Elshafei Mohamed Nabil, Salem Muhammad, Almistarihi Mutasem, Alabd Haider, Khalil Ahmed, Danjuma Mohammed
Clinical Pharmacy Department Hamad Medical Corporation Doha Qatar.
Internal Medicine Department Hamad Medical Corporation Doha Qatar.
EJHaem. 2025 Jun 6;6(3):e70031. doi: 10.1002/jha2.70031. eCollection 2025 Jun.
Despite recent advances in clinical therapeutics in patients with venous thromboembolism, uncertainty remains regarding the optimal anticoagulation strategy in patients with intermediate- to high-risk pulmonary embolism. We aimed to evaluate the direct oral anticoagulants' effectiveness and safety compared to warfarin in patients with intermediate- and high-risk pulmonary embolism.
In this meta-analysis, we systematically searched databases PubMed, EMBASE, Web of Science, and the Cochrane Library from their inception to April 30, 2024, for eligible studies that satisfy inclusion criteria. We included both randomized clinical trials and observational studies reporting on patients diagnosed with intermediate-risk or high-risk pulmonary embolism who were prescribed warfarin or direct oral anticoagulants (dabigatran, rivaroxaban, apixaban, or edoxaban). Two independent reviewers extracted relevant data from included studies based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. Pooled odds ratios were derived from the included studies using the random-effects model. The primary outcomes were the rate of venous thromboembolism recurrence and all-cause mortality. Secondary outcomes were major and minor bleeding.
Six studies, five observational and one randomized ( = 553 patients, out of which 45.7% received advanced therapy), were included in our meta-analysis. Direct oral anticoagulants were associated with comparable recurrence and mortality rates versus warfarin (odds ratio [OR] 0.72, 95% confidence interval [CI] 0.15-3.43) and (OR 0.57, 95% CI 0.16-2.01), respectively. There was no significant difference in the safety outcomes (major and minor bleeding events), with a trend towards a decreased risk among direct oral anticoagulant treated cohorts (OR 0.3, 95% CI 0.08-1.1) and (OR 0.64, 95% CI 0.24-1.7), respectively.
In patients with intermediate- to high-risk pulmonary embolism, with or without advanced therapy use, stabilized on direct oral anticoagulants, efficacy and safety outcomes were comparable to those on warfarin, with a trend towards less risk of major and minor bleeding events.
International PROSPERO database number: CRD42024499532.
尽管近期静脉血栓栓塞症患者的临床治疗取得了进展，但中高危肺栓塞患者的最佳抗凝策略仍存在不确定性。我们旨在评估直接口服抗凝剂与华法林相比，在中高危肺栓塞患者中的有效性和安全性。
在这项荟萃分析中，我们系统地检索了PubMed、EMBASE、Web of Science和Cochrane图书馆数据库，从其创建至2024年4月30日，寻找符合纳入标准的合格研究。我们纳入了随机临床试验和观察性研究，这些研究报告了被诊断为中高危肺栓塞且被处方华法林或直接口服抗凝剂（达比加群、利伐沙班、阿哌沙班或依度沙班）的患者。两名独立评审员根据系统评价和荟萃分析的首选报告项目指南，从纳入研究中提取相关数据。使用随机效应模型从纳入研究中得出合并比值比。主要结局是静脉血栓栓塞复发率和全因死亡率。次要结局是大出血和小出血。
我们的荟萃分析纳入了六项研究，五项观察性研究和一项随机研究（n = 553例患者，其中45.7%接受了高级治疗）。与华法林相比，直接口服抗凝剂的复发率和死亡率相当（比值比[OR] 0.72，95%置信区间[CI] 0.15 - 3.43）和（OR 0.57，95% CI 0.16 - 2.01）。安全结局（大出血和小出血事件）无显著差异，直接口服抗凝剂治疗组的风险有降低趋势（OR 0.3，95% CI 0.08 - 1.1）和（OR 0.64，95% CI 0.24 - 1.7）。
在中高危肺栓塞患者中，无论是否使用高级治疗，使用直接口服抗凝剂稳定治疗后，其疗效和安全性结局与华法林相当，大出血和小出血事件的风险有降低趋势。
国际PROSPERO数据库编号：CRD42024499532。
