SAN ANTONIO – Of 196 U.S. youth who reported use of at least one prescribed stimulant in their lifetimes, 25% also said they used the drugs nonmedically, based on a survey of children and adolescents aged 10-17 years.

Another 5% of the youth surveyed reported exclusively nonmedical use of stimulants. The survey participants lived in six U.S. cities and their outlying areas.

“Parents of both users and nonusers should warn their children of the dangers of using others’ stimulants and giving their own stimulants to others,” concluded Linda B. Cottler, PhD, MPH of the University of Florida, and colleagues.

“Physicians and pharmacists should make users and their families aware of the need to take medications as prescribed and not to share medications with others,” they wrote in their research poster at the annual meeting of the College on Problems of Drug Dependence. “Continuous monitoring of these medications in the community should be a priority.”

Though prevalence research has shown increasing stimulant misuse among youth, little data exist for younger children, the researchers noted. They therefore conducted a survey of 1,777 youth aged 10-17 years from September to October 2018 in six cities in California, Texas, and Florida, the most populous U.S. states.

The participants included youth from urban, rural, and suburban areas of Los Angeles, Dallas, Houston, Tampa, Orlando, and Miami. Trained graduate students and professional raters approached the respondents in entertainment venues and obtained assent but did not require parental consent. The respondents received $30 for completing the survey.

A total of 11.1% of respondents reporting having used prescription stimulants in their lifetime, and 7.6% had done so in the past 30 days. Just under a third of those who used stimulants (30.1%) did so for nonmedical purposes, defined as taking the stimulant nonorally (except for the patch Daytrana), getting the stimulant from someone else, or taking more of the drug than prescribed.

A quarter of the respondents who used stimulants reported both medical use and nonmedical use. And 5.1% of these youths reported only using stimulants nonmedically.

Among those with any lifetime stimulant use, 13.8% reported nonoral administration, including 9.7% who snorted or sniffed the drugs, 4.1% who smoked them, and 1.0% who injected them. Just over half (51.8%) of those reporting nonoral use had also used prescription stimulants orally.

The likelihood of using stimulants nonmedically increased with age (P less than .0001). The researchers found no significant associations between nonmedical use and geography or race/ethnicity. Among 10- to 12-year-olds, 3.1% reported only medical use of stimulants, and 0.7% (2 of 286 respondents in this age group) reported any nonmedical use of stimulants.

Of those aged 13-15 years, 2.1% reported any nonmedical stimulant use.

Nonmedical stimulant use was reported by twice as many boys (67.8%) as girls (32.2%), though this finding may not be surprising as the majority of nonmedical users were also medical users and stimulants are prescribed more frequently to boys than to girls (P less than .0006).

The research was funded by Arbor Pharmaceuticals. The authors noted no conflicts of interest.

SAN ANTONIO – Of 196 U.S. youth who reported use of at least one prescribed stimulant in their lifetimes, 25% also said they used the drugs nonmedically, based on a survey of children and adolescents aged 10-17 years.

Another 5% of the youth surveyed reported exclusively nonmedical use of stimulants. The survey participants lived in six U.S. cities and their outlying areas.

“Parents of both users and nonusers should warn their children of the dangers of using others’ stimulants and giving their own stimulants to others,” concluded Linda B. Cottler, PhD, MPH of the University of Florida, and colleagues.

“Physicians and pharmacists should make users and their families aware of the need to take medications as prescribed and not to share medications with others,” they wrote in their research poster at the annual meeting of the College on Problems of Drug Dependence. “Continuous monitoring of these medications in the community should be a priority.”

Though prevalence research has shown increasing stimulant misuse among youth, little data exist for younger children, the researchers noted. They therefore conducted a survey of 1,777 youth aged 10-17 years from September to October 2018 in six cities in California, Texas, and Florida, the most populous U.S. states.

The participants included youth from urban, rural, and suburban areas of Los Angeles, Dallas, Houston, Tampa, Orlando, and Miami. Trained graduate students and professional raters approached the respondents in entertainment venues and obtained assent but did not require parental consent. The respondents received $30 for completing the survey.

A total of 11.1% of respondents reporting having used prescription stimulants in their lifetime, and 7.6% had done so in the past 30 days. Just under a third of those who used stimulants (30.1%) did so for nonmedical purposes, defined as taking the stimulant nonorally (except for the patch Daytrana), getting the stimulant from someone else, or taking more of the drug than prescribed.

A quarter of the respondents who used stimulants reported both medical use and nonmedical use. And 5.1% of these youths reported only using stimulants nonmedically.

Among those with any lifetime stimulant use, 13.8% reported nonoral administration, including 9.7% who snorted or sniffed the drugs, 4.1% who smoked them, and 1.0% who injected them. Just over half (51.8%) of those reporting nonoral use had also used prescription stimulants orally.

The likelihood of using stimulants nonmedically increased with age (P less than .0001). The researchers found no significant associations between nonmedical use and geography or race/ethnicity. Among 10- to 12-year-olds, 3.1% reported only medical use of stimulants, and 0.7% (2 of 286 respondents in this age group) reported any nonmedical use of stimulants.

Of those aged 13-15 years, 2.1% reported any nonmedical stimulant use.

Nonmedical stimulant use was reported by twice as many boys (67.8%) as girls (32.2%), though this finding may not be surprising as the majority of nonmedical users were also medical users and stimulants are prescribed more frequently to boys than to girls (P less than .0006).

The research was funded by Arbor Pharmaceuticals. The authors noted no conflicts of interest.

SAN ANTONIO – Of 196 U.S. youth who reported use of at least one prescribed stimulant in their lifetimes, 25% also said they used the drugs nonmedically, based on a survey of children and adolescents aged 10-17 years.

Another 5% of the youth surveyed reported exclusively nonmedical use of stimulants. The survey participants lived in six U.S. cities and their outlying areas.

“Parents of both users and nonusers should warn their children of the dangers of using others’ stimulants and giving their own stimulants to others,” concluded Linda B. Cottler, PhD, MPH of the University of Florida, and colleagues.

“Physicians and pharmacists should make users and their families aware of the need to take medications as prescribed and not to share medications with others,” they wrote in their research poster at the annual meeting of the College on Problems of Drug Dependence. “Continuous monitoring of these medications in the community should be a priority.”

Though prevalence research has shown increasing stimulant misuse among youth, little data exist for younger children, the researchers noted. They therefore conducted a survey of 1,777 youth aged 10-17 years from September to October 2018 in six cities in California, Texas, and Florida, the most populous U.S. states.

The participants included youth from urban, rural, and suburban areas of Los Angeles, Dallas, Houston, Tampa, Orlando, and Miami. Trained graduate students and professional raters approached the respondents in entertainment venues and obtained assent but did not require parental consent. The respondents received $30 for completing the survey.

A total of 11.1% of respondents reporting having used prescription stimulants in their lifetime, and 7.6% had done so in the past 30 days. Just under a third of those who used stimulants (30.1%) did so for nonmedical purposes, defined as taking the stimulant nonorally (except for the patch Daytrana), getting the stimulant from someone else, or taking more of the drug than prescribed.

A quarter of the respondents who used stimulants reported both medical use and nonmedical use. And 5.1% of these youths reported only using stimulants nonmedically.

Among those with any lifetime stimulant use, 13.8% reported nonoral administration, including 9.7% who snorted or sniffed the drugs, 4.1% who smoked them, and 1.0% who injected them. Just over half (51.8%) of those reporting nonoral use had also used prescription stimulants orally.

The likelihood of using stimulants nonmedically increased with age (P less than .0001). The researchers found no significant associations between nonmedical use and geography or race/ethnicity. Among 10- to 12-year-olds, 3.1% reported only medical use of stimulants, and 0.7% (2 of 286 respondents in this age group) reported any nonmedical use of stimulants.

Of those aged 13-15 years, 2.1% reported any nonmedical stimulant use.

Nonmedical stimulant use was reported by twice as many boys (67.8%) as girls (32.2%), though this finding may not be surprising as the majority of nonmedical users were also medical users and stimulants are prescribed more frequently to boys than to girls (P less than .0006).

The research was funded by Arbor Pharmaceuticals. The authors noted no conflicts of interest.

PHILADELPHIA – Diffusion-weighted MRI and the presence of at least five of seven clinical features may prove useful for determining which newly diagnosed patients with Parkinson’s disease are likely to have rapidly progressive disease, Frank M. Skidmore, MD, reported at the annual meeting of the American Academy of Neurology.

Patients with gray matter and axonal disease on initial imaging were found to have more aggressive disease associated with early gait dysfunction than were patients with primarily white matter and axonal disease, said Dr. Skidmore, associate professor of neurology at the University of Alabama, Birmingham.

Diffusion-weighted imaging provides a way to assess cellular fluid partitioning and directional information in gray and white matter. Thus, it has the potential to identify brainstem pathology that is associated with disease progression, he said. “Our approach provides a pathway towards using MR to detect early, prognostic, neurodegenerative changes in diseases of the brain.”

Dr. Skidmore and colleagues performed diffusion-weighted imaging on 101 patients with newly diagnosed Parkinson’s disease and 56 healthy controls. They found that Parkinson’s disease was associated with altered radial diffusion in white matter. Changes were observed mainly in the striatonigral tract and the substantia nigra. The investigators also noted atrophy in the cerebellar peduncle among patients with Parkinson’s disease.

At baseline, the patients who went on to have subsequent development of early postural instability and gait dysfunction had decreased intracellular fluid partitioning in the substantia nigra and the mesencephalic locomotor region, which are predominantly gray matter regions. These participants had a lower orientation diffusion index (ODI) and a lower estimate of cellularity, Dr. Skidmore said.

The researchers defined early gait dysfunction as the achievement of a Hoehn and Yahr score of 3 at least once while on medication during the first 5 years after Parkinson’s disease diagnosis. Follow-up was at least 5 years in 79 of the patients.

To identify clinical features associated with early postural instability and gait difficulty, the investigators examined data for 301 patients. In this population, Dr. Skidmore and colleagues identified 218 patients whose Hoehn and Yahr scores never exceeded 2 and 83 patients with at least one Hoehn and Yahr score of 3 or more. Using Bonferroni correction, they examined Unified Parkinson’s Disease Rating Scale (UPDRS) data for all patients to identify significant differences between these two groups. Seven items distinguished patients who developed early postural instability and gait difficulty. They included lightheadedness, fatigue, difficulty walking, ability to rise from a chair, and postural problems. The seven-item scale was superior to the Unified Parkinson’s Disease Rating Scale (UPDRS) at predicting which newly diagnosed patients would develop early postural and gait difficulties

[email protected]

SOURCE: Skidmore F et al. AANN 2019, Abstract S41.004.

PHILADELPHIA – Diffusion-weighted MRI and the presence of at least five of seven clinical features may prove useful for determining which newly diagnosed patients with Parkinson’s disease are likely to have rapidly progressive disease, Frank M. Skidmore, MD, reported at the annual meeting of the American Academy of Neurology.

Patients with gray matter and axonal disease on initial imaging were found to have more aggressive disease associated with early gait dysfunction than were patients with primarily white matter and axonal disease, said Dr. Skidmore, associate professor of neurology at the University of Alabama, Birmingham.

Diffusion-weighted imaging provides a way to assess cellular fluid partitioning and directional information in gray and white matter. Thus, it has the potential to identify brainstem pathology that is associated with disease progression, he said. “Our approach provides a pathway towards using MR to detect early, prognostic, neurodegenerative changes in diseases of the brain.”

Dr. Skidmore and colleagues performed diffusion-weighted imaging on 101 patients with newly diagnosed Parkinson’s disease and 56 healthy controls. They found that Parkinson’s disease was associated with altered radial diffusion in white matter. Changes were observed mainly in the striatonigral tract and the substantia nigra. The investigators also noted atrophy in the cerebellar peduncle among patients with Parkinson’s disease.

At baseline, the patients who went on to have subsequent development of early postural instability and gait dysfunction had decreased intracellular fluid partitioning in the substantia nigra and the mesencephalic locomotor region, which are predominantly gray matter regions. These participants had a lower orientation diffusion index (ODI) and a lower estimate of cellularity, Dr. Skidmore said.

The researchers defined early gait dysfunction as the achievement of a Hoehn and Yahr score of 3 at least once while on medication during the first 5 years after Parkinson’s disease diagnosis. Follow-up was at least 5 years in 79 of the patients.

To identify clinical features associated with early postural instability and gait difficulty, the investigators examined data for 301 patients. In this population, Dr. Skidmore and colleagues identified 218 patients whose Hoehn and Yahr scores never exceeded 2 and 83 patients with at least one Hoehn and Yahr score of 3 or more. Using Bonferroni correction, they examined Unified Parkinson’s Disease Rating Scale (UPDRS) data for all patients to identify significant differences between these two groups. Seven items distinguished patients who developed early postural instability and gait difficulty. They included lightheadedness, fatigue, difficulty walking, ability to rise from a chair, and postural problems. The seven-item scale was superior to the Unified Parkinson’s Disease Rating Scale (UPDRS) at predicting which newly diagnosed patients would develop early postural and gait difficulties

[email protected]

SOURCE: Skidmore F et al. AANN 2019, Abstract S41.004.

PHILADELPHIA – Diffusion-weighted MRI and the presence of at least five of seven clinical features may prove useful for determining which newly diagnosed patients with Parkinson’s disease are likely to have rapidly progressive disease, Frank M. Skidmore, MD, reported at the annual meeting of the American Academy of Neurology.

Patients with gray matter and axonal disease on initial imaging were found to have more aggressive disease associated with early gait dysfunction than were patients with primarily white matter and axonal disease, said Dr. Skidmore, associate professor of neurology at the University of Alabama, Birmingham.

Diffusion-weighted imaging provides a way to assess cellular fluid partitioning and directional information in gray and white matter. Thus, it has the potential to identify brainstem pathology that is associated with disease progression, he said. “Our approach provides a pathway towards using MR to detect early, prognostic, neurodegenerative changes in diseases of the brain.”

Dr. Skidmore and colleagues performed diffusion-weighted imaging on 101 patients with newly diagnosed Parkinson’s disease and 56 healthy controls. They found that Parkinson’s disease was associated with altered radial diffusion in white matter. Changes were observed mainly in the striatonigral tract and the substantia nigra. The investigators also noted atrophy in the cerebellar peduncle among patients with Parkinson’s disease.

At baseline, the patients who went on to have subsequent development of early postural instability and gait dysfunction had decreased intracellular fluid partitioning in the substantia nigra and the mesencephalic locomotor region, which are predominantly gray matter regions. These participants had a lower orientation diffusion index (ODI) and a lower estimate of cellularity, Dr. Skidmore said.

The researchers defined early gait dysfunction as the achievement of a Hoehn and Yahr score of 3 at least once while on medication during the first 5 years after Parkinson’s disease diagnosis. Follow-up was at least 5 years in 79 of the patients.

To identify clinical features associated with early postural instability and gait difficulty, the investigators examined data for 301 patients. In this population, Dr. Skidmore and colleagues identified 218 patients whose Hoehn and Yahr scores never exceeded 2 and 83 patients with at least one Hoehn and Yahr score of 3 or more. Using Bonferroni correction, they examined Unified Parkinson’s Disease Rating Scale (UPDRS) data for all patients to identify significant differences between these two groups. Seven items distinguished patients who developed early postural instability and gait difficulty. They included lightheadedness, fatigue, difficulty walking, ability to rise from a chair, and postural problems. The seven-item scale was superior to the Unified Parkinson’s Disease Rating Scale (UPDRS) at predicting which newly diagnosed patients would develop early postural and gait difficulties

[email protected]

SOURCE: Skidmore F et al. AANN 2019, Abstract S41.004.

An entire year of dual-antiplatelet therapy may be no better at limiting ischemic events or death than a shorter course for patients who have undergone percutaneous coronary intervention with a drug-eluting stent.

The two trials, which tested dual-antiplatelet therapy (DAPT) regimens of 3 months and 1 month, are also noteworthy for giving a P2Y12 inhibitor after DAPT instead of aspirin monotherapy, which is a more common approach. Each randomized about 3,000 patients.

According to lead author Joo-Yong Hahn, MD, of Sungkyunkwan University in Seoul, South Korea, and colleagues, who conducted the first trial (SMART-CHOICE), both shorter and longer DAPT regimens with aspirin have been associated with shortcomings.

Specifically, shorter duration DAPT with subsequent aspirin monotherapy carries increased risks of MI and stent thrombosis, the investigators wrote. “Conversely, prolonged DAPT increases the risk of bleeding, which offsets the benefit from reducing recurrent ischemic events. Therefore, neither prolonged DAPT nor short-duration DAPT followed by aspirin monotherapy is fully satisfactory.” Because of these shortcomings, the investigators suggested that developing novel strategies “is of paramount importance.”

SMART-CHOICE

The multicenter trial by Dr. Hahn and colleagues, conducted in South Korea, involved 2,993 patients undergoing percutaneous coronary intervention with drug-eluting stents. Patients were randomized to receive either standard DAPT with aspirin and a P2Y12 inhibitor for 12 months, or aspirin plus a P2Y12 inhibitor for 3 months followed by 9 months of P2Y12 monotherapy. Patients were stratified by enrolling center, clinical presentation, type of stent, and type of P2Y12 therapy. Stents were limited to those eluting cobalt-chromium everolimus (Xience Prime, Xience Expedition, or Xience Alpine; Abbott Vascular), platinum-chromium everolimus (Promus Element, Promus Premier, or SYNERGY; Boston Scientific), or sirolimus (Orsiro; Biotronik). Acceptable P2Y12 therapies were clopidogrel, ticagrelor, and prasugrel. The primary endpoint was a composite of major adverse cerebrovascular and cardiac events, including stroke, MI, or all-cause death, at 12 months after percutaneous coronary intervention. A number of secondary endpoints were also evaluated, such as bleeding rate, stent thrombosis, and the individual components of the primary endpoint.

Almost all patients (95%) in the DAPT group adhered to the study protocol, while a smaller proportion (79%) followed P2Y12 monotherapy as described. Still, for both groups, more than 97% of patients completed 1-year follow-up. Primary endpoint analysis showed that the cumulative rate of major adverse cerebrovascular and cardiac events was similar between both groups, at 2.9% in the P2Y12 group versus 2.5% in the DAPT group, which was statistically significant for noninferiority (P = .007). Per-protocol analysis supported this finding.

Similarly, the components of the primary endpoint – stroke, MI, or all-cause death – did not vary significantly between groups. No significant difference was detected for the risk of stent thrombosis. Although the major bleeding rate was comparable between groups, the overall bleeding rate was significantly lower in the P2Y12 inhibitor group than the DAPT group (2.0% vs. 3.4%; P = .02); this finding also was supported by per-protocol analysis (1.8% vs. 3.1%; P = .04).

The investigators proposed several explanations for the results. “First, aspirin might provide little additional inhibition of platelet aggregation in the presence of a P2Y12 inhibitor. … Second, the risk of bleeding was significantly lower with P2Y12 inhibitor monotherapy than with DAPT in the present study.”

They noted that second-generation drug-eluting stents were used, which have been shown to significantly reduce MI and stent thrombosis, compared with first-generation products.

STOPDAPT-2

This study, led by Hirotoshi Watanabe, MD, of Kyoto University, and colleagues, followed a similar design, but with an even shorter duration of DAPT in the treatment arm, at 1 month, and stricter criteria for the stent, which was limited to one cobalt-chromium everolimus-eluting model (Xience Series; Abbott Vascular). During the first month of the trial, all patients received aspirin plus either clopidogrel or prasugrel; thereafter, patients in the 12-month group received aspirin and clopidogrel while the 1-month group was given clopidogrel alone.

The primary endpoint was a composite of cardiovascular and bleeding events, including MI, stent thrombosis, cardiovascular death, stroke, and major or minor bleeding. Secondary endpoints included these components individually, as well as a list of other cardiovascular and bleeding measures.

Similarly to the first trial, Dr. Watanabe and colleagues found that the shorter DAPT protocol was noninferior to standard DAPT and associated with a lower rate of bleeding events. The primary endpoint occurred in 2.4% of the 1-month DAPT group, compared with 3.7% of the 12-month DAPT group, thereby meeting noninferiority criteria (P less than .001). This finding was confirmed in the per-protocol population. The 1-month DAPT regimen was significantly associated with fewer major bleeding events than the 12-month protocol (0.41% vs. 1.54%), demonstrating superiority (P = .004). In addition, seven other measures of bleeding frequency were lower in the 1-month DAPT group than the standard DAPT group, including Bleeding Academic Research Consortium type 3 or 5 criteria, and Global Use of Strategies to Open Occluded Arteries moderate or severe criteria.

Dr. Watanabe and colleagues provided some insight into these findings and described clinical implications. “The benefit [of the 1-month DAPT regimen] was driven by a significant reduction of bleeding events without an increase in cardiovascular events,” they wrote. “Therefore, the very short DAPT duration of 1 month would be a potential option even in patients without high bleeding risk. Given the very low rates of stent thrombosis in studies using contemporary drug-eluting stents, avoiding bleeding with de-escalation of antiplatelet therapy may be more important than attempting further reduction of stent thrombosis with intensive antiplatelet therapy.”

SMART-CHOICE was funded by the Korean Society of Interventional Cardiology, Biotronik, Abbott Vascular, and Boston Scientific. Dr. Hahn and colleagues reported receiving additional financial relationships with AstraZeneca, Daiichi Sankyo, Sanofi-Aventis, and others. STOPDAPT-2 was funded by Abbott Vascular. Dr. Watanabe and colleagues reported receiving additional funding from Daiichi Sankyo, Otsuka Pharmaceutical, Kowa Pharmaceuticals, and others.

SOURCES: Watanabe H et al. JAMA. 2019 Jun 25. doi: 10.1001/jama.2019.8145; Hahn J-Y et al. JAMA. 2019 Jun 25. doi: 10.1001/jama.2019.8146.

An entire year of dual-antiplatelet therapy may be no better at limiting ischemic events or death than a shorter course for patients who have undergone percutaneous coronary intervention with a drug-eluting stent.

The two trials, which tested dual-antiplatelet therapy (DAPT) regimens of 3 months and 1 month, are also noteworthy for giving a P2Y12 inhibitor after DAPT instead of aspirin monotherapy, which is a more common approach. Each randomized about 3,000 patients.

According to lead author Joo-Yong Hahn, MD, of Sungkyunkwan University in Seoul, South Korea, and colleagues, who conducted the first trial (SMART-CHOICE), both shorter and longer DAPT regimens with aspirin have been associated with shortcomings.

Specifically, shorter duration DAPT with subsequent aspirin monotherapy carries increased risks of MI and stent thrombosis, the investigators wrote. “Conversely, prolonged DAPT increases the risk of bleeding, which offsets the benefit from reducing recurrent ischemic events. Therefore, neither prolonged DAPT nor short-duration DAPT followed by aspirin monotherapy is fully satisfactory.” Because of these shortcomings, the investigators suggested that developing novel strategies “is of paramount importance.”

SMART-CHOICE

The multicenter trial by Dr. Hahn and colleagues, conducted in South Korea, involved 2,993 patients undergoing percutaneous coronary intervention with drug-eluting stents. Patients were randomized to receive either standard DAPT with aspirin and a P2Y12 inhibitor for 12 months, or aspirin plus a P2Y12 inhibitor for 3 months followed by 9 months of P2Y12 monotherapy. Patients were stratified by enrolling center, clinical presentation, type of stent, and type of P2Y12 therapy. Stents were limited to those eluting cobalt-chromium everolimus (Xience Prime, Xience Expedition, or Xience Alpine; Abbott Vascular), platinum-chromium everolimus (Promus Element, Promus Premier, or SYNERGY; Boston Scientific), or sirolimus (Orsiro; Biotronik). Acceptable P2Y12 therapies were clopidogrel, ticagrelor, and prasugrel. The primary endpoint was a composite of major adverse cerebrovascular and cardiac events, including stroke, MI, or all-cause death, at 12 months after percutaneous coronary intervention. A number of secondary endpoints were also evaluated, such as bleeding rate, stent thrombosis, and the individual components of the primary endpoint.

Almost all patients (95%) in the DAPT group adhered to the study protocol, while a smaller proportion (79%) followed P2Y12 monotherapy as described. Still, for both groups, more than 97% of patients completed 1-year follow-up. Primary endpoint analysis showed that the cumulative rate of major adverse cerebrovascular and cardiac events was similar between both groups, at 2.9% in the P2Y12 group versus 2.5% in the DAPT group, which was statistically significant for noninferiority (P = .007). Per-protocol analysis supported this finding.

Similarly, the components of the primary endpoint – stroke, MI, or all-cause death – did not vary significantly between groups. No significant difference was detected for the risk of stent thrombosis. Although the major bleeding rate was comparable between groups, the overall bleeding rate was significantly lower in the P2Y12 inhibitor group than the DAPT group (2.0% vs. 3.4%; P = .02); this finding also was supported by per-protocol analysis (1.8% vs. 3.1%; P = .04).

The investigators proposed several explanations for the results. “First, aspirin might provide little additional inhibition of platelet aggregation in the presence of a P2Y12 inhibitor. … Second, the risk of bleeding was significantly lower with P2Y12 inhibitor monotherapy than with DAPT in the present study.”

They noted that second-generation drug-eluting stents were used, which have been shown to significantly reduce MI and stent thrombosis, compared with first-generation products.

STOPDAPT-2

This study, led by Hirotoshi Watanabe, MD, of Kyoto University, and colleagues, followed a similar design, but with an even shorter duration of DAPT in the treatment arm, at 1 month, and stricter criteria for the stent, which was limited to one cobalt-chromium everolimus-eluting model (Xience Series; Abbott Vascular). During the first month of the trial, all patients received aspirin plus either clopidogrel or prasugrel; thereafter, patients in the 12-month group received aspirin and clopidogrel while the 1-month group was given clopidogrel alone.

The primary endpoint was a composite of cardiovascular and bleeding events, including MI, stent thrombosis, cardiovascular death, stroke, and major or minor bleeding. Secondary endpoints included these components individually, as well as a list of other cardiovascular and bleeding measures.

Similarly to the first trial, Dr. Watanabe and colleagues found that the shorter DAPT protocol was noninferior to standard DAPT and associated with a lower rate of bleeding events. The primary endpoint occurred in 2.4% of the 1-month DAPT group, compared with 3.7% of the 12-month DAPT group, thereby meeting noninferiority criteria (P less than .001). This finding was confirmed in the per-protocol population. The 1-month DAPT regimen was significantly associated with fewer major bleeding events than the 12-month protocol (0.41% vs. 1.54%), demonstrating superiority (P = .004). In addition, seven other measures of bleeding frequency were lower in the 1-month DAPT group than the standard DAPT group, including Bleeding Academic Research Consortium type 3 or 5 criteria, and Global Use of Strategies to Open Occluded Arteries moderate or severe criteria.

Dr. Watanabe and colleagues provided some insight into these findings and described clinical implications. “The benefit [of the 1-month DAPT regimen] was driven by a significant reduction of bleeding events without an increase in cardiovascular events,” they wrote. “Therefore, the very short DAPT duration of 1 month would be a potential option even in patients without high bleeding risk. Given the very low rates of stent thrombosis in studies using contemporary drug-eluting stents, avoiding bleeding with de-escalation of antiplatelet therapy may be more important than attempting further reduction of stent thrombosis with intensive antiplatelet therapy.”

SMART-CHOICE was funded by the Korean Society of Interventional Cardiology, Biotronik, Abbott Vascular, and Boston Scientific. Dr. Hahn and colleagues reported receiving additional financial relationships with AstraZeneca, Daiichi Sankyo, Sanofi-Aventis, and others. STOPDAPT-2 was funded by Abbott Vascular. Dr. Watanabe and colleagues reported receiving additional funding from Daiichi Sankyo, Otsuka Pharmaceutical, Kowa Pharmaceuticals, and others.

SOURCES: Watanabe H et al. JAMA. 2019 Jun 25. doi: 10.1001/jama.2019.8145; Hahn J-Y et al. JAMA. 2019 Jun 25. doi: 10.1001/jama.2019.8146.

An entire year of dual-antiplatelet therapy may be no better at limiting ischemic events or death than a shorter course for patients who have undergone percutaneous coronary intervention with a drug-eluting stent.

The two trials, which tested dual-antiplatelet therapy (DAPT) regimens of 3 months and 1 month, are also noteworthy for giving a P2Y12 inhibitor after DAPT instead of aspirin monotherapy, which is a more common approach. Each randomized about 3,000 patients.

According to lead author Joo-Yong Hahn, MD, of Sungkyunkwan University in Seoul, South Korea, and colleagues, who conducted the first trial (SMART-CHOICE), both shorter and longer DAPT regimens with aspirin have been associated with shortcomings.

Specifically, shorter duration DAPT with subsequent aspirin monotherapy carries increased risks of MI and stent thrombosis, the investigators wrote. “Conversely, prolonged DAPT increases the risk of bleeding, which offsets the benefit from reducing recurrent ischemic events. Therefore, neither prolonged DAPT nor short-duration DAPT followed by aspirin monotherapy is fully satisfactory.” Because of these shortcomings, the investigators suggested that developing novel strategies “is of paramount importance.”

SMART-CHOICE

The multicenter trial by Dr. Hahn and colleagues, conducted in South Korea, involved 2,993 patients undergoing percutaneous coronary intervention with drug-eluting stents. Patients were randomized to receive either standard DAPT with aspirin and a P2Y12 inhibitor for 12 months, or aspirin plus a P2Y12 inhibitor for 3 months followed by 9 months of P2Y12 monotherapy. Patients were stratified by enrolling center, clinical presentation, type of stent, and type of P2Y12 therapy. Stents were limited to those eluting cobalt-chromium everolimus (Xience Prime, Xience Expedition, or Xience Alpine; Abbott Vascular), platinum-chromium everolimus (Promus Element, Promus Premier, or SYNERGY; Boston Scientific), or sirolimus (Orsiro; Biotronik). Acceptable P2Y12 therapies were clopidogrel, ticagrelor, and prasugrel. The primary endpoint was a composite of major adverse cerebrovascular and cardiac events, including stroke, MI, or all-cause death, at 12 months after percutaneous coronary intervention. A number of secondary endpoints were also evaluated, such as bleeding rate, stent thrombosis, and the individual components of the primary endpoint.

Almost all patients (95%) in the DAPT group adhered to the study protocol, while a smaller proportion (79%) followed P2Y12 monotherapy as described. Still, for both groups, more than 97% of patients completed 1-year follow-up. Primary endpoint analysis showed that the cumulative rate of major adverse cerebrovascular and cardiac events was similar between both groups, at 2.9% in the P2Y12 group versus 2.5% in the DAPT group, which was statistically significant for noninferiority (P = .007). Per-protocol analysis supported this finding.

Similarly, the components of the primary endpoint – stroke, MI, or all-cause death – did not vary significantly between groups. No significant difference was detected for the risk of stent thrombosis. Although the major bleeding rate was comparable between groups, the overall bleeding rate was significantly lower in the P2Y12 inhibitor group than the DAPT group (2.0% vs. 3.4%; P = .02); this finding also was supported by per-protocol analysis (1.8% vs. 3.1%; P = .04).

The investigators proposed several explanations for the results. “First, aspirin might provide little additional inhibition of platelet aggregation in the presence of a P2Y12 inhibitor. … Second, the risk of bleeding was significantly lower with P2Y12 inhibitor monotherapy than with DAPT in the present study.”

They noted that second-generation drug-eluting stents were used, which have been shown to significantly reduce MI and stent thrombosis, compared with first-generation products.

STOPDAPT-2

This study, led by Hirotoshi Watanabe, MD, of Kyoto University, and colleagues, followed a similar design, but with an even shorter duration of DAPT in the treatment arm, at 1 month, and stricter criteria for the stent, which was limited to one cobalt-chromium everolimus-eluting model (Xience Series; Abbott Vascular). During the first month of the trial, all patients received aspirin plus either clopidogrel or prasugrel; thereafter, patients in the 12-month group received aspirin and clopidogrel while the 1-month group was given clopidogrel alone.

The primary endpoint was a composite of cardiovascular and bleeding events, including MI, stent thrombosis, cardiovascular death, stroke, and major or minor bleeding. Secondary endpoints included these components individually, as well as a list of other cardiovascular and bleeding measures.

Similarly to the first trial, Dr. Watanabe and colleagues found that the shorter DAPT protocol was noninferior to standard DAPT and associated with a lower rate of bleeding events. The primary endpoint occurred in 2.4% of the 1-month DAPT group, compared with 3.7% of the 12-month DAPT group, thereby meeting noninferiority criteria (P less than .001). This finding was confirmed in the per-protocol population. The 1-month DAPT regimen was significantly associated with fewer major bleeding events than the 12-month protocol (0.41% vs. 1.54%), demonstrating superiority (P = .004). In addition, seven other measures of bleeding frequency were lower in the 1-month DAPT group than the standard DAPT group, including Bleeding Academic Research Consortium type 3 or 5 criteria, and Global Use of Strategies to Open Occluded Arteries moderate or severe criteria.

Dr. Watanabe and colleagues provided some insight into these findings and described clinical implications. “The benefit [of the 1-month DAPT regimen] was driven by a significant reduction of bleeding events without an increase in cardiovascular events,” they wrote. “Therefore, the very short DAPT duration of 1 month would be a potential option even in patients without high bleeding risk. Given the very low rates of stent thrombosis in studies using contemporary drug-eluting stents, avoiding bleeding with de-escalation of antiplatelet therapy may be more important than attempting further reduction of stent thrombosis with intensive antiplatelet therapy.”

SMART-CHOICE was funded by the Korean Society of Interventional Cardiology, Biotronik, Abbott Vascular, and Boston Scientific. Dr. Hahn and colleagues reported receiving additional financial relationships with AstraZeneca, Daiichi Sankyo, Sanofi-Aventis, and others. STOPDAPT-2 was funded by Abbott Vascular. Dr. Watanabe and colleagues reported receiving additional funding from Daiichi Sankyo, Otsuka Pharmaceutical, Kowa Pharmaceuticals, and others.

SOURCES: Watanabe H et al. JAMA. 2019 Jun 25. doi: 10.1001/jama.2019.8145; Hahn J-Y et al. JAMA. 2019 Jun 25. doi: 10.1001/jama.2019.8146.

Background: Transient elevations in blood pressure are common among adult patients, yet there are no data or guidelines that support long-term medication changes based on these readings. Tight control of blood pressure is likely to improve outcomes among patients with heart failure), myocardial infarction, and stroke. Patients with reduced life expectancy, dementia, or metastatic cancer are less likely to benefit from tight control.

A total of 2,074 (14%) patients were discharged with an intensified hypertension regimen (additional medication or higher dose). While both elevated inpatient and outpatient blood pressures were predictive of intensification, the association with elevated inpatient blood pressure was much stronger (odds ratio, 3.66; 95% confidence interval, 3.29-4.08) than it was with elevated outpatient blood pressure (OR, 1.75; 95% CI, 1.58-1.93).

In a multivariate regression analysis, the investigators found no significant differences in intensification by life expectancy (P = .07), diagnosis of dementia (P = .95), or metastatic malignancy (P = .13). There was a small increased probability of intensification among patients with heart failure, but no such difference for patients with history of MI (P = .53), stroke (P = .37), or renal disease (P = .73).

The generalizability of this trial may be limited given the cohort was predominantly male (97%), white (77%), and 53% had at least four major comorbidities.

Bottom line: Intensification of antihypertensive therapy at discharge is often driven by inpatient blood pressure readings rather than the broader context of their disease, such as prior long-term outpatient blood pressure control or major comorbidities.

Citation: Anderson TS et al. Intensification of older adults’ outpatient blood pressure treatment at hospital discharge: A national retrospective cohort study. BMJ. 2018:362:k3503.

Dr. Holzer is an assistant professor of medicine in the division of hospital medicine at Mount Sinai Hospital, New York.

Background: Transient elevations in blood pressure are common among adult patients, yet there are no data or guidelines that support long-term medication changes based on these readings. Tight control of blood pressure is likely to improve outcomes among patients with heart failure), myocardial infarction, and stroke. Patients with reduced life expectancy, dementia, or metastatic cancer are less likely to benefit from tight control.

A total of 2,074 (14%) patients were discharged with an intensified hypertension regimen (additional medication or higher dose). While both elevated inpatient and outpatient blood pressures were predictive of intensification, the association with elevated inpatient blood pressure was much stronger (odds ratio, 3.66; 95% confidence interval, 3.29-4.08) than it was with elevated outpatient blood pressure (OR, 1.75; 95% CI, 1.58-1.93).

In a multivariate regression analysis, the investigators found no significant differences in intensification by life expectancy (P = .07), diagnosis of dementia (P = .95), or metastatic malignancy (P = .13). There was a small increased probability of intensification among patients with heart failure, but no such difference for patients with history of MI (P = .53), stroke (P = .37), or renal disease (P = .73).

The generalizability of this trial may be limited given the cohort was predominantly male (97%), white (77%), and 53% had at least four major comorbidities.

Bottom line: Intensification of antihypertensive therapy at discharge is often driven by inpatient blood pressure readings rather than the broader context of their disease, such as prior long-term outpatient blood pressure control or major comorbidities.

Citation: Anderson TS et al. Intensification of older adults’ outpatient blood pressure treatment at hospital discharge: A national retrospective cohort study. BMJ. 2018:362:k3503.

Dr. Holzer is an assistant professor of medicine in the division of hospital medicine at Mount Sinai Hospital, New York.

Background: Transient elevations in blood pressure are common among adult patients, yet there are no data or guidelines that support long-term medication changes based on these readings. Tight control of blood pressure is likely to improve outcomes among patients with heart failure), myocardial infarction, and stroke. Patients with reduced life expectancy, dementia, or metastatic cancer are less likely to benefit from tight control.

A total of 2,074 (14%) patients were discharged with an intensified hypertension regimen (additional medication or higher dose). While both elevated inpatient and outpatient blood pressures were predictive of intensification, the association with elevated inpatient blood pressure was much stronger (odds ratio, 3.66; 95% confidence interval, 3.29-4.08) than it was with elevated outpatient blood pressure (OR, 1.75; 95% CI, 1.58-1.93).

In a multivariate regression analysis, the investigators found no significant differences in intensification by life expectancy (P = .07), diagnosis of dementia (P = .95), or metastatic malignancy (P = .13). There was a small increased probability of intensification among patients with heart failure, but no such difference for patients with history of MI (P = .53), stroke (P = .37), or renal disease (P = .73).

The generalizability of this trial may be limited given the cohort was predominantly male (97%), white (77%), and 53% had at least four major comorbidities.

Bottom line: Intensification of antihypertensive therapy at discharge is often driven by inpatient blood pressure readings rather than the broader context of their disease, such as prior long-term outpatient blood pressure control or major comorbidities.

Citation: Anderson TS et al. Intensification of older adults’ outpatient blood pressure treatment at hospital discharge: A national retrospective cohort study. BMJ. 2018:362:k3503.

Dr. Holzer is an assistant professor of medicine in the division of hospital medicine at Mount Sinai Hospital, New York.

Activation of hedgehog (Hh) signaling could predict early disease progression in chronic lymphocytic leukemia (CLL) and offer a new therapeutic target, according to investigators.

Approximately 11% of treatment-naive patients had mutations associated with Hh signaling, reported lead author Emanuela M. Ghia, PhD, of the University of California, San Diego, and colleagues. In addition to early progression, Hh signaling was associated with expression of GLI1, which could be a future therapeutic target. In support of this possibility, in vitro experimentation with a GLI1 inhibitor showed high cytotoxicity for GLI1-positive CLL cells.

“Targeting GLI1 could block ligand-independent and ligand-dependent Hh pathway activation and perhaps overcome the apparent resistance to SMO inhibitors,” the investigators wrote in Blood.

Using the HALT Pan-Leukemia Gene Panel, which includes 103 genes, the investigators tested for mutations in cell samples from 841 patients with treatment-naive CLL. Specifically, the investigators focused on mutations that did not map to seven well-known signaling/metabolic pathways, such as Wnt and Notch.

This strategy revealed that 89 patients (11%) had nonsynonymous mutations in genes that drive Hh signaling. These mutations were highly associated with GLI1 expression (x² test; P less than .0001), which stands to reason, as GLI1 is the main effector of the Hh signaling pathway. Of note, 62 of the 161 patients (38%) who did not test positive for an Hh pathway mutation still tested positive for GLI1, suggesting that they had Hh pathway activation, albeit without an identifiable mutational cause.

These findings are clinically significant, as GLI1 overexpression has been linked to numerous types of cancer and is an adverse prognostic indicator for acute myeloid leukemia and several carcinomas, the investigators wrote.

Considering these associations with other cancer types, the investigators looked for a relationship between GLI1 expression and outcomes in CLL. Comparing 103 patients with GLI1-positive disease with 107 GLI-negative patients revealed that GLI1 positivity was significantly associated with shorter median treatment-free survival (4.7 vs. 6.4 years; P = .002). Additional analysis showed that this prognostic relationship was present regardless of IgVH mutational status.

Based on these findings, the investigators concluded that “[a]ctivation of the Hh pathway can strongly influence disease progression in CLL.”

Two additional tests showed that GLI1-positivity was associated with cell survival. First, silencing GLI1 with a GLI1-specific small interfering RNA led to decreased cell viability. Second, GANT61, a small molecule inhibitor of GLI1, was highly cytotoxic for GLI1-positive cells. According to the investigators, these findings suggest that GLI1 could be a future therapeutic target.

“[T]his report shows that the Hh pathway frequently is activated in CLL and associated with relatively rapid disease progression, while identifying a new avenue for therapeutic intervention for patients with this disease,” they concluded.

The study was funded by the National Institutes of Health, the Cancer Stem Cell Consortium, the Canadian Institutes of Health Research, the Ontario Institute for Cancer Research, and other groups. The investigators reported having no competing financial interests.

SOURCE: Ghia EM et al. Blood. 2019 Jun 20;133(25):2651-63.

Activation of hedgehog (Hh) signaling could predict early disease progression in chronic lymphocytic leukemia (CLL) and offer a new therapeutic target, according to investigators.

Approximately 11% of treatment-naive patients had mutations associated with Hh signaling, reported lead author Emanuela M. Ghia, PhD, of the University of California, San Diego, and colleagues. In addition to early progression, Hh signaling was associated with expression of GLI1, which could be a future therapeutic target. In support of this possibility, in vitro experimentation with a GLI1 inhibitor showed high cytotoxicity for GLI1-positive CLL cells.

“Targeting GLI1 could block ligand-independent and ligand-dependent Hh pathway activation and perhaps overcome the apparent resistance to SMO inhibitors,” the investigators wrote in Blood.

Using the HALT Pan-Leukemia Gene Panel, which includes 103 genes, the investigators tested for mutations in cell samples from 841 patients with treatment-naive CLL. Specifically, the investigators focused on mutations that did not map to seven well-known signaling/metabolic pathways, such as Wnt and Notch.

This strategy revealed that 89 patients (11%) had nonsynonymous mutations in genes that drive Hh signaling. These mutations were highly associated with GLI1 expression (x² test; P less than .0001), which stands to reason, as GLI1 is the main effector of the Hh signaling pathway. Of note, 62 of the 161 patients (38%) who did not test positive for an Hh pathway mutation still tested positive for GLI1, suggesting that they had Hh pathway activation, albeit without an identifiable mutational cause.

These findings are clinically significant, as GLI1 overexpression has been linked to numerous types of cancer and is an adverse prognostic indicator for acute myeloid leukemia and several carcinomas, the investigators wrote.

Considering these associations with other cancer types, the investigators looked for a relationship between GLI1 expression and outcomes in CLL. Comparing 103 patients with GLI1-positive disease with 107 GLI-negative patients revealed that GLI1 positivity was significantly associated with shorter median treatment-free survival (4.7 vs. 6.4 years; P = .002). Additional analysis showed that this prognostic relationship was present regardless of IgVH mutational status.

Based on these findings, the investigators concluded that “[a]ctivation of the Hh pathway can strongly influence disease progression in CLL.”

Two additional tests showed that GLI1-positivity was associated with cell survival. First, silencing GLI1 with a GLI1-specific small interfering RNA led to decreased cell viability. Second, GANT61, a small molecule inhibitor of GLI1, was highly cytotoxic for GLI1-positive cells. According to the investigators, these findings suggest that GLI1 could be a future therapeutic target.

“[T]his report shows that the Hh pathway frequently is activated in CLL and associated with relatively rapid disease progression, while identifying a new avenue for therapeutic intervention for patients with this disease,” they concluded.

The study was funded by the National Institutes of Health, the Cancer Stem Cell Consortium, the Canadian Institutes of Health Research, the Ontario Institute for Cancer Research, and other groups. The investigators reported having no competing financial interests.

SOURCE: Ghia EM et al. Blood. 2019 Jun 20;133(25):2651-63.

Activation of hedgehog (Hh) signaling could predict early disease progression in chronic lymphocytic leukemia (CLL) and offer a new therapeutic target, according to investigators.

Approximately 11% of treatment-naive patients had mutations associated with Hh signaling, reported lead author Emanuela M. Ghia, PhD, of the University of California, San Diego, and colleagues. In addition to early progression, Hh signaling was associated with expression of GLI1, which could be a future therapeutic target. In support of this possibility, in vitro experimentation with a GLI1 inhibitor showed high cytotoxicity for GLI1-positive CLL cells.

“Targeting GLI1 could block ligand-independent and ligand-dependent Hh pathway activation and perhaps overcome the apparent resistance to SMO inhibitors,” the investigators wrote in Blood.

Using the HALT Pan-Leukemia Gene Panel, which includes 103 genes, the investigators tested for mutations in cell samples from 841 patients with treatment-naive CLL. Specifically, the investigators focused on mutations that did not map to seven well-known signaling/metabolic pathways, such as Wnt and Notch.

This strategy revealed that 89 patients (11%) had nonsynonymous mutations in genes that drive Hh signaling. These mutations were highly associated with GLI1 expression (x² test; P less than .0001), which stands to reason, as GLI1 is the main effector of the Hh signaling pathway. Of note, 62 of the 161 patients (38%) who did not test positive for an Hh pathway mutation still tested positive for GLI1, suggesting that they had Hh pathway activation, albeit without an identifiable mutational cause.

These findings are clinically significant, as GLI1 overexpression has been linked to numerous types of cancer and is an adverse prognostic indicator for acute myeloid leukemia and several carcinomas, the investigators wrote.

Considering these associations with other cancer types, the investigators looked for a relationship between GLI1 expression and outcomes in CLL. Comparing 103 patients with GLI1-positive disease with 107 GLI-negative patients revealed that GLI1 positivity was significantly associated with shorter median treatment-free survival (4.7 vs. 6.4 years; P = .002). Additional analysis showed that this prognostic relationship was present regardless of IgVH mutational status.

Based on these findings, the investigators concluded that “[a]ctivation of the Hh pathway can strongly influence disease progression in CLL.”

Two additional tests showed that GLI1-positivity was associated with cell survival. First, silencing GLI1 with a GLI1-specific small interfering RNA led to decreased cell viability. Second, GANT61, a small molecule inhibitor of GLI1, was highly cytotoxic for GLI1-positive cells. According to the investigators, these findings suggest that GLI1 could be a future therapeutic target.

“[T]his report shows that the Hh pathway frequently is activated in CLL and associated with relatively rapid disease progression, while identifying a new avenue for therapeutic intervention for patients with this disease,” they concluded.

The study was funded by the National Institutes of Health, the Cancer Stem Cell Consortium, the Canadian Institutes of Health Research, the Ontario Institute for Cancer Research, and other groups. The investigators reported having no competing financial interests.

SOURCE: Ghia EM et al. Blood. 2019 Jun 20;133(25):2651-63.

Patients given lower prescription quantities of opioid tablets with and without opioid education used significantly less of the medication compared with those given more tablets and no education, according to data from 264 adults and adolescents who underwent anterior cruciate ligament (ACL) surgery.

KatarzynaBialasiewicz/Thinkstock

Although lower default prescription programs have been shown to reduce the number of tablets prescribed, “the effect of reduced prescription quantities on actual patient opioid consumption remains undetermined,” wrote Kevin X. Farley, BS, of Emory University, Atlanta, and colleagues.

In a study published in JAMA, the researchers examined whether patients took fewer tablets if given fewer, and whether patient education about opioids further reduced the number of tablets taken.

The study population included adults and adolescents who underwent ACL surgery at a single center. The patients were divided into three groups: 109 patients received 50 opioid tablets after surgery, 78 received 30 tablets plus education prior to surgery about appropriate opioid use and alternative pain management, and 77 received 30 tablets but no education on opioid use.

Patients given 50 tablets consumed an average of 25 tablets for an average of 5.8 days. By contrast, patients given 30 tablets but no opioid education consumed an average of 16 tablets for an average of 4.5 days, and those given 30 tablets and preoperative education consumed an average of 12 tablets for an average of 3.5 days.

In addition, patients given 30 tablets reported lower levels of constipation and fatigue compared with patients given 50 tablets. No differences were seen in medication refills among the groups.

The findings were limited by several factors including the use of data from a single center, the lack of randomization, and the potential for recall bias, the researchers noted. However, the results suggest that prescribing fewer tablets may further reduce use, as each group consumed approximately half of the tablets given, the researchers added.

“Further investigation should evaluate whether similar opioid stewardship and education protocols would be successful in other patient populations,” they said.

Corresponding author John Xerogeanes, MD, disclosed personal fees from Arthrex and stock options from Trice. The other researchers had no financial conflicts to disclose.

SOURCE: Farley KX et al. JAMA. 2019 June 25.321(24):2465-7.

Patients given lower prescription quantities of opioid tablets with and without opioid education used significantly less of the medication compared with those given more tablets and no education, according to data from 264 adults and adolescents who underwent anterior cruciate ligament (ACL) surgery.

KatarzynaBialasiewicz/Thinkstock

Although lower default prescription programs have been shown to reduce the number of tablets prescribed, “the effect of reduced prescription quantities on actual patient opioid consumption remains undetermined,” wrote Kevin X. Farley, BS, of Emory University, Atlanta, and colleagues.

In a study published in JAMA, the researchers examined whether patients took fewer tablets if given fewer, and whether patient education about opioids further reduced the number of tablets taken.

The study population included adults and adolescents who underwent ACL surgery at a single center. The patients were divided into three groups: 109 patients received 50 opioid tablets after surgery, 78 received 30 tablets plus education prior to surgery about appropriate opioid use and alternative pain management, and 77 received 30 tablets but no education on opioid use.

Patients given 50 tablets consumed an average of 25 tablets for an average of 5.8 days. By contrast, patients given 30 tablets but no opioid education consumed an average of 16 tablets for an average of 4.5 days, and those given 30 tablets and preoperative education consumed an average of 12 tablets for an average of 3.5 days.

In addition, patients given 30 tablets reported lower levels of constipation and fatigue compared with patients given 50 tablets. No differences were seen in medication refills among the groups.

The findings were limited by several factors including the use of data from a single center, the lack of randomization, and the potential for recall bias, the researchers noted. However, the results suggest that prescribing fewer tablets may further reduce use, as each group consumed approximately half of the tablets given, the researchers added.

“Further investigation should evaluate whether similar opioid stewardship and education protocols would be successful in other patient populations,” they said.

Corresponding author John Xerogeanes, MD, disclosed personal fees from Arthrex and stock options from Trice. The other researchers had no financial conflicts to disclose.

SOURCE: Farley KX et al. JAMA. 2019 June 25.321(24):2465-7.

Patients given lower prescription quantities of opioid tablets with and without opioid education used significantly less of the medication compared with those given more tablets and no education, according to data from 264 adults and adolescents who underwent anterior cruciate ligament (ACL) surgery.

KatarzynaBialasiewicz/Thinkstock

Although lower default prescription programs have been shown to reduce the number of tablets prescribed, “the effect of reduced prescription quantities on actual patient opioid consumption remains undetermined,” wrote Kevin X. Farley, BS, of Emory University, Atlanta, and colleagues.

In a study published in JAMA, the researchers examined whether patients took fewer tablets if given fewer, and whether patient education about opioids further reduced the number of tablets taken.

The study population included adults and adolescents who underwent ACL surgery at a single center. The patients were divided into three groups: 109 patients received 50 opioid tablets after surgery, 78 received 30 tablets plus education prior to surgery about appropriate opioid use and alternative pain management, and 77 received 30 tablets but no education on opioid use.

Patients given 50 tablets consumed an average of 25 tablets for an average of 5.8 days. By contrast, patients given 30 tablets but no opioid education consumed an average of 16 tablets for an average of 4.5 days, and those given 30 tablets and preoperative education consumed an average of 12 tablets for an average of 3.5 days.

In addition, patients given 30 tablets reported lower levels of constipation and fatigue compared with patients given 50 tablets. No differences were seen in medication refills among the groups.

The findings were limited by several factors including the use of data from a single center, the lack of randomization, and the potential for recall bias, the researchers noted. However, the results suggest that prescribing fewer tablets may further reduce use, as each group consumed approximately half of the tablets given, the researchers added.

“Further investigation should evaluate whether similar opioid stewardship and education protocols would be successful in other patient populations,” they said.

Corresponding author John Xerogeanes, MD, disclosed personal fees from Arthrex and stock options from Trice. The other researchers had no financial conflicts to disclose.

SOURCE: Farley KX et al. JAMA. 2019 June 25.321(24):2465-7.

Anyone who has tried to “shop” for hospital services knows one thing: It’s hard to get prices.

President Donald Trump on Monday signed an executive order he said would make it easier.

The order directs agencies to draw up rules requiring hospitals and insurers to make public more information on the negotiated prices they hammer out in contract negotiations. Also, hospitals and insurers would have to give estimates to patients on out-of-pocket costs before they go in for nonemergency medical care.

The move, which officials said will help address skyrocketing health care costs, comes amid other efforts by the administration to elicit more price transparency for medical care and initiatives by Congress to limit so-called surprise bills. These are the often-expensive bills consumers get when they unwittingly receive care that is not covered by their insurers.

“This will put American patients in control and address fundamental drivers of health care costs in a way no president has done before,” said Health & Human Services Secretary Alex Azar during a press briefing on Monday.

The proposal is likely to run into opposition from some hospitals and insurers who say disclosing negotiated rates could instead drive up costs.

Just how useful the effort will prove for consumers is unclear.

Much depends on how the administration writes the rules governing what information must be provided, such as whether it will include hospital-specific prices, regional averages, or other measures. While the administration calls for a “consumer-friendly” format, it’s not clear how such a massive amount of data – potentially negotiated price information from thousands of hospitals and insurers for tens of thousands of services – will be presented to consumers.

“It’s well intended, but may grossly overestimate the ability of the average patient to decipher this information overload,” said Dan Ward, a vice president at Waystar, a health care payments service.

So, does this new development advance efforts to better arm consumers with pricing information? Some key point to consider:

Q: What does the order do?

It may expand on price information consumers receive.

The order directs agencies to develop rules to require hospitals and insurers to provide information “based on negotiated rates” to the public.

Currently, such rates are hard to get, even for patients, until after medical care is provided. That’s when insured patients get an “explanation of benefits [EOBs],” which shows how much the hospital charged, how much of a discount their insurer received, and the amount a patient may owe.

In addition to consumers being unable to get price information upfront in many cases, hospital list prices and negotiated discount rates vary widely by hospital and insurer, even in a region. Uninsured patients often are charged the full amounts.

“People are sick and tired of hospitals playing these games with prices,” said George Nation, a business professor at Lehigh University in Bethlehem, Pa. who studies hospital contract law. “That’s what’s driving all of this.”

Some insurers and hospitals do provide online tools or apps that can help individual patients estimate out-of-pocket costs for a service or procedure ahead of time, but research shows few patients use such tools. Also, many medical services are needed without much notice – think of a heart attack or a broken leg – so shopping simply isn’t possible.

Administration officials say they want patients to have access to more information, including “advance EOBs” outlining anticipated costs before patients get nonemergency medical care. In theory, that would allow consumers to shop around for lower-cost care.

Q: Isn’t this information already available?

Not exactly. In January, new rules took effect under the Affordable Care Act that require hospitals to post online their “list prices,” which hospitals set themselves and have little relation to actual costs or what insurers actually pay.

What resulted are often confusing spreadsheets that contain thousands of a la carte charges – ranging from the price of medicines and sutures to room costs, among other things – that patients have to piece together if they can to estimate their total bill. Also, those list charges don’t reflect the discounted rates insurers have negotiated, so they are of little use to insured patients who might want to compare prices hospital to hospital.

The information that would result from President Trump’s executive order would provide more detail based on negotiated, discounted rates.

A senior administration official at the press briefing said details about whether the rates would be aggregated or relate to individual hospitals would be spelled out only when the administration puts forward proposed rules to implement the order later this year. It also is unclear how the administration would enforce the rules.

Another limitation: The order applies only to hospitals and the medical staff they employ. Many hospitals, however, are staffed by doctors who are not directly employed, or laboratories that are also separate. That means negotiated prices for services provided by such laboratories or physicians would not have to be disclosed.

Q: How could consumers use this information?

In theory, consumers could get information allowing them to compare prices for, say, a hip replacement or knee surgery in advance.

But that could prove difficult if the rates were not fairly hospital specific, or if they were not lumped in with all the care needed for a specific procedure or surgery.

“They could take the top 20 common procedures the hospital does, for example, and put negotiated prices on them,” said Mr. Nation. “It makes sense to do an average for that particular hospital, so I can see how much it’s going to cost to have my knee replaced at St. Joe’s versus St. Anne’s.”

Having advance notice of out-of-pocket costs could also help patients who have high-deductible plans.

“Patients are increasingly subject to insurance deductibles and other forms of substantial cost sharing. For a subset of so-called shoppable services, patients would benefit from price estimates in advance that allow them to compare options and plan financially for their care,” said John Rother, president and CEO at the advocacy group National Coalition on Health Care.

Q: Will this push consumers to shop for health care?

The short answer is maybe. Right now, it’s difficult, even with some of the tools available, said Lovisa Gustafsson, assistant vice president at the Commonwealth Fund, which has looked at whether patients use existing tools or the list price information hospitals must post online.

“The evidence to date shows patients aren’t necessarily the best shoppers, but we haven’t given them the best tools to be shoppers,” she said.

Posting negotiated rates might be a step forward, she said, but only if it is easily understandable.

It’s possible that insurers, physician offices, consumer groups, or online businesses may find ways to help direct patients to the most cost-effective locations for surgeries, tests or other procedures based on the information.

“Institutions like Consumer Reports or Consumer Checkbook could do some kind of high-level comparison between facilities or doctors, giving some general information that might be useful for consumers,” said Tim Jost, a professor emeritus at the Washington and Lee University School of Law in Lexington, Va.

But some hospitals and insurers maintain that disclosing specific rates could backfire.

Hospitals charging lower rates, for example, might raise them if they see competitors are getting higher reimbursement from insurers, they say. Insurers say they might be hampered in their ability to negotiate if rivals all know what they each pay.

“We also agree that patients should have accurate, real-time information about costs so they can make the best, most informed decisions about their care,” said a statement from lobbying group America’s Health Insurance Plans. “But publicly disclosing competitively negotiated, proprietary rates will reduce competition and push prices higher – not lower – for consumers, patients, and taxpayers.”

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Anyone who has tried to “shop” for hospital services knows one thing: It’s hard to get prices.

President Donald Trump on Monday signed an executive order he said would make it easier.

The order directs agencies to draw up rules requiring hospitals and insurers to make public more information on the negotiated prices they hammer out in contract negotiations. Also, hospitals and insurers would have to give estimates to patients on out-of-pocket costs before they go in for nonemergency medical care.

The move, which officials said will help address skyrocketing health care costs, comes amid other efforts by the administration to elicit more price transparency for medical care and initiatives by Congress to limit so-called surprise bills. These are the often-expensive bills consumers get when they unwittingly receive care that is not covered by their insurers.

“This will put American patients in control and address fundamental drivers of health care costs in a way no president has done before,” said Health & Human Services Secretary Alex Azar during a press briefing on Monday.

The proposal is likely to run into opposition from some hospitals and insurers who say disclosing negotiated rates could instead drive up costs.

Just how useful the effort will prove for consumers is unclear.

Much depends on how the administration writes the rules governing what information must be provided, such as whether it will include hospital-specific prices, regional averages, or other measures. While the administration calls for a “consumer-friendly” format, it’s not clear how such a massive amount of data – potentially negotiated price information from thousands of hospitals and insurers for tens of thousands of services – will be presented to consumers.

“It’s well intended, but may grossly overestimate the ability of the average patient to decipher this information overload,” said Dan Ward, a vice president at Waystar, a health care payments service.

So, does this new development advance efforts to better arm consumers with pricing information? Some key point to consider:

Q: What does the order do?

It may expand on price information consumers receive.

The order directs agencies to develop rules to require hospitals and insurers to provide information “based on negotiated rates” to the public.

Currently, such rates are hard to get, even for patients, until after medical care is provided. That’s when insured patients get an “explanation of benefits [EOBs],” which shows how much the hospital charged, how much of a discount their insurer received, and the amount a patient may owe.

In addition to consumers being unable to get price information upfront in many cases, hospital list prices and negotiated discount rates vary widely by hospital and insurer, even in a region. Uninsured patients often are charged the full amounts.

“People are sick and tired of hospitals playing these games with prices,” said George Nation, a business professor at Lehigh University in Bethlehem, Pa. who studies hospital contract law. “That’s what’s driving all of this.”

Some insurers and hospitals do provide online tools or apps that can help individual patients estimate out-of-pocket costs for a service or procedure ahead of time, but research shows few patients use such tools. Also, many medical services are needed without much notice – think of a heart attack or a broken leg – so shopping simply isn’t possible.

Administration officials say they want patients to have access to more information, including “advance EOBs” outlining anticipated costs before patients get nonemergency medical care. In theory, that would allow consumers to shop around for lower-cost care.

Q: Isn’t this information already available?

Not exactly. In January, new rules took effect under the Affordable Care Act that require hospitals to post online their “list prices,” which hospitals set themselves and have little relation to actual costs or what insurers actually pay.

What resulted are often confusing spreadsheets that contain thousands of a la carte charges – ranging from the price of medicines and sutures to room costs, among other things – that patients have to piece together if they can to estimate their total bill. Also, those list charges don’t reflect the discounted rates insurers have negotiated, so they are of little use to insured patients who might want to compare prices hospital to hospital.

The information that would result from President Trump’s executive order would provide more detail based on negotiated, discounted rates.

A senior administration official at the press briefing said details about whether the rates would be aggregated or relate to individual hospitals would be spelled out only when the administration puts forward proposed rules to implement the order later this year. It also is unclear how the administration would enforce the rules.

Another limitation: The order applies only to hospitals and the medical staff they employ. Many hospitals, however, are staffed by doctors who are not directly employed, or laboratories that are also separate. That means negotiated prices for services provided by such laboratories or physicians would not have to be disclosed.

Q: How could consumers use this information?

In theory, consumers could get information allowing them to compare prices for, say, a hip replacement or knee surgery in advance.

But that could prove difficult if the rates were not fairly hospital specific, or if they were not lumped in with all the care needed for a specific procedure or surgery.

“They could take the top 20 common procedures the hospital does, for example, and put negotiated prices on them,” said Mr. Nation. “It makes sense to do an average for that particular hospital, so I can see how much it’s going to cost to have my knee replaced at St. Joe’s versus St. Anne’s.”

Having advance notice of out-of-pocket costs could also help patients who have high-deductible plans.

“Patients are increasingly subject to insurance deductibles and other forms of substantial cost sharing. For a subset of so-called shoppable services, patients would benefit from price estimates in advance that allow them to compare options and plan financially for their care,” said John Rother, president and CEO at the advocacy group National Coalition on Health Care.

Q: Will this push consumers to shop for health care?

The short answer is maybe. Right now, it’s difficult, even with some of the tools available, said Lovisa Gustafsson, assistant vice president at the Commonwealth Fund, which has looked at whether patients use existing tools or the list price information hospitals must post online.

“The evidence to date shows patients aren’t necessarily the best shoppers, but we haven’t given them the best tools to be shoppers,” she said.

Posting negotiated rates might be a step forward, she said, but only if it is easily understandable.

It’s possible that insurers, physician offices, consumer groups, or online businesses may find ways to help direct patients to the most cost-effective locations for surgeries, tests or other procedures based on the information.

“Institutions like Consumer Reports or Consumer Checkbook could do some kind of high-level comparison between facilities or doctors, giving some general information that might be useful for consumers,” said Tim Jost, a professor emeritus at the Washington and Lee University School of Law in Lexington, Va.

But some hospitals and insurers maintain that disclosing specific rates could backfire.

Hospitals charging lower rates, for example, might raise them if they see competitors are getting higher reimbursement from insurers, they say. Insurers say they might be hampered in their ability to negotiate if rivals all know what they each pay.

“We also agree that patients should have accurate, real-time information about costs so they can make the best, most informed decisions about their care,” said a statement from lobbying group America’s Health Insurance Plans. “But publicly disclosing competitively negotiated, proprietary rates will reduce competition and push prices higher – not lower – for consumers, patients, and taxpayers.”

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Anyone who has tried to “shop” for hospital services knows one thing: It’s hard to get prices.

President Donald Trump on Monday signed an executive order he said would make it easier.

The order directs agencies to draw up rules requiring hospitals and insurers to make public more information on the negotiated prices they hammer out in contract negotiations. Also, hospitals and insurers would have to give estimates to patients on out-of-pocket costs before they go in for nonemergency medical care.

The move, which officials said will help address skyrocketing health care costs, comes amid other efforts by the administration to elicit more price transparency for medical care and initiatives by Congress to limit so-called surprise bills. These are the often-expensive bills consumers get when they unwittingly receive care that is not covered by their insurers.

“This will put American patients in control and address fundamental drivers of health care costs in a way no president has done before,” said Health & Human Services Secretary Alex Azar during a press briefing on Monday.

The proposal is likely to run into opposition from some hospitals and insurers who say disclosing negotiated rates could instead drive up costs.

Just how useful the effort will prove for consumers is unclear.

Much depends on how the administration writes the rules governing what information must be provided, such as whether it will include hospital-specific prices, regional averages, or other measures. While the administration calls for a “consumer-friendly” format, it’s not clear how such a massive amount of data – potentially negotiated price information from thousands of hospitals and insurers for tens of thousands of services – will be presented to consumers.

“It’s well intended, but may grossly overestimate the ability of the average patient to decipher this information overload,” said Dan Ward, a vice president at Waystar, a health care payments service.

So, does this new development advance efforts to better arm consumers with pricing information? Some key point to consider:

Q: What does the order do?

It may expand on price information consumers receive.

The order directs agencies to develop rules to require hospitals and insurers to provide information “based on negotiated rates” to the public.

Currently, such rates are hard to get, even for patients, until after medical care is provided. That’s when insured patients get an “explanation of benefits [EOBs],” which shows how much the hospital charged, how much of a discount their insurer received, and the amount a patient may owe.

In addition to consumers being unable to get price information upfront in many cases, hospital list prices and negotiated discount rates vary widely by hospital and insurer, even in a region. Uninsured patients often are charged the full amounts.

“People are sick and tired of hospitals playing these games with prices,” said George Nation, a business professor at Lehigh University in Bethlehem, Pa. who studies hospital contract law. “That’s what’s driving all of this.”

Some insurers and hospitals do provide online tools or apps that can help individual patients estimate out-of-pocket costs for a service or procedure ahead of time, but research shows few patients use such tools. Also, many medical services are needed without much notice – think of a heart attack or a broken leg – so shopping simply isn’t possible.

Administration officials say they want patients to have access to more information, including “advance EOBs” outlining anticipated costs before patients get nonemergency medical care. In theory, that would allow consumers to shop around for lower-cost care.

Q: Isn’t this information already available?

Not exactly. In January, new rules took effect under the Affordable Care Act that require hospitals to post online their “list prices,” which hospitals set themselves and have little relation to actual costs or what insurers actually pay.

What resulted are often confusing spreadsheets that contain thousands of a la carte charges – ranging from the price of medicines and sutures to room costs, among other things – that patients have to piece together if they can to estimate their total bill. Also, those list charges don’t reflect the discounted rates insurers have negotiated, so they are of little use to insured patients who might want to compare prices hospital to hospital.

The information that would result from President Trump’s executive order would provide more detail based on negotiated, discounted rates.

A senior administration official at the press briefing said details about whether the rates would be aggregated or relate to individual hospitals would be spelled out only when the administration puts forward proposed rules to implement the order later this year. It also is unclear how the administration would enforce the rules.

Another limitation: The order applies only to hospitals and the medical staff they employ. Many hospitals, however, are staffed by doctors who are not directly employed, or laboratories that are also separate. That means negotiated prices for services provided by such laboratories or physicians would not have to be disclosed.

Q: How could consumers use this information?

In theory, consumers could get information allowing them to compare prices for, say, a hip replacement or knee surgery in advance.

But that could prove difficult if the rates were not fairly hospital specific, or if they were not lumped in with all the care needed for a specific procedure or surgery.

“They could take the top 20 common procedures the hospital does, for example, and put negotiated prices on them,” said Mr. Nation. “It makes sense to do an average for that particular hospital, so I can see how much it’s going to cost to have my knee replaced at St. Joe’s versus St. Anne’s.”

Having advance notice of out-of-pocket costs could also help patients who have high-deductible plans.

“Patients are increasingly subject to insurance deductibles and other forms of substantial cost sharing. For a subset of so-called shoppable services, patients would benefit from price estimates in advance that allow them to compare options and plan financially for their care,” said John Rother, president and CEO at the advocacy group National Coalition on Health Care.

Q: Will this push consumers to shop for health care?

The short answer is maybe. Right now, it’s difficult, even with some of the tools available, said Lovisa Gustafsson, assistant vice president at the Commonwealth Fund, which has looked at whether patients use existing tools or the list price information hospitals must post online.

“The evidence to date shows patients aren’t necessarily the best shoppers, but we haven’t given them the best tools to be shoppers,” she said.

Posting negotiated rates might be a step forward, she said, but only if it is easily understandable.

It’s possible that insurers, physician offices, consumer groups, or online businesses may find ways to help direct patients to the most cost-effective locations for surgeries, tests or other procedures based on the information.

“Institutions like Consumer Reports or Consumer Checkbook could do some kind of high-level comparison between facilities or doctors, giving some general information that might be useful for consumers,” said Tim Jost, a professor emeritus at the Washington and Lee University School of Law in Lexington, Va.

But some hospitals and insurers maintain that disclosing specific rates could backfire.

Hospitals charging lower rates, for example, might raise them if they see competitors are getting higher reimbursement from insurers, they say. Insurers say they might be hampered in their ability to negotiate if rivals all know what they each pay.

“We also agree that patients should have accurate, real-time information about costs so they can make the best, most informed decisions about their care,” said a statement from lobbying group America’s Health Insurance Plans. “But publicly disclosing competitively negotiated, proprietary rates will reduce competition and push prices higher – not lower – for consumers, patients, and taxpayers.”

Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Deep sedation during colonoscopies did not confer any improvement in the detection rate for adenomas or polyps among average-risk patients, based on results from a retrospective analysis at a single institution that switched from moderate to deep sedation.

There remains a question as to whether moderate sedation, such as benzodiazepine plus opioids, might affect adenoma detection rate (ADR). The issue is important in part because of the recent push to use propofol in outpatient colonoscopy clinics, according to Erica Turse, DO, MPH, of the University of Missouri–Columbia, and colleagues.

Previous studies looking at moderate versus deep sedation have yielded mixed results, possibly as a result of confounding variables arising from mixed patient populations and conditions.

The current study, published in Gastrointestinal Endoscopy, aimed to eliminate potential confounders by focusing only on average-risk index colonoscopies, with similar patient populations in both groups.

The researchers examined data from a tertiary care outpatient center at the University of Missouri, which switched from moderate to deep sedation in the spring of 2016. Moderate sedation was achieved using midazolam and fentanyl, and propofol was later used for deep sedation. The study included a total of 585 colonoscopies, with 338 patients in the moderate-sedation group and 247 in the deep-sedation group. The overall polyp detection rate (PDR) was 70.1%, and the ADR was 41.7%.

The two groups did not significantly differ in PDR (71.9% moderate vs. 67.6% deep, P = .27) or ADR (44.1% vs. 38.5%; P = .18). Among women, there was no difference in PDR (69.3% vs. 64.8%; P = .41) or ADR (42.2% vs. 32.4%; P = .09). Among men, the results were the same (PDR, 75.3% vs. 71.4%; P = .56; ADR, 46.6% vs. 46.7%; P = 1.0).

A strength of the study was that the populations in both the moderate- and deep-sedation groups were similar. A weakness is that the study was conducted at a single center. The authors called for a randomized, controlled trial to gain more insight into the benefits of moderate versus deep sedation.

The study had no external funding. The authors reported having no financial conflicts of interest.

SOURCE: Turse E et al. Gastrointest Endosc. 2019 May 15. doi: 10.1016/j.gie.2019.05.011.

Deep sedation during colonoscopies did not confer any improvement in the detection rate for adenomas or polyps among average-risk patients, based on results from a retrospective analysis at a single institution that switched from moderate to deep sedation.

There remains a question as to whether moderate sedation, such as benzodiazepine plus opioids, might affect adenoma detection rate (ADR). The issue is important in part because of the recent push to use propofol in outpatient colonoscopy clinics, according to Erica Turse, DO, MPH, of the University of Missouri–Columbia, and colleagues.

Previous studies looking at moderate versus deep sedation have yielded mixed results, possibly as a result of confounding variables arising from mixed patient populations and conditions.

The current study, published in Gastrointestinal Endoscopy, aimed to eliminate potential confounders by focusing only on average-risk index colonoscopies, with similar patient populations in both groups.

The researchers examined data from a tertiary care outpatient center at the University of Missouri, which switched from moderate to deep sedation in the spring of 2016. Moderate sedation was achieved using midazolam and fentanyl, and propofol was later used for deep sedation. The study included a total of 585 colonoscopies, with 338 patients in the moderate-sedation group and 247 in the deep-sedation group. The overall polyp detection rate (PDR) was 70.1%, and the ADR was 41.7%.

The two groups did not significantly differ in PDR (71.9% moderate vs. 67.6% deep, P = .27) or ADR (44.1% vs. 38.5%; P = .18). Among women, there was no difference in PDR (69.3% vs. 64.8%; P = .41) or ADR (42.2% vs. 32.4%; P = .09). Among men, the results were the same (PDR, 75.3% vs. 71.4%; P = .56; ADR, 46.6% vs. 46.7%; P = 1.0).

A strength of the study was that the populations in both the moderate- and deep-sedation groups were similar. A weakness is that the study was conducted at a single center. The authors called for a randomized, controlled trial to gain more insight into the benefits of moderate versus deep sedation.

The study had no external funding. The authors reported having no financial conflicts of interest.

SOURCE: Turse E et al. Gastrointest Endosc. 2019 May 15. doi: 10.1016/j.gie.2019.05.011.

Deep sedation during colonoscopies did not confer any improvement in the detection rate for adenomas or polyps among average-risk patients, based on results from a retrospective analysis at a single institution that switched from moderate to deep sedation.

There remains a question as to whether moderate sedation, such as benzodiazepine plus opioids, might affect adenoma detection rate (ADR). The issue is important in part because of the recent push to use propofol in outpatient colonoscopy clinics, according to Erica Turse, DO, MPH, of the University of Missouri–Columbia, and colleagues.

Previous studies looking at moderate versus deep sedation have yielded mixed results, possibly as a result of confounding variables arising from mixed patient populations and conditions.

The current study, published in Gastrointestinal Endoscopy, aimed to eliminate potential confounders by focusing only on average-risk index colonoscopies, with similar patient populations in both groups.

The researchers examined data from a tertiary care outpatient center at the University of Missouri, which switched from moderate to deep sedation in the spring of 2016. Moderate sedation was achieved using midazolam and fentanyl, and propofol was later used for deep sedation. The study included a total of 585 colonoscopies, with 338 patients in the moderate-sedation group and 247 in the deep-sedation group. The overall polyp detection rate (PDR) was 70.1%, and the ADR was 41.7%.

The two groups did not significantly differ in PDR (71.9% moderate vs. 67.6% deep, P = .27) or ADR (44.1% vs. 38.5%; P = .18). Among women, there was no difference in PDR (69.3% vs. 64.8%; P = .41) or ADR (42.2% vs. 32.4%; P = .09). Among men, the results were the same (PDR, 75.3% vs. 71.4%; P = .56; ADR, 46.6% vs. 46.7%; P = 1.0).

A strength of the study was that the populations in both the moderate- and deep-sedation groups were similar. A weakness is that the study was conducted at a single center. The authors called for a randomized, controlled trial to gain more insight into the benefits of moderate versus deep sedation.

The study had no external funding. The authors reported having no financial conflicts of interest.

SOURCE: Turse E et al. Gastrointest Endosc. 2019 May 15. doi: 10.1016/j.gie.2019.05.011.

The new National Coverage Determination by Medicare for transcatheter aortic valve replacement should produce a bump in the number of U.S. programs offering the procedure, especially with the Food and Drug Administration on the cusp of approving the procedure for low-risk patients.

Mitchel L. Zoler/MDedge News

In the revised National Coverage Determination (NCD) by the Centers for Medicare & Medicaid Services that went into effect on June 21, 2019, the agency allowed for Medicare coverage of transcatheter aortic valve (TAVR) procedures at hospitals that perform at least 20 of these procedures annually or at least 40 every 2 years, the same volume minimums that CMS first applied to TAVR in its prior 2012 NCD. Retention of this minimum ran against the 2018 proposal of the American College of Cardiology, the Society of Thoracic Surgeons, and two other collaborating societies that called for an annual TAVR volume minimum at a hospital program of 50 procedures annually or 100 every 2 years (J Am Coll Cardiol. 2019 Jan 29;73[3]:340-74).

That change, coupled with a cut in the minimum number of annual percutaneous coronary interventions a TAVR program needs to perform – newly revised to a minimum of 300 cases/year – will likely mean more U.S. sites performing TAVR, predicted James Vavricek, director of regulatory affairs for the ACC in Washington. TAVR volume is seen as a reasonable, approximate surrogate for a more rigorous, statistically adjusted assessment of program quality. The ACC and representatives from the other societies that collaborated on the 2018 statement used a 50 case/year minimum for a TAVR program because volume at that level generates enough outcomes data to allow for a meaningful, risk-adjusted measure of performance.

The ACC does not consider the minimum of 20 TAVR cases/year the “right decision,” Mr. Vavricek said in an interview, but the ACC sees it as a compromise that accommodated the interests of multiple TAVR stakeholders. “It will be interesting to see where new TAVR programs locate,” whether they will expand access in underserved regions or mostly cluster in regions already fairly replete with TAVR access, he added. Currently, over 600 U.S. TAVR programs are in operation.

In April 2019, the president of the ACC along with the presidents of three other U.S. societies with an interest in TAVR told the CMS in a comment letter that “we are extremely concerned that the proposed volume requirements will translate into a proliferation of low-volume TAVR programs at increased risk for having suboptimal outcomes.”

Another change to procedure volume requirements in the new NCD was setting a minimum of 100 total TAVR plus surgical aortic valve replacements in a 2-year period or 50 total procedures/year for each TAVR program. Setting a minimum that bundles TAVR plus surgical valve replacements is a “forward-looking” approach as wider application of TAVR gradually erodes the volume of surgical procedures, Mr. Vavricek said.

An additional notable change in the revised NCD was elimination of the “two-surgeon” rule, which the CMS had made mandatory for TAVR decisions until now, stipulating that a patient considered for TAVR needed independent assessment by two cardiac surgeons. The final 2019 NCD calls for the TAVR decision to come from one cardiac surgeon and one interventional cardiologist working together on a care team.

“The ACC is pleased to see CMS issue updated TAVR coverage criteria that emphasizes care by an interdisciplinary heart team for these complex patients, as well as continues to mandate the collection of TAVR patient data. With the new lowered minimum yearly volume criteria set by CMS in their efforts to improve patient access, the value of the STS/ACC TVT Registry, along with ACC’s Transcatheter Valve Certification, will be critical in assuring quality of care for our patients particularly in low-volume centers,” commented Richard J. Kovacs, MD, ACC’s president.

[email protected]

The new National Coverage Determination by Medicare for transcatheter aortic valve replacement should produce a bump in the number of U.S. programs offering the procedure, especially with the Food and Drug Administration on the cusp of approving the procedure for low-risk patients.

Mitchel L. Zoler/MDedge News

In the revised National Coverage Determination (NCD) by the Centers for Medicare & Medicaid Services that went into effect on June 21, 2019, the agency allowed for Medicare coverage of transcatheter aortic valve (TAVR) procedures at hospitals that perform at least 20 of these procedures annually or at least 40 every 2 years, the same volume minimums that CMS first applied to TAVR in its prior 2012 NCD. Retention of this minimum ran against the 2018 proposal of the American College of Cardiology, the Society of Thoracic Surgeons, and two other collaborating societies that called for an annual TAVR volume minimum at a hospital program of 50 procedures annually or 100 every 2 years (J Am Coll Cardiol. 2019 Jan 29;73[3]:340-74).

That change, coupled with a cut in the minimum number of annual percutaneous coronary interventions a TAVR program needs to perform – newly revised to a minimum of 300 cases/year – will likely mean more U.S. sites performing TAVR, predicted James Vavricek, director of regulatory affairs for the ACC in Washington. TAVR volume is seen as a reasonable, approximate surrogate for a more rigorous, statistically adjusted assessment of program quality. The ACC and representatives from the other societies that collaborated on the 2018 statement used a 50 case/year minimum for a TAVR program because volume at that level generates enough outcomes data to allow for a meaningful, risk-adjusted measure of performance.

The ACC does not consider the minimum of 20 TAVR cases/year the “right decision,” Mr. Vavricek said in an interview, but the ACC sees it as a compromise that accommodated the interests of multiple TAVR stakeholders. “It will be interesting to see where new TAVR programs locate,” whether they will expand access in underserved regions or mostly cluster in regions already fairly replete with TAVR access, he added. Currently, over 600 U.S. TAVR programs are in operation.

In April 2019, the president of the ACC along with the presidents of three other U.S. societies with an interest in TAVR told the CMS in a comment letter that “we are extremely concerned that the proposed volume requirements will translate into a proliferation of low-volume TAVR programs at increased risk for having suboptimal outcomes.”

Another change to procedure volume requirements in the new NCD was setting a minimum of 100 total TAVR plus surgical aortic valve replacements in a 2-year period or 50 total procedures/year for each TAVR program. Setting a minimum that bundles TAVR plus surgical valve replacements is a “forward-looking” approach as wider application of TAVR gradually erodes the volume of surgical procedures, Mr. Vavricek said.

An additional notable change in the revised NCD was elimination of the “two-surgeon” rule, which the CMS had made mandatory for TAVR decisions until now, stipulating that a patient considered for TAVR needed independent assessment by two cardiac surgeons. The final 2019 NCD calls for the TAVR decision to come from one cardiac surgeon and one interventional cardiologist working together on a care team.

“The ACC is pleased to see CMS issue updated TAVR coverage criteria that emphasizes care by an interdisciplinary heart team for these complex patients, as well as continues to mandate the collection of TAVR patient data. With the new lowered minimum yearly volume criteria set by CMS in their efforts to improve patient access, the value of the STS/ACC TVT Registry, along with ACC’s Transcatheter Valve Certification, will be critical in assuring quality of care for our patients particularly in low-volume centers,” commented Richard J. Kovacs, MD, ACC’s president.

[email protected]

The new National Coverage Determination by Medicare for transcatheter aortic valve replacement should produce a bump in the number of U.S. programs offering the procedure, especially with the Food and Drug Administration on the cusp of approving the procedure for low-risk patients.

Mitchel L. Zoler/MDedge News

In the revised National Coverage Determination (NCD) by the Centers for Medicare & Medicaid Services that went into effect on June 21, 2019, the agency allowed for Medicare coverage of transcatheter aortic valve (TAVR) procedures at hospitals that perform at least 20 of these procedures annually or at least 40 every 2 years, the same volume minimums that CMS first applied to TAVR in its prior 2012 NCD. Retention of this minimum ran against the 2018 proposal of the American College of Cardiology, the Society of Thoracic Surgeons, and two other collaborating societies that called for an annual TAVR volume minimum at a hospital program of 50 procedures annually or 100 every 2 years (J Am Coll Cardiol. 2019 Jan 29;73[3]:340-74).

That change, coupled with a cut in the minimum number of annual percutaneous coronary interventions a TAVR program needs to perform – newly revised to a minimum of 300 cases/year – will likely mean more U.S. sites performing TAVR, predicted James Vavricek, director of regulatory affairs for the ACC in Washington. TAVR volume is seen as a reasonable, approximate surrogate for a more rigorous, statistically adjusted assessment of program quality. The ACC and representatives from the other societies that collaborated on the 2018 statement used a 50 case/year minimum for a TAVR program because volume at that level generates enough outcomes data to allow for a meaningful, risk-adjusted measure of performance.

The ACC does not consider the minimum of 20 TAVR cases/year the “right decision,” Mr. Vavricek said in an interview, but the ACC sees it as a compromise that accommodated the interests of multiple TAVR stakeholders. “It will be interesting to see where new TAVR programs locate,” whether they will expand access in underserved regions or mostly cluster in regions already fairly replete with TAVR access, he added. Currently, over 600 U.S. TAVR programs are in operation.

In April 2019, the president of the ACC along with the presidents of three other U.S. societies with an interest in TAVR told the CMS in a comment letter that “we are extremely concerned that the proposed volume requirements will translate into a proliferation of low-volume TAVR programs at increased risk for having suboptimal outcomes.”

Another change to procedure volume requirements in the new NCD was setting a minimum of 100 total TAVR plus surgical aortic valve replacements in a 2-year period or 50 total procedures/year for each TAVR program. Setting a minimum that bundles TAVR plus surgical valve replacements is a “forward-looking” approach as wider application of TAVR gradually erodes the volume of surgical procedures, Mr. Vavricek said.

An additional notable change in the revised NCD was elimination of the “two-surgeon” rule, which the CMS had made mandatory for TAVR decisions until now, stipulating that a patient considered for TAVR needed independent assessment by two cardiac surgeons. The final 2019 NCD calls for the TAVR decision to come from one cardiac surgeon and one interventional cardiologist working together on a care team.

“The ACC is pleased to see CMS issue updated TAVR coverage criteria that emphasizes care by an interdisciplinary heart team for these complex patients, as well as continues to mandate the collection of TAVR patient data. With the new lowered minimum yearly volume criteria set by CMS in their efforts to improve patient access, the value of the STS/ACC TVT Registry, along with ACC’s Transcatheter Valve Certification, will be critical in assuring quality of care for our patients particularly in low-volume centers,” commented Richard J. Kovacs, MD, ACC’s president.

[email protected]