左心耳封堵术在伴有既往卒中的极高危房颤患者中是有效且安全的：来自多中心德国 LAARGE 注册研究的结果。
LAA occlusion is effective and safe in very high-risk atrial fibrillation patients with prior stroke: results from the multicentre German LAARGE registry.
机构信息
Department of Cardiology, Angiology, Haemostaseology and Medical Intensive Care, University Medical Centre Mannheim (UMM), Medical Faculty Mannheim, Heidelberg University, European Center for AngioScience (ECAS), and German Center for Cardiovascular Research (DZHK) Partner Site Heidelberg/Mannheim, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Department of Cardiology, Angiology, and Pneumology, Second Medical Clinic, Coburg Hospital, Coburg, Germany.
出版信息
Clin Res Cardiol. 2024 Oct;113(10):1451-1462. doi: 10.1007/s00392-024-02376-8. Epub 2024 Jan 31.
BACKGROUND
Interventional left atrial appendage occlusion (LAAO) mitigates the risk of thromboembolic events in nonvalvular atrial fibrillation (AF) patients with contraindication for long-term oral anticoagulation (OAC). Patients with prior stroke have a relevantly increased risk of recurrent stroke, so the effectiveness of LAAO could be reduced in this specific very high-risk patient group.
AIM
This sub-study of the LAARGE registry investigates the effectiveness and safety of LAAO for secondary prevention in nonvalvular AF patients with a history of stroke.
METHODS
LAARGE is a prospective, non-randomised registry on the clinical reality of LAAO. The current sub-study employs data from index procedure and 1-year follow-up. Effectiveness and safety were assessed by documentation of all-cause mortality, non-fatal thromboembolism, procedure-related complications, and bleeding events.
RESULTS
A total of 638 patients were consecutively included from 38 hospitals in Germany and divided into two groups: 137 patients with a history of stroke (21.5%) and 501 patients without. Successful implantation was consistent between both groups (98.5% vs. 97.4%, p = NS), while peri-procedural MACCE and other complications were rare (0% vs. 0.6% and 4.4% vs. 4.0%, respectively; each p = NS). Kaplan-Meier estimate showed no significant difference in primary effectiveness outcome measure (freedom from all-cause death or non-fatal stroke) between both groups at follow-up (87.8% vs. 87.7%, p = NS). The incidence of transient ischemic attack or systemic embolism at follow-up was low (0% vs. 0.5% and 0.9% vs. 0%, respectively; each p = NS). Severe bleeding events after hospital discharge were rare (0% vs. 0.7%, p = NS).
CONCLUSIONS
Patients with prior stroke demonstrated similar effectiveness and safety profile for LAAO as compared to patients without prior stroke. LAAO could serve as a feasible alternative to OAC for secondary stroke prevention in this selected group of nonvalvular AF patients.
GOV IDENTIFIER
NCT02230748.
背景
对于有长期口服抗凝治疗（OAC）禁忌的非瓣膜性心房颤动（AF）患者，介入性左心耳封堵（LAAO）可降低血栓栓塞事件的风险。既往有卒中史的患者再次发生卒中的风险明显增加，因此 LAAO 在这种特定的极高风险患者群体中的有效性可能会降低。
目的
本研究旨在探讨 LAAO 在有卒中史的非瓣膜性 AF 患者中的二级预防中的有效性和安全性。
方法
LAARGE 是一项关于 LAAO 临床实际情况的前瞻性、非随机登记研究。本研究采用了指数程序和 1 年随访的数据。通过记录全因死亡率、非致死性血栓栓塞、与程序相关的并发症和出血事件来评估有效性和安全性。
结果
从德国 38 家医院连续纳入 638 例患者，分为两组：有卒中史的 137 例（21.5%）和无卒中史的 501 例。两组的手术成功率一致（98.5%比 97.4%，p=NS），而围手术期 MACCE 和其他并发症罕见（0%比 0.6%和 4.4%比 4.0%，均 p=NS）。Kaplan-Meier 估计显示，两组在随访时主要有效性指标（全因死亡或非致死性卒中的无事件生存）无显著差异（87.8%比 87.7%，p=NS）。随访时短暂性脑缺血发作或全身性栓塞的发生率较低（0%比 0.5%和 0.9%比 0%，均 p=NS）。出院后严重出血事件罕见（0%比 0.7%，p=NS）。
结论
与无卒中史的患者相比，既往有卒中史的患者 LAAO 的有效性和安全性相似。对于非瓣膜性 AF 患者，LAAO 可作为 OAC 用于二级预防卒中的一种可行替代方法。
政府标识符
NCT02230748。
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