What is the clinical evidence from this study?

Study design: RCT. Population: Atrial fibrillation (n=1012). Intervention: Percutaneous left atrial appendage closure (LAAC) vs. Direct oral anticoagulant (DOAC) treatment. Primary outcome: Stroke/transient ischaemic attack/systemic thromboembolism, cerebral haemorrhage, other major haemorrhages (Bleeding Academic Research Consortium ≥2), cardiovascular mortality and all-cause mortality.

What does this research mean for the field?

Left atrial appendage closure is a non-inferior alternative to direct oral anticoagulant therapy for stroke prevention in patients with atrial fibrillation after pulmonary vein isolation. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

To compare the effectiveness of left atrial appendage closure versus direct oral anticoagulants in patients post-pulmonary vein isolation for atrial fibrillation.

February 19, 2026Open Access

Left atrial appendage closure versus direct oral anticoagulants after pulmonary vein isolation for atrial fibrillation: protocol for a multicentre, prospective, randomised, non-inferiority trial (PROMOTE study)

Key Result

The PROMOTE study is a randomized non-inferiority trial designed to compare left atrial appendage closure versus DOAC therapy in 1012 patients with atrial fibrillation after pulmonary vein isolation.

Key Points

To compare the effectiveness of left atrial appendage closure versus direct oral anticoagulants in patients post-pulmonary vein isolation for atrial fibrillation.
Prospective, randomised, multicentre non-inferiority trial
Participants assigned to percutaneous LAAC or DOAC in a 1:1 ratio
Enrolment of 1012 participants across multiple sites
Primary effectiveness measure focusing on major cardiovascular events within 24 months
Primary outcomes include stroke, transient ischaemic attack, and major bleeding events
Expected data collection over a 24-month follow-up period
Comparison aims to clarify the safety and efficacy of LAAC versus DOAC in this specific population

Study Design

Type

RCT (n=1,012)

Randomization

1:1

Multicenter

Yes

Structured PICO

Does left atrial appendage closure (LAAC) prevent stroke, bleeding, and mortality compared to direct oral anticoagulants (DOACs) in patients with non-valvular atrial fibrillation post-pulmonary vein isolation?

Population

1012 patients aged 18-80 years with non-valvular atrial fibrillation (paroxysmal, persistent, or permanent) post-pulmonary vein isolation (PVI) with a CHA₂DS₂-VASc score ≥2 in men or ≥3 in women.

Intervention

Percutaneous left atrial appendage closure (LAAC) using Amulet or Watchman device.

Comparator

Direct oral anticoagulants (DOACs: rivaroxaban, apixaban, or dabigatran) at manufacturer-recommended dosages.

Outcome

Composite of stroke/transient ischaemic attack/systemic thromboembolism, cerebral haemorrhage, other major haemorrhages (Bleeding Academic Research Consortium ≥2), cardiovascular mortality, and all-cause mortality within 24 months after randomisation.composite

Abstract

Introduction Atrial fibrillation (AF), with a prevalence of 1–2%, is the most common cardiac arrhythmia. AF is associated with a fivefold increased risk of cardioembolic events; approximately 20% of all strokes are caused by AF. Pulmonary vein isolation (PVI) has become the first-line treatment for AF. However, PVI cannot eliminate the residual stroke risk. Current guidelines recommend that anticoagulation be continued in this specific group of patients, regardless of the presence or absence of AF. In this large AF population post-PVI, who are considered to be in an earlier stage of AF, it is unknown whether left atrial appendage closure (LAAC) offers an alternative to direct oral anticoagulant (DOAC) therapy. Methods and analysis The trial will be a prospective, randomised, multicentre non-inferiority study comparing two treatment strategies in AF patients after atrial ablation. Patients will be randomly assigned to either percutaneous LAAC (group A) or DOAC treatment (group B) in a 1:1 ratio; both sequential and concomitant planned ablation with or without LAAC are accepted. Randomisation will be conducted using web-based randomisation software. A total of 1012 participants (506 patients per group) will be enrolled. The primary effectiveness measure will be the occurrence of any of the specified events within 24 months after randomisation: stroke/transient ischaemic attack/systemic thromboembolism, cerebral haemorrhage, other major haemorrhages (Bleeding Academic Research Consortium ≥2), cardiovascular mortality and all-cause mortality. Ethics and dissemination The study was approved by the Ethical Review Board of Shanghai Chest Hospital, China (KS(Y)20287). Written informed consent will be obtained from all participants. The trial will follow the Declaration of Helsinki and Good Clinical Practice. Confidentiality will be maintained with anonymised, securely stored data. Findings will be disseminated through peer-reviewed publications and conferences. Trial registration number ChiCTR2000036538.

AIに質問

Bookmark

View Full Paper