非维生素K拮抗剂口服抗凝药与维生素K拮抗剂在心房颤动合并2型瓣膜性心脏病患者中的疗效和安全性：一项系统评价和荟萃分析
Efficacy and Safety of Non-Vitamin K Antagonist Oral Anticoagulants Compared with Vitamin K Antagonists in Patients with Atrial Fibrillation and Type 2 Valvular Heart Disease: A Systematic Review and Meta-Analysis.
作者信息
Liang Xiaoyun, Liu Shangyu, Ji Lishuang, Ma Fangfang, Song Guoyuan, Li Fang, Liu Gang
机构信息
Department of Cardiology, The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.
Hebei Key Laboratory of Cardiac Injury Repair Mechanism Study, Shijiazhuang, Hebei, China.
出版信息
Cardiovasc Drugs Ther. 2024 Aug 17. doi: 10.1007/s10557-024-07616-7.
PURPOSE
This meta-analysis aimed to evaluate the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) compared with vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) and type 2 valvular heart disease (VHD).
METHODS
We searched the PubMed, LILACS, and MEDLINE databases to retrieve, randomized controlled trials (RCTs) comparing NOACs and VKAs in patients with AF and type 2 VHD, excluding mitral stenosis (moderate to severe, of rheumatic origin) or mechanical heart valves. The efficacy outcomes assessed were stroke and systemic embolism (SE), while safety outcomes included major bleeding and intracranial hemorrhage (ICH).
RESULTS
Seven RCTs, including 16,070 patients with AF and type 2 VHD, were included. NOACs reduced the risk of stroke/SE (relative risk [RR], 0.75; 95% confidence interval [CI], 0.64-0.89; P = 0.0005), with no significant difference in major bleeding (RR, 0.88; 95% CI, 0.64-1.21; P = 0.43). The risk of ICH was reduced with NOACs (RR, 0.46; 95% CI, 0.27-0.77; P = 0.003). For patients with AF and bioprosthetic heart valve (five trials, 2805 patients), stroke/SE risks (RR, 0.65, 95% CI, 0.44-0.96) with NOACs were superior to VKAs. Major bleeding risks without ENVISAGE TAVI AF trial (RR, 0.53; 95% CI, 0.30-0.94; P = 0.03) with NOACs were superior to VKAs. The risks of ICH (RR, 0.61; 95% CI 0.34-1.09; P = 0.09) with NOACs were comparable to VKAs.
CONCLUSIONS
NOACs demonstrate efficacy and safety in patients with AF and type 2 VHD and reduce the risk of stroke/SE and ICH when compared with those with VKAs.
目的
本荟萃分析旨在评估非维生素K拮抗剂口服抗凝药（NOACs）与维生素K拮抗剂（VKAs）相比，在心房颤动（AF）合并2型心脏瓣膜病（VHD）患者中的疗效和安全性。
方法
我们检索了PubMed、LILACS和MEDLINE数据库，以获取比较AF合并2型VHD患者使用NOACs和VKAs的随机对照试验（RCTs），排除二尖瓣狭窄（中度至重度，风湿性起源）或机械心脏瓣膜。评估的疗效指标为中风和全身性栓塞（SE），而安全性指标包括大出血和颅内出血（ICH）。
结果
纳入了7项RCTs，包括16070例AF合并2型VHD患者。NOACs降低了中风/SE风险（相对风险[RR]，0.75；95%置信区间[CI]，0.64 - 0.89；P = 0.0005），大出血方面无显著差异（RR，0.88；95% CI，0.64 - 1.21；P = 0.43）。NOACs降低了ICH风险（RR，0.46；95% CI，0.27 - 0.77；P = 0.003）。对于AF合并生物人工心脏瓣膜的患者（5项试验，2805例患者），NOACs的中风/SE风险（RR，0.65，95% CI，0.44 - 0.96）优于VKAs。在不包括ENVISAGE TAVI AF试验的情况下，NOACs的大出血风险（RR，0.53；95% CI，0.30 - 0.94；P = 0.03）优于VKAs。NOACs的ICH风险（RR，0.61；95% CI 0.34 - 1.09；P = 0.09）与VKAs相当。
结论
与VKAs相比，NOACs在AF合并2型VHD患者中显示出疗效和安全性，并降低了中风/SE和ICH风险。
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