Caro Martínez César, Elvira Ruiz Ginés, Flores Blanco Pedro J, Cerezo Manchado Juan José, Albendín Iglesias Helena, Lova Navarro Alejandro, Arregui Montoya Francisco, García Alberola Arcadio, Pascual Figal Domingo Andrés, Bailén Lorenzo José Luis, Manzano Fernández Sergio
Servicio de Cardiología, Hospital Vega Baja, Orihuela, Alicante, Spain; Instituto Murciano de Investigación Biosanitaria (IMIB), Murcia, Spain.
Instituto Murciano de Investigación Biosanitaria (IMIB), Murcia, Spain; Servicio de Cardiología, Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar, Murcia, Spain.
Rev Esp Cardiol (Engl Ed). 2019 Nov;72(11):935-943. doi: 10.1016/j.rec.2018.08.026. Epub 2018 Nov 27.
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.
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.
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).
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.
纳入直接口服抗凝剂（DOAC）临床试验的房颤患者中，瓣膜性心脏病很常见，且与较差的预后相关。本研究的目的是评估瓣膜性心脏病的患病率及其在真实临床实践中对临床事件的影响。
我们进行了一项回顾性多中心注册研究，纳入了2013年1月至2016年12月期间连续2297例开始使用DOAC的非瓣膜性房颤患者。瓣膜性心脏病定义为中度或重度受累。主要研究终点是死亡、卒中或短暂性脑缺血发作/全身性栓塞或大出血的复合终点。使用Fine和Gray回归模型进行竞争风险分析，将死亡作为竞争事件。
共有499例（21.7%）患者患有严重瓣膜性心脏病。最常见的形式是二尖瓣反流（13.7%）。瓣膜性心脏病患者年龄更大，合并症更多。多变量分析后，瓣膜性心脏病与主要终点事件风险更高相关（HR，1.54；95%CI，1.22 - 1.94；P <.001）、死亡（HR，1.44；95%CI，1.09 - 1.91，P =.010）和大出血（HR，1.85；95%CI，1.23 - 2.79，P =.003），但与血栓栓塞事件无关联（P >.05）。
在开始使用DOAC的非瓣膜性房颤患者中，瓣膜性心脏病很常见，且增加了死亡、卒中、短暂性脑缺血发作/全身性栓塞和大出血并发症的风险。这些发现证实了临床试验的结果，并将其扩展到了真实临床环境中。
