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Author Spotlight: Enhancing Coronary Artery Revascularization
Published on: September 15, 2023
Rivaroxaban, Aspirin, or Both to Prevent Early Coronary Bypass Graft Occlusion: The COMPASS-CABG Study
Andre Lamy1, John Eikelboom2, Tej Sheth2
1Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada; CADENCE Research Group, Hamilton Health Sciences, Hamilton, Ontario, Canada; Department of Surgery, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Insights
Rivaroxaban plus aspirin did not prevent graft failure after coronary artery bypass graft surgery. However, the combination therapy showed a similar reduction in major adverse cardiovascular events as seen in the COMPASS trial.
Area of Science:
- Cardiovascular Surgery
- Pharmacology
- Clinical Trials
Background:
- Patients undergoing coronary artery bypass graft (CABG) surgery face risks of early graft failure, myocardial infarction, and death.
- The COMPASS trial demonstrated rivaroxaban plus aspirin reduced major adverse cardiovascular events (MACE) compared to aspirin alone.
- Rivaroxaban 5 mg twice daily monotherapy did not significantly reduce MACE in the COMPASS trial.
Purpose of the Study:
- To evaluate the efficacy of COMPASS trial treatments in preventing graft failure and MACE post-CABG.
- To compare rivaroxaban plus aspirin, rivaroxaban alone, and aspirin alone in a CABG patient substudy.
Main Methods:
- A substudy of 1,448 COMPASS trial patients randomized 4-14 days post-CABG.
- Treatment groups included rivaroxaban plus aspirin, rivaroxaban alone, or aspirin alone.
- Primary outcome was graft failure assessed by CT angiogram at 1 year; MACE was a secondary outcome.
Main Results:
- Neither rivaroxaban plus aspirin nor rivaroxaban alone reduced graft failure rates compared to aspirin alone.
- The combination of rivaroxaban and aspirin showed a trend towards fewer MACE compared to aspirin alone (HR: 0.69; p=0.34).
- Rivaroxaban alone did not significantly alter MACE rates compared to aspirin alone; no fatal bleeding or tamponade occurred within 30 days.
Conclusions:
- Rivaroxaban 2.5 mg twice daily plus aspirin or rivaroxaban 5 mg twice daily alone did not reduce graft failure post-CABG.
- The combination of rivaroxaban and aspirin demonstrated similar MACE reductions as observed in the broader COMPASS trial.
- These findings suggest a potential role for combination therapy in managing cardiovascular risk after CABG, warranting further investigation.
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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