The left atrial appendage exclusion for prophylactic stroke reduction (leaaps) trial: rationale and design.

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2024-10-10 DOI:10.1016/j.ahj.2024.10.006

Richard P Whitlock, Patrick M McCarthy, Marc W Gerdisch, Basel Ramlawi, John H Alexander, David Z Rose, Jeffrey S Healey, Yashasvi Awasthi Sharma, Emilie P Belley-Côté, Stuart J Connolly

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引用次数: 0

Abstract

Introduction: Left atrial appendage exclusion (LAAE) has been shown in randomized trials to reduce ischemic stroke risk in patients undergoing cardiac surgery with known atrial fibrillation (AF). Many patients undergoing cardiac surgery without pre-existing AF are at risk of stroke and may benefit from LAAE.

Methods: Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS) is an international, prospective, randomized, multicenter, blinded trial evaluating the effectiveness of LAAE in preventing ischemic stroke or systemic embolism in patients undergoing cardiac surgery at increased risk of AF and ischemic stroke. The trial will enroll 6500 patients at increased risk of stroke in whom a cardiac surgery is planned at 250 sites worldwide. Eligible patients are ≥18 years old, have no pre-existing AF but are at increased risk for AF and stroke (based on age, CHA₂DS₂-VASc score, left atrium size or brain natriuretic peptide). Patients are randomized 1:1 to receive either LAAE with AtriClip or no LAAE during cardiac surgery. Healthcare providers outside of the operating room and the patient will be blinded to allocation. The primary effectiveness endpoint is the first occurrence of ischemic stroke, systemic arterial embolism, or surgical or endovascular LAA closure. The powered secondary effectiveness endpoint is ischemic stroke or systemic arterial embolism. The primary safety endpoint is the occurrence of one of the following events (through 30 days): pericardial effusion requiring percutaneous or surgical treatment, peri-operative major bleeding, deep sternal wound infection, or myocardial infarction. Other endpoints include mortality, rehospitalizations, clinically diagnosed AF, transient ischemic attack, and cognitive and quality of life assessments. Follow-up is every 6 months for a minimum of 5 years; primary analysis occurs when 469 patients have had an ischemic stroke or systemic embolism.

Conclusion: The results of the LeAAPS trial will demonstrate whether LAAE with AtriClip at the time of other routine cardiac surgery reduces stroke or systemic arterial embolism during long-term follow-up in patients at high risk of stroke without pre-existing AF.

Trial registration: ClinicalTrials.gov, Identifier: NCT05478304, https://clinicaltrials.gov/study/NCT05478304?term=%20NCT05478304&rank=1.

查看原文本刊更多论文

排除左心房阑尾以预防性减少中风（leaaps）试验：原理与设计。

导言：随机试验显示，左心房阑尾切除术（LAAE）可降低已知存在心房颤动（AF）的心脏手术患者的缺血性卒中风险。许多接受心脏手术的患者既往没有房颤，但也有中风风险，可能会从 LAAE 中获益：减少预防性卒中的左心房阑尾置换术（Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction，LeAAPS）是一项国际性、前瞻性、随机、多中心、盲法试验，旨在评估左心房阑尾置换术在预防缺血性卒中或全身性栓塞方面的效果，对象是接受心脏手术且房颤和缺血性卒中风险较高的患者。该试验将在全球 250 个地点招募 6500 名计划接受心脏手术的中风风险增加的患者。符合条件的患者年龄≥18岁，既往无房颤，但房颤和中风风险增加（基于年龄、CHA2DS2-VASc评分、左心房大小或脑钠尿肽）。患者按 1:1 随机分配，在心脏手术期间接受使用 AtriClip 的 LAAE 或不接受 LAAE。手术室外的医护人员和患者均为分配盲人。主要有效性终点是首次发生缺血性中风、全身动脉栓塞、手术或血管内 LAA 封闭。有动力的次要有效性终点是缺血性中风或全身动脉栓塞。主要安全性终点是发生以下事件之一（至 30 天）：需要经皮或手术治疗的心包积液、围手术期大出血、胸骨深伤口感染或心肌梗死。其他终点包括死亡率、再次住院、临床诊断为房颤、短暂性脑缺血发作以及认知和生活质量评估。随访时间为每 6 个月一次，至少 5 年；当 469 名患者发生缺血性中风或全身性栓塞时，将进行主要分析：LeAAPS试验的结果将证明在进行其他常规心脏手术时使用AtriClip进行LAAE是否能在长期随访中减少无房颤的中风高危患者的中风或全身动脉栓塞：试验注册：ClinicalTrials.gov, Identifier：NCT05478304, https://clinicaltrials.gov/study/NCT05478304?term=%20NCT05478304&rank=1.

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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.