Major bleeding in patients with peripheral artery disease: Insights from the EUCLID trial.

Abstract

BACKGROUND:Rates and predictors of major bleeding in patients with peripheral artery disease (PAD) treated with antiplatelets have not been well studied. This post hoc analysis of EUCLID aimed to determine the incidence of major/minor bleeding, predictors of major bleeding, and risk of major adverse cardiovascular events (MACE) following major bleeding events. METHODS:EUCLID, a multicenter randomized controlled trial of 13,885 patients with symptomatic PAD, compared ticagrelor with clopidogrel for the prevention of MACE. The primary safety end point was Thrombolysis in Myocardial Infarction (TIMI) major bleeding. Baseline characteristics were used to develop a multivariable model to determine factors associated with TIMI major bleeding. The occurrence and timing of MACE relative to a first major bleeding event were determined. RESULTS:TIMI major bleeding occurred in 2.3% of participants overall (0.94 event/100 patient-years). There was no significant difference in major bleeding rates by treatment assignment. Factors associated with TIMI major bleeding included older age, geographic region, Rutherford class, and β-blocker use. Patients with TIMI major bleeding postrandomization had an increased risk of MACE (hazard ratio [HR] 4.46; 95% CI 3.40-5.84; P < .0001) compared with those without major bleeding; the association was strongest within 30 days after a bleeding event. CONCLUSIONS:In patients with symptomatic PAD, 0.94 major bleeding event/100 patient-years was observed and associated with older age, residing in North America, disease severity, and β-blocker use. Patients who had a major bleeding event were significantly more likely to experience MACE, especially within the first 30 days, when compared with patients who did not have major bleeding.

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Citation

Published Version (Please cite this version)

10.1016/j.ahj.2019.11.007

Publication Info

Ward, Rachael, Zhen Huang, Frank W Rockhold, Iris Baumgartner, Jeffrey S Berger, Juuso I Blomster, F Gerry R Fowkes, Brian G Katona, et al. (2019). Major bleeding in patients with peripheral artery disease: Insights from the EUCLID trial. American heart journal, 220. pp. 51–58. 10.1016/j.ahj.2019.11.007 Retrieved from https://hdl.handle.net/10161/19573.

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Scholars@Duke

Rockhold

Frank Wesley Rockhold

Professor of Biostatistics & Bioinformatics

Frank is a full time Professor of Biostatistics and Bioinformatics and Faculty Director for Biostatistics at Duke University Medical Center, Affiliate Professor of Biostatistics at Virginia Commonwealth University, and Strategic Consultant at Hunter Rockhold, Inc.  His 40+-year career includes senior research positions at Lilly, Merck, and GlaxoSmithKline, where he retired as Chief Safety Officer and Senior Vice President of Global Clinical Safety and Pharmacovigilance.  He has held faculty appointments at six different universities.    Dr. Rockhold served for 9 years on the board of directors of the non-profit CDISC, most recently as Chairman, and is past president of the Society for Clinical Trials and a past member of the PCORI Clinical Trials Advisory Panel. He is currently Chair of the Board of the Frontier Science and Technology Research Foundation and a technical advisor to EMA.

Dr. Rockhold has diverse research interests and consulting experience in industry and academia including clinical trials design, data monitoring, benefit/risk, safety and pharmacovigilance and has been a leader in the scientific community in promoting data disclosure and transparency in clinical research.    Frank is widely published in major scientific journals across a wide variety of research topics.

Frank holds a BA in Statistics from The University of Connecticut, an ScM in Biostatistics from The Johns Hopkins University, and a PhD in Biostatistics from the Medical College of Virginia at Virginia Commonwealth University. Frank is an Elected Fellow of both the American Statistical Association and the Society for Clinical Trials, a Fellow of the Royal Statistical Society, an Accredited Professional Statistician, PStat®, and a Chartered Statistician, CStat.  

Vemulapalli

Sreekanth Vemulapalli

Associate Professor of Medicine
Povsic

Thomas Joseph Povsic

Professor of Medicine

Rajendra H. Mehta

Consulting Professor in the Department of Medicine

Dr Mehta completed his Medical School in Mumbai, India; Residency at the Cleveland Clinic, Cleveland, Ohio, Cardiology Fellowship at University of Michigan, Ann Arbor, Michigan and Interventional Cardiology Fellowship at Duke University Medical Center, Durham, North Carolina. In addition, he has a Master’s degree from the School of Public Health-University of Michigan in Clinical Research Design and Biostatistics. He is board certified in Internal Medicine, General Cardiology and Interventional Cardiology. He was an Assistant Professor of Medicine with the Division of Cardiology at the University of Michigan in Ann Arbor, MI from 1998 to 2004.

Dr. Mehta is involved in clinical research and teaching at the Duke University Medical Center and the Duke Clinical Research Institute, Durham, NC for past 14 years where he is a Consulting Professor. He has been the principal investigator for a recently completed Phase III clinical trial evaluating the efficacy of drug levosimendan in patients undergoing cardiac surgery. He has played a key role as a Clinical Events Committee (CEC) team member in the adjudication of clinical events as well as in the Phase I adjudication, as well as Phase II committee meetings in over 30 Phase III Clinical Trials. Dr. Mehta was the Chair of the CEC for recently completed large Phase III TRILOGY Trial and the Chair of the CEC for the large Phase III PORTICO Programs (PORTICO IDE PORTICO CAP and PORTICO Japan).

Dr. Mehta is a practicing cardiologist with a focus on Interventional Cardiology (coronary, peripheral, carotid and PFO closures) at the Sparrow Hospital and Allegiance Health System, Michigan. In his private practice, he is the site PI for site-based research studies including site PI for multicenter clinical research trials.

He is currently the Associate Editor of the American Heart Journal and a Section Editor for the Journal of Interventional Cardiology. He is also a reviewer for many peer-reviewed journals that include New England Journal of Medicine, JAMA, Archives of Internal Medicine, Circulation, Journal of the American College of Cardiology, American Journal of Cardiology, American Journal of Medicine, Lancet, British Medical Journal, British Heart Journal, European Heart Journal among others.

Dr. Mehta has authored over 250 articles in major peer-reviewed journals including the New England Journal of Medicine and JAMA on the topics related to various cardiovascular diseases. Specifically, he has been a senior author on multiple pioneering publications on the subject matter of TAVI. Besides research and clinical practice of cardiology, his other main passion has been teaching. As a result of his excellence in teaching, he was awarded the most coveted W Proctor Harvey, America’s Best Young Teacher Award by the American College of Cardiology.

 

Jones

William Schuyler Jones

Associate Professor of Medicine

I am an interventional cardiologist with a specific focus on the diagnosis and treatment of patients with cardiovascular disease. As a clinician, I see patients in the office and do coronary and peripheral vascular procedures (angiography and interventions) in the Duke Cardiac Catheterization Laboratory. I have served as the Medical Director of the cath lab at Duke since 2016. Alongside my partners in the cath lab, we collaborate with our cardiothoracic surgeons to hold Heart Team meetings each week, and we frequently are asked to address complex cardiovascular issues as a multidisciplinary team.

I also have a broad background in cardiovascular site-based research, multicenter clinical trials, clinical event classification, and observational analyses. I have helped to lead clinical trial efforts at the Duke Clinical Research Institute (DCRI) by designing and conducting studies evaluating new and existing treatments for patients with coronary artery disease and peripheral artery disease. My specific research interests include examining access to care and disparities in care for patients with peripheral artery disease and the design and conduct of pragmatic clinical trials in cardiovascular disease.


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