Helen B. Taussig Heart Center, The Johns Hopkins Hospital and School of Medicine, Baltimore, Maryland, USA; Department of Cardiovascular Diseases, University Hospitals Leuven and Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium. Electronic address: https://twitter.com/JefVandenEynde.
Cardiology Department, Cantonal Hospital St Gallen, St Gallen, Switzerland; University Heart Center Zurich, Department of Cardiology, University of Zurich, Zurich, Switzerland. Electronic address: https://twitter.com/m_possner.
J Am Coll Cardiol. 2023 Jan 31;81(4):374-389. doi: 10.1016/j.jacc.2022.10.037.
The optimal strategy for thromboprophylaxis in patients with a Fontan circulation is unknown.
The aim of this study was to compare the efficacy and safety of aspirin, warfarin, and nonvitamin K oral anticoagulants (NOACs) in a network meta-analysis.
Relevant studies published by February 2022 were included. The primary efficacy outcome was thromboembolic events; major bleeding was a secondary safety outcome. Frequentist network meta-analyses were conducted to estimate the incidence rate ratios (IRRs) of both outcomes. Ranking of treatments was performed based on probability (P) score.
A total of 21 studies were included (26,546 patient-years). When compared with no thromboprophylaxis, NOAC (IRR: 0.11; 95% CI: 0.03-0.40), warfarin (IRR: 0.23; 95% CI: 0.14-0.37), and aspirin (IRR: 0.24; 95% CI: 0.15-0.39) were all associated with significantly lower rates of thromboembolic events. However, the network meta-analysis revealed no significant differences in the rates of major bleeding (NOAC: IRR: 1.45 [95% CI: 0.28-7.43]; warfarin: IRR: 1.38 [95% CI: 0.41-4.69]; and aspirin: IRR: 0.72 [95% CI: 0.20-2.58]). Rankings, which simultaneously analyze competing interventions, suggested that NOACs have the highest P score to prevent thromboembolic events (P score 0.921), followed by warfarin (P score 0.582), aspirin (P score 0.498), and no thromboprophylaxis (P score 0.001). Aspirin tended to have the most favorable overall profile.
Aspirin, warfarin, and NOAC are associated with lower risk of thromboembolic events. Recognizing the limited number of patients and heterogeneity of studies using NOACs, the results support the safety and efficacy of NOACs in patients with a Fontan circulation.
对于 Fontan 循环患者,最佳的血栓预防策略尚不清楚。
本研究旨在通过网络荟萃分析比较阿司匹林、华法林和非维生素 K 口服抗凝剂(NOACs)的疗效和安全性。
纳入截至 2022 年 2 月发表的相关研究。主要疗效结局为血栓栓塞事件;主要出血为次要安全性结局。采用频率论网络荟萃分析估计两种结局的发生率比(IRR)。基于概率(P)评分对治疗进行排序。
共纳入 21 项研究(26546 患者年)。与无血栓预防相比,NOAC(IRR:0.11;95%CI:0.03-0.40)、华法林(IRR:0.23;95%CI:0.14-0.37)和阿司匹林(IRR:0.24;95%CI:0.15-0.39)均与血栓栓塞事件发生率显著降低相关。然而,网络荟萃分析显示主要出血率无显著差异(NOAC:IRR:1.45[95%CI:0.28-7.43];华法林:IRR:1.38[95%CI:0.41-4.69];阿司匹林:IRR:0.72[95%CI:0.20-2.58])。同时分析竞争干预措施的排名表明,NOAC 预防血栓栓塞事件的 P 评分最高(P 评分 0.921),其次是华法林(P 评分 0.582)、阿司匹林(P 评分 0.498)和无血栓预防(P 评分 0.001)。阿司匹林总体情况最有利。
阿司匹林、华法林和 NOAC 与血栓栓塞事件风险降低相关。鉴于使用 NOAC 的患者数量有限且研究存在异质性,结果支持 NOAC 在 Fontan 循环患者中的安全性和有效性。