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.

IF 7.6 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Yaser Jenab, Parham Sadeghipour, Reza Mohseni-Badalabadi, Raheleh Kaviani, Kaveh Hosseini, Yeganeh Pasebani, Hamid Khederlou, Ali Rafati, Zohre Mohammadi, Sepehr Jamalkhani, Azita Haj Hossein Talasaz, Ata Firouzi, Hamid Ariannejad, Mohammad Javad Alemzadeh-Ansari, Sajjad Ahmadi-Renani, Mohsen Maadani, Melody Farrashi, Hooman Bakhshandeh, Gregory Piazza, Harlan M Krumholz, Roxana Mehran, Gregory Y H Lip, Behnood Bikdeli
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引用次数: 0

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).

st段抬高型心肌梗死后左室血栓患者直接口服抗凝剂或华法林:一项试点试验和预先指定的随机试验荟萃分析
背景:直接口服抗凝剂(DOACs)在st段抬高型心肌梗死(STEMI)后左室血栓(LVT)治疗中的作用尚不确定。目的:我们旨在比较利伐沙班与华法林在STEMI合并LVT患者中的疗效。方法:在一项开放标签随机临床试验(RCT)中,STEMI和二维经胸超声心动图显示LVT的成年患者被分配给利伐沙班(15mg,每日一次)或华法林(国际标准化比率目标为2.0-2.5)。计划进行一项前瞻性汇总分析,比较DOAC与华法林抗凝治疗相同适应症。RCT的主要结果是3个月时LVT完全分辨率,由盲法成像核心实验室确定。在合并分析中调查了LVT完全消退和出血情况。结果:从2020年6月到2022年11月,共入组50例患者(中位年龄:55岁,女性18%)。利伐沙班组19/25(76.0%)患者3个月LVT完全消退,华法林组13/24(54.2%)患者3个月LVT完全消退(相对风险[RR] 1.40, 95%可信区间[CI]: 0.91-2.15;P =0.12),无血栓形成或大出血事件。综合分析显示,使用doac(利伐沙班和阿哌沙班;93/115(80.8%)和79/112 (70.5%),RR 1.14, 95%置信区间CI: 0.98 - -1.32;p=0.08),大出血较少(2/116[1.7%]和9/112[8.0%],风险差异为-0.06,95% CI: -0.12 ~ 0.00;P =0.05)。结论:虽然研究结果受到小样本量的限制,但结果表明,与华法林相比,DOACs在LVT消退和大出血方面至少具有相似的结果,是安全的。(ClinicalTrials.gov: NCT05705089)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Eurointervention
Eurointervention CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
10.30
自引率
4.80%
发文量
380
审稿时长
3-8 weeks
期刊介绍: EuroIntervention Journal is an international, English language, peer-reviewed journal whose aim is to create a community of high quality research and education in the field of percutaneous and surgical cardiovascular interventions.
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