Division of Cardiology, Department of Translational Medical Sciences, 18994University of Campania "Luigi Vanvitelli," Monaldi Hospital, Naples, Italy.
Division of Cardiology, 18602University of Padua, Padua, Italy.
J Cardiovasc Pharmacol Ther. 2020 Nov;25(6):564-569. doi: 10.1177/1074248420935263. Epub 2020 Jun 30.
Atrial fibrillation (AF) is the most common cardiac arrhythmia and is frequently present in patients with mitral regurgitation (MR). Currently, there is a lack of real-world evidence specifically addressing the clinical performance of direct oral anticoagulants (DOACs) in patients with AF and concomitant MR. Therefore, the aim of the present study was to assess the efficacy and safety profile of DOACs therapy in patients with AF and MR.
Data for this study were sourced from the Atrial Fibrillation Research Database in the Department of Cardiology at Monaldi Hospital. The database was queried for AF patients with MR who were prescribed DOACs therapy. The primary safety outcome was defined as the annual incidence rate of major bleeding events and the primary effectiveness outcome as the annual incidence rate of all events classified as ischemic stroke, transient ischemic attacks, and systemic embolisms.
Consecutive AF patients with concomitant mild to severe MR who received DOACs therapy (n = 259) were included. Patients were dichotomized in 2 groups according to MR severity: a mild-to-moderate group (MR 1-2+; n = 151) and a moderate-to-severe group (MR 3-4+; n = 108). The incidence rate of major bleedings was significantly higher in MR 3-4+ group (3.92%) compared with the MR 1-2+ group (1.18%; hazard ratio [HR]: 3.2; 95% CI: 1.4-7.3; = .0059). The incidence rate of thromboembolic events between MR 3-4+ group (0.66%) and MR 1-2+ group (0.62%) was not significantly different (HR: 0.75; = .823).
In the present study, there was no difference in the efficacy profile of DOACs between AF patients with mild-to-moderate and moderate-to-severe MR. Considering the increased bleeding risk, a close and careful follow-up should be warranted for patients with moderate-to-severe MR.
心房颤动（AF）是最常见的心律失常，常发生于二尖瓣反流（MR）患者中。目前，缺乏专门针对 AF 合并 MR 患者的直接口服抗凝剂（DOACs）临床疗效的真实世界证据。因此，本研究旨在评估 DOACs 治疗 AF 合并 MR 患者的疗效和安全性。
本研究数据来源于莫纳德医院心脏病科心房颤动研究数据库。对接受 DOACs 治疗的 AF 合并 MR 患者的数据库进行了查询。主要安全性结局定义为主要出血事件的年发生率，主要有效性结局定义为所有事件的年发生率，这些事件分为缺血性卒、短暂性脑缺血发作和全身性栓塞。
共纳入 259 例连续接受 DOACs 治疗的 AF 合并轻度至重度 MR 的患者。根据 MR 严重程度将患者分为 2 组：轻度至中度组（MR 1-2+；n=151）和中度至重度组（MR 3-4+；n=108）。MR 3-4+组（3.92%）的大出血发生率明显高于 MR 1-2+组（1.18%；危险比[HR]：3.2；95%置信区间[CI]：1.4-7.3；P=0.0059）。MR 3-4+组（0.66%）和 MR 1-2+组（0.62%）的血栓栓塞事件发生率无显著差异（HR：0.75；P=0.823）。
在本研究中，AF 合并轻度至中度和中度至重度 MR 的患者 DOACs 的疗效特征无差异。考虑到出血风险增加，应对中度至重度 MR 患者进行密切和仔细的随访。
