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Bridging clinical medicine, research, and quality
Editor’s note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-2018 year, offering two options for students to receive funding and engage in scholarly work during their first, second, and third years of medical school. As a part of the longitudinal (18-month) program, recipients are required to write about their experiences on a monthly basis.
I am a third-year medical student at the University of California, San Diego, as well as a recipient of the SHM Longitudinal Scholar Grant. Ultimately, I intend to pursue a career in academic medicine as a clinician-scientist, where I hope to bridge my interests in neuroscience, research, and clinical medicine.
Prior to entering medical school, I participated in a wide array of basic science, translational, and clinical research projects, but none in the area of quality improvement (QI). Given the breadth of my previous research experiences, an attractive feature of the SHM Hospitalist grant was the opportunity to complement this breadth of research exposure with increasing depth by exploring a QI project.
This year, I’ll be getting my first exposure to a QI project under the fine mentorship of Ian Jenkins, MD, SFHM, an attending in the division of hospital medicine at UCSD, who is working on an ongoing effort to combat catheter–associated urinary tract infections (CAUTI). Methods for reducing CAUTI include reducing indwelling urinary catheter (IUC) placement, performing proper maintenance of IUCs, and ensuring prompt removal of unnecessary urinary catheters.
Our project aims to combine all three approaches, along with staff education on IUC management and IUC alternatives. We plan to perform a “measure-vention,” or real-time monitoring and correction of defects by examining the rate of CAUTI as well as the percentage IUC utilization rate in participating units. Ultimately, we hope to optimize patient comfort and publicize our experience to help other health care facilities reduce IUC use and CAUTI.
I am excited to see how basic interventions, such as education and measure-vention can drive the development of improved health outcomes and quality patient care.
Victor Ekuta is a third-year medical student at the University of California, San Diego.
Editor’s note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-2018 year, offering two options for students to receive funding and engage in scholarly work during their first, second, and third years of medical school. As a part of the longitudinal (18-month) program, recipients are required to write about their experiences on a monthly basis.
I am a third-year medical student at the University of California, San Diego, as well as a recipient of the SHM Longitudinal Scholar Grant. Ultimately, I intend to pursue a career in academic medicine as a clinician-scientist, where I hope to bridge my interests in neuroscience, research, and clinical medicine.
Prior to entering medical school, I participated in a wide array of basic science, translational, and clinical research projects, but none in the area of quality improvement (QI). Given the breadth of my previous research experiences, an attractive feature of the SHM Hospitalist grant was the opportunity to complement this breadth of research exposure with increasing depth by exploring a QI project.
This year, I’ll be getting my first exposure to a QI project under the fine mentorship of Ian Jenkins, MD, SFHM, an attending in the division of hospital medicine at UCSD, who is working on an ongoing effort to combat catheter–associated urinary tract infections (CAUTI). Methods for reducing CAUTI include reducing indwelling urinary catheter (IUC) placement, performing proper maintenance of IUCs, and ensuring prompt removal of unnecessary urinary catheters.
Our project aims to combine all three approaches, along with staff education on IUC management and IUC alternatives. We plan to perform a “measure-vention,” or real-time monitoring and correction of defects by examining the rate of CAUTI as well as the percentage IUC utilization rate in participating units. Ultimately, we hope to optimize patient comfort and publicize our experience to help other health care facilities reduce IUC use and CAUTI.
I am excited to see how basic interventions, such as education and measure-vention can drive the development of improved health outcomes and quality patient care.
Victor Ekuta is a third-year medical student at the University of California, San Diego.
Editor’s note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-2018 year, offering two options for students to receive funding and engage in scholarly work during their first, second, and third years of medical school. As a part of the longitudinal (18-month) program, recipients are required to write about their experiences on a monthly basis.
I am a third-year medical student at the University of California, San Diego, as well as a recipient of the SHM Longitudinal Scholar Grant. Ultimately, I intend to pursue a career in academic medicine as a clinician-scientist, where I hope to bridge my interests in neuroscience, research, and clinical medicine.
Prior to entering medical school, I participated in a wide array of basic science, translational, and clinical research projects, but none in the area of quality improvement (QI). Given the breadth of my previous research experiences, an attractive feature of the SHM Hospitalist grant was the opportunity to complement this breadth of research exposure with increasing depth by exploring a QI project.
This year, I’ll be getting my first exposure to a QI project under the fine mentorship of Ian Jenkins, MD, SFHM, an attending in the division of hospital medicine at UCSD, who is working on an ongoing effort to combat catheter–associated urinary tract infections (CAUTI). Methods for reducing CAUTI include reducing indwelling urinary catheter (IUC) placement, performing proper maintenance of IUCs, and ensuring prompt removal of unnecessary urinary catheters.
Our project aims to combine all three approaches, along with staff education on IUC management and IUC alternatives. We plan to perform a “measure-vention,” or real-time monitoring and correction of defects by examining the rate of CAUTI as well as the percentage IUC utilization rate in participating units. Ultimately, we hope to optimize patient comfort and publicize our experience to help other health care facilities reduce IUC use and CAUTI.
I am excited to see how basic interventions, such as education and measure-vention can drive the development of improved health outcomes and quality patient care.
Victor Ekuta is a third-year medical student at the University of California, San Diego.
HEART score can safely identify low risk chest pain
Clinical Question: Can the HEART score risk stratify emergency department patients with chest pain?
Background: Many patients with chest pain are subjected to unnecessary admission and testing. The HEART (History, Electrocardiogram, Age, Risk factors, and initial Troponin) score can accurately predict outcomes in chest pain patients, though it has undergone limited evaluation in real world settings.
Setting: Nine emergency departments in the Netherlands.
Synopsis: All sites started by providing usual care, then sequentially switched over to use of the HEART score to guide treatment. HEART care recommended early discharge if low risk (HEART score, 0-3), admission and further testing if intermediate risk (4-6), and early invasive testing if high risk (7-10).
The study included 3,648 adults presenting with chest pain. The HEART score was noninferior to usual care for the safety outcome of major adverse cardiovascular events (MACE) within 6 weeks. Only 2.0% of low risk patients experienced MACE, though 41% of these patients were still admitted or sent for further testing, and reduction in health care cost was minimal.
Bottom Line: The HEART score accurately predicted risk in patients with chest pain, but a significant portion of low risk patients underwent further testing anyway.
Citation: Poldervaart JM, Reitsma JB, Backus BE, et al. Effect of using the HEART score in patients with chest pain in the emergency department. Ann Intern Med. 2017 May 16;166(10):689-97.
Dr. Troy is assistant professor in the University of Kentucky division of hospital medicine.
Clinical Question: Can the HEART score risk stratify emergency department patients with chest pain?
Background: Many patients with chest pain are subjected to unnecessary admission and testing. The HEART (History, Electrocardiogram, Age, Risk factors, and initial Troponin) score can accurately predict outcomes in chest pain patients, though it has undergone limited evaluation in real world settings.
Setting: Nine emergency departments in the Netherlands.
Synopsis: All sites started by providing usual care, then sequentially switched over to use of the HEART score to guide treatment. HEART care recommended early discharge if low risk (HEART score, 0-3), admission and further testing if intermediate risk (4-6), and early invasive testing if high risk (7-10).
The study included 3,648 adults presenting with chest pain. The HEART score was noninferior to usual care for the safety outcome of major adverse cardiovascular events (MACE) within 6 weeks. Only 2.0% of low risk patients experienced MACE, though 41% of these patients were still admitted or sent for further testing, and reduction in health care cost was minimal.
Bottom Line: The HEART score accurately predicted risk in patients with chest pain, but a significant portion of low risk patients underwent further testing anyway.
Citation: Poldervaart JM, Reitsma JB, Backus BE, et al. Effect of using the HEART score in patients with chest pain in the emergency department. Ann Intern Med. 2017 May 16;166(10):689-97.
Dr. Troy is assistant professor in the University of Kentucky division of hospital medicine.
Clinical Question: Can the HEART score risk stratify emergency department patients with chest pain?
Background: Many patients with chest pain are subjected to unnecessary admission and testing. The HEART (History, Electrocardiogram, Age, Risk factors, and initial Troponin) score can accurately predict outcomes in chest pain patients, though it has undergone limited evaluation in real world settings.
Setting: Nine emergency departments in the Netherlands.
Synopsis: All sites started by providing usual care, then sequentially switched over to use of the HEART score to guide treatment. HEART care recommended early discharge if low risk (HEART score, 0-3), admission and further testing if intermediate risk (4-6), and early invasive testing if high risk (7-10).
The study included 3,648 adults presenting with chest pain. The HEART score was noninferior to usual care for the safety outcome of major adverse cardiovascular events (MACE) within 6 weeks. Only 2.0% of low risk patients experienced MACE, though 41% of these patients were still admitted or sent for further testing, and reduction in health care cost was minimal.
Bottom Line: The HEART score accurately predicted risk in patients with chest pain, but a significant portion of low risk patients underwent further testing anyway.
Citation: Poldervaart JM, Reitsma JB, Backus BE, et al. Effect of using the HEART score in patients with chest pain in the emergency department. Ann Intern Med. 2017 May 16;166(10):689-97.
Dr. Troy is assistant professor in the University of Kentucky division of hospital medicine.
Using EHR data to predict post-acute care placement
Editor’s Note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-2018 year, offering two options for students to receive funding and engage in scholarly work during their first, second, and third years of medical school. As a part of the longitudinal (18-month) program, recipients are required to write about their experience on a monthly basis.
When patients are admitted to the hospital, the focus for the first 24 hours is on the work-up: What do the data point values tell you about how sick this patient is, and what will they need to get better? While the goal for this information is to develop the appropriate treatment and management for the patient’s acute problem, it could be leveraged to help with other parts of the patient’s hospital stay as well. In particular, it could help avoid unnecessarily long stays in the hospital caused by patients’ waiting for a bed at a lower level of care.
My research mentor, Eduard Vasilevskis, MD, created a rough scoring system for predicting post-acute care placement using admission data, just based on his clinical gestalt. Even at this preliminary stage, the model has already functioned well without much refinement; however a validated, statistically robust model could potentially transform the way that we initiate the discharge planning process. Jesse Ehrenfeld, MD has helped us develop it further by giving us access to a curated database of deidentified EHR data, which contains all of the variables we would like to assess.
The strengths of this potential model are manifold. First, it relies on data collected early in the patient’s hospital course. Second, it relies on routinely collected information (both at our home institution and elsewhere, making it potentially generalizable). And third, it relies on objective patient data rather than requiring providers use their impressions of the patients’ functional status to guess whether they will require discharge planning services. Although such prediction models have been generated before, this model would be among the first to incorporate information routinely collected by nursing staff, such as the Braden Scale, instead of relying on additional instruments or surveys. In addition to predicting placement destination, the model may also be predictive of in-hospital mortality.
With this information, we hope to give hospital teams an additional tool to help mobilize resources toward patients who need the most attention – not just while they’re in the hospital, but also on their way out.
Monisha Bhatia, a native of Nashville, Tenn., is a fourth-year medical student at Vanderbilt University in Nashville. She is hoping to pursue either a residency in internal medicine or a combined internal medicine/emergency medicine program. Prior to medical school, she completed a JD/MPH program at Boston University, and she hopes to use her legal training in working with regulatory authorities to improve access to health care for all Americans.
Editor’s Note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-2018 year, offering two options for students to receive funding and engage in scholarly work during their first, second, and third years of medical school. As a part of the longitudinal (18-month) program, recipients are required to write about their experience on a monthly basis.
When patients are admitted to the hospital, the focus for the first 24 hours is on the work-up: What do the data point values tell you about how sick this patient is, and what will they need to get better? While the goal for this information is to develop the appropriate treatment and management for the patient’s acute problem, it could be leveraged to help with other parts of the patient’s hospital stay as well. In particular, it could help avoid unnecessarily long stays in the hospital caused by patients’ waiting for a bed at a lower level of care.
My research mentor, Eduard Vasilevskis, MD, created a rough scoring system for predicting post-acute care placement using admission data, just based on his clinical gestalt. Even at this preliminary stage, the model has already functioned well without much refinement; however a validated, statistically robust model could potentially transform the way that we initiate the discharge planning process. Jesse Ehrenfeld, MD has helped us develop it further by giving us access to a curated database of deidentified EHR data, which contains all of the variables we would like to assess.
The strengths of this potential model are manifold. First, it relies on data collected early in the patient’s hospital course. Second, it relies on routinely collected information (both at our home institution and elsewhere, making it potentially generalizable). And third, it relies on objective patient data rather than requiring providers use their impressions of the patients’ functional status to guess whether they will require discharge planning services. Although such prediction models have been generated before, this model would be among the first to incorporate information routinely collected by nursing staff, such as the Braden Scale, instead of relying on additional instruments or surveys. In addition to predicting placement destination, the model may also be predictive of in-hospital mortality.
With this information, we hope to give hospital teams an additional tool to help mobilize resources toward patients who need the most attention – not just while they’re in the hospital, but also on their way out.
Monisha Bhatia, a native of Nashville, Tenn., is a fourth-year medical student at Vanderbilt University in Nashville. She is hoping to pursue either a residency in internal medicine or a combined internal medicine/emergency medicine program. Prior to medical school, she completed a JD/MPH program at Boston University, and she hopes to use her legal training in working with regulatory authorities to improve access to health care for all Americans.
Editor’s Note: The Society of Hospital Medicine’s (SHM’s) Physician in Training Committee launched a scholarship program in 2015 for medical students to help transform health care and revolutionize patient care. The program has been expanded for the 2017-2018 year, offering two options for students to receive funding and engage in scholarly work during their first, second, and third years of medical school. As a part of the longitudinal (18-month) program, recipients are required to write about their experience on a monthly basis.
When patients are admitted to the hospital, the focus for the first 24 hours is on the work-up: What do the data point values tell you about how sick this patient is, and what will they need to get better? While the goal for this information is to develop the appropriate treatment and management for the patient’s acute problem, it could be leveraged to help with other parts of the patient’s hospital stay as well. In particular, it could help avoid unnecessarily long stays in the hospital caused by patients’ waiting for a bed at a lower level of care.
My research mentor, Eduard Vasilevskis, MD, created a rough scoring system for predicting post-acute care placement using admission data, just based on his clinical gestalt. Even at this preliminary stage, the model has already functioned well without much refinement; however a validated, statistically robust model could potentially transform the way that we initiate the discharge planning process. Jesse Ehrenfeld, MD has helped us develop it further by giving us access to a curated database of deidentified EHR data, which contains all of the variables we would like to assess.
The strengths of this potential model are manifold. First, it relies on data collected early in the patient’s hospital course. Second, it relies on routinely collected information (both at our home institution and elsewhere, making it potentially generalizable). And third, it relies on objective patient data rather than requiring providers use their impressions of the patients’ functional status to guess whether they will require discharge planning services. Although such prediction models have been generated before, this model would be among the first to incorporate information routinely collected by nursing staff, such as the Braden Scale, instead of relying on additional instruments or surveys. In addition to predicting placement destination, the model may also be predictive of in-hospital mortality.
With this information, we hope to give hospital teams an additional tool to help mobilize resources toward patients who need the most attention – not just while they’re in the hospital, but also on their way out.
Monisha Bhatia, a native of Nashville, Tenn., is a fourth-year medical student at Vanderbilt University in Nashville. She is hoping to pursue either a residency in internal medicine or a combined internal medicine/emergency medicine program. Prior to medical school, she completed a JD/MPH program at Boston University, and she hopes to use her legal training in working with regulatory authorities to improve access to health care for all Americans.
Prediction tool for mortality after respiratory compromise
Background: Scoring systems exist to predict outcomes following cardiac arrest. There is currently no reliable model to predict outcome of patients who have survived acute respiratory compromise (ARC).
Study Design: A retrospective cohort study.
Setting: Get with the Guidelines Resuscitation (GWTG-R) is an online medical registry that tracks ARC data from more than 300 hospitals.
Synopsis: Using the GWTG-R database of ARC, researchers identified 13,193 cases of ARC to study the variables affecting prognosis. They randomized the group into derivation (75% of patients) and validation (25% of patients) cohorts and used c-statistics to create the prognostic scoring system. The greatest predictors of in-hospital mortality were age greater than 80 years, hypotension in the four hours preceding the ARC event, and the need for intubation.
This scoring system did not take into account any comorbidities (such as organ failure) that occurred shortly after the ARC event, although these likely affect mortality.
Bottom Line: Predicting in-hospital mortality for survivors of ARC events may help clinical prognostication. Such tools could also facilitate comparisons between hospitals and guide quality improvement projects.
Citation: Moskowitz A, Anderson LW, Karlsson M, et. al. Predicting in-hospital mortality for initial survivors of acute respiratory compromise (ARC) events: Development and validation of the ARC score. Resuscitation. 2017 Jun;115:5-10.
Dr. Suman is clinical instructor of medicine in the University of Kentucky division of hospital medicine.
Background: Scoring systems exist to predict outcomes following cardiac arrest. There is currently no reliable model to predict outcome of patients who have survived acute respiratory compromise (ARC).
Study Design: A retrospective cohort study.
Setting: Get with the Guidelines Resuscitation (GWTG-R) is an online medical registry that tracks ARC data from more than 300 hospitals.
Synopsis: Using the GWTG-R database of ARC, researchers identified 13,193 cases of ARC to study the variables affecting prognosis. They randomized the group into derivation (75% of patients) and validation (25% of patients) cohorts and used c-statistics to create the prognostic scoring system. The greatest predictors of in-hospital mortality were age greater than 80 years, hypotension in the four hours preceding the ARC event, and the need for intubation.
This scoring system did not take into account any comorbidities (such as organ failure) that occurred shortly after the ARC event, although these likely affect mortality.
Bottom Line: Predicting in-hospital mortality for survivors of ARC events may help clinical prognostication. Such tools could also facilitate comparisons between hospitals and guide quality improvement projects.
Citation: Moskowitz A, Anderson LW, Karlsson M, et. al. Predicting in-hospital mortality for initial survivors of acute respiratory compromise (ARC) events: Development and validation of the ARC score. Resuscitation. 2017 Jun;115:5-10.
Dr. Suman is clinical instructor of medicine in the University of Kentucky division of hospital medicine.
Background: Scoring systems exist to predict outcomes following cardiac arrest. There is currently no reliable model to predict outcome of patients who have survived acute respiratory compromise (ARC).
Study Design: A retrospective cohort study.
Setting: Get with the Guidelines Resuscitation (GWTG-R) is an online medical registry that tracks ARC data from more than 300 hospitals.
Synopsis: Using the GWTG-R database of ARC, researchers identified 13,193 cases of ARC to study the variables affecting prognosis. They randomized the group into derivation (75% of patients) and validation (25% of patients) cohorts and used c-statistics to create the prognostic scoring system. The greatest predictors of in-hospital mortality were age greater than 80 years, hypotension in the four hours preceding the ARC event, and the need for intubation.
This scoring system did not take into account any comorbidities (such as organ failure) that occurred shortly after the ARC event, although these likely affect mortality.
Bottom Line: Predicting in-hospital mortality for survivors of ARC events may help clinical prognostication. Such tools could also facilitate comparisons between hospitals and guide quality improvement projects.
Citation: Moskowitz A, Anderson LW, Karlsson M, et. al. Predicting in-hospital mortality for initial survivors of acute respiratory compromise (ARC) events: Development and validation of the ARC score. Resuscitation. 2017 Jun;115:5-10.
Dr. Suman is clinical instructor of medicine in the University of Kentucky division of hospital medicine.
FDA approves Vabomere for complicated UTI in adults
The Food and Drug Administration has approved Vabomere (meropenem and vaborbactam) for adults with complicated urinary tract infection (cUTI), including pyelonephritis caused by susceptible Enterobacteriaceae, the agency has announced.
The approval was based on results of the TANGO 1 trial, a phase 3, multicenter, double-blind study of 545 adult patients with cUTI. Overall, 98.4% of patients treated with Vabomere saw improvement in symptoms and negative urine culture tests by the end of intravenous treatment, compared with 94.3% of those treated with piperacillin/tazobactam (95% confidence interval, 0.3%-8.8%). Improvement continued in about 77% of patients treated with Vabomere who had resolved symptoms 7 days after completing treatment, compared with about 73% of those who were treated with piperacillin/tazobactam, the FDA said Aug. 29 in a press release.
Headache, infusion site reactions, and diarrhea were common adverse effects of Vabomere. The drug also has been associated with allergic reactions and seizures, so it should not be administered to patients with a history of anaphylaxis.
“Vabomere represents a significant new advancement in addressing [Klebsiella pneumoniae carbapenemase]-producing Enterobacteriaceae, for which there are currently limited treatment options,” Clive A. Meanwell, MD, PhD, chief executive officer of The Medicines Company, said in the statement.
Rempex Pharmaceuticals, a Medicines Company unit, received the approval. The Medicines Company said the drug is expected to be available before the end of the year.
The Food and Drug Administration has approved Vabomere (meropenem and vaborbactam) for adults with complicated urinary tract infection (cUTI), including pyelonephritis caused by susceptible Enterobacteriaceae, the agency has announced.
The approval was based on results of the TANGO 1 trial, a phase 3, multicenter, double-blind study of 545 adult patients with cUTI. Overall, 98.4% of patients treated with Vabomere saw improvement in symptoms and negative urine culture tests by the end of intravenous treatment, compared with 94.3% of those treated with piperacillin/tazobactam (95% confidence interval, 0.3%-8.8%). Improvement continued in about 77% of patients treated with Vabomere who had resolved symptoms 7 days after completing treatment, compared with about 73% of those who were treated with piperacillin/tazobactam, the FDA said Aug. 29 in a press release.
Headache, infusion site reactions, and diarrhea were common adverse effects of Vabomere. The drug also has been associated with allergic reactions and seizures, so it should not be administered to patients with a history of anaphylaxis.
“Vabomere represents a significant new advancement in addressing [Klebsiella pneumoniae carbapenemase]-producing Enterobacteriaceae, for which there are currently limited treatment options,” Clive A. Meanwell, MD, PhD, chief executive officer of The Medicines Company, said in the statement.
Rempex Pharmaceuticals, a Medicines Company unit, received the approval. The Medicines Company said the drug is expected to be available before the end of the year.
The Food and Drug Administration has approved Vabomere (meropenem and vaborbactam) for adults with complicated urinary tract infection (cUTI), including pyelonephritis caused by susceptible Enterobacteriaceae, the agency has announced.
The approval was based on results of the TANGO 1 trial, a phase 3, multicenter, double-blind study of 545 adult patients with cUTI. Overall, 98.4% of patients treated with Vabomere saw improvement in symptoms and negative urine culture tests by the end of intravenous treatment, compared with 94.3% of those treated with piperacillin/tazobactam (95% confidence interval, 0.3%-8.8%). Improvement continued in about 77% of patients treated with Vabomere who had resolved symptoms 7 days after completing treatment, compared with about 73% of those who were treated with piperacillin/tazobactam, the FDA said Aug. 29 in a press release.
Headache, infusion site reactions, and diarrhea were common adverse effects of Vabomere. The drug also has been associated with allergic reactions and seizures, so it should not be administered to patients with a history of anaphylaxis.
“Vabomere represents a significant new advancement in addressing [Klebsiella pneumoniae carbapenemase]-producing Enterobacteriaceae, for which there are currently limited treatment options,” Clive A. Meanwell, MD, PhD, chief executive officer of The Medicines Company, said in the statement.
Rempex Pharmaceuticals, a Medicines Company unit, received the approval. The Medicines Company said the drug is expected to be available before the end of the year.
VIDEO: Clopidogrel bests ticagrelor in PCI for ACS in real-world study
BARCELONA – Patients who underwent percutaneous coronary intervention for acute coronary syndrome using newer-generation drug-eluting stents backed by ticagrelor-based dual-antiplatelet therapy had significantly higher net adverse event rates at 1 year than did those with clopidogrel-based DAPT in the CHANGE DAPT study, Clemens von Birgelen, MD, reported at the annual congress of the European Society of Cardiology.
Based upon the CHANGE DAPT findings and those from other recent studies, it would be appropriate to revise ESC and American College of Cardiology/American Heart Association guidelines, which now give the newer, more potent platelet inhibitors ticagrelor (Brilinta) or prasugrel (Effient) preferential status as the P2Y12 inhibitor of choice over clopidogrel, added Dr. von Birgelen, professor of cardiology at the University of Twente in Enschede, the Netherlands, and codirector of the department of cardiology at Thoraxcentrum Twente.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“With the newer drug-eluting stents we see lower ischemic event rates, so the DAPT side effects due to bleeding become more important at this time. It could be that patients with ACS who are undergoing PCI may no longer need the most potent DAPT. Perhaps less potent DAPT with clopidogrel may be sufficient when using these more modern devices,” Dr. von Birgelen said in an interview.
CHANGE DAPT was a prospective, observational registry study that compared 1-year clinical outcomes in 2,062 consecutive ACS patients treated by PCI at Thoraxcentrum Twente, a high-volume PCI center. Half of the patients were treated before the primary DAPT regimen in the region changed from clopidogrel-based to ticagrelor-based DAPT on May 1, 2014, while the other half underwent PCI after the switch. This unique registry study design avoids selection bias, whereby cardiologists might preferentially use clopidogrel – the less potent P2Y12 inhibitor – in frailer patients.
The primary endpoint was the 1-year composite of all-cause mortality, any MI, stroke, or major bleeding. The rate was 7.8% in the ticagrelor period and significantly lower at 5.1% in the clopidogrel period. This difference was driven by the significantly lower major bleeding rate in the clopidogrel group: 1.2% versus 2.7% with ticagrelor-based DAPT.
The increased risk of bleeding associated with ticagrelor wasn’t offset by any advantage in term of ischemic events; indeed, the rate of such events was actually numerically lower with clopidogrel-based DAPT, albeit not statistically significantly so. Definite or probable stent thrombosis occurred in 0.6% of the clopidogrel group and 0.8% of the ticagrelor group, while the composite of cardiac death, MI, or stroke occurred in 3.7% of patients on clopidogrel-based DAPT compared with 4.7% on ticagrelor.
The two patient groups were closely similar at baseline in most respects, although the ticagrelor group was, on average, 1 year older, reflecting the more recent increased willingness of interventional cardiologists to utilize PCI in patients of advanced age. In terms of procedural differences, the ticagrelor group was more likely to undergo a transradial rather than transfemoral approach, less likely to receive a glycoprotein IIb/IIIa inhibitor, and more likely to get a proton pump inhibitor.
“All three of those factors should have reduced the bleeding risk during that second period,” Dr. von Birgelen observed.
In a propensity score–adjusted analysis taking account of the few between-group differences, ticagrelor-based DAPT was associated with a 1.75-fold increased risk of the primary endpoint and a 2.75-fold increased risk of major bleeding.
He noted that the CHANGE DAPT results are consistent with those of TOPIC, a 646-patient, single-center randomized trial conducted in Marseille. In TOPIC, after 1 month on ticagrelor- or prasugrel-backed DAPT, half of patients were switched to vastly less expensive clopidogrel for the remaining 11 months of DAPT. The result in the switched group was a marked decrease in bleeding with no increased risk of ischemic events.
“I see our study as a piece in a mosaic of studies and real-world registries with a similar message that have recently been reported,” the cardiologist said. “I hope the ESC looks carefully at these data.”
Session cochair Laura Mauri, MD, said that while it’s important to look at real-world observational data such as CHANGE DAPT to see if the results of randomized trials are generalizable, she’s not surprised by the evidence of increased risk of bleeding with a more potent agent such as ticagrelor.
“Why there’s a lack of benefit demonstrated, I think, is the bigger question,” said Dr. Mauri, professor of medicine at Harvard Medical School, Boston. “It could be related to changes in procedures over time, with procedures being conducted in a more complex manner, or some other residual confounding. I think whenever we see an observational study that changes the nature of the benefit that we see, it needs to be investigated more deeply. I don’t think it’s time to dismiss the results of very large randomized trials that show a meaningful benefit for the potent agents in the setting of ACS.”
CHANGE DAPT was an investigator-initiated study conducted without external funding. Dr. von Birgelen reported having no financial conflicts of interest.
BARCELONA – Patients who underwent percutaneous coronary intervention for acute coronary syndrome using newer-generation drug-eluting stents backed by ticagrelor-based dual-antiplatelet therapy had significantly higher net adverse event rates at 1 year than did those with clopidogrel-based DAPT in the CHANGE DAPT study, Clemens von Birgelen, MD, reported at the annual congress of the European Society of Cardiology.
Based upon the CHANGE DAPT findings and those from other recent studies, it would be appropriate to revise ESC and American College of Cardiology/American Heart Association guidelines, which now give the newer, more potent platelet inhibitors ticagrelor (Brilinta) or prasugrel (Effient) preferential status as the P2Y12 inhibitor of choice over clopidogrel, added Dr. von Birgelen, professor of cardiology at the University of Twente in Enschede, the Netherlands, and codirector of the department of cardiology at Thoraxcentrum Twente.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
“With the newer drug-eluting stents we see lower ischemic event rates, so the DAPT side effects due to bleeding become more important at this time. It could be that patients with ACS who are undergoing PCI may no longer need the most potent DAPT. Perhaps less potent DAPT with clopidogrel may be sufficient when using these more modern devices,” Dr. von Birgelen said in an interview.
CHANGE DAPT was a prospective, observational registry study that compared 1-year clinical outcomes in 2,062 consecutive ACS patients treated by PCI at Thoraxcentrum Twente, a high-volume PCI center. Half of the patients were treated before the primary DAPT regimen in the region changed from clopidogrel-based to ticagrelor-based DAPT on May 1, 2014, while the other half underwent PCI after the switch. This unique registry study design avoids selection bias, whereby cardiologists might preferentially use clopidogrel – the less potent P2Y12 inhibitor – in frailer patients.
The primary endpoint was the 1-year composite of all-cause mortality, any MI, stroke, or major bleeding. The rate was 7.8% in the ticagrelor period and significantly lower at 5.1% in the clopidogrel period. This difference was driven by the significantly lower major bleeding rate in the clopidogrel group: 1.2% versus 2.7% with ticagrelor-based DAPT.
The increased risk of bleeding associated with ticagrelor wasn’t offset by any advantage in term of ischemic events; indeed, the rate of such events was actually numerically lower with clopidogrel-based DAPT, albeit not statistically significantly so. Definite or probable stent thrombosis occurred in 0.6% of the clopidogrel group and 0.8% of the ticagrelor group, while the composite of cardiac death, MI, or stroke occurred in 3.7% of patients on clopidogrel-based DAPT compared with 4.7% on ticagrelor.
The two patient groups were closely similar at baseline in most respects, although the ticagrelor group was, on average, 1 year older, reflecting the more recent increased willingness of interventional cardiologists to utilize PCI in patients of advanced age. In terms of procedural differences, the ticagrelor group was more likely to undergo a transradial rather than transfemoral approach, less likely to receive a glycoprotein IIb/IIIa inhibitor, and more likely to get a proton pump inhibitor.
“All three of those factors should have reduced the bleeding risk during that second period,” Dr. von Birgelen observed.
In a propensity score–adjusted analysis taking account of the few between-group differences, ticagrelor-based DAPT was associated with a 1.75-fold increased risk of the primary endpoint and a 2.75-fold increased risk of major bleeding.
He noted that the CHANGE DAPT results are consistent with those of TOPIC, a 646-patient, single-center randomized trial conducted in Marseille. In TOPIC, after 1 month on ticagrelor- or prasugrel-backed DAPT, half of patients were switched to vastly less expensive clopidogrel for the remaining 11 months of DAPT. The result in the switched group was a marked decrease in bleeding with no increased risk of ischemic events.
“I see our study as a piece in a mosaic of studies and real-world registries with a similar message that have recently been reported,” the cardiologist said. “I hope the ESC looks carefully at these data.”
Session cochair Laura Mauri, MD, said that while it’s important to look at real-world observational data such as CHANGE DAPT to see if the results of randomized trials are generalizable, she’s not surprised by the evidence of increased risk of bleeding with a more potent agent such as ticagrelor.
“Why there’s a lack of benefit demonstrated, I think, is the bigger question,” said Dr. Mauri, professor of medicine at Harvard Medical School, Boston. “It could be related to changes in procedures over time, with procedures being conducted in a more complex manner, or some other residual confounding. I think whenever we see an observational study that changes the nature of the benefit that we see, it needs to be investigated more deeply. I don’t think it’s time to dismiss the results of very large randomized trials that show a meaningful benefit for the potent agents in the setting of ACS.”
CHANGE DAPT was an investigator-initiated study conducted without external funding. Dr. von Birgelen reported having no financial conflicts of interest.
BARCELONA – Patients who underwent percutaneous coronary intervention for acute coronary syndrome using newer-generation drug-eluting stents backed by ticagrelor-based dual-antiplatelet therapy had significantly higher net adverse event rates at 1 year than did those with clopidogrel-based DAPT in the CHANGE DAPT study, Clemens von Birgelen, MD, reported at the annual congress of the European Society of Cardiology.
Based upon the CHANGE DAPT findings and those from other recent studies, it would be appropriate to revise ESC and American College of Cardiology/American Heart Association guidelines, which now give the newer, more potent platelet inhibitors ticagrelor (Brilinta) or prasugrel (Effient) preferential status as the P2Y12 inhibitor of choice over clopidogrel, added Dr. von Birgelen, professor of cardiology at the University of Twente in Enschede, the Netherlands, and codirector of the department of cardiology at Thoraxcentrum Twente.
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“With the newer drug-eluting stents we see lower ischemic event rates, so the DAPT side effects due to bleeding become more important at this time. It could be that patients with ACS who are undergoing PCI may no longer need the most potent DAPT. Perhaps less potent DAPT with clopidogrel may be sufficient when using these more modern devices,” Dr. von Birgelen said in an interview.
CHANGE DAPT was a prospective, observational registry study that compared 1-year clinical outcomes in 2,062 consecutive ACS patients treated by PCI at Thoraxcentrum Twente, a high-volume PCI center. Half of the patients were treated before the primary DAPT regimen in the region changed from clopidogrel-based to ticagrelor-based DAPT on May 1, 2014, while the other half underwent PCI after the switch. This unique registry study design avoids selection bias, whereby cardiologists might preferentially use clopidogrel – the less potent P2Y12 inhibitor – in frailer patients.
The primary endpoint was the 1-year composite of all-cause mortality, any MI, stroke, or major bleeding. The rate was 7.8% in the ticagrelor period and significantly lower at 5.1% in the clopidogrel period. This difference was driven by the significantly lower major bleeding rate in the clopidogrel group: 1.2% versus 2.7% with ticagrelor-based DAPT.
The increased risk of bleeding associated with ticagrelor wasn’t offset by any advantage in term of ischemic events; indeed, the rate of such events was actually numerically lower with clopidogrel-based DAPT, albeit not statistically significantly so. Definite or probable stent thrombosis occurred in 0.6% of the clopidogrel group and 0.8% of the ticagrelor group, while the composite of cardiac death, MI, or stroke occurred in 3.7% of patients on clopidogrel-based DAPT compared with 4.7% on ticagrelor.
The two patient groups were closely similar at baseline in most respects, although the ticagrelor group was, on average, 1 year older, reflecting the more recent increased willingness of interventional cardiologists to utilize PCI in patients of advanced age. In terms of procedural differences, the ticagrelor group was more likely to undergo a transradial rather than transfemoral approach, less likely to receive a glycoprotein IIb/IIIa inhibitor, and more likely to get a proton pump inhibitor.
“All three of those factors should have reduced the bleeding risk during that second period,” Dr. von Birgelen observed.
In a propensity score–adjusted analysis taking account of the few between-group differences, ticagrelor-based DAPT was associated with a 1.75-fold increased risk of the primary endpoint and a 2.75-fold increased risk of major bleeding.
He noted that the CHANGE DAPT results are consistent with those of TOPIC, a 646-patient, single-center randomized trial conducted in Marseille. In TOPIC, after 1 month on ticagrelor- or prasugrel-backed DAPT, half of patients were switched to vastly less expensive clopidogrel for the remaining 11 months of DAPT. The result in the switched group was a marked decrease in bleeding with no increased risk of ischemic events.
“I see our study as a piece in a mosaic of studies and real-world registries with a similar message that have recently been reported,” the cardiologist said. “I hope the ESC looks carefully at these data.”
Session cochair Laura Mauri, MD, said that while it’s important to look at real-world observational data such as CHANGE DAPT to see if the results of randomized trials are generalizable, she’s not surprised by the evidence of increased risk of bleeding with a more potent agent such as ticagrelor.
“Why there’s a lack of benefit demonstrated, I think, is the bigger question,” said Dr. Mauri, professor of medicine at Harvard Medical School, Boston. “It could be related to changes in procedures over time, with procedures being conducted in a more complex manner, or some other residual confounding. I think whenever we see an observational study that changes the nature of the benefit that we see, it needs to be investigated more deeply. I don’t think it’s time to dismiss the results of very large randomized trials that show a meaningful benefit for the potent agents in the setting of ACS.”
CHANGE DAPT was an investigator-initiated study conducted without external funding. Dr. von Birgelen reported having no financial conflicts of interest.
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: The 1-year composite endpoint of all-cause mortality, MI, stroke, or major bleeding occurred in 5.1% of ACS patients who underwent PCI using newer-generation drug-eluting stents followed by clopidogrel-based DAPT, compared with 7.8% who received ticagrelor-based DAPT.
Data source: This unique design for a prospective observational registry study compared 1-year outcomes in 2,062 consecutive ACS patients who underwent PCI at a single high-volume center, half before a regional switch from clopidogrel- to ticagrelor-based DAPT and half afterward.
Disclosures: CHANGE DAPT was an investigator-initiated study conducted without external funding. The presenter reported having no financial conflicts of interest.
HERDOO2 may guide duration of treatment for unprovoked VTE
Clinical Question: Can HERDOO2 guide anticoagulation cessation in women with unprovoked venous thromboembolism (VTE)?
Background: Patients with unprovoked VTE have increased recurrence rates after stopping anticoagulation, but no tools have been validated to identify low risk patients.
Setting: Forty-four referral centers in seven countries.
Synopsis: Of patients with unprovoked, symptomatic VTE, 2,747 were evaluated after receiving anticoagulation for 5-12 months. HERDOO2 was used to classify women as low (0-1 points) or high (equal to or greater than 2 points) risk categories. Men were considered high risk. Anticoagulation was stopped for low risk patients. Treatment of high risk patients was left to physician choice.
Overall, high risk patients who continued anticoagulation had a 1.6% recurrence rate. Low risk women who stopped anticoagulation had a 3% recurrence rate per patient year, but postmenopausal women aged 50 years or older had a rate of 5.7%. High risk patients who stopped anticoagulation had a 7.4% recurrence rate. This study included multiple sites, but only 44% of participants were women. HERDOO2 should be used cautiously in postmenopausal women aged 50 years or older and in nonwhite women.
Bottom Line: HERDOO2 may help guide the decision to stop anticoagulation in select low-risk women with unprovoked VTE.
Citation: Rodger MA, Gregoire LG, Anderson DR, et al. Validating the HERDOO2 rule to guide treatment duration for women with unprovoked venous thrombosis: Multinational prospective cohort management study. BMJ. 2017 March;356:j1065.
Dr. Helfrich is an assistant professor in the University of Kentucky division of hospital medicine.
Clinical Question: Can HERDOO2 guide anticoagulation cessation in women with unprovoked venous thromboembolism (VTE)?
Background: Patients with unprovoked VTE have increased recurrence rates after stopping anticoagulation, but no tools have been validated to identify low risk patients.
Setting: Forty-four referral centers in seven countries.
Synopsis: Of patients with unprovoked, symptomatic VTE, 2,747 were evaluated after receiving anticoagulation for 5-12 months. HERDOO2 was used to classify women as low (0-1 points) or high (equal to or greater than 2 points) risk categories. Men were considered high risk. Anticoagulation was stopped for low risk patients. Treatment of high risk patients was left to physician choice.
Overall, high risk patients who continued anticoagulation had a 1.6% recurrence rate. Low risk women who stopped anticoagulation had a 3% recurrence rate per patient year, but postmenopausal women aged 50 years or older had a rate of 5.7%. High risk patients who stopped anticoagulation had a 7.4% recurrence rate. This study included multiple sites, but only 44% of participants were women. HERDOO2 should be used cautiously in postmenopausal women aged 50 years or older and in nonwhite women.
Bottom Line: HERDOO2 may help guide the decision to stop anticoagulation in select low-risk women with unprovoked VTE.
Citation: Rodger MA, Gregoire LG, Anderson DR, et al. Validating the HERDOO2 rule to guide treatment duration for women with unprovoked venous thrombosis: Multinational prospective cohort management study. BMJ. 2017 March;356:j1065.
Dr. Helfrich is an assistant professor in the University of Kentucky division of hospital medicine.
Clinical Question: Can HERDOO2 guide anticoagulation cessation in women with unprovoked venous thromboembolism (VTE)?
Background: Patients with unprovoked VTE have increased recurrence rates after stopping anticoagulation, but no tools have been validated to identify low risk patients.
Setting: Forty-four referral centers in seven countries.
Synopsis: Of patients with unprovoked, symptomatic VTE, 2,747 were evaluated after receiving anticoagulation for 5-12 months. HERDOO2 was used to classify women as low (0-1 points) or high (equal to or greater than 2 points) risk categories. Men were considered high risk. Anticoagulation was stopped for low risk patients. Treatment of high risk patients was left to physician choice.
Overall, high risk patients who continued anticoagulation had a 1.6% recurrence rate. Low risk women who stopped anticoagulation had a 3% recurrence rate per patient year, but postmenopausal women aged 50 years or older had a rate of 5.7%. High risk patients who stopped anticoagulation had a 7.4% recurrence rate. This study included multiple sites, but only 44% of participants were women. HERDOO2 should be used cautiously in postmenopausal women aged 50 years or older and in nonwhite women.
Bottom Line: HERDOO2 may help guide the decision to stop anticoagulation in select low-risk women with unprovoked VTE.
Citation: Rodger MA, Gregoire LG, Anderson DR, et al. Validating the HERDOO2 rule to guide treatment duration for women with unprovoked venous thrombosis: Multinational prospective cohort management study. BMJ. 2017 March;356:j1065.
Dr. Helfrich is an assistant professor in the University of Kentucky division of hospital medicine.
Simplified HOSPITAL score predicts 30-day readmissions
Clinical Question: Will a simplified HOSPITAL score accurately predict 30-day readmissions?
Background: Hospital readmissions stress patients and health care systems. Interventions to prevent avoidable readmissions are complex and expensive. The HOSPITAL score predicts 30-day readmissions which may help direct resources toward high risk patients.
Setting: Nine hospitals in four countries.
Synopsis: The HOSPITAL score was simplified by removing the procedure variable, expanding the oncology criteria to include a diagnosis of cancer, and dividing patients into high and low risk groups. The simplified HOSPITAL score was used to predict avoidable readmissions of 117,065 patients from nine hospitals. Readmission rates predicted by the simplified HOSPITAL score matched observed outcomes with a sensitivity of 94% and specificity of 73%. Its discriminatory power was comparable with the original HOSPITAL score.
This was a robust study of medical patients but may not be generalizable to surgical patients. The score does not include patients’ socioeconomic status or support systems. It also cannot indicate what type of intervention may prevent readmissions.
Bottom Line: The simplified HOSPITAL score accurately predicts avoidable 30-day readmission rates.
Citation: Aubert CE, Schnipper JL, Williams MV, et al. Simplification of the HOSPITAL score for predicting 30-day readmissions. BMJ Qual Saf. Published online first. 17 Apr 2017. doi: 10.1136/bmjqs-2016-006239.
Dr. Helfrich is an assistant professor in the University of Kentucky division of hospital medicine.
Clinical Question: Will a simplified HOSPITAL score accurately predict 30-day readmissions?
Background: Hospital readmissions stress patients and health care systems. Interventions to prevent avoidable readmissions are complex and expensive. The HOSPITAL score predicts 30-day readmissions which may help direct resources toward high risk patients.
Setting: Nine hospitals in four countries.
Synopsis: The HOSPITAL score was simplified by removing the procedure variable, expanding the oncology criteria to include a diagnosis of cancer, and dividing patients into high and low risk groups. The simplified HOSPITAL score was used to predict avoidable readmissions of 117,065 patients from nine hospitals. Readmission rates predicted by the simplified HOSPITAL score matched observed outcomes with a sensitivity of 94% and specificity of 73%. Its discriminatory power was comparable with the original HOSPITAL score.
This was a robust study of medical patients but may not be generalizable to surgical patients. The score does not include patients’ socioeconomic status or support systems. It also cannot indicate what type of intervention may prevent readmissions.
Bottom Line: The simplified HOSPITAL score accurately predicts avoidable 30-day readmission rates.
Citation: Aubert CE, Schnipper JL, Williams MV, et al. Simplification of the HOSPITAL score for predicting 30-day readmissions. BMJ Qual Saf. Published online first. 17 Apr 2017. doi: 10.1136/bmjqs-2016-006239.
Dr. Helfrich is an assistant professor in the University of Kentucky division of hospital medicine.
Clinical Question: Will a simplified HOSPITAL score accurately predict 30-day readmissions?
Background: Hospital readmissions stress patients and health care systems. Interventions to prevent avoidable readmissions are complex and expensive. The HOSPITAL score predicts 30-day readmissions which may help direct resources toward high risk patients.
Setting: Nine hospitals in four countries.
Synopsis: The HOSPITAL score was simplified by removing the procedure variable, expanding the oncology criteria to include a diagnosis of cancer, and dividing patients into high and low risk groups. The simplified HOSPITAL score was used to predict avoidable readmissions of 117,065 patients from nine hospitals. Readmission rates predicted by the simplified HOSPITAL score matched observed outcomes with a sensitivity of 94% and specificity of 73%. Its discriminatory power was comparable with the original HOSPITAL score.
This was a robust study of medical patients but may not be generalizable to surgical patients. The score does not include patients’ socioeconomic status or support systems. It also cannot indicate what type of intervention may prevent readmissions.
Bottom Line: The simplified HOSPITAL score accurately predicts avoidable 30-day readmission rates.
Citation: Aubert CE, Schnipper JL, Williams MV, et al. Simplification of the HOSPITAL score for predicting 30-day readmissions. BMJ Qual Saf. Published online first. 17 Apr 2017. doi: 10.1136/bmjqs-2016-006239.
Dr. Helfrich is an assistant professor in the University of Kentucky division of hospital medicine.
How to reduce NICU transfers for asymptomatic hypoglycemia
NASHVILLE, TENN. – At the University of North Carolina at Chapel Hill, many infants who would previously have been transferred to the NICU for asymptomatic hypoglycemia now are staying with their moms, thanks to a new protocol that holds off on blood glucose testing until infants are fed for the first time and glucose homeostasis can begin.
Not too long ago, the university realized it had a problem that’s probably familiar to other institutions: Its system to monitor newborns at risk for hypoglycemia – those born to diabetic mothers, or who are small or large for gestational age – put too many infants with asymptomatic hypoglycemia into the NICU when they didn’t really need to be there.
Nurse practitioners “were tired of transferring babies they felt were responsive to feeding and did not actually require NICU care,” and “a growing number of families were unhappy with being separated from infants that were well-appearing and feeding well at a time when moms were trying to establish breast feeding and bonding. There was frustration with our protocol,” which “seemed rigid and outdated,” said Ashley Sutton, MD, a pediatric hospitalist at the university.
To fix the problem, Dr. Sutton and others on a multidisciplinary team implemented the American Academy of Pediatrics’ 2011 guidelines for monitoring glucose homeostasis in late-preterm and term newborns at-risk for hypoglycemia, with an additional mandate to initiate immediate, continual skin-to-skin contact at delivery (Pediatrics. 2011 Mar;127[3]:575-9).
Under the new system, children are fed with either their mom’s or a donor’s breast milk within an hour of birth, and the initial glucose check comes at 90 minutes; infants are transferred if blood glucose remains below 25 mg/dL after the second feeding. After 4 hours of life, glucose levels below 35 mg/dL trigger an evaluation for symptoms, not necessarily an automatic NICU transfer.
Labor and delivery nurses also are empowered “to immediately feed the baby no matter what number [they are] seeing,” Dr. Sutton said at the meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
The efforts have made a difference. The transfer rate for at-risk infants has fallen from 17% to 3%, and skin-to-skin contact is initiated within the first hour of life in 64%, up from 45%. Feeding of at-risk infants within the first hour has increased from 43% to 61%, and the first glucose check comes at an average of 97 minutes. The number of unnecessary NICU transfers of at-risk infants has fallen sharply.
Meanwhile, there’s been no increase in sepsis evaluations, adverse events, readmissions, and the rates of symptomatic hypoglycemia.
Dr. Sutton and her colleagues had no industry disclosures. The work was funded by the National Institutes of Health.
NASHVILLE, TENN. – At the University of North Carolina at Chapel Hill, many infants who would previously have been transferred to the NICU for asymptomatic hypoglycemia now are staying with their moms, thanks to a new protocol that holds off on blood glucose testing until infants are fed for the first time and glucose homeostasis can begin.
Not too long ago, the university realized it had a problem that’s probably familiar to other institutions: Its system to monitor newborns at risk for hypoglycemia – those born to diabetic mothers, or who are small or large for gestational age – put too many infants with asymptomatic hypoglycemia into the NICU when they didn’t really need to be there.
Nurse practitioners “were tired of transferring babies they felt were responsive to feeding and did not actually require NICU care,” and “a growing number of families were unhappy with being separated from infants that were well-appearing and feeding well at a time when moms were trying to establish breast feeding and bonding. There was frustration with our protocol,” which “seemed rigid and outdated,” said Ashley Sutton, MD, a pediatric hospitalist at the university.
To fix the problem, Dr. Sutton and others on a multidisciplinary team implemented the American Academy of Pediatrics’ 2011 guidelines for monitoring glucose homeostasis in late-preterm and term newborns at-risk for hypoglycemia, with an additional mandate to initiate immediate, continual skin-to-skin contact at delivery (Pediatrics. 2011 Mar;127[3]:575-9).
Under the new system, children are fed with either their mom’s or a donor’s breast milk within an hour of birth, and the initial glucose check comes at 90 minutes; infants are transferred if blood glucose remains below 25 mg/dL after the second feeding. After 4 hours of life, glucose levels below 35 mg/dL trigger an evaluation for symptoms, not necessarily an automatic NICU transfer.
Labor and delivery nurses also are empowered “to immediately feed the baby no matter what number [they are] seeing,” Dr. Sutton said at the meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
The efforts have made a difference. The transfer rate for at-risk infants has fallen from 17% to 3%, and skin-to-skin contact is initiated within the first hour of life in 64%, up from 45%. Feeding of at-risk infants within the first hour has increased from 43% to 61%, and the first glucose check comes at an average of 97 minutes. The number of unnecessary NICU transfers of at-risk infants has fallen sharply.
Meanwhile, there’s been no increase in sepsis evaluations, adverse events, readmissions, and the rates of symptomatic hypoglycemia.
Dr. Sutton and her colleagues had no industry disclosures. The work was funded by the National Institutes of Health.
NASHVILLE, TENN. – At the University of North Carolina at Chapel Hill, many infants who would previously have been transferred to the NICU for asymptomatic hypoglycemia now are staying with their moms, thanks to a new protocol that holds off on blood glucose testing until infants are fed for the first time and glucose homeostasis can begin.
Not too long ago, the university realized it had a problem that’s probably familiar to other institutions: Its system to monitor newborns at risk for hypoglycemia – those born to diabetic mothers, or who are small or large for gestational age – put too many infants with asymptomatic hypoglycemia into the NICU when they didn’t really need to be there.
Nurse practitioners “were tired of transferring babies they felt were responsive to feeding and did not actually require NICU care,” and “a growing number of families were unhappy with being separated from infants that were well-appearing and feeding well at a time when moms were trying to establish breast feeding and bonding. There was frustration with our protocol,” which “seemed rigid and outdated,” said Ashley Sutton, MD, a pediatric hospitalist at the university.
To fix the problem, Dr. Sutton and others on a multidisciplinary team implemented the American Academy of Pediatrics’ 2011 guidelines for monitoring glucose homeostasis in late-preterm and term newborns at-risk for hypoglycemia, with an additional mandate to initiate immediate, continual skin-to-skin contact at delivery (Pediatrics. 2011 Mar;127[3]:575-9).
Under the new system, children are fed with either their mom’s or a donor’s breast milk within an hour of birth, and the initial glucose check comes at 90 minutes; infants are transferred if blood glucose remains below 25 mg/dL after the second feeding. After 4 hours of life, glucose levels below 35 mg/dL trigger an evaluation for symptoms, not necessarily an automatic NICU transfer.
Labor and delivery nurses also are empowered “to immediately feed the baby no matter what number [they are] seeing,” Dr. Sutton said at the meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
The efforts have made a difference. The transfer rate for at-risk infants has fallen from 17% to 3%, and skin-to-skin contact is initiated within the first hour of life in 64%, up from 45%. Feeding of at-risk infants within the first hour has increased from 43% to 61%, and the first glucose check comes at an average of 97 minutes. The number of unnecessary NICU transfers of at-risk infants has fallen sharply.
Meanwhile, there’s been no increase in sepsis evaluations, adverse events, readmissions, and the rates of symptomatic hypoglycemia.
Dr. Sutton and her colleagues had no industry disclosures. The work was funded by the National Institutes of Health.
AT PHM 2017
Key clinical point:
Major finding: After making that and other changes, the transfer rate for at-risk infants at a major academic center fell from 17% to 3%, without an increase in rates of symptomatic hypoglycemia and adverse events.
Data source: Quality improvement project at the University of North Carolina at Chapel Hill.
Disclosures: The investigators had no financial disclosures. The work was funded by the National Institutes of Health.
VIDEO: Rivaroxaban plus aspirin cut cardiovascular events in stable patients
BARCELONA – Combined treatment with a very low dosage of the anticoagulant rivaroxaban plus low-dose aspirin produced significant cuts in major adverse coronary, cerebral, and peripheral artery disease events with just a modest rise in major bleeding events in patients with stable disease in the COMPASS pivotal, randomized trial with more than 27,000 patients.
The benefits from the rivaroxaban plus aspirin regimen included a statistically significant 24% relative risk reduction in the study’s primary, combined endpoint, and a significant 18% relative risk reduction in all-cause death compared with a standard regimen of aspirin only, John W. Eikelboom, MD, said at the annual congress of the European Society of Cardiology. In addition, analysis of the net clinical benefit from treatment that took into account both the major adverse cardiovascular events prevented and major bleeding events induced, showed that the rivaroxaban-plus-aspirin regimen cut these by a statistically significant 20%, compared with aspirin alone.
Other notable benefits documented by the findings included a statistically significant 42% relative risk reduction for stroke and a statistically significant 46% relative risk reduction in the incidence of major adverse limb events among the roughly one-quarter of enrolled patients who entered the study with evidence of peripheral artery disease.
These risk reductions are similar in magnitude to the secondary-prevention benefits produced by controlling hypertension or dyslipidemia, noted Dr. Eikelboom, a researcher at McMaster University in Hamilton, Ont. “In the future, rivaroxaban will take its place among the other foundational treatments for long-term, secondary prevention,” he predicted in a video interview.
The COMPASS trial produced “unambiguous results that should change guidelines and the management of stable coronary artery disease,” commented Eugene Braunwald, MD, designated discussant for Dr. Eikelboom’s report. The results are “an important step for thrombocardiology,” said Dr. Braunwald, professor of medicine at Harvard Medical School in Boston.
Concurrently with Dr. Eikelboom’s report the results appeared in an article published online (N Engl J Med. 2017 Aug 27. doi: 10.1056/NEJMoa1709118). This publication also include an editorial by Dr. Braunwald (N Engl J Med. 2017 Aug 27. doi: 10.1056/NEJMe1710241).
The Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease (COMPASS) trial enrolled 27,395 patients with stable coronary, carotid, or peripheral artery disease, or a combination of two or more of these, at 602 centers in 33 countries. About 90% of enrolled patients had coronary artery disease and 27% had peripheral artery disease. The enrolled patients averaged 68 year old and were an average of 7 years removed from their index arterial event. Randomization assigned patients to receive 2.5 mg rivaroxaban (Xarelto) twice daily plus 100 mg aspirin daily, 5 mg rivaroxaban twice daily, or 100 mg aspirin once daily. The trial stopped early, after an average follow-up of 23 months, because of the overwhelming benefit seen for the rivaroxaban plus aspirin combination. The rivaroxaban-monotherapy arm failed to show any statistically significant benefits, compared with the aspirin-monotherapy control group.
The study’s primary endpoint – the combined rate of cardiovascular disease death, nonfatal stroke, and nonfatal MI – occurred in 4.1% of patients in the rivaroxaban-plus-aspirin group and in 5.4% of patients on aspirin alone. The rate of major bleeding events was 3.1% among patients on rivaroxaban plus aspirin and 1.9% in those who received aspirin only, a 51% relative increase among patients on the dual regimen, but the results showed no statistically significant increase in the rates of fatal bleeds, intracerebral bleeds, or bleeding in other critical organs.
Sonia Anand, MD, a colleague of Dr. Eikelboom’s at McMaster, presented a separate set of analyses that focused on the 7,470 enrolled patients who had been diagnosed at enrollment with peripheral artery disease. In this subgroup, the rivaroxaban-plus-aspirin regimen produced a statistically significant 28% relative risk reduction in the rate of the primary endpoint, compared with the aspirin control group. The dual regimen also produced a statistically significant 46% relative risk reduction in major adverse limb events and a significant 70% relative reduction in the incidence of major lower-extremity amputations, reported Dr. Anand, professor of medicine and director of the vascular medicine clinic at McMaster.
The COMPASS findings follow a 2012 published report from the ATLAS ACS 2-TIMI 51 trial showing that treatment with the same low-dose rivaroxaban regimen plus aspirin and a thienopyridine (clopidogrel or ticlopidine) reduced the same combined triple endpoint by a statistically significant 16%, compared with aspirin and a thienopyridine alone, in patients with a recent acute coronary syndrome event (N Engl J Med. 2012 Jan 5;366[1]:9-19). Despite this evidence, the Food and Drug Administration never approved the 2.5-mg formulation of rivaroxaban, nor did it approve marketing of rivaroxaban for this acute coronary syndrome population. This decision may have been driven in part by a problem with incomplete follow-up of several of the enrolled patients.
The COMPASS results were “very consistent” with the ATLAS ACS 2-TIMI 51 results. noted Dr. Eikelboom. “I think it’s time to look at these two trials in combination,” he suggested. Availability of the 2.5-mg rivaroxaban formulation used in both trials would allow “a treatment strategy that could start early after an acute coronary syndrome event and then extend long term,” he said.
COMPASS was sponsored by Bayer, which markets rivaroxaban (Xarelto). Dr. Eikelboom has received research support from Bayer and also from Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi, Janssen, Pfizer, Portola, and Sanofi. Dr. Anand has received speaking honoraria from several drug compnies. Dr. Braunwald had no disclosures.
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On Twitter @mitchelzoler
The key message from COMPASS was that, although adding a very low dosage of rivaroxaban to aspirin in patients with stable coronary or peripheral artery disease resulted in a clear increase in major bleeding events, patients received an overall net beneficial effect from the combined regimen. The finding that clinches the net benefit from the rivaroxaban plus aspirin combination, compared with aspirin alone, was that the combined regimen produced a statistically significant relative risk reduction of 18% for all-cause mortality. This finding reinforces the idea that the primary outcome was beneficial despite an increase in major bleeding events.
The finding that rivaroxaban plus aspirin produced benefit with a modest increase in bleeding risk in patients with peripheral artery disease (PAD) is especially important because PAD is really difficult to treat. Very few interventions have previously been proven to have a beneficial effect for patients with PAD. It’s very important to find an intervention that can reduce critical limb ischemia events in addition to reducing coronary events, stroke, and overall mortality.
The very low dosage of rivaroxaban used in COMPASS, 2.5 mg twice daily, seems to be a very important part of the study’s design. This dosage appeared to hit the sweet spot of being large enough to reduce events but with a gentle enough anticoagulation effect to avoid a significant increase in fatal, intracerebral, or critical organ bleeds. However, the patients enrolled in COMPASS, like most patients who enter trials, were generally at a lower risk for bleeding complications than we usually see in routine practice in patients with stable coronary or peripheral artery disease. Presuming that the Food and Drug Administration will soon approve the 2.5-mg formulation of rivaroxaban used in COMPASS, clinicians will need to be careful using this regimen on patients at increased risk for bleeding, such as frail or elderly patients with a history of bleeding events or taking other treatments that could increase bleeding risk, such as nonsteroidal anti-inflammatory drugs. In general, clinicians are wary of using treatments that increase bleeding risk, and so they may hesitate to use this combination of rivaroxaban plus aspirin in patients with a high bleeding risk.
The success of the approach used in COMPASS became possible with the introduction of the new oral anticoagulant drugs. Now that this class of agents has been available for a few years, clinicians have grown increasingly comfortable with them, compared with warfarin. When the new oral anticoagulants first came out, many considered them similar to warfarin. Today, there is a better appreciation that these drugs are distinct from warfarin by really causing fewer bleeding complications.
Christopher B. Granger, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. He has been a consultant to and has received research support from Bayer and from other drugs companies that market new oral anticoagulants. He made these comments in an interview.
The key message from COMPASS was that, although adding a very low dosage of rivaroxaban to aspirin in patients with stable coronary or peripheral artery disease resulted in a clear increase in major bleeding events, patients received an overall net beneficial effect from the combined regimen. The finding that clinches the net benefit from the rivaroxaban plus aspirin combination, compared with aspirin alone, was that the combined regimen produced a statistically significant relative risk reduction of 18% for all-cause mortality. This finding reinforces the idea that the primary outcome was beneficial despite an increase in major bleeding events.
The finding that rivaroxaban plus aspirin produced benefit with a modest increase in bleeding risk in patients with peripheral artery disease (PAD) is especially important because PAD is really difficult to treat. Very few interventions have previously been proven to have a beneficial effect for patients with PAD. It’s very important to find an intervention that can reduce critical limb ischemia events in addition to reducing coronary events, stroke, and overall mortality.
The very low dosage of rivaroxaban used in COMPASS, 2.5 mg twice daily, seems to be a very important part of the study’s design. This dosage appeared to hit the sweet spot of being large enough to reduce events but with a gentle enough anticoagulation effect to avoid a significant increase in fatal, intracerebral, or critical organ bleeds. However, the patients enrolled in COMPASS, like most patients who enter trials, were generally at a lower risk for bleeding complications than we usually see in routine practice in patients with stable coronary or peripheral artery disease. Presuming that the Food and Drug Administration will soon approve the 2.5-mg formulation of rivaroxaban used in COMPASS, clinicians will need to be careful using this regimen on patients at increased risk for bleeding, such as frail or elderly patients with a history of bleeding events or taking other treatments that could increase bleeding risk, such as nonsteroidal anti-inflammatory drugs. In general, clinicians are wary of using treatments that increase bleeding risk, and so they may hesitate to use this combination of rivaroxaban plus aspirin in patients with a high bleeding risk.
The success of the approach used in COMPASS became possible with the introduction of the new oral anticoagulant drugs. Now that this class of agents has been available for a few years, clinicians have grown increasingly comfortable with them, compared with warfarin. When the new oral anticoagulants first came out, many considered them similar to warfarin. Today, there is a better appreciation that these drugs are distinct from warfarin by really causing fewer bleeding complications.
Christopher B. Granger, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. He has been a consultant to and has received research support from Bayer and from other drugs companies that market new oral anticoagulants. He made these comments in an interview.
The key message from COMPASS was that, although adding a very low dosage of rivaroxaban to aspirin in patients with stable coronary or peripheral artery disease resulted in a clear increase in major bleeding events, patients received an overall net beneficial effect from the combined regimen. The finding that clinches the net benefit from the rivaroxaban plus aspirin combination, compared with aspirin alone, was that the combined regimen produced a statistically significant relative risk reduction of 18% for all-cause mortality. This finding reinforces the idea that the primary outcome was beneficial despite an increase in major bleeding events.
The finding that rivaroxaban plus aspirin produced benefit with a modest increase in bleeding risk in patients with peripheral artery disease (PAD) is especially important because PAD is really difficult to treat. Very few interventions have previously been proven to have a beneficial effect for patients with PAD. It’s very important to find an intervention that can reduce critical limb ischemia events in addition to reducing coronary events, stroke, and overall mortality.
The very low dosage of rivaroxaban used in COMPASS, 2.5 mg twice daily, seems to be a very important part of the study’s design. This dosage appeared to hit the sweet spot of being large enough to reduce events but with a gentle enough anticoagulation effect to avoid a significant increase in fatal, intracerebral, or critical organ bleeds. However, the patients enrolled in COMPASS, like most patients who enter trials, were generally at a lower risk for bleeding complications than we usually see in routine practice in patients with stable coronary or peripheral artery disease. Presuming that the Food and Drug Administration will soon approve the 2.5-mg formulation of rivaroxaban used in COMPASS, clinicians will need to be careful using this regimen on patients at increased risk for bleeding, such as frail or elderly patients with a history of bleeding events or taking other treatments that could increase bleeding risk, such as nonsteroidal anti-inflammatory drugs. In general, clinicians are wary of using treatments that increase bleeding risk, and so they may hesitate to use this combination of rivaroxaban plus aspirin in patients with a high bleeding risk.
The success of the approach used in COMPASS became possible with the introduction of the new oral anticoagulant drugs. Now that this class of agents has been available for a few years, clinicians have grown increasingly comfortable with them, compared with warfarin. When the new oral anticoagulants first came out, many considered them similar to warfarin. Today, there is a better appreciation that these drugs are distinct from warfarin by really causing fewer bleeding complications.
Christopher B. Granger, MD , is a cardiologist and professor of medicine at Duke University in Durham, N.C. He has been a consultant to and has received research support from Bayer and from other drugs companies that market new oral anticoagulants. He made these comments in an interview.
BARCELONA – Combined treatment with a very low dosage of the anticoagulant rivaroxaban plus low-dose aspirin produced significant cuts in major adverse coronary, cerebral, and peripheral artery disease events with just a modest rise in major bleeding events in patients with stable disease in the COMPASS pivotal, randomized trial with more than 27,000 patients.
The benefits from the rivaroxaban plus aspirin regimen included a statistically significant 24% relative risk reduction in the study’s primary, combined endpoint, and a significant 18% relative risk reduction in all-cause death compared with a standard regimen of aspirin only, John W. Eikelboom, MD, said at the annual congress of the European Society of Cardiology. In addition, analysis of the net clinical benefit from treatment that took into account both the major adverse cardiovascular events prevented and major bleeding events induced, showed that the rivaroxaban-plus-aspirin regimen cut these by a statistically significant 20%, compared with aspirin alone.
Other notable benefits documented by the findings included a statistically significant 42% relative risk reduction for stroke and a statistically significant 46% relative risk reduction in the incidence of major adverse limb events among the roughly one-quarter of enrolled patients who entered the study with evidence of peripheral artery disease.
These risk reductions are similar in magnitude to the secondary-prevention benefits produced by controlling hypertension or dyslipidemia, noted Dr. Eikelboom, a researcher at McMaster University in Hamilton, Ont. “In the future, rivaroxaban will take its place among the other foundational treatments for long-term, secondary prevention,” he predicted in a video interview.
The COMPASS trial produced “unambiguous results that should change guidelines and the management of stable coronary artery disease,” commented Eugene Braunwald, MD, designated discussant for Dr. Eikelboom’s report. The results are “an important step for thrombocardiology,” said Dr. Braunwald, professor of medicine at Harvard Medical School in Boston.
Concurrently with Dr. Eikelboom’s report the results appeared in an article published online (N Engl J Med. 2017 Aug 27. doi: 10.1056/NEJMoa1709118). This publication also include an editorial by Dr. Braunwald (N Engl J Med. 2017 Aug 27. doi: 10.1056/NEJMe1710241).
The Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease (COMPASS) trial enrolled 27,395 patients with stable coronary, carotid, or peripheral artery disease, or a combination of two or more of these, at 602 centers in 33 countries. About 90% of enrolled patients had coronary artery disease and 27% had peripheral artery disease. The enrolled patients averaged 68 year old and were an average of 7 years removed from their index arterial event. Randomization assigned patients to receive 2.5 mg rivaroxaban (Xarelto) twice daily plus 100 mg aspirin daily, 5 mg rivaroxaban twice daily, or 100 mg aspirin once daily. The trial stopped early, after an average follow-up of 23 months, because of the overwhelming benefit seen for the rivaroxaban plus aspirin combination. The rivaroxaban-monotherapy arm failed to show any statistically significant benefits, compared with the aspirin-monotherapy control group.
The study’s primary endpoint – the combined rate of cardiovascular disease death, nonfatal stroke, and nonfatal MI – occurred in 4.1% of patients in the rivaroxaban-plus-aspirin group and in 5.4% of patients on aspirin alone. The rate of major bleeding events was 3.1% among patients on rivaroxaban plus aspirin and 1.9% in those who received aspirin only, a 51% relative increase among patients on the dual regimen, but the results showed no statistically significant increase in the rates of fatal bleeds, intracerebral bleeds, or bleeding in other critical organs.
Sonia Anand, MD, a colleague of Dr. Eikelboom’s at McMaster, presented a separate set of analyses that focused on the 7,470 enrolled patients who had been diagnosed at enrollment with peripheral artery disease. In this subgroup, the rivaroxaban-plus-aspirin regimen produced a statistically significant 28% relative risk reduction in the rate of the primary endpoint, compared with the aspirin control group. The dual regimen also produced a statistically significant 46% relative risk reduction in major adverse limb events and a significant 70% relative reduction in the incidence of major lower-extremity amputations, reported Dr. Anand, professor of medicine and director of the vascular medicine clinic at McMaster.
The COMPASS findings follow a 2012 published report from the ATLAS ACS 2-TIMI 51 trial showing that treatment with the same low-dose rivaroxaban regimen plus aspirin and a thienopyridine (clopidogrel or ticlopidine) reduced the same combined triple endpoint by a statistically significant 16%, compared with aspirin and a thienopyridine alone, in patients with a recent acute coronary syndrome event (N Engl J Med. 2012 Jan 5;366[1]:9-19). Despite this evidence, the Food and Drug Administration never approved the 2.5-mg formulation of rivaroxaban, nor did it approve marketing of rivaroxaban for this acute coronary syndrome population. This decision may have been driven in part by a problem with incomplete follow-up of several of the enrolled patients.
The COMPASS results were “very consistent” with the ATLAS ACS 2-TIMI 51 results. noted Dr. Eikelboom. “I think it’s time to look at these two trials in combination,” he suggested. Availability of the 2.5-mg rivaroxaban formulation used in both trials would allow “a treatment strategy that could start early after an acute coronary syndrome event and then extend long term,” he said.
COMPASS was sponsored by Bayer, which markets rivaroxaban (Xarelto). Dr. Eikelboom has received research support from Bayer and also from Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi, Janssen, Pfizer, Portola, and Sanofi. Dr. Anand has received speaking honoraria from several drug compnies. Dr. Braunwald had no disclosures.
[email protected]
On Twitter @mitchelzoler
BARCELONA – Combined treatment with a very low dosage of the anticoagulant rivaroxaban plus low-dose aspirin produced significant cuts in major adverse coronary, cerebral, and peripheral artery disease events with just a modest rise in major bleeding events in patients with stable disease in the COMPASS pivotal, randomized trial with more than 27,000 patients.
The benefits from the rivaroxaban plus aspirin regimen included a statistically significant 24% relative risk reduction in the study’s primary, combined endpoint, and a significant 18% relative risk reduction in all-cause death compared with a standard regimen of aspirin only, John W. Eikelboom, MD, said at the annual congress of the European Society of Cardiology. In addition, analysis of the net clinical benefit from treatment that took into account both the major adverse cardiovascular events prevented and major bleeding events induced, showed that the rivaroxaban-plus-aspirin regimen cut these by a statistically significant 20%, compared with aspirin alone.
Other notable benefits documented by the findings included a statistically significant 42% relative risk reduction for stroke and a statistically significant 46% relative risk reduction in the incidence of major adverse limb events among the roughly one-quarter of enrolled patients who entered the study with evidence of peripheral artery disease.
These risk reductions are similar in magnitude to the secondary-prevention benefits produced by controlling hypertension or dyslipidemia, noted Dr. Eikelboom, a researcher at McMaster University in Hamilton, Ont. “In the future, rivaroxaban will take its place among the other foundational treatments for long-term, secondary prevention,” he predicted in a video interview.
The COMPASS trial produced “unambiguous results that should change guidelines and the management of stable coronary artery disease,” commented Eugene Braunwald, MD, designated discussant for Dr. Eikelboom’s report. The results are “an important step for thrombocardiology,” said Dr. Braunwald, professor of medicine at Harvard Medical School in Boston.
Concurrently with Dr. Eikelboom’s report the results appeared in an article published online (N Engl J Med. 2017 Aug 27. doi: 10.1056/NEJMoa1709118). This publication also include an editorial by Dr. Braunwald (N Engl J Med. 2017 Aug 27. doi: 10.1056/NEJMe1710241).
The Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease (COMPASS) trial enrolled 27,395 patients with stable coronary, carotid, or peripheral artery disease, or a combination of two or more of these, at 602 centers in 33 countries. About 90% of enrolled patients had coronary artery disease and 27% had peripheral artery disease. The enrolled patients averaged 68 year old and were an average of 7 years removed from their index arterial event. Randomization assigned patients to receive 2.5 mg rivaroxaban (Xarelto) twice daily plus 100 mg aspirin daily, 5 mg rivaroxaban twice daily, or 100 mg aspirin once daily. The trial stopped early, after an average follow-up of 23 months, because of the overwhelming benefit seen for the rivaroxaban plus aspirin combination. The rivaroxaban-monotherapy arm failed to show any statistically significant benefits, compared with the aspirin-monotherapy control group.
The study’s primary endpoint – the combined rate of cardiovascular disease death, nonfatal stroke, and nonfatal MI – occurred in 4.1% of patients in the rivaroxaban-plus-aspirin group and in 5.4% of patients on aspirin alone. The rate of major bleeding events was 3.1% among patients on rivaroxaban plus aspirin and 1.9% in those who received aspirin only, a 51% relative increase among patients on the dual regimen, but the results showed no statistically significant increase in the rates of fatal bleeds, intracerebral bleeds, or bleeding in other critical organs.
Sonia Anand, MD, a colleague of Dr. Eikelboom’s at McMaster, presented a separate set of analyses that focused on the 7,470 enrolled patients who had been diagnosed at enrollment with peripheral artery disease. In this subgroup, the rivaroxaban-plus-aspirin regimen produced a statistically significant 28% relative risk reduction in the rate of the primary endpoint, compared with the aspirin control group. The dual regimen also produced a statistically significant 46% relative risk reduction in major adverse limb events and a significant 70% relative reduction in the incidence of major lower-extremity amputations, reported Dr. Anand, professor of medicine and director of the vascular medicine clinic at McMaster.
The COMPASS findings follow a 2012 published report from the ATLAS ACS 2-TIMI 51 trial showing that treatment with the same low-dose rivaroxaban regimen plus aspirin and a thienopyridine (clopidogrel or ticlopidine) reduced the same combined triple endpoint by a statistically significant 16%, compared with aspirin and a thienopyridine alone, in patients with a recent acute coronary syndrome event (N Engl J Med. 2012 Jan 5;366[1]:9-19). Despite this evidence, the Food and Drug Administration never approved the 2.5-mg formulation of rivaroxaban, nor did it approve marketing of rivaroxaban for this acute coronary syndrome population. This decision may have been driven in part by a problem with incomplete follow-up of several of the enrolled patients.
The COMPASS results were “very consistent” with the ATLAS ACS 2-TIMI 51 results. noted Dr. Eikelboom. “I think it’s time to look at these two trials in combination,” he suggested. Availability of the 2.5-mg rivaroxaban formulation used in both trials would allow “a treatment strategy that could start early after an acute coronary syndrome event and then extend long term,” he said.
COMPASS was sponsored by Bayer, which markets rivaroxaban (Xarelto). Dr. Eikelboom has received research support from Bayer and also from Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi, Janssen, Pfizer, Portola, and Sanofi. Dr. Anand has received speaking honoraria from several drug compnies. Dr. Braunwald had no disclosures.
[email protected]
On Twitter @mitchelzoler
AT THE ESC CONGRESS 2017
Key clinical point:
Major finding: The dual regimen reduced the combined rate of cardiovascular disease events by 24%, compared with aspirin alone.
Data source: COMPASS is a multicenter, randomized controlled trial with 27,395 patients.
Disclosures: COMPASS was sponsored by Bayer, which markets rivaroxaban (Xarelto). Dr. Eikelboom has received research support from Bayer and also from Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi, Janssen, Pfizer, Portola, and Sanofi. Dr. Anand has received speaking honoraria from several drug compnies. Dr. Braunwald had no disclosures.
