Department of Internal Medicine, Hospital Clínic, IDIBAPS, University of Barcelona, Barcelona, Spain.
Department of Medicine, Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada.
Semin Thromb Hemost. 2021 Sep;47(6):709-723. doi: 10.1055/s-0041-1725057. Epub 2021 May 10.
There is a scarcity of high-quality randomized controlled trials (RCTs) comparing antithrombotic regimens for secondary prevention of arterial thrombosis (AT) in antiphospholipid syndrome (APS). We reviewed different antithrombotic regimens used for this purpose. We searched for studies on management of AT in APS on PubMed and Web of Science. Eleven studies (5 RCTs, 3 prospective, and 3 retrospective cohort studies) comparing different regimens and reporting outcomes specifically for patients with index AT events were identified. Treatments were vitamin K antagonists (VKA; 9 studies), non-VKA oral anticoagulant (NOAC; 3 studies), single antiplatelet therapy (SAPT; 7 studies), dual antiplatelet therapy (DAPT; 2 studies), and VKA combined with SAPT (4 studies). We performed a meta-analysis for the outcomes: recurrent AT, any (arterial or venous) recurrent thromboembolism, and major bleeding. Recurrent AT was reduced with VKA plus SAPT versus VKA (risk ratio [RR]: 0.43; 95% confidence interval [CI]: 0.22-0.85) and with DAPT versus SAPT (RR: 0.29; 95% CI: 0.09-0.99). Any recurrent thromboembolism was reduced with VKA plus SAPT versus VKA alone (RR: 0.41; 95% CI: 0.24-0.69) and versus SAPT alone (RR: 0.36; 95% CI: 0.13-0.96). There were no significant differences between other treatments for thromboembolism and for none of the comparisons regarding major bleeding. In a sensitivity analysis, excluding low-quality studies, VKA was more effective than NOAC to prevent recurrent AT (RR: 0.25; 95% CI: 0.07-0.93). Combined antithrombotic therapy might be more effective than single agents as secondary prophylaxis in APS with AT, and does not seem to compromise with safety, but the quality of evidence is generally low. NOACs should be avoided for patients with APS and AT.
抗磷脂综合征(APS)患者发生动脉血栓(AT)后的二级预防中,抗血栓治疗方案的高质量随机对照试验(RCT)相对匮乏。我们对不同的抗血栓治疗方案进行了综述。我们在 PubMed 和 Web of Science 上检索了有关 APS 中 AT 管理的研究。共确定了 11 项研究(5 项 RCT、3 项前瞻性研究和 3 项回顾性队列研究),这些研究比较了不同的方案,并专门报告了索引 AT 事件患者的结局。治疗方法包括维生素 K 拮抗剂(VKA;9 项研究)、非维生素 K 口服抗凝剂(NOAC;3 项研究)、单一抗血小板治疗(SAPT;7 项研究)、双联抗血小板治疗(DAPT;2 项研究)和 VKA 联合 SAPT(4 项研究)。我们对以下结局进行了荟萃分析:复发性 AT、任何(动脉或静脉)复发性血栓栓塞和大出血。与 VKA 相比,VKA 联合 SAPT(风险比 [RR]:0.43;95%置信区间 [CI]:0.22-0.85)和 DAPT 联合 SAPT(RR:0.29;95% CI:0.09-0.99)可降低复发性 AT 的风险。与 VKA 单药治疗相比,VKA 联合 SAPT(RR:0.41;95% CI:0.24-0.69)和 SAPT 单药治疗(RR:0.36;95% CI:0.13-0.96)均可降低任何复发性血栓栓塞的风险。其他治疗方法在血栓栓塞和大出血方面均无显著差异。在敏感性分析中,排除低质量研究后,VKA 比 NOAC 更能有效预防复发性 AT(RR:0.25;95% CI:0.07-0.93)。对于发生 AT 的 APS 患者,联合抗血栓治疗可能比单一药物作为二级预防更有效,且似乎不会影响安全性,但证据质量普遍较低。NOAC 应避免用于 APS 合并 AT 的患者。