Prevalence and Prognostic Implications of Valve Disease in Patients With Atrial Fibrillation Initiating Direct Oral Anticoagulants.

INTRODUCTION AND

OBJECTIVES

Valvular heart disease in patients with atrial fibrillation included in clinical trials with direct oral anticoagulants (DOAC) is common and is associated with worse prognosis. The aim of this study was to evaluate the prevalence of valvular heart disease and its influence on clinical events in real-world clinical practice.

METHODS

We conducted a retrospective multicenter registry including 2297 consecutive patients with nonvalvular atrial fibrillation initiating DOAC between January 2013 and December 2016. Valvular heart disease was defined as moderate or severe involvement. The primary study endopoint was the composite of death, stroke or transient ischemic attack/systemic embolism or major bleeding. A competing risks analysis was carried out using a Fine and Gray regression model, with death being the competing event.

RESULTS

A total of 499 (21.7%) patients had significant valvular heart disease. The most common form was mitral regurgitation (13.7%). Patients with valvular heart disease were older and had more comorbidities. After multivariable analysis, valvular heart disease was associated with a higher risk for the primary endpoint (HR, 1.54; 95%CI, 1.22-1.94; P<.001), death (HR, 1.44; 95%CI, 1.09-1.91, P=.010), and major bleeding (HR, 1.85; 95%CI, 1.23-2.79, P=.003), but there was no association with thromboembolic events (P >.05).

CONCLUSIONS

In patients with nonvalvular atrial fibrillation initiating DOACs, valvular heart disease is common and increases the risk of mortality, stroke, transient ischemic attack/systemic embolism, and major bleeding complications. These findings confirm the results of clinical trials and expand them to a real-life clinical setting.