Department of Pharmacy, XinChang County Hospital of Traditional Chinese Medicine, Shaoxing, Zhejiang Province, P.R. China.
Eur Rev Med Pharmacol Sci. 2021 Aug;25(15):5006-5017. doi: 10.26355/eurrev_202108_26457.
To compare the outcomes between direct-acting oral anticoagulants and vitamin K antagonists, particularly for risk of stroke and bleeding, among patients with atrial fibrillation (AF) and bioprosthetic heart valve replacement or repair.
A systematic search was conducted in the PubMed, Scopus, Cochrane Database of Systematic Reviews and Google scholar databases. Studies that were done in patients with AF who underwent bioprosthetic heart valve replacement or repair and that compared the outcomes between the use of direct-acting oral anticoagulants (DOACs) and vitamin K antagonists were eligible for inclusion. Studies that were preferably randomized controlled trials or adopted a cohort approach or retrospective data-based studies were considered for inclusion. The strength of association was presented in the form of pooled hazards risk (HR). Statistical analysis was done using STATA version 16.0.
A total of 8 articles were included in the meta-analysis. There were no significant differences in the risk of "all-cause stroke" [HR 0.72, 95% CI: 0.39, 1.34] and ischemic stroke [HR 0.79, 95% CI: 0.49, 1.29] between the two groups. The risk of "any bleeding" [HR 0.74, 95% CI: 0.64, 0.87], major bleeding [HR 0.60, 95% CI: 0.42, 0.86] and intra-cranial bleeding [HR 0.54, 95% CI: 0.36, 0.81] was much lower in those that received DOAC compared to warfarin. Compared to those receiving warfarin, those on DOACs had substantially reduced risk of any clinical thromboembolic events [HR 0.52, 95% CI: 0.39, 0.70]. No significant differences were noted for all-cause mortality [HR 0.88, 95% CI: 0.74, 1.05], cardiovascular events/myocardial infarction (MI) [HR 0.58, 95% CI: 0.33, 1.04] and and readmission rates [HR 0.85, 95% CI: 0.62, 1.18].
Findings suggest that the use DOACs in patients with AF with bioprosthetic valve replacement or repair is comparatively better than vitamin K antagonists in reducing the risk of bleeding and thrombo-embolic events. Future studies with a randomized design and larger sample sizes are needed to further substantiate these findings.
比较直接口服抗凝剂与维生素 K 拮抗剂在接受生物瓣置换或修复的心房颤动（AF）患者中的疗效差异，特别是在卒中风险和出血风险方面。
我们在 PubMed、Scopus、Cochrane 系统评价数据库和 Google Scholar 数据库中进行了系统性检索。纳入了比较直接口服抗凝剂（DOAC）与维生素 K 拮抗剂在接受生物瓣置换或修复的 AF 患者中的疗效差异的研究。纳入的研究最好为随机对照试验或采用队列研究或基于回顾性数据的研究。关联强度以合并危害比（HR）的形式呈现。采用 STATA 版本 16.0 进行统计学分析。
共有 8 篇文章纳入荟萃分析。两组间“全因卒中”[HR 0.72，95%CI：0.39，1.34]和缺血性卒中[HR 0.79，95%CI：0.49，1.29]风险无显著差异。两组间“任何出血”[HR 0.74，95%CI：0.64，0.87]、大出血[HR 0.60，95%CI：0.42，0.86]和颅内出血[HR 0.54，95%CI：0.36，0.81]风险显著降低。与华法林相比，DOAC 组的任何临床血栓栓塞事件[HR 0.52，95%CI：0.39，0.70]风险显著降低。两组间全因死亡率[HR 0.88，95%CI：0.74，1.05]、心血管事件/心肌梗死（MI）[HR 0.58，95%CI：0.33，1.04]和再入院率[HR 0.85，95%CI：0.62，1.18]无显著差异。
这些发现表明，在接受生物瓣置换或修复的 AF 患者中，与维生素 K 拮抗剂相比，使用 DOAC 可降低出血和血栓栓塞事件的风险。需要进一步进行随机设计和更大样本量的研究来进一步证实这些发现。
