Apixaban in Comparison With Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease

Valvular heart disease (VHD) is associated with a higher incidence of thromboembolic events, regardless of the underlying cardiac rhythm [1]. Atrial fibrillation (AF) is associated with a higher incidence of thromboembolic events in patients with rheumatic mitral stenosis or in patients with nonvalvular AF [2,3]. Warfarin is indicated for prevention of thromboembolic events in patients with mechanical prosthetic heart valves and in patients with AF and mitral stenosis [3-5]. The Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial showed that apixaban reduced stroke or systemic embolism, caused less bleeding, and decreased mortality in comparison with warfarin [6], and on the basis of this trial, has been approved for prevention of thromboembolic events in patients with nonvalvular AF. The ARISTOTLE trial excluded patients with mechanical prosthetic heart valves and patients with moderate or severe mitral stenosis but included patients with other VHD [6]. Of the 18,201 patients with AF in the ARISTOTLE trial, 4808 patients (26.4%) had a history of moderate or severe other VHD or previous valve surgery. The present study showed that there was no evidence of a different effect of apixaban compared with warfarin in patients with and without VHD in reducing stroke and systemic embolism (hazard ratio =0.70; 95% CI, 0.51-0.97 versus hazard ratio =0.84; 95% CI, 0.67-1.04; interaction p = 0.38), in reducing major bleeding (hazard ratio =0.79; 95% CI, 0.61-1.04; versus hazard ratio = 0.65; 95% CI, 0.55-0.77; interaction p=0.23), and in decreasing mortality (hazard ratio =1.01; 95% CI, 0.84-1.22; versus hazard ratio = 0.84; 95% CI, 0.73-0.96; interaction p=0.10).

 

 

Conclusion

The coexistence of AF and VHD is associated with a higher risk of thromboembolic events and bleeding. There is a lack of available data evaluating direct oral anticoagulants in patients with VHD and AF. The current analysis provides a reliable evaluation of the efficacy and safety of apixaban in patients with VHD. Apixaban, in comparison with warfarin, had similar relative and larger absolute benefits in reducing stroke or systemic embolism, causing less bleeding, and reducing mortality in patients with VHD in comparison with those without VHD. These results will potentially improve the cardiovascular burden of AF in VHD.

 

Corresponding author from original paper

Alvaro Avezum, MD, PhD, Dante Pazzanese

Institute of Cardiology, Av. Dante Pazzanese, 500 04012909 São Paulo, Brazil.

E-mail avezum@dantepazzanese.org.br

 

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Citation: Avezum A, Lopes RD, Schulte PJ, Lanas F, Gersh BJ, Hanna M, et al. Apixaban in Comparison With Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease: Findings From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Trial. Circulation. 2015; 132(8):624-32 .