Impact of Procedural Bleeding in Peripheral Artery Disease: An Analysis From EUCLID Trial

Division of Cardiology, Duke Heart Center (A.K., M.R.P., S.J.), Duke University, Durham, NC. Duke Clinical Research Institute, Duke University School of Medicine (Z.H., F.W.R., M.R.P., W.S.J.), Duke University, Durham, NC. Swiss Cardiovascular Centre, Inselspital, Bern University Hospital, University of Bern, Switzerland (I.B.). Departments of Medicine and Surgery, New York University School of Medicine (J.S.B.). Turku University Hospital, Turku University, Finland (J.I.B.). Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, United Kingdom (F.G.F.). AstraZeneca Gaithersburg, MD (B.K.). Stanford Center for Clinical Research, Stanford University School of Medicine, CA (K.W.M.). Faculty of Medicine and Health, Orebro University, Sweden (L.N.). University of Colorado School of Medicine, Division of Cardiology and CPC Clinical Research, Aurora (W.R.H.).

Circulation. Cardiovascular interventions. 2019;12(10):e008069
BACKGROUND The relationship between invasive vascular procedures and bleeding in patients with peripheral artery disease has not been well described in the literature. This post hoc analysis from the EUCLID trial (Examining Use of Ticagrelor in Peripheral Artery Disease) aimed to describe the incidence of major and minor postprocedural bleeding and characterize the timing and severity of bleeding events relative to the procedure. METHODS EUCLID was a multicenter, randomized controlled trial of 13 885 patients with symptomatic peripheral artery disease that tested the efficacy and safety of ticagrelor compared with clopidogrel for the prevention of major adverse cardiovascular events. A total of 2661 patients underwent 3062 coronary revascularization, peripheral revascularization, and amputation during the study. The primary safety end point was Thrombolysis in Myocardial Infarction major or minor bleeding. All bleeding events were formally adjudicated by a clinical end point classification group. RESULTS Major bleeding events most often occurred ≤7 days following the procedure. The incidence of Thrombolysis in Myocardial Infarction major or minor bleeding ≤7 days following peripheral revascularization (3.3%; 95% CI, 2.5%-4.1%) was similar to rates after coronary revascularization (4.0%; 95% CI, 2.6%-5.4%) and lower extremity amputation (2.3%; 95% CI, 0.8%-3.8%). The severity of bleeding events (as graded by drop in hemoglobin, need for transfusion, bleeding in a critical location, and fatal bleeding) was also similar following peripheral, coronary revascularization, and lower extremity amputation. CONCLUSIONS The incidence of Thrombolysis in Myocardial Infarction major/minor bleeding following peripheral revascularization is comparable to rates after coronary revascularization and lower extremity amputation, and the majority of bleeding events occur within 7 days following the procedure. The severity of periprocedural bleeding is also similar after procedures, with the most frequently adjudicated reason being a drop in hemoglobin ≥2 g/dL. Future studies should be performed to enhance our understanding of bleeding risk related to revascularization and amputation procedures in peripheral artery disease patients.
Study details
Language : eng
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