Mandefro Bethel T, Sundara Sri Vidya, Lu Xinyu, Busmail Hamide, Weerakoon Sasika, Avula Sravanthi, Iftikhar Laraib
Medicine, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA.
Cureus. 2025 Aug 10;17(8):e89736. doi: 10.7759/cureus.89736. eCollection 2025 Aug.
Patients with mechanical heart valves require lifelong anticoagulation primarily due to the thrombogenic nature of these valves. Warfarin has been the mainstay of therapy, but its drug-drug interactions and frequent monitoring requirements have diverted attention toward DOACs (direct oral anticoagulants) such as apixaban, rivaroxaban, and dabigatran. However, the use of DOACs in this group of patients remains controversial, particularly after negative outcomes in earlier trials. This systematic review focuses on the efficacy of DOACs compared to warfarin for preventing thromboembolic events and associated bleeding risks in patients with mechanical heart valves. Most evidence comes from observational studies and meta-analyses. More limited data exist for patients with mechanical heart valves. We systematically searched PubMed, PubMed Central, and Google Scholar for English-language studies published between January 2015 and May 5, 2025. Eligible studies included randomized controlled trials (RCTs), observational studies, systematic reviews, and meta-analyses comparing DOACs and warfarin in adults with mechanical heart valves and related comorbidities such as atrial fibrillation and valvular heart disease. Articles were screened and assessed using standard quality appraisal tools. We included three observational studies, two RCTs, and six systematic reviews and meta-analyses. Most of the studies favored warfarin as the standard therapy for patients with mechanical heart valves, while DOACs showed relatively inferior outcomes. Current practice guidelines from the American College of Cardiology Foundation/American Heart Association Task Force suggest warfarin as the standard treatment for patients with mechanical heart valves. There is a further need for long-term, high-quality clinical trials using a newer generation of DOACs among this high-risk group.
患有机械心脏瓣膜的患者主要由于这些瓣膜的血栓形成特性而需要终身抗凝治疗。华法林一直是治疗的主要药物，但它的药物相互作用以及频繁的监测需求使得人们将注意力转向了阿哌沙班、利伐沙班和达比加群等直接口服抗凝剂（DOACs）。然而，在这组患者中使用DOACs仍存在争议，特别是在早期试验出现负面结果之后。本系统评价聚焦于DOACs与华法林相比，在预防机械心脏瓣膜患者血栓栓塞事件及相关出血风险方面的疗效。大多数证据来自观察性研究和荟萃分析。关于机械心脏瓣膜患者的数据更为有限。我们系统地检索了PubMed、PubMed Central和谷歌学术，以查找2015年1月至2025年5月5日发表的英文研究。符合条件的研究包括随机对照试验（RCTs）、观察性研究、系统评价和荟萃分析，这些研究比较了DOACs和华法林在患有机械心脏瓣膜及相关合并症（如心房颤动和瓣膜性心脏病）的成年人中的应用。使用标准质量评估工具对文章进行筛选和评估。我们纳入了三项观察性研究、两项RCTs以及六项系统评价和荟萃分析。大多数研究倾向于将华法林作为机械心脏瓣膜患者的标准治疗方法，而DOACs的结果相对较差。美国心脏病学会基金会/美国心脏协会工作组的现行实践指南建议将华法林作为机械心脏瓣膜患者的标准治疗方法。在这个高危人群中，进一步需要开展使用新一代DOACs的长期、高质量临床试验。
