A randomized, double-blind, placebo-controlled trial investigating the effect of ticagrelor on saphenous vein graft patency in patients undergoing coronary artery bypass grafting surgery-Rationale and design of the POPular CABG trial
Willemsen, Laura M; Janssen, Paul W A; Hackeng, Chris M; Kelder, Johannes C; Tijssen, Jan G P; van Straten, Albert H M; Soliman-Hamad, Mohammed A; Deneer, Vera H M; Daeter, Edgar J; Sonker, Uday; Klein, Patrick; Ten Berg, Jurriën M
(2020) American Heart Journal, volume 220, pp. 237 - 245
(Article)
Abstract
RATIONALE: An estimated 15% of saphenous vein grafts (SVGs) occlude in the first year after coronary artery bypass grafting (CABG) despite aspirin therapy. Graft occlusion can result in symptoms, myocardial infarction, and death. SVG occlusion is primarily caused by atherothrombosis, in which platelet activation plays a pivotal role. Evidence regarding
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the effect of stronger platelet inhibition on SVG patency after CABG is limited. The main objective of the POPular CABG trial is to determine whether dual antiplatelet therapy with aspirin plus ticagrelor improves SVG patency when compared to aspirin alone. STUDY: The POPular CABG is a randomized, double-blind, placebo-controlled, multicenter trial investigating the effect of adding ticagrelor to standard aspirin therapy on the rate of SVG occlusion. A total of 500 patients undergoing CABG with ≥ 1 SVG are randomized to ticagrelor or placebo. The primary end point is SVG occlusion rate, assessed with coronary computed tomography angiography at 1 year. Secondary end points are stenoses and occlusions in both SVGs and arterial grafts and SVG failure at 1 year, defined as a composite of SVG occlusion on coronary computed tomography angiography or coronary angiography, SVG revascularization, myocardial infarction in the territory supplied by an SVG, or sudden death. Safety end points are bleeding events at 30 days and 1 year. CONCLUSION: The POPular CABG trial investigates whether adding ticagrelor to standard aspirin after CABG reduces the rate of SVG occlusion at 1 year.
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Keywords: Aged, Aspirin/therapeutic use, Computed Tomography Angiography, Coronary Angiography/methods, Coronary Artery Bypass, Death, Sudden, Cardiac/etiology, Double-Blind Method, Drug Therapy, Combination, Graft Occlusion, Vascular/diagnostic imaging, Humans, Myocardial Infarction/etiology, Placebos/pharmacology, Platelet Aggregation Inhibitors/pharmacology, Research Design, Sample Size, Saphenous Vein/transplantation, Ticagrelor/pharmacology, Vascular Patency/drug effects, Cardiology and Cardiovascular Medicine, Randomized Controlled Trial, Multicenter Study, Journal Article
ISSN: 0002-8703
Publisher: Mosby Inc.
Note: Funding Information: The POPular CABG trial is registered on ClinicalTrials.gov ( NCT02352402 ) and is approved by the local ethics committee. The trial is conducted according to the principles of the Declaration of Helsinki and in accordance with the Medical Research Involving Human Subjects Act. Integrity of the study is warranted by a Data Safety Monitoring Board, and data will be monitored by an independent monitoring office. The trial is funded by AstraZeneca . AstraZeneca was not involved with study design and study processes, including site selection and management, or data collection and analysis. The authors are solely responsible for the design, data collection, and conduct of this study; all study analyses; the drafting and editing of this paper; and its final contents. Funding Information: The POPular CABG trial is registered on ClinicalTrials.gov (NCT02352402) and is approved by the local ethics committee. The trial is conducted according to the principles of the Declaration of Helsinki and in accordance with the Medical Research Involving Human Subjects Act. Integrity of the study is warranted by a Data Safety Monitoring Board, and data will be monitored by an independent monitoring office. The trial is funded by AstraZeneca. AstraZeneca was not involved with study design and study processes, including site selection and management, or data collection and analysis. The authors are solely responsible for the design, data collection, and conduct of this study; all study analyses; the drafting and editing of this paper; and its final contents.The study was conducted with an institutional research subsidy from AstraZeneca. J. t. B. reports advisory/consulting/speakers from AstraZeneca. Publisher Copyright: © 2019
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