Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy

Study Overview
=================
Brief Summary
-----------------
Coronary endarterectomy (CE) combined with coronary artery bypass grafting (CABG) can be the final option for achieving complete revascularization in diffuse coronary artery disease patients. Since the exposure of subendothelial tissue to the blood flow after CE, the coagulation cascade can be activated, resulting in the increased risk of graft failure. Therefore, anticoagulation with warfarin in this group of patients might be beneficial. However, evidence is limited. This study aims to compare the clinical outcomes between dual antiplatelet therapy with or without warfarin after CE+CABG.

Official Title
-----------------
Comparison of Antithrombotic Therapy After Coronary Artery Bypass Grafting Combined With Coronary Endarterectomy

Conditions
-----------------
Anticoagulation, Coronary Endarterectomy

Intervention / Treatment
-----------------
* Drug: Warfarin
* Drug: DAPT
* Other: CE+CABG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with diffuse coronary artery disease undergoing CE+CABG during the study period. No contraindications for both dual antiplatelet therapy and anticoagulation therapy with warfarin. Must be able to swallow tablets after the surgery. Exclusion Criteria: Patients with high bleeding risk (HAS-BLED ≥ 3); Patients undergoing concomitant aortic valve or mitral valve surgery, or undergoing cardiac surgery for the second time; Emergency surgery; Serum creatinine >130μmol/L, or significant liver dysfunction (elevated ALT and/or AST); History of digestive or urinary tract bleeding, active gastric bleeding caused by gastric ulcer, or postoperative new-onset gastric bleeding; History of hemorrhagic stroke, or platelet dysfunction; Allergic or with contraindication to any of aspirin, clopidogrel or warfarin; Participated in other clinical trial for drug or device within 30 days; Pregnant or planning to be pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DAPT<br>Comparison group: dual antiplatelet only | Drug: DAPT<br>* Dual antiplatelet therapy (aspirin plus either clopidogrel or ticagrelor)<br>Other: CE+CABG<br>* Coronary endarterectomy combined with coronary artery bypass grafting<br>|
| Experimental: DAPT+warfarin<br>Intervention group: dual antiplatelet combined with warfarin | Drug: Warfarin<br>* dual antiplatelet therapy combined with warfarin<br>Drug: DAPT<br>* Dual antiplatelet therapy (aspirin plus either clopidogrel or ticagrelor)<br>Other: CE+CABG<br>* Coronary endarterectomy combined with coronary artery bypass grafting<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of coronary endarterectomy-targeted graft patency. | Defined as less than 50% stenosis of the coronary endarterectomy target and coronary endarterectomy-targeted graft evaluated through either of coronary computed tomography angiography or coronary angiography. | 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients suffering from major adverse cardiovascular and cerebrovascular events | Major adverse cardiovascular and cerebrovascular events is defined as the composite of all-cause death, myocardial infarction, stroke and repeat revascularization. | During 6-month follow-up | 
| Bleeding events | The Bleeding Academic Research Consortium (BARC) scale type 2 5 [see in reference]. | during 6-month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary endarterectomy, coronary artery bypass grafting, anticoagulation, antiplatelet