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直接口服抗凝剂与华法林在左心室血栓中的应用:随机对照试验的汇总分析。

Direct Oral Anticoagulation Versus Warfarin in Left Ventricular Thrombus: Pooled Analysis of Randomized Controlled Trials.

机构信息

National Heart Centre Singapore, Singapore, Singapore.

Duke-NUS Medical School, Singapore, Singapore.

出版信息

J Clin Pharmacol. 2023 Oct;63(10):1101-1107. doi: 10.1002/jcph.2267. Epub 2023 May 24.

DOI:10.1002/jcph.2267
PMID:37139934
Abstract

Patients with impaired left ventricular (LV) function can develop LV thrombus, a potentially life-threatening condition due to risk of stroke and embolization. Conventional treatment with vitamin K antagonists (VKAs; e.g., warfarin) puts patients at risk of bleeding, and the use of direct oral anticoagulants (DOACs) appears promising, although data are scant. We searched the published English language literature for randomized controlled trials (RCTs) comparing DOACs with VKAs in LV thrombus. End points were failure to resolve, thromboembolic events (stroke, embolism), bleeding, or any adverse event (composite of thromboembolism or bleeding), or all-cause death. Data were pooled and analyzed in hierarchical Bayesian models. In three eligible RCTs, 141 patients were studied during an average of 4.6 months (53.8 patient-years; n = 71 assigned to DOAC, n = 70 assigned to VKA). A similar number of patients in each treatment arm demonstrated failure to resolve (DOAC: 14/71 vs. VKA: 15/70) and death events (3/71 vs. 4/70). However, patients on DOACs suffered fewer strokes/thromboembolic events (1/71 vs. 7/70; log odds ratio [OR], -2.02 [95% credible interval (CI ), -4.53 to -0.31]) and fewer bleeding events (2/71 vs. 9/70; log OR, -1.62 [CI , -3.43 to -0.26]), leading to fewer patients on DOACs with any adverse event versus VKAs (3/71 vs. 16/70; log OR, -1.93 [CI , -3.33 to -0.75]). In conclusion, pooled analysis of RCT data favors DOACs over VKAs in patients with LV thrombus in terms of both efficacy and safety.

摘要

患有左心室(LV)功能障碍的患者可能会形成 LV 血栓,这是一种潜在的危及生命的病症,因为存在中风和栓塞的风险。传统的维生素 K 拮抗剂(VKAs;例如华法林)治疗会使患者出血风险增加,而直接口服抗凝剂(DOACs)的应用似乎很有前景,尽管数据有限。我们在已发表的英文文献中搜索了比较 DOACs 与 VKAs 在 LV 血栓治疗中的随机对照试验(RCTs)。终点是未能解决、血栓栓塞事件(中风、栓塞)、出血或任何不良事件(血栓栓塞或出血的复合事件)或全因死亡。数据汇总并在分层贝叶斯模型中进行分析。在三项符合条件的 RCT 中,141 名患者在平均 4.6 个月(53.8 患者年;n=71 名接受 DOAC 治疗,n=70 名接受 VKA 治疗)的时间内接受了研究。每个治疗组的失访患者数量相似(DOAC:14/71 例;VKA:15/70 例)和死亡事件(3/71 例;4/70 例)。然而,DOAC 组的中风/血栓栓塞事件(1/71 例;7/70 例;对数优势比[OR],-2.02[95%可信区间[CI],-4.53 至-0.31])和出血事件(2/71 例;9/70 例;对数 OR,-1.62[CI,-3.43 至-0.26])较少,因此 DOAC 组发生任何不良事件的患者人数少于 VKA 组(3/71 例;16/70 例;对数 OR,-1.93[CI,-3.33 至-0.75])。总之,基于 RCT 数据的汇总分析表明,在 LV 血栓患者中,DOACs 比 VKAs 具有更好的疗效和安全性。

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