Surgical left atrial appendage occlusion in valvular heart disease without atrial fibrillation: the OPINION trial.

The aim of this study was to evaluate whether prophylactic SLAAO reduces post-operative thrombo-embolic events in valvular surgery patients.

本研究的目的是评估预防性SLAAO是否能减少瓣膜手术患者的术后血栓栓塞事件。

Methods

The OPINION was a multicentre, open-label, randomized, superiority trial conducted at three cardiac surgery centres in China.

OPINION是一项在中国三家心脏外科中心进行的多中心、开放标签、随机、优效性试验。

Eligible non-AF patients with CHA₂DS₂-VASc ≥2 and an indication for valve repair or replacement due to mitral or aortic valve lesions were randomly assigned (1:1) to undergo SLAAO (intervention arm) or not undergo SLAAO (control arm) during surgery.

符合资格的非房颤患者，如果CHA₂DS₂-VASc评分≥2，并且因二尖瓣或主动脉瓣病变需要进行瓣膜修复或置换手术，将被随机分配（1:1）在手术中接受SLAAO（干预组）或不接受SLAAO（对照组）。

The primary outcome was a composite of ischaemic stroke, transient ischaemic attack (TIA), or cardiovascular mortality assessed at 1 year.

主要结果是1年内评估的缺血性中风、短暂性脑缺血发作（TIA）或心血管死亡的复合终点。

The primary analysis was done in the intention-to-treatpopulation.

主要分析是在意向治疗人群中进行的。

Results

Between April 2021 and June 2024, a total of 2157 patients were enrolled and randomized.

2021年4月至2024年6月期间，共有2157名患者被纳入并随机分组。

After exclusion of 39 patients who withdrew informed consent, 2118 participants were included in the intention-to-treatpopulation (1062 in the SLAAO group and 1056 in the control group).

在排除了39名撤回知情同意的患者后，共有2118名参与者被纳入意向治疗人群（SLAAO组1062人，对照组1056人）。

Baseline characteristics were well-balanced between the SLAAO group and control group (mean age 55.5 [11.4] vs 55.6 [11.5] years, P = .65; female 32.9% vs 32.3%, P = .78; CHA2DS2-VASc score 2.88 [0.98] vs 2.87 [0.96], P = .83; median EuroSCORE II 1.58% [1.42%] vs 1.56% [1.28%], P = .74).

基线特征在SLAAO组和对照组之间均衡（平均年龄55.5 [11.4]岁对比55.6 [11.5]岁，P = .65；女性32.9%对比32.3%，P = .78；CHA2DS2-VASc评分2.88 [0.98]对比2.87 [0.96]，P = .83；中位数EuroSCORE II 1.58% [1.42%]对比1.56% [1.28%]，P = .74）。

The 1-year primary endpoint occurred in 73 (6.9%) patients in the SLAAO group and in 87 (8.2%) patients in the control group (hazard ratio0.83; 95% confidence interval0.61-1.14; P = .25).

1年主要终点事件在SLAAO组的73名（6.9%）患者和对照组的87名（8.2%）患者中发生（风险比0.83；95%置信区间0.61-1.14；P = .25）。

Conclusions

For valvular surgery patients with CHA₂DS₂-VASc scores ≥2 but no pre-operative AF, routine prophylactic left atrial appendage closure did not significantly reduce the incidenceof the primary composite endpoint (ischaemic stroke, TIA, and cardiovascular mortality) at 1-year follow-up.

对于CHA₂DS₂-VASc评分≥2但术前无房颤的瓣膜手术患者，常规预防性左心耳封堵在1年随访期间，并未显著降低主要复合终点（缺血性中风、TIA和心血管死亡）的发生率。

trial_registration

ChiCTR.org registry ChiCTR2100042238.

ChiCTR.org注册 ChiCTR2100042238。