Anticoagulation, Coronary Endarterectomy
Conditions
Keywords
coronary endarterectomy, coronary artery bypass grafting, anticoagulation, antiplatelet
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.
Interventions
DRUGWarfarin
dual antiplatelet therapy combined with warfarin
DRUGDAPT
Dual antiplatelet therapy (aspirin plus either clopidogrel or ticagrelor)
OTHERCE+CABG
Coronary endarterectomy combined with coronary artery bypass grafting
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
1. Patients with high bleeding risk (HAS-BLED ≥ 3); 2. Patients undergoing concomitant aortic valve or mitral valve surgery, or undergoing cardiac surgery for the second time; 3. Emergency surgery; 4. Serum creatinine \>130μmol/L, or significant liver dysfunction (elevated ALT and/or AST); 5. History of digestive or urinary tract bleeding, active gastric bleeding caused by gastric ulcer, or postoperative new-onset gastric bleeding; 6. History of hemorrhagic stroke, or platelet dysfunction; 7. Allergic or with contraindication to any of aspirin, clopidogrel or warfarin; 8. Participated in other clinical trial for drug or device within 30 days; 9. Pregnant or planning to be pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of coronary endarterectomy-targeted graft patency. | 6 months postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients suffering from major adverse cardiovascular and cerebrovascular events | During 6-month follow-up | Major adverse cardiovascular and cerebrovascular events is defined as the composite of all-cause death, myocardial infarction, stroke and repeat revascularization. |
| Bleeding events | during 6-month follow-up | The Bleeding Academic Research Consortium (BARC) scale type 2\ 5 \[see in reference\]. |
Countries
China
Contacts
Primary ContactXieraili Tiemuerniyazi, M.D.
Outcome results
None listed