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- Title
Rivaroxaban Versus Warfarin in Patients with Mechanical Heart Valves: Open-Label, Proof-of-Concept trial—The RIWA study.
- Authors
Duraes, Andre Rodrigues; de Souza Lima Bitar, Yasmin; Schonhofen, Igor Santos; Travassos, Kethyren Santos Oliveira; Pereira, Larissa Vitória; Filho, Jose Admirço Lima; Neto, Mansueto Gomes; Junior, Roque Aras; Roever, Leonardo
- Abstract
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.
- Subjects
THROMBOEMBOLISM prevention; PILOT projects; CONFIDENCE intervals; WARFARIN; ANTICOAGULANTS; RIVAROXABAN; TREATMENT effectiveness; RANDOMIZED controlled trials; PROSTHETIC heart valves; THROMBOEMBOLISM; STATISTICAL sampling; HEMORRHAGE
- Publication
American Journal of Cardiovascular Drugs, 2021, Vol 21, Issue 3, p363
- ISSN
1175-3277
- Publication type
Article
- DOI
10.1007/s40256-020-00449-3