Sufyan Shahid, Minahil Iqbal, Mariam Shahabi, Muhammad Abdullah Ali, Allahdad Khan, Muhammad Ali Shahid, Hamyial Iqbal, Khadija Shahid, Salman Khalid
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Risk ratios (RR) with 95% confidence intervals (CI) were pooled using a random-effects model. Statistical analysis was performed in RevMan 5.4 with p-value < 0.05 considered significant, and meta-analyses were conducted using a bivariate random-effects model. Study heterogeneity was measured using I<sup>2</sup> statistics, and study quality was assessed using the revised Cochrane risk-of-bias (RoB 2) tool.</p><p><strong>Results: </strong>Three RCTs comprising 16,845 patients (41% females) were included. The mean age of the participants was 74 years. Factor XIa inhibitors were associated with a significantly higher risk of ischemic stroke (RR: 3.32; 95% CI: 2.24-4.90, I<sup>2</sup>: 0%, p < 0.00001) but a lower risk of major or clinically relevant non-major (CRNM) bleeding (RR: 0.41; 95% CI: 0.33-0.49, I<sup>2</sup>: 0%, p < 0.00001) and minor bleeding (RR: 0.68; 95% CI: 0.49-0.93, I<sup>2</sup>: 64%, p = 0.02) compared to DOACs. However, there was no significant difference in the risk of all-cause mortality, cardiovascular mortality, or hemorrhagic stroke between the two groups.</p><p><strong>Conclusion: </strong>Factor XIa inhibitors are associated with a reduced risk of major, minor, and clinically relevant non-major bleeding than DOACs but simultaneously increase the risk of ischemic stroke. 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The mean age of the participants was 74 years. Factor XIa inhibitors were associated with a significantly higher risk of ischemic stroke (RR: 3.32; 95% CI: 2.24-4.90, I<sup>2</sup>: 0%, p < 0.00001) but a lower risk of major or clinically relevant non-major (CRNM) bleeding (RR: 0.41; 95% CI: 0.33-0.49, I<sup>2</sup>: 0%, p < 0.00001) and minor bleeding (RR: 0.68; 95% CI: 0.49-0.93, I<sup>2</sup>: 64%, p = 0.02) compared to DOACs. However, there was no significant difference in the risk of all-cause mortality, cardiovascular mortality, or hemorrhagic stroke between the two groups.</p><p><strong>Conclusion: </strong>Factor XIa inhibitors are associated with a reduced risk of major, minor, and clinically relevant non-major bleeding than DOACs but simultaneously increase the risk of ischemic stroke. 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引用次数: 0
摘要
简介：直接口服抗凝剂（DOACs）是降低心房颤动（AF）患者血栓栓塞风险的标准治疗；然而，出血仍然是一个主要问题。因子XIa抑制剂已成为潜在的替代方案，但其治疗潜力的证据尚不清楚。我们进行了一项系统回顾和荟萃分析，以评估XIa因子抑制剂与DOACs治疗AF的比较疗效和安全性。方法：系统检索PubMed， Embase和Cochrane图书馆，直到2025年2月15日，以确定比较XIa因子抑制剂与DOACs治疗AF患者的随机对照试验。采用随机效应模型合并95%置信区间的风险比（RR）。采用RevMan 5.4进行统计学分析，采用p值2统计量，采用修订后的Cochrane风险偏倚（RoB 2）工具评估研究质量。结果：纳入3项随机对照试验，共16,845例患者（41%为女性）。参与者的平均年龄为74岁。因子XIa抑制剂与缺血性卒中风险显著升高相关(RR: 3.32；95%置信区间:2.24—-4.90,I2: 0%, p 2: 0%, p 2: 64%, p = 0.02) DOACs相比。然而，两组在全因死亡率、心血管死亡率或出血性中风的风险方面没有显著差异。结论：与DOACs相比，XIa因子抑制剂可降低大、小及临床相关的非大出血风险，但同时增加缺血性卒中的风险。与DOACs相比，出血性中风的风险或总死亡率没有显著差异。
Factor XIa Inhibitors Versus Direct Oral Anticoagulants for Atrial Fibrillation: A Systematic Review and Meta-analysis of Randomized Controlled Trials.
Introduction: Direct oral anticoagulants (DOACs) are the standard treatment for reducing thromboembolic risk in patients with atrial fibrillation (AF); however, bleeding remains a major concern. Factor XIa inhibitors have emerged as a potential alternative, but evidence about their therapeutic potential remains unclear. We performed a systematic review and meta-analysis to evaluate the comparative efficacy and safety of Factor XIa inhibitors versus DOACs for AF.
Methods: PubMed, Embase, and Cochrane Library were systematically searched until February 15, 2025, to identify RCTs comparing Factor XIa inhibitors with DOACs in AF patients. Risk ratios (RR) with 95% confidence intervals (CI) were pooled using a random-effects model. Statistical analysis was performed in RevMan 5.4 with p-value < 0.05 considered significant, and meta-analyses were conducted using a bivariate random-effects model. Study heterogeneity was measured using I2 statistics, and study quality was assessed using the revised Cochrane risk-of-bias (RoB 2) tool.
Results: Three RCTs comprising 16,845 patients (41% females) were included. The mean age of the participants was 74 years. Factor XIa inhibitors were associated with a significantly higher risk of ischemic stroke (RR: 3.32; 95% CI: 2.24-4.90, I2: 0%, p < 0.00001) but a lower risk of major or clinically relevant non-major (CRNM) bleeding (RR: 0.41; 95% CI: 0.33-0.49, I2: 0%, p < 0.00001) and minor bleeding (RR: 0.68; 95% CI: 0.49-0.93, I2: 64%, p = 0.02) compared to DOACs. However, there was no significant difference in the risk of all-cause mortality, cardiovascular mortality, or hemorrhagic stroke between the two groups.
Conclusion: Factor XIa inhibitors are associated with a reduced risk of major, minor, and clinically relevant non-major bleeding than DOACs but simultaneously increase the risk of ischemic stroke. No significant differences were found in the risk of hemorrhagic stroke or overall mortality rates compared to DOACs.
期刊介绍：
Designed to objectively cover the process of bench to bedside development of cardiovascular drug, device and cell therapy, and to bring you the information you need most in a timely and useful format, Cardiovascular Drugs and Therapy takes a fresh and energetic look at advances in this dynamic field.
Homing in on the most exciting work being done on new therapeutic agents, Cardiovascular Drugs and Therapy focusses on developments in atherosclerosis, hyperlipidemia, diabetes, ischemic syndromes and arrhythmias. The Journal is an authoritative source of current and relevant information that is indispensable for basic and clinical investigators aiming for novel, breakthrough research as well as for cardiologists seeking to best serve their patients.
Providing you with a single, concise reference tool acknowledged to be among the finest in the world, Cardiovascular Drugs and Therapy is listed in Web of Science and PubMed/Medline among other abstracting and indexing services. The regular articles and frequent special topical issues equip you with an up-to-date source defined by the need for accurate information on an ever-evolving field. Cardiovascular Drugs and Therapy is a careful and accurate guide through the maze of new products and therapies which furnishes you with the details on cardiovascular pharmacology that you will refer to time and time again.
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