Key result
Rivaroxaban plus aspirin fails to reduce 1-year graft failure vs. aspirin alone after CABG.
Why the study?
Patients with recent CABG surgery are at risk for early graft failure, and it is uncertain whether rivaroxaban alone or combined with aspirin is more effective than aspirin alone to prevent graft failure and MACE after CABG.
Does rivaroxaban (with or without aspirin) prevent graft failure and MACE in patients 4 to 14 days after CABG surgery compared to aspirin alone?
RCT (n=1,448)
randomized
Does rivaroxaban (with or without aspirin) prevent graft failure and MACE in patients 4 to 14 days after CABG surgery compared to aspirin alone?
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Coronary bypass graft failure, however, was not affected”
In patients with recent CABG surgery, the addition of low-dose rivaroxaban to aspirin, or rivaroxaban alone, did not reduce the rate of early graft failure compared to aspirin alone.
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).
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Lamy et al. (2019) conducted an RCT in Recent coronary artery bypass graft (CABG) surgery (n=1,448). Rivaroxaban plus aspirin vs. Aspirin alone was evaluated on Graft failure, diagnosed by computed tomography angiogram 1 year after surgery (OR 1.13, 95% CI 0.82 to 1.57, p=0.45). Rivaroxaban plus aspirin did not significantly reduce graft failure 1 year after CABG surgery compared with aspirin alone (9.1% vs 8.0%; OR 1.13; 95% CI 0.82-1.57; P=0.45).
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