Postoperative antithrombotic therapy after coronary artery bypass grafting combined with coronary endarterectomy (PATH-CARE): study protocol for a randomised controlled clinical trial

INTRODUCTION: Coronary endarterectomy (CE) combined with coronary artery bypass grafting (CABG) has been associated with poor graft patency, which might be attributed to the activation of coagulation cascade caused by the exposure of the subendothelial tissue to the blood stream, which could necessitate anticoagulation therapy. However, the optimal antithrombotic therapy after CE+CABG remains unclear. METHODS AND ANALYSIS: The PATH-CARE is a double-centre, two-armed, blinded to outcome assessed, randomised controlled trial, aimed to determine the optimal antithrombotic therapy after CE+CABG. A total of 202 patients are expected to be recruited. Patients will be randomly assigned in a 1:1 ratio to the control (dual antiplatelet therapy (AT) group) and the intervention (dual AT+warfarin (ATW) group). Patients in the AT group will receive aspirin plus clopidogrel for 1 year, while patients in the ATW group receive aspirin plus clopidogrel for 1 year with extra warfarin therapy for the first 3 months postoperatively. All patients will receive life-long aspirin treatment after the first year. All of the patients will be required to complete a 6-month follow-up. The primary endpoint is the patency of CE-targeted coronary grafts, assessed through coronary CT angiography or coronary angiography. Secondary outcomes include the occurrence of major adverse cardiovascular and cerebrovascular events and bleeding events. ETHICS APPROVAL AND DISSEMINATION: 2023-048-01). Findings of this trial will be disseminated via peer-reviewed research papers and academic conference presentations. TRIAL REGISTRATION NUMBER: NCT05782270.