Rivaroxaban, Aspirin, or Both to Prevent Early Coronary Bypass Graft Occlusion: The COMPASS-CABG Study
Language English Country United States Media print
Document type Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
30654882
DOI
10.1016/j.jacc.2018.10.048
PII: S0735-1097(18)39066-1
Knihovny.cz E-resources
- Keywords
- anticoagulation, cardiac surgery, coronary artery disease, graft failures,
- MeSH
- Aspirin therapeutic use MeSH
- Double-Blind Method MeSH
- Fibrinolytic Agents therapeutic use MeSH
- Factor Xa Inhibitors therapeutic use MeSH
- Drug Therapy, Combination MeSH
- Coronary Artery Bypass * MeSH
- Middle Aged MeSH
- Humans MeSH
- Graft Occlusion, Vascular prevention & control MeSH
- Rivaroxaban therapeutic use MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Aspirin MeSH
- Fibrinolytic Agents MeSH
- Factor Xa Inhibitors MeSH
- Rivaroxaban MeSH
BACKGROUND: Patients with recent coronary artery bypass graft (CABG) surgery are at risk for early graft failure, which is associated with a risk of myocardial infarction and death. In the COMPASS (Cardiovascular OutcoMes for People Using Anticoagulation StrategieS) trial, rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily compared with aspirin 100 mg once daily reduced the primary major adverse cardiovascular events (MACE) outcome of cardiovascular death, stroke, or myocardial infarction. Rivaroxaban 5 mg twice daily alone did not significantly reduce MACE. OBJECTIVES: This pre-planned substudy sought to determine whether the COMPASS treatments are more effective than aspirin alone for preventing graft failure and MACE after CABG surgery. METHODS: The substudy randomized 1,448 COMPASS trial patients 4 to 14 days after CABG surgery to receive the combination of rivaroxaban plus aspirin, rivaroxaban alone, or aspirin alone. The primary outcome was graft failure, diagnosed by computed tomography angiogram 1 year after surgery. RESULTS: The combination of rivaroxaban and aspirin and the regimen of rivaroxaban alone did not reduce the graft failure rates compared with aspirin alone (combination vs. aspirin: 113 [9.1%] vs. 91 [8.0%] failed grafts; odds ratio [OR]: 1.13; 95% confidence interval [CI]: 0.82 to 1.57; p = 0.45; rivaroxaban alone vs. aspirin: 92 [7.8%] vs. 92 [8.0%] failed grafts; OR: 0.95; 95% CI: 0.67 to 1.33; p = 0.75). Compared with aspirin, the combination was associated with fewer MACE (12 [2.4%] vs. 16 [3.5%]; hazard ratio [HR]: 0.69; 95% CI: 0.33 to 1.47; p = 0.34), whereas rivaroxaban alone was not (16 [3.3%] vs. 16 [3.5%]; HR: 0.99, CI: 0.50 to 1.99; p = 0.98). There was no fatal bleeding or tamponade within 30 days of randomization. CONCLUSIONS: The combination of rivaroxaban 2.5 mg twice daily plus aspirin or rivaroxaban 5 mg twice daily alone compared with aspirin alone did not reduce graft failure in patients with recent CABG surgery, but the combination of rivaroxaban 2.5 mg twice daily plus aspirin was associated with similar reductions in MACE, as observed in the larger COMPASS trial. (Cardiovascular OutcoMes for People Using Anticoagulation StrategieS [COMPASS]; NCT01776424).
Brigham and Women's Hospital Heart and Vascular Center Harvard Medical School Boston Massachusetts
Centre for Cardiovascular Science University of Edinburgh Edinburgh United Kingdom
Institut Universitaire de Cardiologie et de Pnemologie de Québec Quebec City Quebec Canada
Population Health Research Institute McMaster University Hamilton Ontario Canada
Quebec Heart and Lung University Institute Laval University Quebec City Quebec Canada
Shanghai Chest Hospital Affiliated with Shanghai Jiao Tong University Shanghai China
References provided by Crossref.org
ClinicalTrials.gov
NCT01776424