直接口服抗凝剂治疗抗磷脂综合征血栓栓塞事件二级预防的疗效：随机试验的系统评价和荟萃分析。
Therapy with direct oral anticoagulants for secondary prevention of thromboembolic events in the antiphospholipid syndrome: a systematic review and meta-analysis of randomised trials.
机构信息
Department of Rheumatology, Odense University Hospital, Odense, Denmark.
Section for Biostatistics and Evidence-Based Research, the Parker Institute, Copenhagen University Hospital, Copenhagen, Denmark.
出版信息
Lupus Sci Med. 2023 Oct;10(2). doi: 10.1136/lupus-2023-001018.
OBJECTIVE
Antiphospholipid syndrome (APS) is a systemic autoimmune disorder characterised by venous thrombosis (VT) or arterial thrombosis (AT) and/or pregnancy morbidity and the presence of antiphospholipid antibodies. Direct oral anticoagulants (DOACs) hold several advantages to vitamin K antagonists (VKAs) for prevention of thrombosis and we wish to evaluate DOACs compared with VKAs in secondary prevention of thromboembolic events in patients with APS.
METHODS
We conducted searches of the published literature using relevant data sources (MEDLINE, Embase and Cochrane CENTRAL), and of trial registers for unpublished data and ongoing trials. We included randomised trials examining individuals >18 years with APS classified according to the criteria valid when the trial was carried out. Randomised controlled trials had to examine any DOAC agent compared with any comparable drug. We tabulated all occurrences of events from all eligible randomised trials. Due to few events, ORs and 95% CIs were calculated using the Peto method.
RESULTS
5 randomised trials comprising 624 patients met the predefined eligibility criteria. The primary outcome measure was new thrombotic events, a composite endpoint of any VT or AT, during the VKA-controlled phase of treatment. According to the I inconsistency index, there was evidence of statistical heterogeneity across the studies (I=60%). Across trials, 29 and 10 thrombotic events were observed in 305 and 319 patients with APS treated with DOAC and VKA, respectively, corresponding to a combined Peto OR of 3.01 (95% CI 1.56 to 5.78, p=0.001). There was a significantly increased risk of AT while treated with DOACs compared with VKA (OR 5.5 (2.5, 12.1) p<0.0001), but no difference in the risk of VT (p=0.87). We found no significant difference in risk of bleeding.
CONCLUSIONS
DOACs were associated with a significant increase in the risk of a new thrombotic event, especially AT, favouring standard prophylaxis with warfarin.
PROSPERO REGISTRATION NUMBER
CRD42019126720.
目的
抗磷脂综合征（APS）是一种以静脉血栓形成（VT）或动脉血栓形成（AT）和/或妊娠并发症以及存在抗磷脂抗体为特征的系统性自身免疫性疾病。直接口服抗凝剂（DOAC）在预防血栓形成方面相对于维生素 K 拮抗剂（VKA）具有多项优势，我们希望评估 DOAC 在 APS 患者的血栓栓塞事件二级预防中与 VKA 的比较。
方法
我们使用相关的文献资料来源（MEDLINE、Embase 和 Cochrane CENTRAL）进行了已发表文献的检索，并对试验登记处进行了未发表数据和正在进行的试验的检索。我们纳入了根据试验进行时有效的标准分类的>18 岁的 APS 个体的随机试验。随机对照试验必须检查任何 DOAC 药物与任何可比药物的比较。我们对所有合格的随机试验中所有事件的发生情况进行了制表。由于事件数量较少，使用 Peto 法计算了 OR 和 95%CI。
结果
5 项符合预先设定的纳入标准的随机试验共纳入 624 名患者。主要终点是 VKA 治疗控制阶段新的血栓形成事件，即任何 VT 或 AT 的复合终点。根据 I 不一致性指数，研究之间存在统计学异质性（I=60%）。在试验中，APS 患者分别接受 DOAC 和 VKA 治疗的 305 例和 319 例患者中观察到 29 例和 10 例血栓形成事件，相应的 Peto OR 为 3.01（95%CI 1.56 至 5.78，p=0.001）。与 VKA 相比，DOAC 治疗时 AT 的风险显著增加（OR 5.5[2.5，12.1]，p<0.0001），但 VT 风险无差异（p=0.87）。我们未发现出血风险的显著差异。
结论
DOAC 与新血栓形成事件风险的显著增加相关，尤其是 AT，这支持了华法林的标准预防。
PROSPERO 注册号：CRD42019126720。
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