A randomized trial of antithrombotic therapy in patients with acute coronary syndrome and coronary ectasia

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS American heart journal Pub Date : 2024-11-29 DOI:10.1016/j.ahj.2024.11.012

Diego Araiza-Garaygordobil MD, MSc , Rodrigo Gopar-Nieto MD, MSc , Jorge Daniel Sierra-Lara Martínez MD , Ajit S Mullasari MBBS, MD, DM , Nallely Belderrain-Morales MD , Nitzha Andrea Nájera-Rojas MD , Braiana Angeles Diaz-Herrera MD , Vianney Sarabia-Chao MD , Diana Laura Alfaro-Ponce MD , Jose Luis Briseño-De la Cruz MD , Maximiliano Ruiz-Beltrán MD , Marco Antonio Martínez-Ríos MD , Yigal Piña-Reyna MD , Ximena Latapi-Ruiz Esparza MD , Flavio Adrian Grimaldo-Gomez MD , Evelyn Cortina-De la Rosa QFB , María Oliva Romero-Arroyo QFB , Alejandro Sierra-Gonzalez de Cossio MD , Héctor González-Pacheco MD , Alexandra Arias-Mendoza MD, MBA

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Abstract

Background

Coronary artery ectasia (CAE) of the culprit infarct artery is a rare finding in patients with acute coronary syndrome (ACS). While anticoagulants have been suggested to reduce recurrent events, the optimal antithrombotic therapy remains unclear.

Methods

OVER-TIME was an open label, exploratory, randomized controlled trial comparing dual antiplatelet therapy (DAPT; acetyl-salicylic-acid 100mg plus clopidogrel 75mg daily) versus single antiplatelet (SAPT, clopidogrel 75mg) plus DOAC (rivaroxaban 15mg) in patients with ACS and CAE. The study primary objectives were 1) the composite of cardiovascular death, recurrent MI and repeat revascularization and 2) total bleeding events (BARC 1-5) at 12 months. The secondary objective was fibrin clot lysis time (using turbidimetry).

Results

A total of 62 patients were randomized, 32 (51.6%) to receive DAPT and 30 (48.3%) to receive SAPT+DOAC. Patients were aged 55.5 years (±10.6) and mostly male (86.9%); STEMI was the most common presentation (83.8%). No statistically significant differences (HR 0.24, 95% CI 0.02-2.16, P = .20) in the risk of the primary endpoint were found; however, a numerically lower rate of recurrent MI (4 events – 12.5% - in the DAPT arm vs. 1 event – 3.3% in the SAPT+DOAC arm) was observed. The risk of bleeding events was not different HR 0.75 (95% CI 0.26-2.16, P = .59). A statistically significant reduction in fibrin clot lysis time (-24.7% reduction, P = .038) was observed in those randomized to SAPT+DOAC, but not in DAPT (-14.7% reduction, P = .25).

Conclusions

In this exploratory study including patients with ACS and CAE of the culprit artery, the use of rivaroxaban 15mg in addition to clopidogrel was not associated with a statistically lower risk of major adverse cardiovascular events; however, a lower rate of recurrent MI and a reduction in fibrin clot lysis time were observed. Future studies to address antithrombotic therapy in CAE are needed.

Trial Registration

ClinicalTrials.gov ID NCT05233124, URL: https://clinicaltrials.gov/study/NCT05233124

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急性冠状动脉综合征和冠状动脉扩张患者抗血栓治疗的随机试验。

背景：在急性冠脉综合征（ACS）患者中，罪魁祸首梗死动脉的冠状动脉扩张（CAE）是一种罕见的发现。虽然抗凝剂已被建议减少复发事件，但最佳的抗血栓治疗仍不清楚。方法：OVER-TIME是一项开放标签、探索性、随机对照试验，比较双重抗血小板治疗(DAPT；在ACS和CAE患者中，乙酰水杨酸100mg +氯吡格雷75mg /天)与单一抗血小板药物（SAPT，氯吡格雷75mg） + DOAC（利伐沙班15mg）比较。研究的主要目标是：1)心血管死亡、复发性心肌梗死和重复血运重建的综合情况；2)12个月的总出血事件（barc1 -5）。次要目的是纤维蛋白凝块溶解时间（使用浊度法）。结果：共62例患者随机化，32例（51.6%）患者接受DAPT， 30例（48.3%）患者接受SAPT+DOAC。患者年龄55.5岁（±10.6岁），以男性为主（86.9%）；STEMI是最常见的表现（83.8%）。主要终点的风险无统计学差异（HR 0.24, 95% CI 0.02-2.16, p = 0.20）；然而，观察到数值上较低的心肌梗死复发率（DAPT组为4例，12.5%，SAPT+DOAC组为1例，3.3%）。出血事件的风险无差异，HR 0.75 （95% CI 0.26-2.16, p = 0.59）。随机分配到SAPT+DOAC组的患者纤维蛋白凝块溶解时间有统计学意义的减少（减少-24.7%,p = 0.038），但DAPT组没有（减少-14.7%,p = 0.25）。结论：在这项包括ACS和CAE患者的探索性研究中，在氯吡格雷的基础上使用利伐沙班15mg与主要不良心血管事件的风险降低没有统计学意义上的相关性；然而，观察到心肌梗死复发率较低，纤维蛋白凝块溶解时间缩短。需要进一步研究CAE的抗血栓治疗。

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.

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