Servicio de Cardiología, Hospital Costa del Sol, Marbella, Málaga, Spain.
Servicio de Cardiología, Hospital de la Serranía de Ronda, Ronda, Málaga, Spain.
Rev Esp Cardiol (Engl Ed). 2023 Sep;76(9):690-699. doi: 10.1016/j.rec.2023.02.002. Epub 2023 Feb 17.
Direct oral anticoagulant (DOAC) therapy has been shown to be safe and effective in patients with atrial fibrillation (AF). However, outcomes in AF patients with bioprosthetic valves are unclear, as this population has been underrepresented in clinical trials. The aim of this study was to assess the safety and efficacy of DOACs in this population based on the existing published literature.
A systematic search and review were conducted to identify randomized clinical trials and comparative observational studies published from 2017 to January 2022 that compared DOACs and vitamin K antagonists (VKAs) in AF patients with bioprosthetic valves. Hazard ratios (HR) were collected to compare the 2 treatments in terms of cardiovascular and all-cause mortality, stroke/systemic embolism, and major bleeding. A meta-analysis combining the results was performed.
We included 12 studies (30 283 patients). DOACs and VKAs were compared based on HRs at the 95% confidence interval. DOAC therapy was associated with a significant 9% reduction in all-cause mortality (HR, 0.91; 95%CI, 0.85-0.97; P=.0068; I=8%), with no significant differences in the risk of stroke/systemic embolism (HR, 0.87; 95%CI, 0.67-1.14; P=.29; I=45%) or major bleeding (HR, 0.82; 95%CI, 0.67-1.00; P=.054; I=48.7%).
DOAC therapy in AF patients with bioprosthetic valves may be associated with a significant reduction in all-cause mortality, with no reduction in the efficacy of stroke/systemic embolism prevention or increase in major bleeding risk.
直接口服抗凝剂(DOAC)在房颤(AF)患者中的应用已被证明是安全有效的。然而,生物瓣患者的结局尚不清楚,因为这一人群在临床试验中代表性不足。本研究的目的是根据现有文献评估 DOAC 在这一人群中的安全性和疗效。
系统检索并回顾了 2017 年至 2022 年 1 月发表的比较 DOAC 和维生素 K 拮抗剂(VKA)在生物瓣房颤患者中的随机临床试验和观察性对照研究。收集风险比(HR),比较两种治疗方法在心血管和全因死亡率、卒中和全身性栓塞以及大出血方面的差异。对结果进行了荟萃分析。
共纳入 12 项研究(30283 例患者)。根据 95%置信区间的 HR 比较了 DOAC 和 VKA。DOAC 治疗与全因死亡率降低 9%相关(HR,0.91;95%CI,0.85-0.97;P=.0068;I=8%),卒中和全身性栓塞风险无显著差异(HR,0.87;95%CI,0.67-1.14;P=.29;I=45%)或大出血风险(HR,0.82;95%CI,0.67-1.00;P=.054;I=48.7%)。
生物瓣房颤患者使用 DOAC 治疗可能与全因死亡率显著降低相关,而卒中和全身性栓塞预防的疗效无降低,大出血风险无增加。