Low-Dose Rivaroxaban to Prevent Left Ventricular Thrombosis After Anterior Myocardial Infarction: The APERITIF Randomized Clinical Trial.

The benefit and risk of adding an oral anticoagulant to dual antiplatelet therapy (DAPT) in preventing LV thrombus remain uncertain.

在预防LV血栓方面，将口服抗凝药物添加到双重抗血小板治疗(DAPT)中的益处和风险仍然不确定。

Background

To determine whether the addition of low-dose rivaroxaban to DAPT reduces the incidenceof LV thrombus at 1 month in patients with anterior ST-segment elevation myocardial infarction (STEMI).

确定在前壁ST段抬高型心肌梗死（STEMI）患者中，低剂量利伐沙班联合双联抗血小板治疗（DAPT）是否能在1个月内降低左心室血栓的发生率。

DESIGN, SETTING, AND PARTICIPANTS: This multicenter, open-label, blinded-end point randomized clinical trial was performed in 29 centers in France.

设计、环境和参与者：这项多中心、开放标签、终点盲法的随机临床试验在法国的29个中心进行。

The trial was nested in the ongoing FRENCHIE (French Cohort of Myocardial Infarction Evaluation) registry.

该试验嵌套在正在进行的FRENCHIE（法国心肌梗死评估队列）登记中。

Between October 2021 and January 2023, patients with anterior STEMI were enrolled.

在2021年10月至2023年1月期间，招募了前壁ST段抬高型心肌梗死患者。

The last date of participant follow-up was in March 2023.

参与者的最后随访日期为2023年3月。

Data analysis was performed from September 2024 to July 2025.

数据分析工作从2024年9月持续到2025年7月。

Methods

Patients were randomized to receive either DAPT plus rivaroxaban, 2.5 mg, twice daily for 4 weeks (n = 283) or DAPT alone (aspirin ≤100 mg per day and either clopidogrel, 75 mg per day, or ticagrelor, 90 mg twice a day [n = 277]), as soon as possible following completion of the initial percutaneous coronary intervention or angiography procedure.

患者被随机分配接受双联抗血小板治疗（DAPT）加利伐沙班，每日两次，每次2.5毫克，持续4周（n = 283）或仅接受DAPT（阿司匹林≤100毫克/天，以及氯吡格雷，每天75毫克，或替格瑞洛，每天两次90毫克[n = 277]），在完成初次经皮冠状动脉介入治疗或血管造影程序后尽快开始。

main_outcomes_and_measures

The primary end point was presence of LV thrombus on contrast-enhanced cardiac magnetic resonance imaging at 1 month.

主要终点是在1个月时通过对比增强心脏磁共振成像检查左心室血栓的存在。

Results

Among 560 patients with anterior STEMI enrolled (mean [SD] age, 61.1 [11.6] years; 121 female patients [21.6%]), LV thrombus was detected in 38 patients (13.7%) receiving rivaroxaban and 47 patients (16.6%) with DAPT alone (difference, -2.9%; 95% CI, -8.9% to 3.2%; P = .34).

在纳入的560名前壁ST段抬高型心肌梗死患者中（平均年龄[标准差]为61.1[11.6]岁；121名女性患者[21.6%]），在使用利伐沙班的38名患者（13.7%）和仅使用DAPT的47名患者（16.6%）中检测到左心室血栓（差异，-2.9%；95%置信区间，-8.9%至3.2%；P = .34）。

No difference was observed between the 2 groups regarding the largest diameter of LV thrombus or the incidenceof major adverse cardiovascular events.

在两组患者中，关于左心室血栓的最大直径或主要不良心血管事件的发生率没有观察到差异。

The incidenceof major bleeding events (Bleeding Academic Research Consortium [BARC] ≥type 2) was also comparable (4 [1.5%] with DAPT plus rivaroxaban vs 2 [0.7%] with DAPT alone; difference, 0.7%; 95% CI, -1.3% to 3.1%), whereas minor bleeding events (BARC type 1) occurred more frequently in the DAPT plus rivaroxaban group (45 [16.4%] vs 20 [7.2%]; difference, 9.3%; 95% CI, 3.6%-14.8%).

主要出血事件（Bleeding Academic Research Consortium [BARC] ≥2型）的发生率也相当（4例[1.5%]使用DAPT加利伐沙班与2例[0.7%]仅使用DAPT；差异，0.7%；95%置信区间，-1.3%至3.1%），而轻微出血事件（BARC 1型）在DAPT加利伐沙班组中发生更频繁（45例[16.4%]与20例[7.2%]；差异，9.3%；95%置信区间，3.6%-14.8%）。

conclusions_and_relevance

In this multicenter randomized clinical trial among patients with anterior STEMI, the addition of low-dose rivaroxaban to DAPT did not demonstrate a statistically significant reduction in LV thrombus formation at 1 month but did increase minor bleeding.

在这项针对前壁ST段抬高型心肌梗死患者的多中心随机临床试验中，低剂量利伐沙班联合DAPT并未在1个月时显示出统计学上显著减少左心室血栓形成的效果，但增加了轻微出血。

Given the limited power of the study, these findings should be interpreted with caution, as a modest effect cannot be excluded.

鉴于研究的统计功效有限，这些发现应谨慎解读，因为不能排除存在轻微效应的可能性。

trial_registration

ClinicalTrials.gov Identifier: NCT05077683.

ClinicalTrials.gov 注册号：NCT05077683。