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
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.
EuroIntervention. 2025 Jan 6;21(1):82-92. doi: 10.4244/EIJ-D-24-00527.
The role of direct oral anticoagulants (DOACs) in the treatment of left ventricular thrombus (LVT) after ST-elevation myocardial infarction (STEMI) remains uncertain.
We aimed to compare the effect of rivaroxaban versus warfarin in patients with STEMI complicated by LVT.
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.
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.
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).
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。
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。
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。
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）。
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）
