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.

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 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.

• Authors: Laura M Willemsen, Paul W A Janssen, Chris M Hackeng, Johannes C Kelder, Jan G P Tijssen, Albert H M van Straten, Mohammed A Soliman-Hamad, Vera H M Deneer, Edgar J Daeter, Uday Sonker, Patrick Klein, Jurriën M Ten Berg
• Journal: American heart journal (Am Heart J) Vol. 220 Pg. 237-245 (02 2020) ISSN: 1097-6744 [Electronic] United States
• PMID: 31884246 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2019. Published by Elsevier Inc.

Chemical References

• Placebos
• Platelet Aggregation Inhibitors
• Ticagrelor
• Aspirin

Topics

• 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, drug therapy, epidemiology)
• Humans
• Myocardial Infarction (etiology)
• Placebos (pharmacology)
• Platelet Aggregation Inhibitors (pharmacology)
• Research Design
• Sample Size
• Saphenous Vein (transplantation)
• Ticagrelor (pharmacology)
• Vascular Patency (drug effects)