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Clinical Characteristics and Outcomes With Rivaroxaban vs. Warfarin in Patients With Non-Valvular Atrial Fibrillation but Underlying Native Mitral and Aortic Valve Disease Participating in the ROCKET AF Trial
Study Questions:
What were the clinical characteristics and outcomes of patients with significant valvular disease in the ROCKET-AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) trial comparing rivaroxaban to warfarin in atrial fibrillation (AF) patients?
Methods:
The ROCKET-AF trial compared rivaroxaban to warfarin for stroke prevention in nonvalvular AF, defined as hemodynamically significant mitral stenosis and mitral valve replacement surgery. In this post-hoc analysis, patients who had significant valve disease (primarily mitral regurgitation, aortic stenosis, or aortic regurgitation) were analyzed.
Results:
Among 14,171 patients in the ROCKET-AF trial, 2,003 (14.1%) had significant valvular disease. Mitral regurgitation was the most common valve lesion reported (89.6%), followed by aortic regurgitation (24.8%) and aortic stenosis (11.0%). The rate of stroke and systemic embolism was similar between patients treated with warfarin versus rivaroxaban who had significant valve disease (2.01% vs. 2.43%; hazard ratio [HR], 0.83; 95% confidence interval [CI], 0.55-1.27). Similar findings existed in patients without significant valve disease treated with warfarin versus rivaroxaban (1.96% vs. 2.22%; HR, 0.89; 95% CI, 0.75-1.07). Rates of major and nonmajor clinically relevant bleeding were higher in the rivaroxaban-treated patients with significant valve disease compared to the warfarin-treated group (19.8% vs. 16.8%; HR, 1.25; 95% CI, 1.05-1.49). Similar rates of bleeding were seen in patients without significant valve disease (14.2% vs. 14.1%).
Conclusions:
The authors concluded that many patients with “nonvalvular AF” still have significant valve lesions, and that their risk of stroke is similar to patients without valve lesions. They also concluded that the efficacy of rivaroxaban was similar in patients with and without valve lesions, but that the risk of bleeding was elevated in rivaroxaban-treated patients with significant valve disease.
Perspective:
This study highlights an important clinical question: Do patients with valve lesions experience equal benefit from direct oral anticoagulants as from warfarin? While the degree of valve lesion was not quantified in this report, included patients were deemed to have ‘significant valve disease’ by the referring provider. The results are reassuring that these patients, who are commonly seen with AF, derive the same stroke risk reduction with rivaroxaban as with warfarin. It is important for clinicians to remember that patients with prosthetic valves (both mechanical and bioprosthetic) were excluded from each of the phase III trials of direct oral anticoagulants, and that use of dabigatran was shown to be dangerous in mechanical valve patients. Those patients should still be treated with warfarin when AF is present.
Keywords: Vitamin K, Stroke, Morpholines, Anticoagulants, Heart Defects, Congenital, Risk Reduction Behavior, Mitral Valve Insufficiency, Thiophenes, Warfarin, beta-Alanine, Benzimidazoles, Mitral Valve Stenosis, Aortic Valve Stenosis, Atrial Fibrillation, Factor Xa, Embolism, Aortic Valve Insufficiency
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