Abstract

This editorial refers to ‘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’[†][1], by G. Breithardt et al. on page 3377. With the introduction of the target-specific oral anticoagulants (TSOAs), primary and secondary stroke prevention in atrial fibrillation (AF) has been revolutionized. Large randomized clinical trials and subsequent meta-analyses have clearly demonstrated that these agents have at least comparable if not superior efficacy and cause no more or even less major bleeding than vitamin K antagonists.1–5 The improved safety profile of these new compounds is particularly reflected by the significantly reduced risk of intracranial bleeds in comparison with warfarin, a property which all TSOAs have in common.6 Because of the historical studies on stroke prevention in patients with AF, all of the pivotal trials of TSOAs were conducted in patients with non-valvular AF, defined as patients with AF without rheumatic valve disease (mainly severe/moderate mitral stenosis) and/or without prosthetic heart valves. All other types of valve disease such as mitral regurgitation, aortic regurgitation, or aortic stenosis, for example, were allowed to be included in these trials. However, the historical term ‘non-valvular AF’ recently used in TSOA studies has created some confusion and led to concerns about the use of the TSOAs in patients with AF and valvular abnormalities. The recently published European and North American recommendations for management of AF have defined valvular AF as AF related … [1]: #fn-2

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