LAAO With DAPT Versus Antithrombotic Therapy

Completed

• Conditions: Coronary Artery Disease; Atrial Fibrillation
• Interventions: Procedure: ACP or Watchman

• Registration Number: NCT03310801
• Lead Sponsor: Korea University Anam Hospital

Brief Summary

This study will retrospectively review and compare clinical outcomes between left atrial appendage occlusion with dual antiplatelet therapy versus conventional antithrombotic therapy in patients with atrial fibrillation undergoing drug-eluting stent implantation.

Detailed Description

Composite of stroke and major bleeding will be compared after adjusting those groups using inverse probability weighted model.

Study Timeline

• Study Start: 2016-08-01
• Primary Completion: 2017-08-01
• Study Completion: 2017-08-30
• Study First Submitted: 2017-09-17
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-10
• Last Update Submitted: 2017-10-10
• Study First Posted: 2017-10-16
• Last Update Posted: 2017-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

• patients with AF who underwent PCI and treated with LAAO and DAPT or conventional antithrombotic therapy

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LAAO with DAPT	ACP or Watchman	patients with AF who underwent PCI and treated with LAAO(either ACP or Watchman) and DAPT

Primary Outcome Measures

Name	Time	Method
Composite of stroke and major bleeding	From date of index procedure until the date of primary endpoint occur or date of last follow up, whichever came first, assessed up to 50 months	Primary endpoint is a composite of stroke and major bleeding. Stroke is defined as ischemic cerebrovascular event included both transient ischemic attack and ischemic cerebral infarction. Major bleeding event was defined as moderate or severe bleeding according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries criteria.