Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association · 2025
The safety and efficacy of factor XIa inhibitors for the prevention of stroke and thromboembolism: A systematic review and meta-analysis of randomized controlled trials.
СтатьяСистематический обзорМетаанализНазвание и аннотация: Перевод в очереди
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Zahid Nayab, Iqbal Fatima, Siddique Amber, Nadeem Anushah, Hussain Waqar, Ishaq Amna, Ahmed Mansoor, Lal Nauman, Abdullah Saad, Yousaf Humyoun, Jafar Uzair, Ayyan Muhammad, Farhan Muzammil, Noushad Muhammad Ameen, Ahmed Raheel
Аннотация
BACKGROUND: Stroke and thromboembolism remain the leading causes of mortality worldwide. Factor Xia inhibitors (FXIa) might prevent thromboembolism without interfering with hemostasis, thus leading to a lower risk of bleeding than direct oral anticoagulants (DOACs).
METHODS: We conducted a systematic search using PubMed, Embase, and Clinicaltrials.gov to retrieve randomized controlled trials comparing FXIa inhibitors to placebo or DOACs in patients at risk of stroke or thromboembolism. All statistical analyses were carried out using RevMan 5.4, using a random effects model.
RESULTS: Our meta-analysis included 14 RCTs involving 30,952 patients. FXIa inhibitors significantly decreased the risk of major bleeding (RR 0.47, 95% CI: 0.33-0.66, I2= 46%) with no significant change in systemic embolism or thromboembolism (RR 0.83, 95% CI: 0.64-1.07, I2= 70%). There was no significant change between the two groups when assessing the rate of all bleeding events (RR 0.78, 95% CI: 0.55-1.11, I2= 73%), all-cause mortality (RR 0.87, 95% CI: 0.70-1.09, I2= 0%), ischemic stroke (RR 0.99, 95%CI: 0.49-1.98, I2= 86%), myocardial infarction (RR 1.30; 95% CI, 0.54 - 3.13; I² = 68%), and intracranial hemorrhage (RR 0.49, 95% CI: 0.23- 1.05, I2= 9%). The rate of all adverse events (RR 1.05, 95% CI: 0.86-1.29, I2= 79%) and serious adverse events (RR 1.16, 95% CI: 0.86-1.55, I2= 74%) remained comparable between the two groups.
CONCLUSION: In conclusion, FXIa inhibitors show promise as safer anticoagulant agents, demonstrating favorable bleeding outcomes without changing thromboembolism, mortality, or other safety outcomes. The presence of heterogeneity across various subgroups warrants data from further high-quality, large-scale RCTs to establish evidence of its clinical benefit. This is especially important in atrial fibrillation, where conflicting evidence regarding thromboembolism warrants cautious interpretation and further investigation.
METHODS: We conducted a systematic search using PubMed, Embase, and Clinicaltrials.gov to retrieve randomized controlled trials comparing FXIa inhibitors to placebo or DOACs in patients at risk of stroke or thromboembolism. All statistical analyses were carried out using RevMan 5.4, using a random effects model.
RESULTS: Our meta-analysis included 14 RCTs involving 30,952 patients. FXIa inhibitors significantly decreased the risk of major bleeding (RR 0.47, 95% CI: 0.33-0.66, I2= 46%) with no significant change in systemic embolism or thromboembolism (RR 0.83, 95% CI: 0.64-1.07, I2= 70%). There was no significant change between the two groups when assessing the rate of all bleeding events (RR 0.78, 95% CI: 0.55-1.11, I2= 73%), all-cause mortality (RR 0.87, 95% CI: 0.70-1.09, I2= 0%), ischemic stroke (RR 0.99, 95%CI: 0.49-1.98, I2= 86%), myocardial infarction (RR 1.30; 95% CI, 0.54 - 3.13; I² = 68%), and intracranial hemorrhage (RR 0.49, 95% CI: 0.23- 1.05, I2= 9%). The rate of all adverse events (RR 1.05, 95% CI: 0.86-1.29, I2= 79%) and serious adverse events (RR 1.16, 95% CI: 0.86-1.55, I2= 74%) remained comparable between the two groups.
CONCLUSION: In conclusion, FXIa inhibitors show promise as safer anticoagulant agents, demonstrating favorable bleeding outcomes without changing thromboembolism, mortality, or other safety outcomes. The presence of heterogeneity across various subgroups warrants data from further high-quality, large-scale RCTs to establish evidence of its clinical benefit. This is especially important in atrial fibrillation, where conflicting evidence regarding thromboembolism warrants cautious interpretation and further investigation.