Incidence, Predictors, Management, and Clinical Impact of Major Bleeding Following Left Atrial Appendage Occlusion: The Amulet IDE Randomized Clinical Trial.

Background

To evaluate the incidence, predictors, management, and clinical outcomes of MB after LAAO in the Amulet IDE trial. DESIGN, SETTING, AND PARTICIPANTS: The randomized clinical Amulet IDE trial enrolled patients from 2016 through 2019 with 5-year follow-up.

在Amulet IDE试验中评估LAAO后重大出血（MB）的发生率、预测因素、管理及临床结果。设计、环境和参与者：Amulet IDE随机临床试验从2016年至2019年招募患者，随访期为5年。

Procedures were performed at specialized LAAO centers.

手术在专门的左心耳封堵术（LAAO）中心进行。

Of 1878 randomized patients (1:1 Amulet vs Watchman), 1833 underwent attempted LAAO implantation.

在1878名随机分配的患者中（1:1 Amulet对比Watchman），有1833名患者尝试进行了左心耳封堵术（LAAO）植入。

These data were analyzed from May 2025 through November 2025.

这些数据的分析工作是从2025年5月持续到2025年11月。

main_outcomes_and_measures

Pooled (Amulet and Watchman) patients with vs without MB (Bleeding Academic Research Consortium [BARC] score ≥3: overt bleeding with transfusion and ≥3 g/dL hemoglobin drop) were compared.

对Amulet和Watchman患者的合并数据进行了分析，比较了有无MB（Bleeding Academic Research Consortium [BARC]评分≥3：明显出血需输血且血红蛋白下降≥3 g/dL）的患者。

Results

This study included a total of 1833 patients (57.7% male and 42.3% female; mean [SD] age, 75.8 [7.5] years).

本研究共纳入了1833名患者（男性占57.7%，女性占42.3%；平均年龄[标准差]为75.8[7.5]岁）。

MB occurred in 331 patients (18.1%) over 5 years (annualized rate 5.9% per year).

在5年的时间里，有331名患者（占18.1%）发生了MB（每年的年化发生率为5.9%）。

Patients with MB were older (76.8 vs 74.7 years) and had higher CHA2DS2-VASc (4.8 vs 4.6) and HAS-BLED (3.4 vs 3.2) scores, as well as greater prevalenceof diabetes (38.7% vs 34.1%), prior MB (45.3% vs 28.0%), and kidney disease (9.4% vs 4.5%).

患有MB的患者年龄较大（76.8岁对比74.7岁），并且CHA2DS2-VASc评分（4.8对比4.6）和HAS-BLED评分（3.4对比3.2）更高，同时糖尿病（38.7%对比34.1%）、既往MB（45.3%对比28.0%）和肾脏疾病的患病率也更高（9.4%对比4.5%）。

MB risk was highest in the first 6 months after LAAO (20.5% per year), then decreased to 3.9% per year through 5 years.

在LAAO后的前6个月内，MB的风险最高（每年20.5%），随后在5年内降低到每年3.9%。

Most MB events were nonprocedural (88.8%) with gastrointestinal bleeding accounting for 252 of 438 events.

大多数MB事件为非程序性事件（占88.8%），其中胃肠道出血占438起事件中的252起。

Independent predictors of MB included increasing age (hazard ratio[HR], 1.04; 95% CI, 1.02-1.06), female sex (HR, 1.25; 95% CI, 1.01-1.56), diabetes (HR, 1.26; 95% CI, 1.01-1.58), prior MB (HR, 1.93; 95% CI, 1.55-2.40), and kidney disease (HR, 2.15; 95% CI, 1.48, 3.12).

MB的独立预测因素包括年龄增长（风险比[HR]，1.04；95%置信区间，1.02-1.06）、女性性别（HR，1.25；95%置信区间，1.01-1.56）、糖尿病（HR，1.26；95%置信区间，1.01-1.58）、既往MB（HR，1.93；95%置信区间，1.55-2.40）和肾脏疾病（HR，2.15；95%置信区间，1.48, 3.12）。

At first MB event, 47.1% of patients were not receiving antithrombotic therapy and 92 patients had recurrent events.

在首次微栓塞(MB)事件时，47.1%的患者未接受抗血栓治疗，有92名患者发生了复发事件。

Patients with MB had significantly higher rates of the composite of stroke, systemic embolism, or cardiovascular death (32.5% vs 18.0%; P < .001), driven by higher stroke (14.7% vs 6.6%) and cardiovascular death (24.4% vs 12.9%) rates.

患有微栓塞(MB)的患者中，中风、全身性栓塞或心血管死亡的复合率显著更高（32.5%对比18.0%；P<.001），这一结果主要由较高的中风率（14.7%对比6.6%）和心血管死亡率（24.4%对比12.9%）所驱动。

All-cause mortality was also higher (49.2% vs 25.4%; P < .001).

全因死亡率也更高（49.2%对比25.4%；P<.001）。

MB was fatal (BARC score of 5) in 25 patients (1.4%).

在25名患者中，MB是致命的（BARC评分为5）（1.4%）。

conclusions_and_relevance

In this study, MB was common in this high-risk population and largely related to underlying patient factors.

在这项研究中，心肌桥（MB）在这一高风险人群中很常见，且主要与患者的基础因素有关。

Early MB risk was highest 6 months post-LAAO, then dropped considerably.

早期心肌桥（MB）风险在左心耳封堵术（LAAO）术后6个月时最高，之后显著下降。

Most events were gastrointestinal and occurred even in patients on minimal or no antithrombotic therapy.

大多数事件是胃肠道的，并且即使在使用最小剂量或无抗血栓治疗的患者中也发生了。

MB after LAAO was strongly associated with increased stroke and mortality.

左心耳封堵术后的微血栓与中风和死亡率的增加有很强的关联。

trial_registration

ClinicalTrials.gov Identifier: NCT02879448.

临床试验注册号：NCT02879448。