Epicardial left atrial appendage clipping versus direct oral anticoagulant to reduce stroke risk in non-paroxysmal atrial fibrillation (LAA-CLIP): rationale, design and study protocol for a multicentre randomised controlled trial

• Published in: BMJ open 2024-03, Vol.14 (3), p.e083153
• Main Authors: Yu, Chunyu, Li, Haojie, Lei, Chuxiang, Wang, Yang, Chen, Sipeng, Zhao, Yan, Zheng, Zhe
• Format: Article
• Language: English
• Subjects: Ablation; Age; Aged; Anticoagulants; Anticoagulants - therapeutic use; Atrial Appendage - surgery; atrial fibrillation; Atrial Fibrillation - complications; Atrial Fibrillation - surgery; bleeding; Blood clots; Brain Ischemia; Cardiac arrhythmia; Cardiovascular Medicine; Cardioversion; Contraindications; Creatinine; Diabetes; direct oral anticoagulants; Disease prevention; Drug therapy; Embolisms; Ethics; Female; Heart failure; Hepatitis; Humans; Hypertension; Ischemia; left atrial appendage clipping; Male; Multicenter Studies as Topic; Prospective Studies; Randomized Controlled Trials as Topic; Stroke; Stroke - etiology; Stroke - prevention & control; Surgeons; Thoracic surgery; Womens health
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2023-083153

IntroductionThe prevalence of atrial fibrillation (AF) is increasing globally, and stroke prevention is the key to reduce the morbidity and mortality related to AF. Currently, direct oral anticoagulants (DOACs) are the primary options for stroke prevention, while it increases risk of bleeding. Left atrial appendage (LAA) is suspected as a vital source of cerebral emboli and may lead to ischaemic stroke, and thoracoscopic LAA clipping procedure provides an alternative option for stroke prevention in high-risk patients. However, high-quality evidence comparing LAA clipping to DOACs in terms of stroke prevention is lacking. This trial is designed to assess whether the efficacy of thoracoscopic LAA clipping is superior to DOACs for stroke prevention in AF patients at high risk of thrombosis (CHA2DS2-VASc≥2 in men and ≥3 in women)[CHA2DS2-VASc stands for "congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female)”].Methods and analysisThis is a prospective, multicentre, open-labelled, randomised controlled study. This trial will randomly assign 290 patients with non-paroxysmal AF to thoracoscopic LAA clipping group or DOAC therapy group in a 1:1 randomisation. The primary endpoint is defined as a composite endpoint event consisting of stroke, systemic embolism, all-cause mortality, major bleeding events and clinically relevant non-major bleeding events at 24 months after randomisation. The secondary endpoints consist of the components of the primary composite endpoint, surgery-related adverse events and minor bleeding events.Ethics and disseminationThe central ethics committee at Fuwai Hospital approved the trial entitled “Epicardial left atrial appendage clipping versus direct oral anticoagulant to reduce stroke risk in non-paroxysmal atrial fibrillation (LAA-CLIP trial)”. The results of this study will be disseminated through publications in peer-reviewed journals and conference presentations.Trial registration numberNCT06021808.