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COMPASS: Low-dose rivaroxaban plus aspirin may benefit patients with chronic CAD, PAD, HF
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Patients with chronic CAD and peripheral artery disease with or without HF who were treated with low-dose rivaroxaban plus aspirin had reduced rates of major adverse CV events and showed a net clinical benefit compared with those treated with aspirin alone, according to a subanalysis of the COMPASS trial presented at Heart Failure 2018 & World Congress on Acute Heart Failure.
Kelley R. Branch, MD, MSc, associate professor in the division of cardiology, director of cardiovascular clinical trials and associate director of the clinical trials service unit at University of Washington in Seattle, and colleagues assessed the effects of a low dose of the direct oral anticoagulant rivaroxaban (Xarelto, Janssen/Bayer) plus aspirin compared with aspirin alone in 27,395 patients (mean age, 68 years; 22% women) from the COMPASS trial. All patients had chronic CAD or PAD and were stratified by whether they had HF (n = 5,902; mean age, 66 years; 23% women) or not (n = 21,493; mean age, 69 years; 22% women).
As previously reported by Cardiology Today, the COMPASS trial found that patients with stable atherosclerotic vascular disease who were treated with 2.5 mg rivaroxaban plus aspirin had improved CV outcomes vs. aspirin alone, although they had more major bleeding events.
The primary outcome of interest was major adverse CV events, including stroke, CV death or MI. The safety outcome of interest was a modified International Society on Thrombosis and Haemostasis (ISTH) major bleeding. The net clinical benefit of interest was the primary outcome and severe bleeding, which was defined as fatal or critical organ bleeding.
Compared with patients without HF, those with HF were more likely to be current smokers (29.7% vs. 19.1%), have hypertension (84.7% vs. 72.7%), diabetes (41.1% vs. 36.8%), previous MI (76.8% vs. 58.1%) and an estimated glomerular filtration rate of less than 60 mL/min (26% vs. 22%; P < .0001 for all).
The rate of the primary major adverse CV event outcome was reduced in patients with HF (HR = 0.68; 95% CI, 0.53-0.86) who were assigned rivaroxaban and aspirin compared with those assigned aspirin alone. The same was true for patients without HF (HR = 0.79; 95% CI, 0.68-0.93). The results were not statistically significant when tested for interaction (P = .28).
“Although there was no statistical significance between the two groups, we did show a substantial difference in absolute risk reduction in those patients with heart failure, where patients with heart failure had an absolute risk reduction of 2.4% with a number needed to treat of 42,” Branch said during his presentation.
Patients who did not have HF had an absolute risk reduction of 0.9% and a number needed to treat of 111, according to the presentation.
Compared with patients assigned aspirin alone, the risk for bleeding increased by 36% in patients with HF (HR = 1.36; 95% CI, 0.88-2.89) and 79% in patients without HF (HR = 1.79; 95% CI, 1.45-2.21) who were assigned rivaroxaban plus aspirin, but there was no statistically significant interaction by HF status (P = .26).
Rivaroxaban plus aspirin showed a substantial net clinical benefit in patients with HF (HR = 0.69; 95% CI, 0.55-0.88) and without HF (HR = 0.85; 95% CI, 0.73-0.99) compared with aspirin alone; again, interaction by HF status was not significant (P = .15).
“With this substudy, we hope that this adds additional information for treatment options for our patients,” Branch said. “However, we do know that there’s an upcoming study that will be looking at a similar dose in patients with reduced ejection fraction and coronary artery disease, the COMMANDER HF trial.” – by Darlene Dobkowski
Reference:
Branch KR, et al. Late-breaking Trial IV: Registries. Presented at: Heart Failure 2018 & World Congress on Acute Heart Failure; May 26-29, 2018; Vienna.
Disclosure: COMPASS was funded by Bayer. Branch reports he has research contracts with Astellas and Bayer and holds equity in Janssen.