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ST段抬高型心肌梗死后左心室血栓患者使用直接口服抗凝剂或华法林:一项试点试验及随机试验的预先设定的荟萃分析

Direct oral anticoagulants or warfarin in patients with left ventricular thrombus after ST-elevation myocardial infarction: a pilot trial and a prespecified meta-analysis of randomised trials.

作者信息

Jenab Yaser, Sadeghipour Parham, Mohseni-Badalabadi Reza, Kaviani Raheleh, Hosseini Kaveh, Pasebani Yeganeh, Khederlou Hamid, Rafati Ali, Mohammadi Zohre, Jamalkhani Sepehr, Talasaz Azita Haj Hossein, Firouzi Ata, Ariannejad Hamid, Alemzadeh-Ansari Mohammad Javad, Ahmadi-Renani Sajjad, Maadani Mohsen, Farrashi Melody, Bakhshandeh Hooman, Piazza Gregory, Krumholz Harlan M, Mehran Roxana, Lip Gregory Y H, Bikdeli Behnood

机构信息

Tehran Heart Center, Cardiovascular Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.

Vascular Disease and Thrombosis Research Center, Rajaie Cardiovascular Institute, Tehran, Iran.

出版信息

EuroIntervention. 2025 Jan 6;21(1):82-92. doi: 10.4244/EIJ-D-24-00527.

Abstract

BACKGROUND

The role of direct oral anticoagulants (DOACs) in the treatment of left ventricular thrombus (LVT) after ST-elevation myocardial infarction (STEMI) remains uncertain.

AIMS

We aimed to compare the effect of rivaroxaban versus warfarin in patients with STEMI complicated by LVT.

METHODS

Adult patients with STEMI and two-dimensional transthoracic echocardiography showing LVT were assigned to rivaroxaban (15 mg once daily) or warfarin (international normalised ratio goal of 2.0-2.5) in an open-label, randomised clinical trial (RCT). A prospective pooled analysis was planned comparing DOAC- versus warfarin-based anticoagulation for the same indication. The main outcome of the RCT was complete LVT resolution at 3 months, determined by a blinded imaging core laboratory. Complete LVT resolution and bleeding were investigated in the pooled analysis.

RESULTS

A total of 50 patients (median age: 55 years, 18% females) were enrolled from June 2020 to November 2022. Three-month complete LVT resolution occurred in 19/25 (76.0%) patients assigned to rivaroxaban and 13/24 (54.2%) assigned to warfarin (relative risk [RR] 1.40, 95% confidence interval [CI]: 0.91-2.15; p=0.12) with no thrombotic or major bleeding events. Pooled analysis showed numerically better complete LVT resolution with DOACs (rivaroxaban and apixaban; 93/115 [80.8%] vs 79/112 [70.5%], RR 1.14, 95% CI: 0.98-1.32; p=0.08) and less major bleeding (2/116 [1.7%] and 9/112 [8.0%], risk difference -0.06, 95% CI: -0.12 to 0.00; p=0.05) than with warfarin.

CONCLUSIONS

Although the findings are limited by a small sample size, the results suggest that DOACs are safe with at least similar outcomes concerning LVT resolution and major bleeding compared with warfarin. (ClinicalTrials.gov: NCT05705089).

摘要

背景

直接口服抗凝剂(DOACs)在ST段抬高型心肌梗死(STEMI)后左心室血栓(LVT)治疗中的作用仍不明确。

目的

我们旨在比较利伐沙班与华法林对合并LVT的STEMI患者的疗效。

方法

在一项开放标签的随机临床试验(RCT)中,将经二维经胸超声心动图显示有LVT的成年STEMI患者分配至利伐沙班组(每日一次,15毫克)或华法林组(国际标准化比值目标为2.0 - 2.5)。计划进行一项前瞻性汇总分析,比较针对相同适应症的DOACs抗凝治疗与华法林抗凝治疗。RCT的主要结局是3个月时LVT完全溶解,由一个盲法影像核心实验室确定。在汇总分析中研究LVT完全溶解情况和出血情况。

结果

2020年6月至2022年11月共纳入50例患者(中位年龄:55岁,18%为女性)。在分配至利伐沙班组的25例患者中,19例(76.0%)在3个月时LVT完全溶解;在分配至华法林组的24例患者中,13例(54.2%)完全溶解(相对风险[RR] 1.40,95%置信区间[CI]:0.91 - 2.15;p = 0.12),且无血栓形成或大出血事件。汇总分析显示,DOACs(利伐沙班和阿哌沙班)在数值上LVT完全溶解情况更好(115例中的93例[80.8%]对比112例中的79例[70.5%],RR 1.14,95% CI:0.98 - 1.32;p = 0.08),且大出血情况少于华法林(116例中的2例[1.7%]和112例中的9例[8.0%],风险差 -0.06,95% CI: -0.12至0.00;p = 0.05)。

结论

尽管研究结果受样本量小的限制,但结果表明与华法林相比,DOACs在LVT溶解和大出血方面至少有相似的结局且安全性良好。(ClinicalTrials.gov:NCT05705089)

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