Rivaroxaban Versus Warfarin in Patients with Mechanical Heart Valves: Open-Label, Proof-of-Concept trial—The RIWA study

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.

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Correspondence to Andre Rodrigues Duraes.

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Funding

This work was supported by General Hospital Roberto Santos.

Conflict of interest

The authors, ARD, YdSLB, ISS, KSOT, LVP, JALF, MGN, RAJ, and LR, declare that they have no conflict of interest.

Ethics approval

The trial protocol was approved by the local ethics committee.

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All patients provided written informed consent before enrollment.

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Not applicable.

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Duraes, A.R., de Souza Lima Bitar, Y., Schonhofen, I.S. et al. Rivaroxaban Versus Warfarin in Patients with Mechanical Heart Valves: Open-Label, Proof-of-Concept trial—The RIWA study. Am J Cardiovasc Drugs (2020). https://doi.org/10.1007/s40256-020-00449-3

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