The left atrial appendage closure by surgery 2 trial: statistical analysis plan for a randomized multicenter trial...

Area of Science:

• Cardiovascular Surgery
• Thromboembolism Prevention
• Clinical Trials

Background:

• Surgical left atrial appendage (LAA) closure is used to prevent thromboembolism in high-risk patients undergoing open-heart surgery.
• High-level evidence is lacking for LAA closure in patients with any CHA₂DS₂-VASc score and preoperative atrial fibrillation (AF) or flutter.
• This trial aims to provide crucial evidence for LAA closure in this specific patient population.

Purpose of the Study:

• To evaluate the efficacy and safety of concomitant surgical LAA closure during open-heart surgery.
• To provide evidence for LAA closure in patients with diverse CHA₂DS₂-VASc scores and AF status.
• To inform future clinical guidelines on surgical LAA closure.

Main Methods:

• A randomized, open-label, blinded outcome assessor, multicenter trial involving 1500 adult patients undergoing first-time elective open-heart surgery.
• Patients stratified by site, surgery type, and anticoagulation status, then randomized (1:1) to LAA closure plus cardiac surgery or standard care.
• Primary outcome: stroke/transient ischemic attack (TIA). Secondary outcomes include composite stroke/TIA and silent cerebral infarcts, ischemic stroke, and stroke/all-cause mortality.

Main Results:

• The trial is designed to detect a 60% relative risk reduction in the primary outcome with LAA closure.
• Patient follow-up is planned for 2 years post-randomization.
• Neurologists blinded to treatment allocation will adjudicate stroke and TIA events.

Conclusions:

• The study is expected to generate high-level evidence to guide clinical practice and future guidelines for surgical LAA closure.
• The statistical analysis plan ensures transparency and minimizes reporting bias.
• Findings will impact decision-making for thromboembolism prevention in cardiac surgery patients.