COMPASS: Rivaroxaban plus aspirin reduces overall, CV mortality vs. aspirin alone
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In a new analysis of the COMPASS trial, rivaroxaban plus aspirin outperformed aspirin alone in overall and CV mortality among patients with chronic CAD or peripheral artery disease.
“The mortality benefit demonstrated in the COMPASS trial ... is externally consistent with prior evidence of a mortality benefit seen in the randomized ATLAS ACS 2-TIMI 51 trial,” John W. Eikelboom, MBBS, MSc, associate professor of medicine at McMaster University in Hamilton, Ontario, Canada, and hematologist in the Thrombosis Service at Hamilton General Hospital, and colleagues wrote.
Of the 27,395 patients with chronic CAD or PAD enrolled in the COMPASS trial, 18,278 were randomly assigned to the combination therapy of aspirin plus rivaroxaban (Xarelto, Janssen/Bayer) or aspirin alone. As Healio previously reported, in the main results of COMPASS, rivaroxaban plus aspirin was associated with reduced risk for CV death, MI or stroke but elevated risk for major bleeding compared with aspirin alone; the net clinical benefit outcome combining CV death, MI, stroke and major bleeding favored the rivaroxaban plus aspirin group.
CV death was defined as death due to MI, stroke, HF, a CV procedure, CHD or other CV cause, as well as sudden CV death. Non-CV death was any death for which there existed definite evidence of primary non-CV cause.
Mortality benefit with combination therapy
During follow-up (median, 23 months), fewer deaths occurred in the combination therapy arm compared with the aspirin alone arm (3.4% vs. 4.1%; HR = 0.82; 95% CI, 0.71-0.96; P = .01). Similarly, CV death was also reduced with combination therapy compared with aspirin alone (1.7% vs. 2.2%; HR = 0.78; 95% CI, 0.64-0.96; P = .02), a decrease observed among all causes of CV death except HF.
There was no difference between the groups in non-CV death.
In other data, the mortality benefits with combination therapy were greater as baseline risk increased.
“This reduction in mortality should be considered when evaluating the choice of long-term antithrombotic secondary prevention therapies in patients with chronic CAD and/or PAD,” the researchers wrote.
Important questions remain
In an accompanying editorial, Jonathan L. Halperin, MD, of Mount Sinai Medical Center, and colleagues wrote that the study provides important new information that helps to identify the patients most likely to benefit from a dual-pathway inhibitor regimen. However, they wrote, important questions still need to be answered, specifically those the trial was not designed to address.
“Among these is whether antiplatelet medication more potent than aspirin, such as a thienopyridine or P2Y12 inhibitor, given alone or combined with rivaroxaban or another target-specific anticoagulant ... in low dosage would exhibit efficacy and safety comparable to or better than the rivaroxaban plus aspirin regimen they tested,” they wrote.
Further, they noted: “Whereas we might speculate about potentially safer or simpler options, the immediate challenge is to identify patients who are likely to gain survival advantage from the specific dual pathway regimen they validated. That regimen is not appropriate for every patient with atherosclerosis, but for many of those with diabetes, involvement of more than one vascular bed or ischemic heart disease underlying clinical heart failure, such treatment can begin today.”
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