Thrombosis Research Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Thrombosis Research Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA; Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
J Am Coll Cardiol. 2023 Jan 3;81(1):16-30. doi: 10.1016/j.jacc.2022.10.008. Epub 2022 Oct 31.
The efficacy and safety of direct oral anticoagulants (DOACs) for patients with thrombotic antiphospholipid syndrome remain controversial.
The authors performed a systematic review and meta-analysis of randomized controlled trials that compared DOACs with vitamin K antagonists (VKAs).
We searched PubMed, EMBASE, and Cochrane Central Register of Controlled Trials through April 9, 2022. The 2 main efficacy outcomes were a composite of arterial thrombotic events and venous thromboembolic events (VTEs). The main safety outcome was major bleeding. Random effects models with inverse variance were used.
Our search retrieved 253 studies. Four open-label randomized controlled trials involving 472 patients were included (mean control-arm time-in-therapeutic-range 60%). All had proper random sequence generation and adequate allocation concealment. Overall, the use of DOACs compared with VKAs was associated with increased odds of subsequent arterial thrombotic events (OR: 5.43; 95% CI: 1.87-15.75; P < 0.001, I = 0%), especially stroke, and the composite of arterial thrombotic events or VTE (OR: 4.46; 95% CI: 1.12-17.84; P = 0.03, I = 0%). The odds of subsequent VTE (OR: 1.20; 95% CI: 0.31-4.55; P = 0.79, I = 0%), or major bleeding (OR: 1.02; 95% CI: 0.42-2.47; P = 0.97; I = 0%) were not significantly different between the 2 groups. Most findings were consistent within subgroups.
Patients with thrombotic antiphospholipid syndrome randomized to DOACs compared with VKAs appear to have increased risk for arterial thrombosis. No significant differences were observed between patients randomized to DOACs vs VKAs in the risk of subsequent VTE or major bleeding.
直接口服抗凝剂（DOACs）治疗血栓性抗磷脂综合征患者的疗效和安全性仍存在争议。
作者对比较 DOACs 与维生素 K 拮抗剂（VKA）的随机对照试验进行了系统评价和荟萃分析。
我们检索了 PubMed、EMBASE 和 Cochrane 对照试验中心数据库，检索时间截至 2022 年 4 月 9 日。主要疗效结局为动脉血栓事件和静脉血栓栓塞事件（VTEs）的复合结局。主要安全性结局为大出血。采用逆方差的随机效应模型。
我们的检索共检索到 253 项研究。纳入了 4 项涉及 472 例患者的开放性随机对照试验（平均对照组治疗范围内时间为 60%）。所有研究均采用正确的随机序列生成和充分的分配隐藏。总体而言，与 VKA 相比，使用 DOACs 与随后发生动脉血栓事件（OR：5.43；95%CI：1.87-15.75；P<0.001，I²=0%），特别是卒中的风险增加相关，以及动脉血栓事件或 VTE 的复合结局（OR：4.46；95%CI：1.12-17.84；P=0.03，I²=0%）。两组之间随后发生 VTE（OR：1.20；95%CI：0.31-4.55；P=0.79，I²=0%）或大出血（OR：1.02；95%CI：0.42-2.47；P=0.97；I²=0%）的风险无显著差异。大多数发现的亚组内一致。
与 VKAs 相比，随机分配到 DOACs 的血栓性抗磷脂综合征患者似乎有更高的动脉血栓形成风险。随机分配到 DOACs 与 VKAs 的患者在随后发生 VTE 或大出血的风险方面无显著差异。
