Trial Design

DOI: 10.4244/EIJ-D-23-00699

One-month DAPT with ticagrelor and aspirin for patients undergoing coronary artery bypass grafting: rationale and design of the randomised, multicentre, double-blind, placebo-controlled ODIN trial

Sigrid Sandner1, MD, MSCE; Mario Gaudino2, MD, PhD, MSCE; Björn Redfors3,4, MD, PhD; Dominick J. Angiolillo5, MD, PhD; Ori Ben-Yehuda6, MD; Deepak L. Bhatt7, MD, MPH; Stephen E. Fremes8, MD; Andre Lamy9, MD; Riccardo Marano10, MD; Roxana Mehran11, MD; Stuart Pocock12, MD; Sunil V. Rao13, MD; John A. Spertus14, MD, MPH; Jonathan W. Weinsaft15, MD; George Wells16, MD; Marc Ruel17, MD, MPH

Abstract

The optimal antiplatelet strategy after coronary artery bypass graft (CABG) surgery in patients with chronic coronary syndromes (CCS) is unclear. Adding the P2Y12 inhibitor, ticagrelor, to low-dose aspirin for 1 year is associated with a reduction in graft failure, particularly saphenous vein grafts, at the expense of an increased risk of clinically important bleeding. As the risk of thrombotic graft failure and ischaemic events is highest early after CABG surgery, a better risk-to-benefit profile may be attained with short-term dual antiplatelet therapy followed by single antiplatelet therapy. The One Month Dual Antiplatelet Therapy With Ticagrelor in Coronary Artery Bypass Graft Patients (ODIN) trial is a prospective, randomised, double-blind, placebo-controlled, international, multicentre study of 700 subjects that will evaluate the effect of short-term dual antiplatelet therapy with ticagrelor plus low-dose aspirin after CABG in patients with CCS. Patients will be randomised 1:1 to ticagrelor 90 mg twice daily or matching placebo, in addition to aspirin 75-150 mg once daily for 1 month; after the first month, antiplatelet therapy will be continued with aspirin alone. The primary endpoint is a hierarchical composite of all-cause death, stroke, myocardial infarction, revascularisation and graft failure at 1 year. The key secondary endpoint is a hierarchical composite of all-cause death, stroke, myocardial infarction, Bleeding Academic Research Consortium (BARC) type 3 bleeding, revascularisation and graft failure at 1 year (net clinical benefit). ODIN will report whether the addition of ticagrelor to low-dose aspirin for 1 month after CABG reduces ischaemic events and provides a net clinical benefit in patients with CCS. (ClinicalTrials.gov: NCT05997693)

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Volume 20 Number 5
Mar 4, 2024
Volume 20 Number 5
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