近日，德国柏林夏里特大学医学院Ulf Landmesser团队研究了心房颤动左心耳封堵术或医师指导药物治疗的效果和安全性。这一研究成果发表在2026年3月18日出版的《新英格兰医学杂志》上。

经导管左心耳封堵术是房颤患者预防卒中的口服抗凝药替代疗法。对于高卒中合并高出血风险患者，该策略相较于医师指导的最佳药物治疗的有效性尚不明确。

研究组在德国开展了一项多中心随机试验，将具有高卒中合并高出血风险的房颤患者分配接受左心耳封堵术或医师指导的最佳药物治疗（包括符合条件者使用直接口服抗凝药）。主要终点（检验非劣效性）为卒中（缺血性或出血性）、体循环栓塞、大出血或心血管性/不明原因死亡的复合结局，采用事件发生时间分析。非劣效性界值为风险比1.3。

共912例成年患者接受随机分组。主要终点分析纳入446例接受左心耳封堵术的患者（器械组）和442例接受医师指导最佳药物治疗的患者（药物治疗组）。平均（±SD）年龄77.9±7.1岁，女性占38.6%，平均CHA₂DS₂-VASc评分为5.2±1.5（范围0-9分，分值越高卒中风险越大），平均HAS-BLED评分为3.0±0.9（范围0-9分，分值越高出血风险越大）。中位随访3年（四分位距1.7-4.7）后，器械组155例发生首次主要终点事件（每100患者年发生率16.8），药物治疗组127例发生首次主要终点事件（每100患者年发生率13.3）（限制性平均生存时间差异为-0.36年；95%置信区间-0.70至-0.01；非劣效性P=0.44）。器械组368例（82.5%）发生严重不良事件，药物治疗组342例（77.4%）发生严重不良事件。

研究结果表明，在高卒中合并高出血风险的房颤患者中，针对卒中、体循环栓塞、大出血或心血管性/不明原因死亡的复合终点，左心耳封堵术不劣于医师指导的最佳药物治疗。

附：英文原文

Title: Left Atrial Appendage Closure or Medical Therapy in Atrial Fibrillation

Author: Ulf Landmesser, Carsten Skurk, Paulus Kirchhof, Thorsten Lewalter, Johannes Hartung, Andi Rroku, Burkert Pieske, Johannes Brachmann, Ibrahim Akin, Claudius Jacobshagen, Benjamin Meder, Andreas Zeiher, Stefan D. Anker, Holger Thiele, Stefan Blankenberg, Steffen Massberg, Heribert Schunkert, Norbert Frey, Alexander Joost, Martin Bergmann, Ralph Stephan von Bardeleben, Tim Friede, Marius Placzek, Anna Suling, Karl Georg Haeusler, Matthias Endres, Karl Wegscheider, Leif-Hendrik Boldt, Ingo Eitel

Issue&Volume: 2026-03-18

Abstract:

Background

Catheter-based closure of the left atrial appendage is an alternative to oral anticoagulation for stroke prevention in patients with atrial fibrillation. The effectiveness of this strategy, as compared with physician-directed best medical care, in patients at high risk for stroke and bleeding is unknown.

Methods

In this multicenter randomized trial conducted in Germany, we assigned patients with atrial fibrillation and a high risk of stroke and bleeding to undergo left atrial appendage closure or to receive physician-directed best medical care (including direct oral anticoagulants, if eligible). The primary end point, tested for noninferiority, was a composite of stroke (ischemic or hemorrhagic), systemic embolism, major bleeding, or cardiovascular or unexplained death, assessed in a time-to-event analysis. The noninferiority margin was a hazard ratio of 1.3.

Results

A total of 912 adult patients underwent randomization. The primary end-point analysis included 446 patients who were assigned to undergo left atrial appendage closure (device group) and 442 who were assigned to physician-directed best medical care (medical-therapy group). The mean (±SD) age was 77.9±7.1 years; 38.6% of the patients were women, the mean CHA2DS2-VASc score was 5.2±1.5 (range, 0 to 9, with higher scores indicating a greater risk of stroke), and the mean HAS-BLED score was 3.0±0.9 (range, 0 to 9, with higher scores indicating higher risk of bleeding). After a median follow-up of 3 years (interquartile range, 1.7 to 4.7), a first primary end-point event had occurred in 155 patients (incidence per 100 patient-years, 16.8) in the device group and in 127 patients (incidence per 100 patient-years, 13.3) in the medical-therapy group (difference in restricted mean survival time, 0.36 years; 95% confidence interval, 0.70 to 0.01; P=0.44 for noninferiority). Serious adverse events occurred in 368 patients (82.5%) in the device group and 342 (77.4%) in the medical-therapy group.

Conclusions

Among patients with atrial fibrillation at high risk for stroke and bleeding, left atrial appendage closure was not noninferior to physician-directed best medical care with regard to a composite end point of stroke, systemic embolism, major bleeding, or cardiovascular or unexplained death.

DOI: NJ202603180000001

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2513310