Author + information
- Diamantis I. Tsilimigras, MD∗ (, )
- Fragiska Sigala, MD, PhD,
- Christos Kontogiannis, MD, PhD and
- Dimitrios Moris, MD, MSc, PhD
- ↵∗First Department of Propaedeutic Surgery, National and Kapodistrian University of Athens, 114 Vasilissis Sofias Avenue, Athens, 11527, Greece
In a recent issue of the Journal, Lamy et al. (1) performed a substudy of the COMPASS (Cardiovascular OutcoMes for People Using Anticoagulation StrategieS) trial investigating the effectiveness of 3 antithrombotic strategies in preventing graft failure and major adverse cardiovascular events (MACE) after coronary artery bypass graft (CABG) surgery. The authors found that the combination of rivaroxaban and aspirin (odds ratio: 1.13; 95% confidence interval [CI]: 0.82 to 1.57; p = 0.45) as well as rivaroxaban alone (odds ratio: 0.95; 95% CI: 0.67 to 1.33; p = 0.75) did not reduce the graft failure rates when compared with aspirin alone. In addition, Lamy et al. (1) reported that the combination of rivaroxaban plus aspirin did decrease MACE (hazard ratio [HR]: 0.69; 95% CI: 0.33 to 1.47; p = 0.34), whereas rivaroxaban alone did not (HR: 0.99; 95% CI: 0.50 to 1.99; p = 0.98), compared with aspirin. The authors concluded that the combination of rivaroxaban 2.5 mg twice daily plus aspirin 100 mg daily was associated with similar reductions in MACE, as observed in the larger COMPASS trial.
We believe that the interpretation of the results missed 2 fundamental considerations. First, the authors made an overestimation of the effect of the combination therapy on the incidence of MACE. The HR of the combination therapy (rivaroxaban plus aspirin) reported was not significant and, thus, the combination therapy cannot be considered to decrease MACE or even have similar reductions as in the larger COMPASS trial. Of note, the risk of MACE was significantly reduced by 24% in the rivaroxaban plus aspirin arm compared with aspirin alone (4.1% vs. 5.4%, respectively; HR: 0.76; 95% CI: 0.66 to 0.86) in the original trial, which is different from the results of this substudy (2).
Second, it is important to emphasize the need for an additional cost-effectiveness analysis of the combination therapy (rivaroxaban plus aspirin) focusing on patients undergoing CABG surgery only. Although such an analysis has been previously performed for patients with peripheral artery disease, showing meaningful cost offsets with the addition of rivaroxaban to aspirin in such patients (3), the 5-fold higher market value of rivaroxaban may be an added economic burden, especially in countries facing an economic crisis; thus, the addition of such medication should be thoroughly investigated in all disease settings, including CABG surgery (4).
In conclusion, we believe that Lamy et al. (1) performed a great quality COMPASS substudy, but it also needs a more careful interpretation taking into account the noted considerations.
Please note: The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- 2019 American College of Cardiology Foundation
- Lamy A.,
- Eikelboom J.,
- Sheth T.,
- et al.
- ↵Lamy A, on behalf of the COMPASS Investigators. Costs impact rivaroxaban plus aspirin versus aspirin in the COMPASS trial. Paper presented at: 2017 AHA Scientific Sessions; November 14, 2017; Anaheim, CA.
- Tsilimigras D.I.,
- Moris D.,
- Karaolanis G.,
- Kakkos S.K.,
- Filis K.,
- Sigala F.