{"title":"心脏瓣膜置换术或修复后直接口服抗凝剂的疗效和安全性：一项系统综述和网络meta分析。","authors":"Weiqi Gao, Zhijiao Zhang, Pengyan Jia, Lingjun Dong, Ruijuan Li, Juan Xu, Jingmin Zhang, Weihong Chen","doi":"10.1016/j.clinthera.2025.08.017","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>The optimal anticoagulation strategy following bioprosthetic heart valve replacement or valve repair remains controversial. Therefore, we conducted a meta-analysis to compare the efficacy and safety of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) in patients with heart valve disease.</p><p><strong>Methods: </strong>We searched PubMed, Cochrane Library, Embase, Web of Science, CNKI, and Wanfang for clinical studies comparing DOACs and VKAs in patients following bioprosthetic heart valve replacement or repair, up to November 1, 2023. The meta-analysis was conducted using RevMan 5.3 and Stata 17.0.</p><p><strong>Findings: </strong>Thirty-three studies involving 59,660 individuals were included in the meta-analysis. Compared with VKAs, DOACs may reduce the risk of stroke or systemic embolism (risk ratios [RR] = 0.83, 95% confidence interval [CI] 0.75-0.93, P = 0.0007) and major bleeding (RR = 0.76, 95% CI 0.62-0.94, P = 0.009), while the risks of all-cause death and intracranial bleeding were similar. DOACs may increase the risk of gastrointestinal bleeding (RR = 1.42, 95% CI 1.04-1.95, P = 0.03). Twelve studies (4,789 patients) were included in a network meta-analysis. Indirect comparisons suggested rivaroxaban appears most favorable in reducing stroke or systemic embolism and major bleeding, though based on indirect evidence.</p><p><strong>Implications: </strong>In patients following bioprosthetic heart valve replacement or repair, DOACs may reduce the risk of stroke or systemic embolism and major bleeding, but may increase gastrointestinal bleeding compared with VKAs. Among DOACs, rivaroxaban appears to be the optimal choice. These findings should be interpreted cautiously due to limited RCT evidence and incomplete drug-specific reporting.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6000,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of Direct Oral Anticoagulants in Patients After Heart Valve Replacement or Repair: A Systematic Review and Network Meta-Analysis.\",\"authors\":\"Weiqi Gao, Zhijiao Zhang, Pengyan Jia, Lingjun Dong, Ruijuan Li, Juan Xu, Jingmin Zhang, Weihong Chen\",\"doi\":\"10.1016/j.clinthera.2025.08.017\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>The optimal anticoagulation strategy following bioprosthetic heart valve replacement or valve repair remains controversial. Therefore, we conducted a meta-analysis to compare the efficacy and safety of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) in patients with heart valve disease.</p><p><strong>Methods: </strong>We searched PubMed, Cochrane Library, Embase, Web of Science, CNKI, and Wanfang for clinical studies comparing DOACs and VKAs in patients following bioprosthetic heart valve replacement or repair, up to November 1, 2023. The meta-analysis was conducted using RevMan 5.3 and Stata 17.0.</p><p><strong>Findings: </strong>Thirty-three studies involving 59,660 individuals were included in the meta-analysis. Compared with VKAs, DOACs may reduce the risk of stroke or systemic embolism (risk ratios [RR] = 0.83, 95% confidence interval [CI] 0.75-0.93, P = 0.0007) and major bleeding (RR = 0.76, 95% CI 0.62-0.94, P = 0.009), while the risks of all-cause death and intracranial bleeding were similar. DOACs may increase the risk of gastrointestinal bleeding (RR = 1.42, 95% CI 1.04-1.95, P = 0.03). Twelve studies (4,789 patients) were included in a network meta-analysis. Indirect comparisons suggested rivaroxaban appears most favorable in reducing stroke or systemic embolism and major bleeding, though based on indirect evidence.</p><p><strong>Implications: </strong>In patients following bioprosthetic heart valve replacement or repair, DOACs may reduce the risk of stroke or systemic embolism and major bleeding, but may increase gastrointestinal bleeding compared with VKAs. Among DOACs, rivaroxaban appears to be the optimal choice. 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引用次数: 0
摘要
目的：生物人工心脏瓣膜置换术或瓣膜修复后的最佳抗凝策略仍然存在争议。因此，我们进行了一项荟萃分析，比较直接口服抗凝剂（DOACs）和维生素K拮抗剂（VKAs）在心脏瓣膜疾病患者中的疗效和安全性。方法：我们检索PubMed、Cochrane Library、Embase、Web of Science、CNKI和万方，检索截至2023年11月1日比较生物人工心脏瓣膜置换术或修复后患者DOACs和vka的临床研究。meta分析采用RevMan 5.3和Stata 17.0进行。研究结果：meta分析包括33项研究，涉及59,660人。与vka相比，DOACs可降低卒中或全身性栓塞的风险（风险比[RR] = 0.83, 95%可信区间[CI] 0.75 ~ 0.93, P = 0.0007）和大出血的风险（RR = 0.76, 95% CI 0.62 ~ 0.94, P = 0.009），而全因死亡和颅内出血的风险相似。DOACs可能增加胃肠道出血的风险（RR = 1.42, 95% CI 1.04-1.95, P = 0.03）。12项研究（4789例患者）纳入网络荟萃分析。间接比较表明，利伐沙班在减少中风或全身栓塞和大出血方面最有利，尽管这是基于间接证据。意义：在生物人工心脏瓣膜置换术或修复后的患者中，doac可能降低中风或全身性栓塞和大出血的风险，但与vka相比，doac可能增加胃肠道出血。在doac中，利伐沙班似乎是最佳选择。由于有限的随机对照试验证据和不完整的药物特异性报告，这些发现应谨慎解释。
Efficacy and Safety of Direct Oral Anticoagulants in Patients After Heart Valve Replacement or Repair: A Systematic Review and Network Meta-Analysis.
Purpose: The optimal anticoagulation strategy following bioprosthetic heart valve replacement or valve repair remains controversial. Therefore, we conducted a meta-analysis to compare the efficacy and safety of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) in patients with heart valve disease.
Methods: We searched PubMed, Cochrane Library, Embase, Web of Science, CNKI, and Wanfang for clinical studies comparing DOACs and VKAs in patients following bioprosthetic heart valve replacement or repair, up to November 1, 2023. The meta-analysis was conducted using RevMan 5.3 and Stata 17.0.
Findings: Thirty-three studies involving 59,660 individuals were included in the meta-analysis. Compared with VKAs, DOACs may reduce the risk of stroke or systemic embolism (risk ratios [RR] = 0.83, 95% confidence interval [CI] 0.75-0.93, P = 0.0007) and major bleeding (RR = 0.76, 95% CI 0.62-0.94, P = 0.009), while the risks of all-cause death and intracranial bleeding were similar. DOACs may increase the risk of gastrointestinal bleeding (RR = 1.42, 95% CI 1.04-1.95, P = 0.03). Twelve studies (4,789 patients) were included in a network meta-analysis. Indirect comparisons suggested rivaroxaban appears most favorable in reducing stroke or systemic embolism and major bleeding, though based on indirect evidence.
Implications: In patients following bioprosthetic heart valve replacement or repair, DOACs may reduce the risk of stroke or systemic embolism and major bleeding, but may increase gastrointestinal bleeding compared with VKAs. Among DOACs, rivaroxaban appears to be the optimal choice. These findings should be interpreted cautiously due to limited RCT evidence and incomplete drug-specific reporting.
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