Rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome
Rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome
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DOI：
10.1182/blood-2018-04-848333
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发表时间：
2018-09-27
期刊：
影响因子：
20.3
通讯作者：
Banzato, Alessandra
中科院分区：
文献类型：
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作者：
Pengo, Vittorio;Denas, Gentian;Banzato, Alessandra
利伐沙班是房颤和静脉血栓栓塞患者华法林的有效和安全的替代品。我们在血栓性抗磷脂综合征高危患者中比较了利伐沙班与华法林的疗效和安全性。这是一项随机、开放标签、多中心、非劣效性研究，具有设盲终点裁定。在抗磷脂综合征患者中，比较利伐沙班20 mg每日一次（15 mg每日一次，基于肾功能）与华法林（国际标准化比值目标2.5）预防血栓栓塞事件、大出血和血管性死亡的效果。只有狼疮抗凝剂、抗心磷脂和相同同种型的抗β 2-糖蛋白I抗体三重阳性（三重阳性）的高危患者才被纳入研究。由于利伐沙班组患者中的事件过多，该试验在招募了120名患者（59名随机分配至利伐沙班组，61名随机分配至华法林组）后提前终止。平均随访时间为569天。利伐沙班组有11例（19%）事件，华法林组有2例（3%）事件。随机分配至利伐沙班组的7例（12%）患者发生血栓栓塞事件（4例缺血性卒中和3例心肌梗死），而随机分配至华法林组的患者未记录任何事件。6例患者发生大出血：利伐沙班组4例（7%），华法林组2例（3%）。未报告死亡。与华法林相比，在抗磷脂综合征高危患者中使用利伐沙班与事件发生率增加相关，因此显示无获益和过度风险。
Rivaroxaban is an effective and safe alternative to warfarin in patients with atrial fibrillation and venous thromboembolism. We tested the efficacy and safety of rivaroxaban compared with warfarin in high-risk patients with thrombotic antiphospholipid syndrome. This is a randomized open-label multicenter noninferiority study with blinded end point adjudication. Rivaroxaban, 20 mg once daily (15 mg once daily based on kidney function) was compared with warfarin (international normalized ratio target 2.5) for the prevention of thromboembolic events, major bleeding, and vascular death in patients with antiphospholipid syndrome. Only high-risk patients triple positive for lupus anticoagulant, anticardiolipin, and anti-beta 2-glycoprotein I antibodies of the same isotype (triple positivity) were included in the study. The trial was terminated prematurely after the enrollment of 120 patients (59 randomized to rivaroxaban and 61 to warfarin) because of an excess of events among patients in the rivaroxaban arm. Mean follow-up was 569 days. There were 11 (19%) events in the rivaroxaban group, and 2 (3%) events in the warfarin group. Thromboembolic events occurred in 7 (12%) patients randomized to rivaroxaban (4 ischemic stroke and 3 myocardial infarction), whereas no event was recorded in those randomized to warfarin. Major bleeding occurred in 6 patients: 4 (7%) in the rivaroxaban group and 2 (3%) in the warfarin group. No death was reported. The use of rivaroxaban in high-risk patients with antiphospholipid syndrome was associated with an increased rate of events compared with warfarin, thus showing no benefit and excess risk.