Journal
AMERICAN JOURNAL OF CARDIOVASCULAR DRUGS
Volume 21, Issue 3, Pages 363-371Publisher
ADIS INT LTD
DOI: 10.1007/s40256-020-00449-3
Keywords
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Funding
- General Hospital Roberto Santos
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The RIWA study compared the incidence of thromboembolic and bleeding events between rivaroxaban and dose-adjusted warfarin in patients with mechanical heart valves, showing similar outcomes between the two groups with a lower rate of primary outcome in the rivaroxaban group. Based on these findings, a larger trial with a similar design may be considered for further evaluation.
Background and Purpose To date, vitamin K antagonists are the only available oral anticoagulants in patients with mechanical heart valves. In this way, we developed a pilot trial with rivaroxaban. Methods The RIWA study was a proof-of-concept, open-label, randomized clinical trial and was designed to assess the incidence of thromboembolic and bleeding events of the rivaroxaban-based strategy (15 mg twice daily) in comparison to dose-adjusted warfarin. Patients were randomly assigned in a 1:1 ratio and were followed prospectively for 90 days. Results A total of 72 patients were enrolled in the present study. Of these, 44 patients were randomized: 23 patients were allocated to the rivaroxaban group and 21 to the warfarin group. After 90 days of follow-up, the primary outcome occurred in one patient (4.3%) in the rivaroxaban group and three patients (14.3%) in the warfarin group (risk ratio [RR] 0.27; 95% confidence interval [CI] 0.02-2.85; P = 0.25). Minor bleeding (without discontinuation of medical therapy) occurred in six patients (26.1%) in the rivaroxaban group versus six patients (28.6%) in the warfarin group (RR 0.88; 95% CI 0.23-3.32; P = 0.85). One patient in the warfarin group died from myocardial infarction. No cases of hemorrhagic stroke, valve thrombosis, peripheral embolic events, or new intracardiac thrombus were related in both groups. Conclusions In this pilot study, rivaroxaban 15 mg twice daily had thromboembolic and bleeding events similar to warfarin in patients with mechanical heart valves. These data confirm the authors' proof-of-concept and suggest that a larger trial with a similar design is not unreasonable. ClinicalTrial.gov identifier NCT03566303.
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