Chaudhri Moiuz, Ellebedy Mohamed, Al Mahrizi Ahmed D, Rajendran Pranesh, Ramachandran Arjun, Shahzad Areej, Nadeem Aiman, Patel Neil, Acquah Frederick, Kaunzinger Christian, Raza Muhammad R
Internal Medicine, Hackensack Meridian Health Ocean University Medical Center, Brick Township, USA.
Faculty of Medicine, Sohag University, Sohag, EGY.
Cureus. 2025 May 26;17(5):e84846. doi: 10.7759/cureus.84846. eCollection 2025 May.
The optimal anticoagulation strategy following mitral bioprosthetic valve replacement (BPVR) remains unclear. This meta-analysis evaluates the safety and efficacy of non-vitamin K antagonist oral anticoagulants (NOACs) compared to warfarin in this context. We systematically searched PubMed, Embase, Cochrane, and other databases for studies published between 2015 and 2025, comparing NOACs to warfarin in adults with mitral bioprostheses. Eligible studies reported thromboembolic and/or bleeding outcomes, with a minimum of six months' follow-up. Random-effects meta-analysis was performed, calculating odds ratios (ORs) with 95% confidence intervals (CIs). Heterogeneity was assessed using the I² statistic, and publication bias was assessed via funnel plot and Egger's test. Eight studies met the inclusion criteria, comprising 1,506 patients (709 on NOACs and 797 on warfarin). Included studies were randomized controlled trials (RCTs) and observational cohorts. NOACs studied were apixaban, rivaroxaban, and dabigatran. Three studies were included in the quantitative synthesis for each primary outcome. For stroke/systemic embolism, the pooled OR for NOACs was 0.57 (95% CI: 0.02-16.87, p = 0.55; I² = 33.7%). For major bleeding, the pooled OR was 1.06 (95% CI: 0.12-9.47, p = 0.94; I² = 74.9%). No significant publication bias was detected. Qualitative findings suggested NOACs had similar or lower rates of stroke, major and minor bleeding, and all-cause mortality. Valve thrombosis and rehospitalization were infrequently reported and comparable. NOACs appear to be a safe and effective alternative to warfarin after mitral BPVR. However, current evidence is limited by heterogeneity and wide CIs. Further large-scale RCTs are needed to confirm these findings.
二尖瓣生物瓣置换术(BPVR)后的最佳抗凝策略仍不明确。本荟萃分析评估了在这种情况下,与华法林相比,非维生素K拮抗剂口服抗凝药(NOACs)的安全性和有效性。我们系统检索了PubMed、Embase、Cochrane及其他数据库,以查找2015年至2025年期间发表的研究,这些研究比较了NOACs与华法林在二尖瓣生物瓣置换成年患者中的应用。符合条件的研究报告了血栓栓塞和/或出血结局,且随访时间至少为6个月。进行随机效应荟萃分析,计算比值比(OR)及95%置信区间(CI)。使用I²统计量评估异质性,并通过漏斗图和Egger检验评估发表偏倚。八项研究符合纳入标准,共纳入1506例患者(709例使用NOACs,797例使用华法林)。纳入的研究包括随机对照试验(RCT)和观察性队列研究。所研究的NOACs为阿哌沙班、利伐沙班和达比加群。每项主要结局的定量分析纳入三项研究。对于卒中/全身性栓塞,NOACs的合并OR为0.57(95%CI:0.02 - 16.87,p = 0.55;I² = 33.7%)。对于大出血,合并OR为1.06(95%CI:0.12 - 9.47,p = 0.94;I² = 74.9%)。未检测到显著的发表偏倚。定性研究结果表明,NOACs的卒中和大出血、小出血及全因死亡率发生率相似或更低。瓣膜血栓形成和再次住院的报告较少且相当。二尖瓣BPVR后,NOACs似乎是华法林的一种安全有效的替代药物。然而,目前的证据受异质性和宽置信区间的限制。需要进一步的大规模RCT来证实这些发现。