Short-Term Anticoagulation Versus Dual Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure: The ANDES Randomized Clinical Trial.

The objective of this trial was to compare anticoagulation and antiplatelet therapy for preventing device-related thrombosis (DRT) after LAAC.

本试验的目的是比较抗凝和抗血小板治疗在预防LAAC后器械相关血栓形成（DRT）的效果。

Methods

This was a prospective multicenter international randomized trial comparing 2 different antithrombotic strategies for preventing DRT after LAAC in patients with nonvalvular atrial fibrillation.

这是一项前瞻性多中心国际随机试验，比较了两种不同的抗血栓策略，用于预防非瓣膜性房颤患者在左心耳封堵术（LAAC）后发生器械相关血栓形成（DRT）。

Patients were randomized (1:1) to receive direct oral anticoagulants (DOACs) or dual antiplatelet therapy (DAPT; aspirin+clopidogrel) for 60 days.

患者按1:1的比例随机分配，接受直接口服抗凝药（DOACs）或双重抗血小板治疗（DAPT；阿司匹林+氯吡格雷）治疗60天。

Patients underwent transesophageal echocardiography at 60 days, and the images were analyzed in a central echocardiography laboratory by experienced echocardiographers blinded to the allocated treatment.

患者在60天时接受了经食管超声心动图检查，图像由经验丰富的超声心动图专家在中央超声心动图实验室进行分析，这些专家对分配的治疗方案不知情。

The primary outcome was DRT as determined by transesophageal echocardiography 60 days after LAAC in patients receiving the allocated treatment at the time of transesophageal echocardiography (per-protocol analysis).

主要结果是通过经食管超声心动图在左心耳封堵术（LAAC）后60天确定的左心耳血栓（DRT），分析对象为在经食管超声心动图时接受分配治疗的患者（按方案分析）。

The safety outcome included all-cause mortality, stroke, bleeding, or site-reported DRT within 60 days after LAAC in all randomized patients (intention-to-treatanalysis).

安全性结果包括所有随机患者的全因死亡率、中风、出血或在LAAC后60天内由研究地点报告的DRT（意向治疗分析）。

Results

A total of 510 patients (mean age 77±9 years, 35% women) were included between October 2018 and May 2025, and 253 and 257 patients were randomized to the DOAC and DAPT groups, respectively.

共有510名患者（平均年龄77±9岁，35%为女性）在2018年10月至2025年5月期间被纳入研究，其中253名和257名患者分别被随机分配到DOAC组和DAPT组。

Of these, 399 patients underwent transesophageal echocardiography and were receiving the allocated treatment at 60 days after LAAC.

在这些患者中，有399名患者接受了经食管超声心动图检查，并在左心耳封堵术（LAAC）后60天接受了分配的治疗。

The primary outcome occurred in 3 patients (1.5%) in the DOAC group compared with 8 patients (4.1%) in the DAPT group (difference, -2.7% [95% CI, -6.0% to 0.6%]; P=0.110).

主要结果在DOAC组的3名患者（1.5%）中发生，而在DAPT组的8名患者（4.1%）中发生（差异，-2.7% [95% 置信区间, -6.0% 至 0.6%]; P=0.110）。

The safety outcome occurred in 52 patients (22.5%) in the DOAC group compared with 82 patients (34.9%) in the DAPT group (difference, -12.4% [95% CI, -20.6% to -4.2%]; P=0.003), and differences were mainly driven by a lower rate of bleeding events in the DOAC group (44 patients [17.4%] versus 64 patients [24.9%]; difference, -7.5% [95% CI, -14.6% to -0.4%]; P=0.038).

在DOAC组中，有52名患者（22.5%）发生了安全事件，而在DAPT组中有82名患者（34.9%）发生了安全事件（差异，-12.4% [95% 置信区间, -20.6% 至 -4.2%]；P=0.003），差异主要是由于DOAC组的出血事件率较低（44名患者[17.4%]对比64名患者[24.9%]；差异，-7.5% [95% 置信区间, -14.6% 至 -0.4%]；P=0.038）。

Conclusions

The use of DOACs after LAAC failed to reduce DRT compared with DAPT, but it was associated with an improved safety profile.

在LAAC失败后使用DOACs未能减少DRT，与DAPT相比，但它与改善的安全性特征相关。

The results of this study should be interpreted with caution because of statistical power issues related to the narrower-than-expected between-group differences and will need confirmation in future larger studies.

由于统计功效问题，本研究结果应谨慎解释，这与预期之外的组间差异较窄有关，并将在未来更大规模的研究中需要确认。

registration

URL: https://www.clinicaltrials.gov; Unique identifier: NCT03568890.

网址：https://www.clinicaltrials.gov; 唯一标识符：NCT03568890。