Background: Treatment outcomes of patients with atrial fibrillation (AF) and significant valvular disease (SVD) treated with warfarin or novel factor Xa inhibitors are unknown. ROCKET AF enrolled patients with nonvalvular AF defined as the absence of mitral stenosis or artificial valves which allowed the inclusion of patients with other SVDs. Methods: We conducted a post-hoc analysis of thromboembolic and bleeding outcomes among AF patients with and without SVD according to intention to treat (warfarin vs. rivaroxaban). Results: Of 14,171 patients, 1992 (14.1%) had SVD, often with combined lesions (89.6% mitral regurgitation +/- aortic stenosis or regurgitation). Treatment comparisons after multivariate adjustment are shown (Table). Combined efficacy endpoints in patients (ITT population) with and without SVD did not show any significant differences in those treated with warfarin or rivaroxaban. Bleeding outcomes (safety on-treatment population) were not different in those without SVD but were more frequent on rivaroxaban than warfarin in SVD patients (interaction p value=0.034 and 0.010). Intracranial bleeding was significantly reduced by rivaroxaban in those without SVD (HR 0.59, 95% CI 0.40[[Unable to Display Character: -]]0.86) but not in SVD patients (interaction p-value=0.084). Conclusions: These post hoc analyses suggest that the effects of warfarin and rivaroxaban on thromboembolic and ischemic CV outcomes are similar among AF patients with and without SVD, whereas bleeding rates may differ. (Table Presented).
Breithardt, G., Berkowitz, S., Baumgartner, H., Hellkamp, A., Piccini, J., Stevens, S., … Fox, K. (2013). OUTCOMES OF PATIENTS WITH ATRIAL FIBRILLATION AND SIGNIFICANT VALVULAR LESIONS: COMPARISON OF THE EFFECTS OF RIVAROXABAN AND WARFARIN IN THE ROCKET AF TRIAL. Journal of the American College of Cardiology, 61(10), E339. https://doi.org/10.1016/s0735-1097(13)60339-3