk patients because these are the patients that we deal with on a daily basis in our clinical practice and we need data to inform our decisions,” he said. “I’m not sure I could use the science contained in this study and extrapolate them to patients on dialysis because these patients really have a high risk of restenosis on follow-up.”
Dr. Baber disclosed relationships with Amgen and Abbott. Dr. Azzalini had no relevant disclosures.
AT SCAI 2023
Real-world data validate ESC risk model in NSTE-ACS
ESC model appropriately identifies risk
A real-world study of more than 12,000 cases over 7 years has validated the predictive ability of the proposed guidelines for stratifying thrombotic risks at 1 year for patients with non–ST-elevated acute coronary syndrome (NSTE-ACS) undergoing percutaneous coronary intervention (PCI).
In research presented at the Society for Cardiovascular Angiography & Interventions annual scientific sessions, George Dangas, MD, PhD, current SCAI president and professor of cardiology and vascular surgery at the Icahn School of Medicine at Mount Sinai, New York, reported that the European Society of Cardiology risk stratification criteria appropriately predicted risk in 12,538 patients treated from 2012 to 2019.
Despite these proposed guidelines put forward by the ESC in 2020, no consensus exists on criteria for ischemic or thrombotic risk in NSTE-ACS patients, Dr. Dangas noted.
The new study shows that the 1-year major adverse cardiovascular events (MACE) risk was four times greater in patients classified as medium risk (hazard ratio, 4.31; 95% confidence interval, 2.47-7.52) and six times greater in high-risk patients (HR, 6.16; 95% CI, 3.52-10.8), compared with the low-risk group, mostly because of higher rates of all-cause death and myocardial infarction, Dr. Dangas said in an interview.
“Indeed, we found some good correlation between the three risk categories and gradation of risk that validates essentially, but with the statistical testing that we need, that this classification is meaningful if not perfect,” Dr. Dangas said. “In the future we may perform calibrations to enhance its performance.”
The study used data on consecutive patients from the Angioplasty and Stent Procedures Database of Mount Sinai, grouping them into low, medium, and high thrombotic risk based on the proposed ESC guidelines for the management of NSTE-ACS.
The guidelines included a subset of criteria to identify patients with increased thrombotic risk who may benefit from extended treatment with a second antithrombotic agent.
This study aimed to evaluate the value of the criteria to identify patients at higher risk of ischemic events. “That’s why we went to our database to see how this might work,” Dr. Dangas said.
The researchers also found that high-risk patients had about a 40% greater risk of major bleeding (HR, 1.39; 95% CI, 1.06-1.84). Bleeding risks were similar between the low- and moderate-risk groups.
The risk categories reflected the rates of all-cause death, myocardial infarction, or stroke: 5.4%, 4.1%, and 1.6% in the high-, moderate-, and low-risks groups, respectively (P < .001).
“This identification of ischemic risks worked very well for all-cause mortality,” Dr. Dangas said. “I feel this is a strength because mortality is a leader of outcomes. And of course, we’ve had some associations with all events like mortality, myocardial infarction, repeat revascularization, which are interesting and valid, but I think a study result that indicates the mortality itself is known to be unidirectional and a very good correlation makes the result more robust.”
Critical role
Risk prediction models such as the proposed ESC guidelines will play a critical role as individualized medicine continues to evolve, Somjot Brar, MD, MPH, director of the regional department of cardiac catheterization at Kaiser Permanente, Los Angeles Medical Center, and associate clinical professor at the University of California, Los Angeles, said in an interview.
“This study highlights again the importance of the value for predictive and precision medicine,” Dr. Brar said. “Everything is moving in this direction where we make decisions that are more appropriate for a given patient as opposed to a population of patients.”
Study strengths are the large sample size in a real-world setting and thorough 1-year follow-up, Dr. Brar said.
A limitation is the three risk categories the guidelines proposed. “These are still pretty big boxes,” he said. “The low-, moderate- and high-risk categorization is still very, very broad and can be very vague.”
The relatively low percentage of low-risk patients – 12% versus 56% and 32% for the moderate- and high-risk groups – in this data set may also skew results, Dr. Brar said.
“As we move toward predictive analytics and medicine, we want to make these boxes smaller and smaller and smaller to be able to better understand which treatments should be administered to which patients to maximize the benefit against the risk,” he said. That would be a focus for future analyses, Dr. Brar said.
Dr. Dangas and Dr. Brar have no relevant financial disclosures.
ESC model appropriately identifies risk
ESC model appropriately identifies risk
A real-world study of more than 12,000 cases over 7 years has validated the predictive ability of the proposed guidelines for stratifying thrombotic risks at 1 year for patients with non–ST-elevated acute coronary syndrome (NSTE-ACS) undergoing percutaneous coronary intervention (PCI).
In research presented at the Society for Cardiovascular Angiography & Interventions annual scientific sessions, George Dangas, MD, PhD, current SCAI president and professor of cardiology and vascular surgery at the Icahn School of Medicine at Mount Sinai, New York, reported that the European Society of Cardiology risk stratification criteria appropriately predicted risk in 12,538 patients treated from 2012 to 2019.
Despite these proposed guidelines put forward by the ESC in 2020, no consensus exists on criteria for ischemic or thrombotic risk in NSTE-ACS patients, Dr. Dangas noted.
The new study shows that the 1-year major adverse cardiovascular events (MACE) risk was four times greater in patients classified as medium risk (hazard ratio, 4.31; 95% confidence interval, 2.47-7.52) and six times greater in high-risk patients (HR, 6.16; 95% CI, 3.52-10.8), compared with the low-risk group, mostly because of higher rates of all-cause death and myocardial infarction, Dr. Dangas said in an interview.
“Indeed, we found some good correlation between the three risk categories and gradation of risk that validates essentially, but with the statistical testing that we need, that this classification is meaningful if not perfect,” Dr. Dangas said. “In the future we may perform calibrations to enhance its performance.”
The study used data on consecutive patients from the Angioplasty and Stent Procedures Database of Mount Sinai, grouping them into low, medium, and high thrombotic risk based on the proposed ESC guidelines for the management of NSTE-ACS.
The guidelines included a subset of criteria to identify patients with increased thrombotic risk who may benefit from extended treatment with a second antithrombotic agent.
This study aimed to evaluate the value of the criteria to identify patients at higher risk of ischemic events. “That’s why we went to our database to see how this might work,” Dr. Dangas said.
The researchers also found that high-risk patients had about a 40% greater risk of major bleeding (HR, 1.39; 95% CI, 1.06-1.84). Bleeding risks were similar between the low- and moderate-risk groups.
The risk categories reflected the rates of all-cause death, myocardial infarction, or stroke: 5.4%, 4.1%, and 1.6% in the high-, moderate-, and low-risks groups, respectively (P < .001).
“This identification of ischemic risks worked very well for all-cause mortality,” Dr. Dangas said. “I feel this is a strength because mortality is a leader of outcomes. And of course, we’ve had some associations with all events like mortality, myocardial infarction, repeat revascularization, which are interesting and valid, but I think a study result that indicates the mortality itself is known to be unidirectional and a very good correlation makes the result more robust.”
Critical role
Risk prediction models such as the proposed ESC guidelines will play a critical role as individualized medicine continues to evolve, Somjot Brar, MD, MPH, director of the regional department of cardiac catheterization at Kaiser Permanente, Los Angeles Medical Center, and associate clinical professor at the University of California, Los Angeles, said in an interview.
“This study highlights again the importance of the value for predictive and precision medicine,” Dr. Brar said. “Everything is moving in this direction where we make decisions that are more appropriate for a given patient as opposed to a population of patients.”
Study strengths are the large sample size in a real-world setting and thorough 1-year follow-up, Dr. Brar said.
A limitation is the three risk categories the guidelines proposed. “These are still pretty big boxes,” he said. “The low-, moderate- and high-risk categorization is still very, very broad and can be very vague.”
The relatively low percentage of low-risk patients – 12% versus 56% and 32% for the moderate- and high-risk groups – in this data set may also skew results, Dr. Brar said.
“As we move toward predictive analytics and medicine, we want to make these boxes smaller and smaller and smaller to be able to better understand which treatments should be administered to which patients to maximize the benefit against the risk,” he said. That would be a focus for future analyses, Dr. Brar said.
Dr. Dangas and Dr. Brar have no relevant financial disclosures.
A real-world study of more than 12,000 cases over 7 years has validated the predictive ability of the proposed guidelines for stratifying thrombotic risks at 1 year for patients with non–ST-elevated acute coronary syndrome (NSTE-ACS) undergoing percutaneous coronary intervention (PCI).
In research presented at the Society for Cardiovascular Angiography & Interventions annual scientific sessions, George Dangas, MD, PhD, current SCAI president and professor of cardiology and vascular surgery at the Icahn School of Medicine at Mount Sinai, New York, reported that the European Society of Cardiology risk stratification criteria appropriately predicted risk in 12,538 patients treated from 2012 to 2019.
Despite these proposed guidelines put forward by the ESC in 2020, no consensus exists on criteria for ischemic or thrombotic risk in NSTE-ACS patients, Dr. Dangas noted.
The new study shows that the 1-year major adverse cardiovascular events (MACE) risk was four times greater in patients classified as medium risk (hazard ratio, 4.31; 95% confidence interval, 2.47-7.52) and six times greater in high-risk patients (HR, 6.16; 95% CI, 3.52-10.8), compared with the low-risk group, mostly because of higher rates of all-cause death and myocardial infarction, Dr. Dangas said in an interview.
“Indeed, we found some good correlation between the three risk categories and gradation of risk that validates essentially, but with the statistical testing that we need, that this classification is meaningful if not perfect,” Dr. Dangas said. “In the future we may perform calibrations to enhance its performance.”
The study used data on consecutive patients from the Angioplasty and Stent Procedures Database of Mount Sinai, grouping them into low, medium, and high thrombotic risk based on the proposed ESC guidelines for the management of NSTE-ACS.
The guidelines included a subset of criteria to identify patients with increased thrombotic risk who may benefit from extended treatment with a second antithrombotic agent.
This study aimed to evaluate the value of the criteria to identify patients at higher risk of ischemic events. “That’s why we went to our database to see how this might work,” Dr. Dangas said.
The researchers also found that high-risk patients had about a 40% greater risk of major bleeding (HR, 1.39; 95% CI, 1.06-1.84). Bleeding risks were similar between the low- and moderate-risk groups.
The risk categories reflected the rates of all-cause death, myocardial infarction, or stroke: 5.4%, 4.1%, and 1.6% in the high-, moderate-, and low-risks groups, respectively (P < .001).
“This identification of ischemic risks worked very well for all-cause mortality,” Dr. Dangas said. “I feel this is a strength because mortality is a leader of outcomes. And of course, we’ve had some associations with all events like mortality, myocardial infarction, repeat revascularization, which are interesting and valid, but I think a study result that indicates the mortality itself is known to be unidirectional and a very good correlation makes the result more robust.”
Critical role
Risk prediction models such as the proposed ESC guidelines will play a critical role as individualized medicine continues to evolve, Somjot Brar, MD, MPH, director of the regional department of cardiac catheterization at Kaiser Permanente, Los Angeles Medical Center, and associate clinical professor at the University of California, Los Angeles, said in an interview.
“This study highlights again the importance of the value for predictive and precision medicine,” Dr. Brar said. “Everything is moving in this direction where we make decisions that are more appropriate for a given patient as opposed to a population of patients.”
Study strengths are the large sample size in a real-world setting and thorough 1-year follow-up, Dr. Brar said.
A limitation is the three risk categories the guidelines proposed. “These are still pretty big boxes,” he said. “The low-, moderate- and high-risk categorization is still very, very broad and can be very vague.”
The relatively low percentage of low-risk patients – 12% versus 56% and 32% for the moderate- and high-risk groups – in this data set may also skew results, Dr. Brar said.
“As we move toward predictive analytics and medicine, we want to make these boxes smaller and smaller and smaller to be able to better understand which treatments should be administered to which patients to maximize the benefit against the risk,” he said. That would be a focus for future analyses, Dr. Brar said.
Dr. Dangas and Dr. Brar have no relevant financial disclosures.
FROM SCAI 2023
Distal radial access doesn’t harm hand function at 1 year
Outcomes equal to proximal approach
In what may be the first randomized trial to compare coronary intervention access using the distal or proximal radial arteries, researchers have found no significant differences between the two in hand function a year after the procedure.
The distal radial artery (DRA) access point is just below the thumb on the inside of the wrist. The proximal radial artery (PRA) entry is in the inside lower forearm above the wrist.
“There has been growing interest in the use of distal radial access given its ease of hemostasis, lower incidence of radial artery occlusions, as well as the more ergonomic favorable setup for a left radial access, which is typically utilized in patients with prior CABG who undergo a cardiac catheterization when used as alternative to femoral artery access,” Karim Al-Azizi, MD, of Texas A&M University, an interventional cardiologist and associate program director of the cardiology fellowship at Baylor Scott & White Health, in Plano, Tex., said in an interview.
Dr Al-Azizi presented the late-breaking 1-year results of the DIPRA–for Distal vs. Proximal Radial Artery–study at the Society for Cardiovascular Angiography & Interventions annual scientific sessions. The 30-day results of the DIPRA trial were presented in 2022 at this meeting.
Dr. Al-Azizi said DIPRA is the first randomized, controlled trial comparing hand function outcomes with the two approaches. “I think the biggest question for most investigators and most practitioners is that, is this safe on the hand? Are we doing the right thing by going into the radial artery in the anatomical snuff box in proximity to the radial nerve and would that affect motor function?” he said. “And it does not seem like it from a head-to-head comparison of proximal versus distal access.”
The DIPRA study randomized 300 patients 1:1 to cardiac catheterization through either the distal or proximal access. Of those, 216 completed 1-year follow-up, 112 randomized to DRA and 104 to PRA.
The study used three metrics to evaluate hand function: hand-grip strength; pinch test, which measured the strength of a pinch between the thumb and index finger; and QuickDASH, an abbreviated version of the Disabilities of the Arm, Shoulder, and Hand questionnaire, in which participants self-evaluate their hand function. Study protocol mandated that operators use ultrasound guidance for DRA access.
The 1-year results of all three measures showed no significant difference in change of hand function from baseline between the two groups. The composite average score change was –0.07 (–0.41, 0.44) for the DRA patients and –0.03. (–0.36, 0.44) for the PRA group (P = .59).
One-year change for the specific hand function measures for DRA and PRA, respectively, were: hand grip, 0.7 (–3, 4.5) vs. 1.3 (–2, 4.3) kg (P = .57); pinch grip, –0.1 (–1.1, 1) vs. –0.3 (–1, 0.7) kg (P = .66); and none for change in the QuickDASH score (–6.6, 2.3 vs. –4.6, 2.9) points (P = .58).
Outcomes at intervention were also similar. Bleeding incidence was 0% and 1.4% (P = .25) in the respective groups. Successful RA access was achieved in 96.7% and 98% (P = .72).
Baseline characteristics were balanced between the two groups: 75% were male; mean age was 66.6 ± 9.6 years; 32% had diabetes; 77% had hypertension; and 19% had a previous percutaneous coronary intervention.
One key strength of the DIPRA study Dr. Al-Azizi noted is that it included some investigators who were at the early stage of the learning curve with the procedure. A limitation is that it didn’t evaluate hand numbness or tingling, but hand sensory testing is “very subjective,” he said. “To avoid confusion, we decided to go with the more repeatable questionnaire rather than a sensation or sensory test,” he added.
The next step for his research team is to conduct a meta-analysis of studies that have evaluated DRA and PRA, Dr. Al-Azizi said.
‘Slow to the party’
U.S. interventional cardiologists have been “slow to the party” in adopting radial artery access for PCI, said David A. Cox, MD, of Sanger Heart and Vascular Institute in Charlotte, N.C., and SCAI communications committee chair. Even now uptake is low, compared with the rest of the world, he said.
“I can tell you what patients care about: Did you have to stick my groin?” he said at a SCAI press conference. “What they just want to know is that there are no issues with hand function.”
Some patients who need fine motor hand function would still opt for femoral access, he said.
“Are we looking at the right metric?” he asked Dr. Al-Azizi. “It took a long time to get American doctors to stick the radial, so why would I want to learn distal radial artery if I’m really pretty good at proximal and if it’s not inferior?”
Dr. Al-Azizi noted that previous studies showed a trend toward a lower incidence of radial artery occlusion (RAO) with DRA access. It also better preserves the renal arteries for dialysis and CABG, he said.
“The metric that would move the needle,” Dr. Cox noted, “is if you had radial artery occlusion rates vs. snuff box occlusion rates, and we don’t have that rate.”
Dr. Al-Azizi has no relevant financial disclosures. Dr. Cox disclosed financial relationships with Medtronic.
Outcomes equal to proximal approach
Outcomes equal to proximal approach
In what may be the first randomized trial to compare coronary intervention access using the distal or proximal radial arteries, researchers have found no significant differences between the two in hand function a year after the procedure.
The distal radial artery (DRA) access point is just below the thumb on the inside of the wrist. The proximal radial artery (PRA) entry is in the inside lower forearm above the wrist.
“There has been growing interest in the use of distal radial access given its ease of hemostasis, lower incidence of radial artery occlusions, as well as the more ergonomic favorable setup for a left radial access, which is typically utilized in patients with prior CABG who undergo a cardiac catheterization when used as alternative to femoral artery access,” Karim Al-Azizi, MD, of Texas A&M University, an interventional cardiologist and associate program director of the cardiology fellowship at Baylor Scott & White Health, in Plano, Tex., said in an interview.
Dr Al-Azizi presented the late-breaking 1-year results of the DIPRA–for Distal vs. Proximal Radial Artery–study at the Society for Cardiovascular Angiography & Interventions annual scientific sessions. The 30-day results of the DIPRA trial were presented in 2022 at this meeting.
Dr. Al-Azizi said DIPRA is the first randomized, controlled trial comparing hand function outcomes with the two approaches. “I think the biggest question for most investigators and most practitioners is that, is this safe on the hand? Are we doing the right thing by going into the radial artery in the anatomical snuff box in proximity to the radial nerve and would that affect motor function?” he said. “And it does not seem like it from a head-to-head comparison of proximal versus distal access.”
The DIPRA study randomized 300 patients 1:1 to cardiac catheterization through either the distal or proximal access. Of those, 216 completed 1-year follow-up, 112 randomized to DRA and 104 to PRA.
The study used three metrics to evaluate hand function: hand-grip strength; pinch test, which measured the strength of a pinch between the thumb and index finger; and QuickDASH, an abbreviated version of the Disabilities of the Arm, Shoulder, and Hand questionnaire, in which participants self-evaluate their hand function. Study protocol mandated that operators use ultrasound guidance for DRA access.
The 1-year results of all three measures showed no significant difference in change of hand function from baseline between the two groups. The composite average score change was –0.07 (–0.41, 0.44) for the DRA patients and –0.03. (–0.36, 0.44) for the PRA group (P = .59).
One-year change for the specific hand function measures for DRA and PRA, respectively, were: hand grip, 0.7 (–3, 4.5) vs. 1.3 (–2, 4.3) kg (P = .57); pinch grip, –0.1 (–1.1, 1) vs. –0.3 (–1, 0.7) kg (P = .66); and none for change in the QuickDASH score (–6.6, 2.3 vs. –4.6, 2.9) points (P = .58).
Outcomes at intervention were also similar. Bleeding incidence was 0% and 1.4% (P = .25) in the respective groups. Successful RA access was achieved in 96.7% and 98% (P = .72).
Baseline characteristics were balanced between the two groups: 75% were male; mean age was 66.6 ± 9.6 years; 32% had diabetes; 77% had hypertension; and 19% had a previous percutaneous coronary intervention.
One key strength of the DIPRA study Dr. Al-Azizi noted is that it included some investigators who were at the early stage of the learning curve with the procedure. A limitation is that it didn’t evaluate hand numbness or tingling, but hand sensory testing is “very subjective,” he said. “To avoid confusion, we decided to go with the more repeatable questionnaire rather than a sensation or sensory test,” he added.
The next step for his research team is to conduct a meta-analysis of studies that have evaluated DRA and PRA, Dr. Al-Azizi said.
‘Slow to the party’
U.S. interventional cardiologists have been “slow to the party” in adopting radial artery access for PCI, said David A. Cox, MD, of Sanger Heart and Vascular Institute in Charlotte, N.C., and SCAI communications committee chair. Even now uptake is low, compared with the rest of the world, he said.
“I can tell you what patients care about: Did you have to stick my groin?” he said at a SCAI press conference. “What they just want to know is that there are no issues with hand function.”
Some patients who need fine motor hand function would still opt for femoral access, he said.
“Are we looking at the right metric?” he asked Dr. Al-Azizi. “It took a long time to get American doctors to stick the radial, so why would I want to learn distal radial artery if I’m really pretty good at proximal and if it’s not inferior?”
Dr. Al-Azizi noted that previous studies showed a trend toward a lower incidence of radial artery occlusion (RAO) with DRA access. It also better preserves the renal arteries for dialysis and CABG, he said.
“The metric that would move the needle,” Dr. Cox noted, “is if you had radial artery occlusion rates vs. snuff box occlusion rates, and we don’t have that rate.”
Dr. Al-Azizi has no relevant financial disclosures. Dr. Cox disclosed financial relationships with Medtronic.
In what may be the first randomized trial to compare coronary intervention access using the distal or proximal radial arteries, researchers have found no significant differences between the two in hand function a year after the procedure.
The distal radial artery (DRA) access point is just below the thumb on the inside of the wrist. The proximal radial artery (PRA) entry is in the inside lower forearm above the wrist.
“There has been growing interest in the use of distal radial access given its ease of hemostasis, lower incidence of radial artery occlusions, as well as the more ergonomic favorable setup for a left radial access, which is typically utilized in patients with prior CABG who undergo a cardiac catheterization when used as alternative to femoral artery access,” Karim Al-Azizi, MD, of Texas A&M University, an interventional cardiologist and associate program director of the cardiology fellowship at Baylor Scott & White Health, in Plano, Tex., said in an interview.
Dr Al-Azizi presented the late-breaking 1-year results of the DIPRA–for Distal vs. Proximal Radial Artery–study at the Society for Cardiovascular Angiography & Interventions annual scientific sessions. The 30-day results of the DIPRA trial were presented in 2022 at this meeting.
Dr. Al-Azizi said DIPRA is the first randomized, controlled trial comparing hand function outcomes with the two approaches. “I think the biggest question for most investigators and most practitioners is that, is this safe on the hand? Are we doing the right thing by going into the radial artery in the anatomical snuff box in proximity to the radial nerve and would that affect motor function?” he said. “And it does not seem like it from a head-to-head comparison of proximal versus distal access.”
The DIPRA study randomized 300 patients 1:1 to cardiac catheterization through either the distal or proximal access. Of those, 216 completed 1-year follow-up, 112 randomized to DRA and 104 to PRA.
The study used three metrics to evaluate hand function: hand-grip strength; pinch test, which measured the strength of a pinch between the thumb and index finger; and QuickDASH, an abbreviated version of the Disabilities of the Arm, Shoulder, and Hand questionnaire, in which participants self-evaluate their hand function. Study protocol mandated that operators use ultrasound guidance for DRA access.
The 1-year results of all three measures showed no significant difference in change of hand function from baseline between the two groups. The composite average score change was –0.07 (–0.41, 0.44) for the DRA patients and –0.03. (–0.36, 0.44) for the PRA group (P = .59).
One-year change for the specific hand function measures for DRA and PRA, respectively, were: hand grip, 0.7 (–3, 4.5) vs. 1.3 (–2, 4.3) kg (P = .57); pinch grip, –0.1 (–1.1, 1) vs. –0.3 (–1, 0.7) kg (P = .66); and none for change in the QuickDASH score (–6.6, 2.3 vs. –4.6, 2.9) points (P = .58).
Outcomes at intervention were also similar. Bleeding incidence was 0% and 1.4% (P = .25) in the respective groups. Successful RA access was achieved in 96.7% and 98% (P = .72).
Baseline characteristics were balanced between the two groups: 75% were male; mean age was 66.6 ± 9.6 years; 32% had diabetes; 77% had hypertension; and 19% had a previous percutaneous coronary intervention.
One key strength of the DIPRA study Dr. Al-Azizi noted is that it included some investigators who were at the early stage of the learning curve with the procedure. A limitation is that it didn’t evaluate hand numbness or tingling, but hand sensory testing is “very subjective,” he said. “To avoid confusion, we decided to go with the more repeatable questionnaire rather than a sensation or sensory test,” he added.
The next step for his research team is to conduct a meta-analysis of studies that have evaluated DRA and PRA, Dr. Al-Azizi said.
‘Slow to the party’
U.S. interventional cardiologists have been “slow to the party” in adopting radial artery access for PCI, said David A. Cox, MD, of Sanger Heart and Vascular Institute in Charlotte, N.C., and SCAI communications committee chair. Even now uptake is low, compared with the rest of the world, he said.
“I can tell you what patients care about: Did you have to stick my groin?” he said at a SCAI press conference. “What they just want to know is that there are no issues with hand function.”
Some patients who need fine motor hand function would still opt for femoral access, he said.
“Are we looking at the right metric?” he asked Dr. Al-Azizi. “It took a long time to get American doctors to stick the radial, so why would I want to learn distal radial artery if I’m really pretty good at proximal and if it’s not inferior?”
Dr. Al-Azizi noted that previous studies showed a trend toward a lower incidence of radial artery occlusion (RAO) with DRA access. It also better preserves the renal arteries for dialysis and CABG, he said.
“The metric that would move the needle,” Dr. Cox noted, “is if you had radial artery occlusion rates vs. snuff box occlusion rates, and we don’t have that rate.”
Dr. Al-Azizi has no relevant financial disclosures. Dr. Cox disclosed financial relationships with Medtronic.
FROM SCAI 2023
Anticipating FDA action, SCAI drafts guidance for adoption of renal denervation
Anticipating Food and Drug Administration approval of at least one investigational device for renal denervation (RDN) as a treatment for hypertension (HTN) refractory to medical therapies, the Society for Cardiovascular Angiography and Interventions is asking its members and the public to provide input on a draft position statement to guide use of the procedure.
SCAI is requesting feedback by June 14.
“With the anticipated FDA approval of renal denervation, there will be a need for SCAI to formulate an official position around clinical competence and training standards, best practices, and institutional and operator requirements for RDN,” Herbert D. Aronow, MD, MPH, chair of the statement writing committee, said in an interview.
RDN is an endoscopic procedure that disrupts the sympathetic nerves near the renal arteries. A number of studies, including sham-controlled, randomized trials, have shown that RDN can achieve short-term reductions in blood pressure for patients for whom HTN medications don’t work. Two devices are awaiting FDA premarket approval: the Paradise uRDN system, by ReCor Medical; and the Symplicity Spyral device, by Medtronic.
However, the trajectory of RDN has been uneven, said Dr. Aronow, president of the Society for Vascular Medicine and medical director for heart and vascular services and Benson Ford Chair in cardiology at Henry Ford Health, Detroit.
“Despite supportive early animal and human data, the first sham-controlled randomized trial of RDN was negative on its primary endpoint,” he said. “Modifications to patient inclusion/exclusion criteria, refinements in denervation technology and protocols, and selection of more appropriate study endpoints resulted in a series of positive randomized, sham-controlled trials. These second-generation trials found that RDN, when compared with sham therapy, substantially reduced ambulatory and office blood pressures.”
The draft is available for review at the SCAI website. Comments may be submitted via a link to a questionnaire.
“Through the open comment process, we are hoping to gain broad perspective from stakeholders, including clinicians, hospitals, payers, professional societies, industry and patients,” Dr. Aronow said. “By incorporating this feedback, we hope to enhance the quality of the document before we submit it for publication.”
The bulk of the SCAI draft position statement is devoted to patient selection and procedural and technical considerations. “We believe it will serve as a road map for the successful launch of RDN programs around the United States,” Dr. Aronow said.
Patient selection considerations
The draft statement notes that RDN for all patients with uncontrolled HTN “would not currently be practical.” The average age of patients for whom RDN showed effectiveness in the cited clinical trials was less than 60 years. The effectiveness of RDN for patients in whom arterial stiffness is a primary driver of HTN “is less certain.”
Patients who may benefit most from RDN are those with limited medical treatment options. Initially, RDN was tried on patients who had continued to experience resistant HTN despite taking three or more medications, including a diuretic, the statement noted. But even nonadherent patients may derive some potential benefit from RDN.
The statement also added that RDN isn’t a panacea; about one-third of trial patients didn’t respond to the procedure. The most reliable predictor of response may be higher levels of baseline systolic blood pressure, otherwise known as Wilder’s principle. The statement listed other potential markers of success, including higher nocturnal blood pressure and wider swings in nocturnal blood pressure.
Procedural and technical considerations
The statement also provided direction on a protocol for RDN procedures. The preprocedure evaluation should include noninvasive imaging to rule out disqualifying secondary causes of HTN, such as renal artery stenosis or fibromuscular dysplasia.
Patient characteristics should drive the selection of imaging modality, and availability as well as local expertise should be taken into account. The statement gave CT angiography or magnetic resonance angiography the edge over duplex ultrasound.
The statement also noted a number of anatomic considerations, citing preclinical analyses that “consistently reinforce” circumferential, perivascular RDN to ablate the renal nerves. In planning the procedure, consideration should be given to accessory renal arteries.
Additionally, operators should have training in obtaining access, and they should be familiar with different catheters and console devices as well as troubleshooting.
Training, competency, and institutional requirements
Interventional cardiologists who want to perform RDN should demonstrate proficiency in a number of specific skill sets germane to the procedure, from arterial vascular access and hemostasis to recognizing and treating potential renovascular complications.
For institutions that want to offer RDN, the statement offered a number of requirements. One is to designate a primary physician stakeholder who’s well versed in HTN management to oversee the long-term management of RDN patients.
The institution must have a dedicated HTN program and a multidisciplinary team to manage treated patients. Requirements for RDN referral centers range from operators experienced with FDA-approved RDN devices to an infrastructure that includes CT or MR angiography to identify appropriate candidates.
“Renal denervation has been a long time coming, and it’s a great example of how academicians, clinicians and industry leaders can partner to move the cardiovascular field forward, addressing a major public health issue for which alternative solutions are greatly needed,” Dr. Aronow said.
Dr. Aronow has served as an unpaid council member for Medtronic and as a paid moderator for ReCor.
A version of this article first appeared on Medscape.com.
Anticipating Food and Drug Administration approval of at least one investigational device for renal denervation (RDN) as a treatment for hypertension (HTN) refractory to medical therapies, the Society for Cardiovascular Angiography and Interventions is asking its members and the public to provide input on a draft position statement to guide use of the procedure.
SCAI is requesting feedback by June 14.
“With the anticipated FDA approval of renal denervation, there will be a need for SCAI to formulate an official position around clinical competence and training standards, best practices, and institutional and operator requirements for RDN,” Herbert D. Aronow, MD, MPH, chair of the statement writing committee, said in an interview.
RDN is an endoscopic procedure that disrupts the sympathetic nerves near the renal arteries. A number of studies, including sham-controlled, randomized trials, have shown that RDN can achieve short-term reductions in blood pressure for patients for whom HTN medications don’t work. Two devices are awaiting FDA premarket approval: the Paradise uRDN system, by ReCor Medical; and the Symplicity Spyral device, by Medtronic.
However, the trajectory of RDN has been uneven, said Dr. Aronow, president of the Society for Vascular Medicine and medical director for heart and vascular services and Benson Ford Chair in cardiology at Henry Ford Health, Detroit.
“Despite supportive early animal and human data, the first sham-controlled randomized trial of RDN was negative on its primary endpoint,” he said. “Modifications to patient inclusion/exclusion criteria, refinements in denervation technology and protocols, and selection of more appropriate study endpoints resulted in a series of positive randomized, sham-controlled trials. These second-generation trials found that RDN, when compared with sham therapy, substantially reduced ambulatory and office blood pressures.”
The draft is available for review at the SCAI website. Comments may be submitted via a link to a questionnaire.
“Through the open comment process, we are hoping to gain broad perspective from stakeholders, including clinicians, hospitals, payers, professional societies, industry and patients,” Dr. Aronow said. “By incorporating this feedback, we hope to enhance the quality of the document before we submit it for publication.”
The bulk of the SCAI draft position statement is devoted to patient selection and procedural and technical considerations. “We believe it will serve as a road map for the successful launch of RDN programs around the United States,” Dr. Aronow said.
Patient selection considerations
The draft statement notes that RDN for all patients with uncontrolled HTN “would not currently be practical.” The average age of patients for whom RDN showed effectiveness in the cited clinical trials was less than 60 years. The effectiveness of RDN for patients in whom arterial stiffness is a primary driver of HTN “is less certain.”
Patients who may benefit most from RDN are those with limited medical treatment options. Initially, RDN was tried on patients who had continued to experience resistant HTN despite taking three or more medications, including a diuretic, the statement noted. But even nonadherent patients may derive some potential benefit from RDN.
The statement also added that RDN isn’t a panacea; about one-third of trial patients didn’t respond to the procedure. The most reliable predictor of response may be higher levels of baseline systolic blood pressure, otherwise known as Wilder’s principle. The statement listed other potential markers of success, including higher nocturnal blood pressure and wider swings in nocturnal blood pressure.
Procedural and technical considerations
The statement also provided direction on a protocol for RDN procedures. The preprocedure evaluation should include noninvasive imaging to rule out disqualifying secondary causes of HTN, such as renal artery stenosis or fibromuscular dysplasia.
Patient characteristics should drive the selection of imaging modality, and availability as well as local expertise should be taken into account. The statement gave CT angiography or magnetic resonance angiography the edge over duplex ultrasound.
The statement also noted a number of anatomic considerations, citing preclinical analyses that “consistently reinforce” circumferential, perivascular RDN to ablate the renal nerves. In planning the procedure, consideration should be given to accessory renal arteries.
Additionally, operators should have training in obtaining access, and they should be familiar with different catheters and console devices as well as troubleshooting.
Training, competency, and institutional requirements
Interventional cardiologists who want to perform RDN should demonstrate proficiency in a number of specific skill sets germane to the procedure, from arterial vascular access and hemostasis to recognizing and treating potential renovascular complications.
For institutions that want to offer RDN, the statement offered a number of requirements. One is to designate a primary physician stakeholder who’s well versed in HTN management to oversee the long-term management of RDN patients.
The institution must have a dedicated HTN program and a multidisciplinary team to manage treated patients. Requirements for RDN referral centers range from operators experienced with FDA-approved RDN devices to an infrastructure that includes CT or MR angiography to identify appropriate candidates.
“Renal denervation has been a long time coming, and it’s a great example of how academicians, clinicians and industry leaders can partner to move the cardiovascular field forward, addressing a major public health issue for which alternative solutions are greatly needed,” Dr. Aronow said.
Dr. Aronow has served as an unpaid council member for Medtronic and as a paid moderator for ReCor.
A version of this article first appeared on Medscape.com.
Anticipating Food and Drug Administration approval of at least one investigational device for renal denervation (RDN) as a treatment for hypertension (HTN) refractory to medical therapies, the Society for Cardiovascular Angiography and Interventions is asking its members and the public to provide input on a draft position statement to guide use of the procedure.
SCAI is requesting feedback by June 14.
“With the anticipated FDA approval of renal denervation, there will be a need for SCAI to formulate an official position around clinical competence and training standards, best practices, and institutional and operator requirements for RDN,” Herbert D. Aronow, MD, MPH, chair of the statement writing committee, said in an interview.
RDN is an endoscopic procedure that disrupts the sympathetic nerves near the renal arteries. A number of studies, including sham-controlled, randomized trials, have shown that RDN can achieve short-term reductions in blood pressure for patients for whom HTN medications don’t work. Two devices are awaiting FDA premarket approval: the Paradise uRDN system, by ReCor Medical; and the Symplicity Spyral device, by Medtronic.
However, the trajectory of RDN has been uneven, said Dr. Aronow, president of the Society for Vascular Medicine and medical director for heart and vascular services and Benson Ford Chair in cardiology at Henry Ford Health, Detroit.
“Despite supportive early animal and human data, the first sham-controlled randomized trial of RDN was negative on its primary endpoint,” he said. “Modifications to patient inclusion/exclusion criteria, refinements in denervation technology and protocols, and selection of more appropriate study endpoints resulted in a series of positive randomized, sham-controlled trials. These second-generation trials found that RDN, when compared with sham therapy, substantially reduced ambulatory and office blood pressures.”
The draft is available for review at the SCAI website. Comments may be submitted via a link to a questionnaire.
“Through the open comment process, we are hoping to gain broad perspective from stakeholders, including clinicians, hospitals, payers, professional societies, industry and patients,” Dr. Aronow said. “By incorporating this feedback, we hope to enhance the quality of the document before we submit it for publication.”
The bulk of the SCAI draft position statement is devoted to patient selection and procedural and technical considerations. “We believe it will serve as a road map for the successful launch of RDN programs around the United States,” Dr. Aronow said.
Patient selection considerations
The draft statement notes that RDN for all patients with uncontrolled HTN “would not currently be practical.” The average age of patients for whom RDN showed effectiveness in the cited clinical trials was less than 60 years. The effectiveness of RDN for patients in whom arterial stiffness is a primary driver of HTN “is less certain.”
Patients who may benefit most from RDN are those with limited medical treatment options. Initially, RDN was tried on patients who had continued to experience resistant HTN despite taking three or more medications, including a diuretic, the statement noted. But even nonadherent patients may derive some potential benefit from RDN.
The statement also added that RDN isn’t a panacea; about one-third of trial patients didn’t respond to the procedure. The most reliable predictor of response may be higher levels of baseline systolic blood pressure, otherwise known as Wilder’s principle. The statement listed other potential markers of success, including higher nocturnal blood pressure and wider swings in nocturnal blood pressure.
Procedural and technical considerations
The statement also provided direction on a protocol for RDN procedures. The preprocedure evaluation should include noninvasive imaging to rule out disqualifying secondary causes of HTN, such as renal artery stenosis or fibromuscular dysplasia.
Patient characteristics should drive the selection of imaging modality, and availability as well as local expertise should be taken into account. The statement gave CT angiography or magnetic resonance angiography the edge over duplex ultrasound.
The statement also noted a number of anatomic considerations, citing preclinical analyses that “consistently reinforce” circumferential, perivascular RDN to ablate the renal nerves. In planning the procedure, consideration should be given to accessory renal arteries.
Additionally, operators should have training in obtaining access, and they should be familiar with different catheters and console devices as well as troubleshooting.
Training, competency, and institutional requirements
Interventional cardiologists who want to perform RDN should demonstrate proficiency in a number of specific skill sets germane to the procedure, from arterial vascular access and hemostasis to recognizing and treating potential renovascular complications.
For institutions that want to offer RDN, the statement offered a number of requirements. One is to designate a primary physician stakeholder who’s well versed in HTN management to oversee the long-term management of RDN patients.
The institution must have a dedicated HTN program and a multidisciplinary team to manage treated patients. Requirements for RDN referral centers range from operators experienced with FDA-approved RDN devices to an infrastructure that includes CT or MR angiography to identify appropriate candidates.
“Renal denervation has been a long time coming, and it’s a great example of how academicians, clinicians and industry leaders can partner to move the cardiovascular field forward, addressing a major public health issue for which alternative solutions are greatly needed,” Dr. Aronow said.
Dr. Aronow has served as an unpaid council member for Medtronic and as a paid moderator for ReCor.
A version of this article first appeared on Medscape.com.
Marijuana linked to higher PAD risk
But death, intervention rates same
PHOENIX – although there was no greater risk of death from myocardial infarction or other cardiac causes or need for revascularization.
The researchers noted, however, that the study population was young, with an average age of 37.4 years, and that the study period, from 2016 to 2019, predates the legalization of recreational marijuana in a number of states.
Nonetheless, even in this young study population, marijuana users’ risk of developing peripheral artery disease (PAD) was 3.68 times greater (P < .001) than that of nonusers. PAD at a young age could precede worse outcomes later in life, the study authors said.
“Basically, marijuana users were at increased risk of being diagnosed with peripheral artery disease, but there was no increased risk for them requiring any intervention, such as a peripheral vascular intervention, nor were they at increased risk of death from what we found,” said Hirva Vyas, DO, an internal medicine resident at Hackensack University Medical Center in New Jersey, who presented the results at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.
The study used data on 623,768 marijuana users from the National Inpatient Sample, a nationwide database of inpatient visits covered by all public and commercial payers, then extracted a diagnosis for PAD from all 30 million–plus patient encounters to compare PAD rates between marijuana users and nonusers. Marijuana users were more likely to be White and to have elective rather than emergency admissions (P < .001). The researchers used diagnostic codes to identify marijuana users and PAD patients.
Recreational marijuana is legal in 22 states and the District of Columbia, according to ProCon.org. Since 2019, the last year of the study, 11 states have legalized marijuana for recreational use. “It’s a data point that we studied at one point in time, only from 2016 to 2019,” Dr. Vyas said in an interview.
“As we’ve seen over the past 4-5 years, legalization has skyrocketed and recreational use has become more and more favorable not only among younger folks but older folks,” study coauthor Harsh Jain, MD, a second-year internal medicine resident at Montefiore Medical Center in New York, said in the interview. “It would be really refreshing to see how these data change as we look at endpoints from 2019 to 2023.”
Because of the young age of the study population, Dr. Jain said, these findings may not accurately represent the true cardiovascular risks of marijuana use, especially later in life.
“One of the biggest secondary endpoints that we wanted to study was the development of chronic conditions that lead to multiple rehospitalizations, the most significant one of which would be the development of heart failure,” Dr. Jain said. “However, it was difficult to stratify because, again, many of these patients were very young and so they did not carry the diagnosis for heart failure, so we couldn’t complete that subset analysis.”
The goal is to extend the study period out to 2023, Dr. Jain said. “We know that these are very crude and rudimentary data findings that we presented so far, but we’re hoping that the final paper gives us a chance to flesh out all the details of our study and also gives us a chance to expand going forward,” he said.
The findings are in line with other research into the effects of marijuana and cardiovascular disease, said Carl “Chip” Lavie, MD, medical director for cardiac rehabilitation and prevention at the John Ochsner Heart and Vascular Institute in New Orleans who’s published a number of studies on PAD and substance use, including marijuana.
“It is known that cannabis is associated with more vasoconstriction, has sympathomimetic effects, causes endothelial dysfunction and increased platelet aggregation, and is known to increase the risk of acute myocardial infarction, especially in the hour or so after use,” he said in written comments sent to this news organization.
“It is also well known to be a cause of thromboangiitis obliterans, which is in the PAD family,” he added. “Based on these mechanisms, one would expect an increased PAD and, especially, PAD events. The 3.7-fold increased risk is supportive of this increased PAD.”
One study strength, Dr. Lavie pointed out, is that it’s one of the few studies that found an association between marijuana and PAD, which hasn’t been studied as well as other cardiovascular endpoints. “However,” he said, “the limitation is this is just an inpatient sample, and it is all based on coding – e.g., a patient could have PAD and it may not have been coded.”
But death, intervention rates same
But death, intervention rates same
PHOENIX – although there was no greater risk of death from myocardial infarction or other cardiac causes or need for revascularization.
The researchers noted, however, that the study population was young, with an average age of 37.4 years, and that the study period, from 2016 to 2019, predates the legalization of recreational marijuana in a number of states.
Nonetheless, even in this young study population, marijuana users’ risk of developing peripheral artery disease (PAD) was 3.68 times greater (P < .001) than that of nonusers. PAD at a young age could precede worse outcomes later in life, the study authors said.
“Basically, marijuana users were at increased risk of being diagnosed with peripheral artery disease, but there was no increased risk for them requiring any intervention, such as a peripheral vascular intervention, nor were they at increased risk of death from what we found,” said Hirva Vyas, DO, an internal medicine resident at Hackensack University Medical Center in New Jersey, who presented the results at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.
The study used data on 623,768 marijuana users from the National Inpatient Sample, a nationwide database of inpatient visits covered by all public and commercial payers, then extracted a diagnosis for PAD from all 30 million–plus patient encounters to compare PAD rates between marijuana users and nonusers. Marijuana users were more likely to be White and to have elective rather than emergency admissions (P < .001). The researchers used diagnostic codes to identify marijuana users and PAD patients.
Recreational marijuana is legal in 22 states and the District of Columbia, according to ProCon.org. Since 2019, the last year of the study, 11 states have legalized marijuana for recreational use. “It’s a data point that we studied at one point in time, only from 2016 to 2019,” Dr. Vyas said in an interview.
“As we’ve seen over the past 4-5 years, legalization has skyrocketed and recreational use has become more and more favorable not only among younger folks but older folks,” study coauthor Harsh Jain, MD, a second-year internal medicine resident at Montefiore Medical Center in New York, said in the interview. “It would be really refreshing to see how these data change as we look at endpoints from 2019 to 2023.”
Because of the young age of the study population, Dr. Jain said, these findings may not accurately represent the true cardiovascular risks of marijuana use, especially later in life.
“One of the biggest secondary endpoints that we wanted to study was the development of chronic conditions that lead to multiple rehospitalizations, the most significant one of which would be the development of heart failure,” Dr. Jain said. “However, it was difficult to stratify because, again, many of these patients were very young and so they did not carry the diagnosis for heart failure, so we couldn’t complete that subset analysis.”
The goal is to extend the study period out to 2023, Dr. Jain said. “We know that these are very crude and rudimentary data findings that we presented so far, but we’re hoping that the final paper gives us a chance to flesh out all the details of our study and also gives us a chance to expand going forward,” he said.
The findings are in line with other research into the effects of marijuana and cardiovascular disease, said Carl “Chip” Lavie, MD, medical director for cardiac rehabilitation and prevention at the John Ochsner Heart and Vascular Institute in New Orleans who’s published a number of studies on PAD and substance use, including marijuana.
“It is known that cannabis is associated with more vasoconstriction, has sympathomimetic effects, causes endothelial dysfunction and increased platelet aggregation, and is known to increase the risk of acute myocardial infarction, especially in the hour or so after use,” he said in written comments sent to this news organization.
“It is also well known to be a cause of thromboangiitis obliterans, which is in the PAD family,” he added. “Based on these mechanisms, one would expect an increased PAD and, especially, PAD events. The 3.7-fold increased risk is supportive of this increased PAD.”
One study strength, Dr. Lavie pointed out, is that it’s one of the few studies that found an association between marijuana and PAD, which hasn’t been studied as well as other cardiovascular endpoints. “However,” he said, “the limitation is this is just an inpatient sample, and it is all based on coding – e.g., a patient could have PAD and it may not have been coded.”
PHOENIX – although there was no greater risk of death from myocardial infarction or other cardiac causes or need for revascularization.
The researchers noted, however, that the study population was young, with an average age of 37.4 years, and that the study period, from 2016 to 2019, predates the legalization of recreational marijuana in a number of states.
Nonetheless, even in this young study population, marijuana users’ risk of developing peripheral artery disease (PAD) was 3.68 times greater (P < .001) than that of nonusers. PAD at a young age could precede worse outcomes later in life, the study authors said.
“Basically, marijuana users were at increased risk of being diagnosed with peripheral artery disease, but there was no increased risk for them requiring any intervention, such as a peripheral vascular intervention, nor were they at increased risk of death from what we found,” said Hirva Vyas, DO, an internal medicine resident at Hackensack University Medical Center in New Jersey, who presented the results at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.
The study used data on 623,768 marijuana users from the National Inpatient Sample, a nationwide database of inpatient visits covered by all public and commercial payers, then extracted a diagnosis for PAD from all 30 million–plus patient encounters to compare PAD rates between marijuana users and nonusers. Marijuana users were more likely to be White and to have elective rather than emergency admissions (P < .001). The researchers used diagnostic codes to identify marijuana users and PAD patients.
Recreational marijuana is legal in 22 states and the District of Columbia, according to ProCon.org. Since 2019, the last year of the study, 11 states have legalized marijuana for recreational use. “It’s a data point that we studied at one point in time, only from 2016 to 2019,” Dr. Vyas said in an interview.
“As we’ve seen over the past 4-5 years, legalization has skyrocketed and recreational use has become more and more favorable not only among younger folks but older folks,” study coauthor Harsh Jain, MD, a second-year internal medicine resident at Montefiore Medical Center in New York, said in the interview. “It would be really refreshing to see how these data change as we look at endpoints from 2019 to 2023.”
Because of the young age of the study population, Dr. Jain said, these findings may not accurately represent the true cardiovascular risks of marijuana use, especially later in life.
“One of the biggest secondary endpoints that we wanted to study was the development of chronic conditions that lead to multiple rehospitalizations, the most significant one of which would be the development of heart failure,” Dr. Jain said. “However, it was difficult to stratify because, again, many of these patients were very young and so they did not carry the diagnosis for heart failure, so we couldn’t complete that subset analysis.”
The goal is to extend the study period out to 2023, Dr. Jain said. “We know that these are very crude and rudimentary data findings that we presented so far, but we’re hoping that the final paper gives us a chance to flesh out all the details of our study and also gives us a chance to expand going forward,” he said.
The findings are in line with other research into the effects of marijuana and cardiovascular disease, said Carl “Chip” Lavie, MD, medical director for cardiac rehabilitation and prevention at the John Ochsner Heart and Vascular Institute in New Orleans who’s published a number of studies on PAD and substance use, including marijuana.
“It is known that cannabis is associated with more vasoconstriction, has sympathomimetic effects, causes endothelial dysfunction and increased platelet aggregation, and is known to increase the risk of acute myocardial infarction, especially in the hour or so after use,” he said in written comments sent to this news organization.
“It is also well known to be a cause of thromboangiitis obliterans, which is in the PAD family,” he added. “Based on these mechanisms, one would expect an increased PAD and, especially, PAD events. The 3.7-fold increased risk is supportive of this increased PAD.”
One study strength, Dr. Lavie pointed out, is that it’s one of the few studies that found an association between marijuana and PAD, which hasn’t been studied as well as other cardiovascular endpoints. “However,” he said, “the limitation is this is just an inpatient sample, and it is all based on coding – e.g., a patient could have PAD and it may not have been coded.”
AT SCAI 2023
Colchicine’s 2010 price spike had major impact on gout care
A large price increase for colchicine in 2010 led to a significant falloff in its use for gout that persisted for the next decade while emergency and rheumatology visits for gout rose, suggesting poorer disease control, a retrospective cohort study reported.
The price of colchicine, commonly prescribed for acute gout attacks, climbed from $11.25 per prescription in 2009 to $190.49 in 2011, with the average out-of-pocket cost more than quadrupling, from $7.37 to $29.42, the study noted. Colchicine prescriptions for gout declined 27% over the next decade, according to adjusted analyses that the study authors performed.
“A roughly 16-fold increase in colchicine prices appeared to have lowered colchicine use over the next decade,” senior author Zirui Song, MD, PhD, an associate professor of health care policy and medicine at Harvard Medical School and an internist at Massachusetts General Hospital in Boston, told this news organization in written comments. “Over the same period, patients with gout used more of other medications that could treat gout. They also had more emergency department visits for gout and rheumatologist visits for gout, which potentially signals poorer disease control.”
The study, published online in JAMA Internal Medicine, examined MarketScan data from a longitudinal cohort of patients who had employer-sponsored health insurance and a diagnosis of gout from 2007 to 2019. MarketScan is an IBM database of medical and drug data from employers and health plans. The study examined more than 2.7 million patient-year observations over the 13-year period.
How the price increase happened
After 2011, a large percentage of patients shifted to less effective but more affordable drugs to treat gout. Prescriptions for allopurinol increased 32% (P < .001) and oral corticosteroids 8.3% over the decade. “These are imperfect substitutes,” Dr. Song said. “Allopurinol is used to prevent gout, while oral corticosteroids can be used to treat a gout flare.”
At the same time, visits for gout-related complaints to emergency departments and rheumatology offices increased through the ensuing years: 39.8% and 10.5% on an adjusted analysis, respectively (P < .001 for both).
Colchicine is actually a drug that predates the creation of the U.S. Food and Drug Administration in 1938 and had been grandfathered under its Unapproved Drug Initiative. Then in 2009, the FDA determined that colchicine was effective for treating arthritis-related gout flares after the manufacturer, URL Pharma, presented results of a randomized, controlled trial of 185 patients with gout.
The next year, the FDA granted URL Pharma 3 years of market exclusivity for the drug under the brand name Colcrys, now trademarked by Takeda Pharmaceuticals.
The latest study noted that longer-term analysis of the impact of the FDA’s decision had been lacking. The goal, said Dr. Song, was “to better understand the long-run implications of large drug price increases in the U.S. by studying the case of colchicine.”
He added, “For drugs that lack competition, large price increases can have large economic and clinical consequences over many years.”
Absorbing the cost
Lead author Dan P. Ly, MD, PhD, MPP, assistant professor at the University of California, Los Angeles, added, “Our study has large implications [for] when generic medications or other medications experience large price increases. Use of the medication in question drops or patients have to pay more out of pocket, and patient health can suffer as a result.”
The dropoff in colchicine use in this patient population could have been worse, Dr. Song said. “Despite colchicine use decreasing by 27% over nearly a decade, the fact that it did not decline more suggests that for patients with gout, the large price increase was mostly absorbed by their insurers, employers, or themselves – e.g., passed through to higher premiums, lower wages, or higher cost-sharing.”
Aaron Kesselheim, MD, JD, MPH, a professor at Harvard Medical School, Boston, reported previously on the price consequences of colchicine early on after the FDA granted the manufacturer market exclusivity.
“In our past research, we looked at how the massive increase in the price of colchicine increased spending on the drug and reduced use in a relatively short time period after the price hike,” said Dr. Kesselheim, who was not involved in this current study by Dr. Ly, Dr. Song, and Mia Giuriato, BBA, MA, from Harvard Medical School. “This study evaluated the experiences of patients with gout over multiple years and showed that the reductions in use persisted and were associated with increases in ED and rheumatology visits, suggesting worsening control of gout due to the relative inaccessibility of the drug at the new high price.”
The latest findings have public policy implications, Dr. Kesselheim said. “In the case of colchicine, the FDA made a bad pitch, leading to a home run for the manufacturer and a shutout for patients.”
“The FDA needs to make sure to take into account the quite predictable patient effects that can result from disruptions to competition when it considers taking steps like it did in the colchicine case to disrupt the market and create an artificial monopoly, even if the FDA acted in the best of intentions in this case,” Dr. Kesselheim added.
Dr. Song received funding for the study from the National Institutes of Health and Arnold Ventures. He also disclosed receiving personal fees from the Research Triangle Institute, Google Ventures, VBID Health, and the International Foundation of Employee Benefit Plans. Dr. Ly, Ms. Giuriato, and Dr. Kesselheim report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A large price increase for colchicine in 2010 led to a significant falloff in its use for gout that persisted for the next decade while emergency and rheumatology visits for gout rose, suggesting poorer disease control, a retrospective cohort study reported.
The price of colchicine, commonly prescribed for acute gout attacks, climbed from $11.25 per prescription in 2009 to $190.49 in 2011, with the average out-of-pocket cost more than quadrupling, from $7.37 to $29.42, the study noted. Colchicine prescriptions for gout declined 27% over the next decade, according to adjusted analyses that the study authors performed.
“A roughly 16-fold increase in colchicine prices appeared to have lowered colchicine use over the next decade,” senior author Zirui Song, MD, PhD, an associate professor of health care policy and medicine at Harvard Medical School and an internist at Massachusetts General Hospital in Boston, told this news organization in written comments. “Over the same period, patients with gout used more of other medications that could treat gout. They also had more emergency department visits for gout and rheumatologist visits for gout, which potentially signals poorer disease control.”
The study, published online in JAMA Internal Medicine, examined MarketScan data from a longitudinal cohort of patients who had employer-sponsored health insurance and a diagnosis of gout from 2007 to 2019. MarketScan is an IBM database of medical and drug data from employers and health plans. The study examined more than 2.7 million patient-year observations over the 13-year period.
How the price increase happened
After 2011, a large percentage of patients shifted to less effective but more affordable drugs to treat gout. Prescriptions for allopurinol increased 32% (P < .001) and oral corticosteroids 8.3% over the decade. “These are imperfect substitutes,” Dr. Song said. “Allopurinol is used to prevent gout, while oral corticosteroids can be used to treat a gout flare.”
At the same time, visits for gout-related complaints to emergency departments and rheumatology offices increased through the ensuing years: 39.8% and 10.5% on an adjusted analysis, respectively (P < .001 for both).
Colchicine is actually a drug that predates the creation of the U.S. Food and Drug Administration in 1938 and had been grandfathered under its Unapproved Drug Initiative. Then in 2009, the FDA determined that colchicine was effective for treating arthritis-related gout flares after the manufacturer, URL Pharma, presented results of a randomized, controlled trial of 185 patients with gout.
The next year, the FDA granted URL Pharma 3 years of market exclusivity for the drug under the brand name Colcrys, now trademarked by Takeda Pharmaceuticals.
The latest study noted that longer-term analysis of the impact of the FDA’s decision had been lacking. The goal, said Dr. Song, was “to better understand the long-run implications of large drug price increases in the U.S. by studying the case of colchicine.”
He added, “For drugs that lack competition, large price increases can have large economic and clinical consequences over many years.”
Absorbing the cost
Lead author Dan P. Ly, MD, PhD, MPP, assistant professor at the University of California, Los Angeles, added, “Our study has large implications [for] when generic medications or other medications experience large price increases. Use of the medication in question drops or patients have to pay more out of pocket, and patient health can suffer as a result.”
The dropoff in colchicine use in this patient population could have been worse, Dr. Song said. “Despite colchicine use decreasing by 27% over nearly a decade, the fact that it did not decline more suggests that for patients with gout, the large price increase was mostly absorbed by their insurers, employers, or themselves – e.g., passed through to higher premiums, lower wages, or higher cost-sharing.”
Aaron Kesselheim, MD, JD, MPH, a professor at Harvard Medical School, Boston, reported previously on the price consequences of colchicine early on after the FDA granted the manufacturer market exclusivity.
“In our past research, we looked at how the massive increase in the price of colchicine increased spending on the drug and reduced use in a relatively short time period after the price hike,” said Dr. Kesselheim, who was not involved in this current study by Dr. Ly, Dr. Song, and Mia Giuriato, BBA, MA, from Harvard Medical School. “This study evaluated the experiences of patients with gout over multiple years and showed that the reductions in use persisted and were associated with increases in ED and rheumatology visits, suggesting worsening control of gout due to the relative inaccessibility of the drug at the new high price.”
The latest findings have public policy implications, Dr. Kesselheim said. “In the case of colchicine, the FDA made a bad pitch, leading to a home run for the manufacturer and a shutout for patients.”
“The FDA needs to make sure to take into account the quite predictable patient effects that can result from disruptions to competition when it considers taking steps like it did in the colchicine case to disrupt the market and create an artificial monopoly, even if the FDA acted in the best of intentions in this case,” Dr. Kesselheim added.
Dr. Song received funding for the study from the National Institutes of Health and Arnold Ventures. He also disclosed receiving personal fees from the Research Triangle Institute, Google Ventures, VBID Health, and the International Foundation of Employee Benefit Plans. Dr. Ly, Ms. Giuriato, and Dr. Kesselheim report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A large price increase for colchicine in 2010 led to a significant falloff in its use for gout that persisted for the next decade while emergency and rheumatology visits for gout rose, suggesting poorer disease control, a retrospective cohort study reported.
The price of colchicine, commonly prescribed for acute gout attacks, climbed from $11.25 per prescription in 2009 to $190.49 in 2011, with the average out-of-pocket cost more than quadrupling, from $7.37 to $29.42, the study noted. Colchicine prescriptions for gout declined 27% over the next decade, according to adjusted analyses that the study authors performed.
“A roughly 16-fold increase in colchicine prices appeared to have lowered colchicine use over the next decade,” senior author Zirui Song, MD, PhD, an associate professor of health care policy and medicine at Harvard Medical School and an internist at Massachusetts General Hospital in Boston, told this news organization in written comments. “Over the same period, patients with gout used more of other medications that could treat gout. They also had more emergency department visits for gout and rheumatologist visits for gout, which potentially signals poorer disease control.”
The study, published online in JAMA Internal Medicine, examined MarketScan data from a longitudinal cohort of patients who had employer-sponsored health insurance and a diagnosis of gout from 2007 to 2019. MarketScan is an IBM database of medical and drug data from employers and health plans. The study examined more than 2.7 million patient-year observations over the 13-year period.
How the price increase happened
After 2011, a large percentage of patients shifted to less effective but more affordable drugs to treat gout. Prescriptions for allopurinol increased 32% (P < .001) and oral corticosteroids 8.3% over the decade. “These are imperfect substitutes,” Dr. Song said. “Allopurinol is used to prevent gout, while oral corticosteroids can be used to treat a gout flare.”
At the same time, visits for gout-related complaints to emergency departments and rheumatology offices increased through the ensuing years: 39.8% and 10.5% on an adjusted analysis, respectively (P < .001 for both).
Colchicine is actually a drug that predates the creation of the U.S. Food and Drug Administration in 1938 and had been grandfathered under its Unapproved Drug Initiative. Then in 2009, the FDA determined that colchicine was effective for treating arthritis-related gout flares after the manufacturer, URL Pharma, presented results of a randomized, controlled trial of 185 patients with gout.
The next year, the FDA granted URL Pharma 3 years of market exclusivity for the drug under the brand name Colcrys, now trademarked by Takeda Pharmaceuticals.
The latest study noted that longer-term analysis of the impact of the FDA’s decision had been lacking. The goal, said Dr. Song, was “to better understand the long-run implications of large drug price increases in the U.S. by studying the case of colchicine.”
He added, “For drugs that lack competition, large price increases can have large economic and clinical consequences over many years.”
Absorbing the cost
Lead author Dan P. Ly, MD, PhD, MPP, assistant professor at the University of California, Los Angeles, added, “Our study has large implications [for] when generic medications or other medications experience large price increases. Use of the medication in question drops or patients have to pay more out of pocket, and patient health can suffer as a result.”
The dropoff in colchicine use in this patient population could have been worse, Dr. Song said. “Despite colchicine use decreasing by 27% over nearly a decade, the fact that it did not decline more suggests that for patients with gout, the large price increase was mostly absorbed by their insurers, employers, or themselves – e.g., passed through to higher premiums, lower wages, or higher cost-sharing.”
Aaron Kesselheim, MD, JD, MPH, a professor at Harvard Medical School, Boston, reported previously on the price consequences of colchicine early on after the FDA granted the manufacturer market exclusivity.
“In our past research, we looked at how the massive increase in the price of colchicine increased spending on the drug and reduced use in a relatively short time period after the price hike,” said Dr. Kesselheim, who was not involved in this current study by Dr. Ly, Dr. Song, and Mia Giuriato, BBA, MA, from Harvard Medical School. “This study evaluated the experiences of patients with gout over multiple years and showed that the reductions in use persisted and were associated with increases in ED and rheumatology visits, suggesting worsening control of gout due to the relative inaccessibility of the drug at the new high price.”
The latest findings have public policy implications, Dr. Kesselheim said. “In the case of colchicine, the FDA made a bad pitch, leading to a home run for the manufacturer and a shutout for patients.”
“The FDA needs to make sure to take into account the quite predictable patient effects that can result from disruptions to competition when it considers taking steps like it did in the colchicine case to disrupt the market and create an artificial monopoly, even if the FDA acted in the best of intentions in this case,” Dr. Kesselheim added.
Dr. Song received funding for the study from the National Institutes of Health and Arnold Ventures. He also disclosed receiving personal fees from the Research Triangle Institute, Google Ventures, VBID Health, and the International Foundation of Employee Benefit Plans. Dr. Ly, Ms. Giuriato, and Dr. Kesselheim report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Study of hospitalizations in Canada quantifies benefit of COVID-19 vaccine to reduce death, ICU admissions
A cohort study of more than 1.5 million hospital admissions in Canada through the first 2 years of the COVID-19 pandemic has quantified the benefit of vaccinations. Unvaccinated patients were found to be up to 15 times more likely to die from COVID-19 than fully vaccinated patients.
Investigators analyzed 1.513 million admissions at 155 hospitals across Canada from March 15, 2020, to May 28, 2022. The study included 51,679 adult admissions and 4,035 pediatric admissions for COVID-19. Although the share of COVID-19 admissions increased in the fifth and sixth waves, from Dec. 26, 2021, to March 19, 2022 – after the full vaccine rollout – to 7.73% from 2.47% in the previous four waves, the proportion of adults admitted to the intensive care unit was significantly lower, at 8.7% versus 21.8% (odds ratio, 0.35; 95% confidence interval, 0.32-0.36).
“The good thing about waves five and six was we were able to show the COVID cases tended to be less severe, but on the other hand, because the disease in the community was so much higher, the demands on the health care system were much higher than the previous waves,” study author Charles Frenette, MD, director of infection prevention and control at McGill University, Montreal, and chair of the study’s adult subgroup, said in an interview. “But here we were able to show the benefit of vaccinations, particularly the boosting dose, in protecting against those severe outcomes.”
The study, published in JAMA Network Open, used the Canadian Nosocomial Infection Surveillance Program database, which collects hospital data across Canada. It was activated in March 2020 to collect details on all COVID-19 admissions, co-author Nisha Thampi, MD, chair of the study’s pediatric subgroup, told this news organization.
“We’re now over 3 years into the pandemic, and CNISP continues to monitor COVID-19 as well as other pathogens in near real time,” said Dr. Thampi, an associate professor and infectious disease specialist at Children’s Hospital of Eastern Ontario.
“That’s a particular strength of this surveillance program as well. We would see this data on a biweekly basis, and that allows for [us] to implement timely protection and action.”
Tracing trends over six waves
The study tracked COVID-19 hospitalizations during six waves. The first lasted from March 15 to August 31, 2020, and the second lasted from Sept. 1, 2020, to Feb. 28, 2021. The wild-type variant was dominant during both waves. The third wave lasted from March 1 to June 30, 2021, and was marked by the mixed Alpha, Beta, and Gamma variants. The fourth wave lasted from July 1 to Dec. 25, 2021, when the Alpha variant was dominant. The Omicron variant dominated during waves five (Dec. 26, 2021, to March 19, 2022) and six (March 20 to May 28, 2022).
Hospitalizations reached a peak of 14,461 in wave five. ICU admissions, however, peaked at 2,164 during wave four, and all-cause deaths peaked at 1,663 during wave two.
The investigators also analyzed how unvaccinated patients fared, compared with the fully vaccinated and the fully vaccinated-plus (that is, patients with one or more additional doses). During waves five and six, unvaccinated patients were 4.3 times more likely to end up in the ICU than fully vaccinated patients and were 12.2 times more likely than fully vaccinated-plus patients. Likewise, the rate for all-cause in-hospital death for unvaccinated patients was 3.9 times greater than that for fully vaccinated patients and 15.1 times greater than that for fully vaccinated-plus patients.
The effect of vaccines emerged in waves three and four, said Dr. Frenette. “We started to see really, really significant protection and benefit from the vaccine, not only in incidence of admission but also in the incidence of complications of ICU care, ventilation, and mortality.”
Results for pediatric patients were similar to those for adults, Dr. Thampi noted. During waves five and six, overall admissions peaked, but the share of ICU admissions decreased to 9.4% from 18.1%, which was the rate during the previous four waves (OR, 0.47).
“What’s important is how pediatric hospitalizations changed over the course of the various waves,” said Dr. Thampi.
“Where we saw the highest admissions during the early Omicron dominance, we actually had the lowest numbers of hospitalizations with death and admissions into ICUs.”
Doing more with the data
David Fisman, MD, MPH, a professor of epidemiology at the University of Toronto, said, “This is a study that shows us how tremendously dramatic the effects of the COVID-19 vaccine were in terms of saving lives during the pandemic.” Dr. Fisman was not involved in the study.
But CNISP, which receives funding from Public Health Agency of Canada, could do more with the data it collects to better protect the public from COVID-19 and other nosocomial infections, Dr. Fisman said.
“The first problematic thing about this paper is that Canadians are paying for a surveillance system that looks at risks of acquiring infections, including COVID-19 infections, in the hospital, but that data is not fed back to the people paying for its production,” he said.
“So, Canadians don’t have the ability to really understand in real time how much risk they’re experiencing via going to the hospital for some other reason.”
The study was independently supported. Dr. Frenette and Dr. Thampi report no relevant financial relationships. Dr. Fisman has disclosed financial relationships with Pfizer, AstraZeneca, Sanofi, Seqirus, Merck, the Ontario Nurses Association, and the Elementary Teachers’ Federation of Ontario.
A version of this article first appeared on Medscape.com.
A cohort study of more than 1.5 million hospital admissions in Canada through the first 2 years of the COVID-19 pandemic has quantified the benefit of vaccinations. Unvaccinated patients were found to be up to 15 times more likely to die from COVID-19 than fully vaccinated patients.
Investigators analyzed 1.513 million admissions at 155 hospitals across Canada from March 15, 2020, to May 28, 2022. The study included 51,679 adult admissions and 4,035 pediatric admissions for COVID-19. Although the share of COVID-19 admissions increased in the fifth and sixth waves, from Dec. 26, 2021, to March 19, 2022 – after the full vaccine rollout – to 7.73% from 2.47% in the previous four waves, the proportion of adults admitted to the intensive care unit was significantly lower, at 8.7% versus 21.8% (odds ratio, 0.35; 95% confidence interval, 0.32-0.36).
“The good thing about waves five and six was we were able to show the COVID cases tended to be less severe, but on the other hand, because the disease in the community was so much higher, the demands on the health care system were much higher than the previous waves,” study author Charles Frenette, MD, director of infection prevention and control at McGill University, Montreal, and chair of the study’s adult subgroup, said in an interview. “But here we were able to show the benefit of vaccinations, particularly the boosting dose, in protecting against those severe outcomes.”
The study, published in JAMA Network Open, used the Canadian Nosocomial Infection Surveillance Program database, which collects hospital data across Canada. It was activated in March 2020 to collect details on all COVID-19 admissions, co-author Nisha Thampi, MD, chair of the study’s pediatric subgroup, told this news organization.
“We’re now over 3 years into the pandemic, and CNISP continues to monitor COVID-19 as well as other pathogens in near real time,” said Dr. Thampi, an associate professor and infectious disease specialist at Children’s Hospital of Eastern Ontario.
“That’s a particular strength of this surveillance program as well. We would see this data on a biweekly basis, and that allows for [us] to implement timely protection and action.”
Tracing trends over six waves
The study tracked COVID-19 hospitalizations during six waves. The first lasted from March 15 to August 31, 2020, and the second lasted from Sept. 1, 2020, to Feb. 28, 2021. The wild-type variant was dominant during both waves. The third wave lasted from March 1 to June 30, 2021, and was marked by the mixed Alpha, Beta, and Gamma variants. The fourth wave lasted from July 1 to Dec. 25, 2021, when the Alpha variant was dominant. The Omicron variant dominated during waves five (Dec. 26, 2021, to March 19, 2022) and six (March 20 to May 28, 2022).
Hospitalizations reached a peak of 14,461 in wave five. ICU admissions, however, peaked at 2,164 during wave four, and all-cause deaths peaked at 1,663 during wave two.
The investigators also analyzed how unvaccinated patients fared, compared with the fully vaccinated and the fully vaccinated-plus (that is, patients with one or more additional doses). During waves five and six, unvaccinated patients were 4.3 times more likely to end up in the ICU than fully vaccinated patients and were 12.2 times more likely than fully vaccinated-plus patients. Likewise, the rate for all-cause in-hospital death for unvaccinated patients was 3.9 times greater than that for fully vaccinated patients and 15.1 times greater than that for fully vaccinated-plus patients.
The effect of vaccines emerged in waves three and four, said Dr. Frenette. “We started to see really, really significant protection and benefit from the vaccine, not only in incidence of admission but also in the incidence of complications of ICU care, ventilation, and mortality.”
Results for pediatric patients were similar to those for adults, Dr. Thampi noted. During waves five and six, overall admissions peaked, but the share of ICU admissions decreased to 9.4% from 18.1%, which was the rate during the previous four waves (OR, 0.47).
“What’s important is how pediatric hospitalizations changed over the course of the various waves,” said Dr. Thampi.
“Where we saw the highest admissions during the early Omicron dominance, we actually had the lowest numbers of hospitalizations with death and admissions into ICUs.”
Doing more with the data
David Fisman, MD, MPH, a professor of epidemiology at the University of Toronto, said, “This is a study that shows us how tremendously dramatic the effects of the COVID-19 vaccine were in terms of saving lives during the pandemic.” Dr. Fisman was not involved in the study.
But CNISP, which receives funding from Public Health Agency of Canada, could do more with the data it collects to better protect the public from COVID-19 and other nosocomial infections, Dr. Fisman said.
“The first problematic thing about this paper is that Canadians are paying for a surveillance system that looks at risks of acquiring infections, including COVID-19 infections, in the hospital, but that data is not fed back to the people paying for its production,” he said.
“So, Canadians don’t have the ability to really understand in real time how much risk they’re experiencing via going to the hospital for some other reason.”
The study was independently supported. Dr. Frenette and Dr. Thampi report no relevant financial relationships. Dr. Fisman has disclosed financial relationships with Pfizer, AstraZeneca, Sanofi, Seqirus, Merck, the Ontario Nurses Association, and the Elementary Teachers’ Federation of Ontario.
A version of this article first appeared on Medscape.com.
A cohort study of more than 1.5 million hospital admissions in Canada through the first 2 years of the COVID-19 pandemic has quantified the benefit of vaccinations. Unvaccinated patients were found to be up to 15 times more likely to die from COVID-19 than fully vaccinated patients.
Investigators analyzed 1.513 million admissions at 155 hospitals across Canada from March 15, 2020, to May 28, 2022. The study included 51,679 adult admissions and 4,035 pediatric admissions for COVID-19. Although the share of COVID-19 admissions increased in the fifth and sixth waves, from Dec. 26, 2021, to March 19, 2022 – after the full vaccine rollout – to 7.73% from 2.47% in the previous four waves, the proportion of adults admitted to the intensive care unit was significantly lower, at 8.7% versus 21.8% (odds ratio, 0.35; 95% confidence interval, 0.32-0.36).
“The good thing about waves five and six was we were able to show the COVID cases tended to be less severe, but on the other hand, because the disease in the community was so much higher, the demands on the health care system were much higher than the previous waves,” study author Charles Frenette, MD, director of infection prevention and control at McGill University, Montreal, and chair of the study’s adult subgroup, said in an interview. “But here we were able to show the benefit of vaccinations, particularly the boosting dose, in protecting against those severe outcomes.”
The study, published in JAMA Network Open, used the Canadian Nosocomial Infection Surveillance Program database, which collects hospital data across Canada. It was activated in March 2020 to collect details on all COVID-19 admissions, co-author Nisha Thampi, MD, chair of the study’s pediatric subgroup, told this news organization.
“We’re now over 3 years into the pandemic, and CNISP continues to monitor COVID-19 as well as other pathogens in near real time,” said Dr. Thampi, an associate professor and infectious disease specialist at Children’s Hospital of Eastern Ontario.
“That’s a particular strength of this surveillance program as well. We would see this data on a biweekly basis, and that allows for [us] to implement timely protection and action.”
Tracing trends over six waves
The study tracked COVID-19 hospitalizations during six waves. The first lasted from March 15 to August 31, 2020, and the second lasted from Sept. 1, 2020, to Feb. 28, 2021. The wild-type variant was dominant during both waves. The third wave lasted from March 1 to June 30, 2021, and was marked by the mixed Alpha, Beta, and Gamma variants. The fourth wave lasted from July 1 to Dec. 25, 2021, when the Alpha variant was dominant. The Omicron variant dominated during waves five (Dec. 26, 2021, to March 19, 2022) and six (March 20 to May 28, 2022).
Hospitalizations reached a peak of 14,461 in wave five. ICU admissions, however, peaked at 2,164 during wave four, and all-cause deaths peaked at 1,663 during wave two.
The investigators also analyzed how unvaccinated patients fared, compared with the fully vaccinated and the fully vaccinated-plus (that is, patients with one or more additional doses). During waves five and six, unvaccinated patients were 4.3 times more likely to end up in the ICU than fully vaccinated patients and were 12.2 times more likely than fully vaccinated-plus patients. Likewise, the rate for all-cause in-hospital death for unvaccinated patients was 3.9 times greater than that for fully vaccinated patients and 15.1 times greater than that for fully vaccinated-plus patients.
The effect of vaccines emerged in waves three and four, said Dr. Frenette. “We started to see really, really significant protection and benefit from the vaccine, not only in incidence of admission but also in the incidence of complications of ICU care, ventilation, and mortality.”
Results for pediatric patients were similar to those for adults, Dr. Thampi noted. During waves five and six, overall admissions peaked, but the share of ICU admissions decreased to 9.4% from 18.1%, which was the rate during the previous four waves (OR, 0.47).
“What’s important is how pediatric hospitalizations changed over the course of the various waves,” said Dr. Thampi.
“Where we saw the highest admissions during the early Omicron dominance, we actually had the lowest numbers of hospitalizations with death and admissions into ICUs.”
Doing more with the data
David Fisman, MD, MPH, a professor of epidemiology at the University of Toronto, said, “This is a study that shows us how tremendously dramatic the effects of the COVID-19 vaccine were in terms of saving lives during the pandemic.” Dr. Fisman was not involved in the study.
But CNISP, which receives funding from Public Health Agency of Canada, could do more with the data it collects to better protect the public from COVID-19 and other nosocomial infections, Dr. Fisman said.
“The first problematic thing about this paper is that Canadians are paying for a surveillance system that looks at risks of acquiring infections, including COVID-19 infections, in the hospital, but that data is not fed back to the people paying for its production,” he said.
“So, Canadians don’t have the ability to really understand in real time how much risk they’re experiencing via going to the hospital for some other reason.”
The study was independently supported. Dr. Frenette and Dr. Thampi report no relevant financial relationships. Dr. Fisman has disclosed financial relationships with Pfizer, AstraZeneca, Sanofi, Seqirus, Merck, the Ontario Nurses Association, and the Elementary Teachers’ Federation of Ontario.
A version of this article first appeared on Medscape.com.