PDF(Pubmed)
Abstract：
BACKGROUND: 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).
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.
CONCLUSIONS: 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.
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.
CONCLUSIONS: 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.
摘要：
背景：这项研究是一项开创性的随机临床试验（RCT），旨在评估利伐沙班治疗急性冠脉综合征（ACS）患者左心室血栓（LVT）的有效性和安全性。
方法：这是一个随机的，控制,介入,开放标签研究。将患者随机分为华法林和利伐沙班组。我们在研究开始时和三个月后再次进行了经胸超声心动图检查，以平方毫米为单位测量血栓面积。血栓的形态分为壁和圆形，移动性被归类为不可移动，半移动和超移动。我们还监测了不良事件，包括出血，全身栓塞事件,再住院,和主要不良心脏事件（MACE）。
结果：该研究纳入了52名患者的意向治疗分析，利伐沙班和华法林组(每组26例患者)。平均随访3个月。利伐沙班(76.9%)和华法林(69.2%)组的血栓消退率,以及血栓大小的减少，组间无统计学意义。在利伐沙班和华法林组中，所有半移动或过度移动的血栓都转化为不动的，所有圆形LVT都变成了壁。两组在出血并发症和再住院方面差异无统计学意义。
结论：试验证明利伐沙班在血栓消退率方面与华法林一样有效，减少血栓大小，出血风险,和再住院率。我们的发现表明，利伐沙班是华法林治疗左心室血栓的可行替代品。
方法：这是一个随机的，控制,介入,开放标签研究。将患者随机分为华法林和利伐沙班组。我们在研究开始时和三个月后再次进行了经胸超声心动图检查，以平方毫米为单位测量血栓面积。血栓的形态分为壁和圆形，移动性被归类为不可移动，半移动和超移动。我们还监测了不良事件，包括出血，全身栓塞事件,再住院,和主要不良心脏事件（MACE）。
结果：该研究纳入了52名患者的意向治疗分析，利伐沙班和华法林组(每组26例患者)。平均随访3个月。利伐沙班(76.9%)和华法林(69.2%)组的血栓消退率,以及血栓大小的减少，组间无统计学意义。在利伐沙班和华法林组中，所有半移动或过度移动的血栓都转化为不动的，所有圆形LVT都变成了壁。两组在出血并发症和再住院方面差异无统计学意义。
结论：试验证明利伐沙班在血栓消退率方面与华法林一样有效，减少血栓大小，出血风险,和再住院率。我们的发现表明，利伐沙班是华法林治疗左心室血栓的可行替代品。
