评估利伐沙班与华法林相比对左心室心尖血栓患者的疗效和安全性:随机临床试验。

IF 2.6 4区 医学 Q2 HEMATOLOGY Thrombosis Journal Pub Date : 2024-07-19 DOI:10.1186/s12959-024-00632-5
Pejman Mansouri, Zahra Azamian Jazi, Mohammad Hadi Mansouri, Hooman Dehghan, Reihaneh Zavar, Seyedeh Melika Hashemi, Fereshteh Sattar, Masoumeh Sadeghi, Afshin Amirpour, Morteza Abdar
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引用次数: 0

摘要

简介这项研究是开创性的随机临床试验(RCT)之一,旨在评估利伐沙班治疗急性冠状动脉综合征(ACS)患者左心室血栓(LVT)的有效性和安全性:这是一项随机、对照、介入、开放标签研究。患者被随机分为华法林组和利伐沙班组。我们在研究开始时进行了经胸超声心动图检查,并在三个月后再次测量血栓面积(以平方毫米为单位)。血栓的形态分为壁状和圆形,流动性分为不动、半动和高流动。我们还监测了不良事件,包括出血、全身性栓塞发生、再住院和主要心脏不良事件(MACE):该研究纳入了 52 名患者进行意向性治疗分析,利伐沙班组和华法林组各占一半(各 26 名患者)。平均随访时间为三个月。利伐沙班组(76.9%)和华法林组(69.2%)的血栓溶解率以及血栓缩小率在组间没有统计学意义。利伐沙班组和华法林组的所有半移动或高移动血栓均转化为不动血栓,所有圆形低密度血栓均转化为壁状血栓。两组在出血并发症和再住院方面无明显差异:试验表明,在血栓溶解率、血栓体积缩小、出血风险和再住院率方面,利伐沙班与华法林同样有效。我们的研究结果表明,利伐沙班是华法林治疗左心室血栓的可行替代方案。
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Evaluation of the efficacy and safety of rivaroxaban compared to warfarin in patients with left ventricular apical thrombus: a randomized clinical trial.

Introduction: This research is one of the pioneering randomized clinical trials (RCTs) aimed at assessing the effectiveness and safety of rivaroxaban in treating left ventricular thrombus (LVT) in patients who have experienced acute coronary syndrome (ACS).

Materials and methods: This is a randomized, controlled, interventional, open-label study. The patients were randomly divided into warfarin and rivaroxaban groups. We performed transthoracic echocardiography at the start of the study and again after three months to measure the thrombus area in square millimeters. The morphology of the thrombus was categorized into mural and round, and the mobility was classified into immobile, semi-mobile and hypermobile. We also monitored for adverse events including bleeding, systemic embolic occurrences, rehospitalization, and major adverse cardiac events (MACE).

Results: The study included fifty-two patients in the intention-to-treat analysis, with an equal split between the rivaroxaban and warfarin groups (26 patients each). The average follow-up duration was three months. The thrombus resolution rates in the rivaroxaban (76.9%) and warfarin (69.2%) groups, as well as the thrombus size reduction, did not show statistical significance between groups. All semi-mobile or hypermobile thrombi transformed into immobile and all of the round LVTs changed into a mural in both rivaroxaban and warfarin groups. No significant difference was observed in bleeding complications and rehospitalization between the two groups.

Conclusion: The trial demonstrated that rivaroxaban is as effective as warfarin in terms of thrombus resolution rate, reduction in thrombus size, bleeding risk, and rehospitalization rate. Our findings suggest that rivaroxaban is a viable alternative to warfarin for managing left ventricular thrombus.

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来源期刊
Thrombosis Journal
Thrombosis Journal Medicine-Hematology
CiteScore
3.80
自引率
3.20%
发文量
69
审稿时长
16 weeks
期刊介绍: Thrombosis Journal is an open-access journal that publishes original articles on aspects of clinical and basic research, new methodology, case reports and reviews in the areas of thrombosis. Topics of particular interest include the diagnosis of arterial and venous thrombosis, new antithrombotic treatments, new developments in the understanding, diagnosis and treatments of atherosclerotic vessel disease, relations between haemostasis and vascular disease, hypertension, diabetes, immunology and obesity.
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