The combined use of twice-daily rivaroxaban 2.5 mg plus aspirin was associated with a reduction in major adverse cardiovascular events among patients with recent coronary artery bypass graft (CABG) surgery, according to a study recently published in the Journal of the American College of Cardiology.1 However, twice-daily rivaroxaban 2.5 mg plus aspirin or twice-daily rivaroxaban 5 mg alone did not demonstrate superiority to aspirin alone in reducing graft failure among those with recent CABG surgery.

This was a substudy of the COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies; ClinicalTrials.gov identifier: NCT01776424) trial,2 which included 1448 of the larger trial’s 27,395 participants. Participants were randomly assigned to receive aspirin alone (n=463), rivaroxaban 5 mg alone (n=483), or rivaroxaban 2.5 mg plus aspirin (n=502) in the time period 4 to 14 days post-CABG surgery. The primary outcome was the number of participants who experienced complete occlusion of the coronary bypass graft via vessel-level analysis, which was computed as a proportion with mixed logistic regression.

Compared with aspirin alone, graft failure did not decrease with rivaroxaban plus aspirin combination (9.1% vs 8.0% failed grafts; odds ratio 1.13; 95% CI, 0.82-1.57; =.45)]. The same was true for rivaroxaban alone vs aspirin (7.8% vs 8.0% failed grafts; odds ratio 0.95; 95% CI, 0.67-1.33; =.75).

However, fewer major adverse cardiovascular events occurred with the combination regimen (12 vs 16 events; hazard ratio 0.69; 95% CI, 0.33-1.47; =.34), though this did not achieve statistical significance. Rivaroxaban alone did not correlate with lower rates of major adverse cardiovascular events (16 vs 16 events; hazard ratio 0.99; 95% CI, 0.50-1.99; =.98). Tamponade or fatal bleeding did not occur within 1 month of random assignment.

Limitations to this study included a smaller number of randomly assigned participants than planned, as well as limited ability to identify benefits within rivaroxaban-based medication regimens.

The study researchers conclude that “combination of rivaroxaban 2.5 mg twice daily plus aspirin 100 mg daily or rivaroxaban 5 mg twice daily alone compared with aspirin 100 mg daily alone did not reduce graft failure in patients with recent CABG surgery…The combination of rivaroxaban 2.5 mg twice daily plus aspirin was associated with similar reductions in [major adverse cardiovascular events]…Therefore, it is reasonable and safe to use the combination of rivaroxaban 2.5 mg twice daily plus aspirin in patients who undergo CABG surgery.”

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Disclosures: Multiple authors report financial associations with pharmaceutical companies. For a full list of author disclosures, visit the reference.

References

  1. Lamy A, Eikelboom J, Sheth T, et al. Rivaroxaban, aspirin, or both to prevent early coronary bypass graft occlusionJ Am Coll Cardiol. 2019; 73(2):121-130.
  2. Eikelboom JW, Connolly SJ, Bosch J, et al; COMPASS Investigators. Rivaroxaban with or without aspirin in stable cardiovascular disease. N Engl J Med. 2017;377(14):1319-1330.