Major bleeding in patients with peripheral artery disease: Insights from the EUCLID trial.
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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.
Published Version (Please cite this version)10.1016/j.ahj.2019.11.007
Publication InfoJones, William; Rockhold, Frank; Ward, Rachael; Huang, Zhen; Baumgartner, Iris; Berger, Jeffrey S; ... Patel, Manesh R (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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Associate Professor of Medicine
I am an interventional cardiologist with a specific focus on the diagnosis and treatment of patients with vascular disease, and I perform coronary and peripheral angiography and interventions. I have a broad background in cardiovascular site-based research, multicenter clinical trials, clinical event classification, and observational analyses. Currently, I am helping to lead a Duke Clinical Research Institute (DCRI) effort to coordinate a multinational, multicenter randomized clinical tria
Professor of Biostatistics & Bioinformatics
Frank is a fulltime Professor of Biostatistics and Bioinformatics at Duke University Medical Center (Scholars at Duke), Affiliate Professor of Biostatistics at Virginia Commonwealth University, and Managing Partner of HunterRockhold, 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 Clini
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