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Xarelto monotherapy noninferior to combination therapy for CV events
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Xarelto monotherapy was noninferior to Xarelto plus an antiplatelet agent in regards to CV events and death from any cause in patients with atrial fibrillation and stable coronary artery disease, according to open-label trial data presented at the European Society of Cardiology Congress.
The drug was also safer, causing less major bleeding, researchers said.
Researchers randomly assigned 2,236 patients to receive only 10 mg or 15 mg of Xarelto (rivaroxaban, Bayer/Janssen) once a day or rivaroxaban plus a single antiplatelet agent.
Data from the trial showed monotherapy was noninferior to combination therapy for the primary efficacy endpoint — a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization or death from any cause.
According to the researchers, the trial was stopped early because of increased mortality in the combination-therapy group.
The event rate after 24 months of follow-up was 4.14% per patient-year vs. 5.75% per patient-year (HR = 0.72; 95% CI, 0.55-0.95). Event rates were 1.62% per patient-year vs. 2.76% per patient-year (HR = 0.59; 95% CI, 0.39-0.89).
“The [trial] results confirm the [European Union] and U.S. guidelines to quit antiplatelet therapy 1 year after PCI in atrial fibrillation patients on oral anticoagulation: stopping at 1 year is safer and more effective than continuation and, most of all, it saves lives,” Freek W.A. Verheugt, MD, from the Heart-Lung Center of the University Center of Nijmegen in the Netherlands, said at the conference. “Yet, since an earlier and smaller Japanese study [OAC-ALONE] did not show a benefit of stopping antiplatelet therapy at 1 year, the [trial] results should be confirmed in a next large trial, preferably in a non-Asian population.”
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References:
Yasuda S. Hot Line Session 3. Presented at: European Society of Cardiology Congress; Aug. 31 to Sept. 4, 2019; Paris.
Yasuda S, et al. N Engl J Med. 2019;doi:10.1056/NEJMoa1904143.
Disclosures: Yasuda reports that he has research contracts with Takeda, financial ties with Abbott, and consulting/royalties/owner/stockholder status with Bristol-Myers Squibb and Daiichi Sankyo. Please see the study for all other authors’ relevant financial disclosures.