Left Atrial Appendage Occlusion Versus New Oral Anticoagulants for Stroke Prevention in Patients With Non-valvular Atrial Fibrillation

Recruiting

Phase N/A Results N/A

Trial Description

We will compare long-term effectiveness and safety in patients with atrial fibrillation treated with left atrial appendage occlusion versus new oral anticoagulants to prevent ischemic stroke from multicenter registry data

Detailed Description

Atrial fibrillation (AF) is associated with a substantial risk of stroke and systemic embolism. Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation and high risk of ischemic stroke. However, their use is limited by a narrow therapeutic range, increased risk of intracranial hemorrhage, the need for continuous monitoring of INR, and drug or food interaction. New oral anticoagulants (NOACs), the direct thrombin inhibitor and the factor Xa inhibitor, have settled these limitations of warfarin therapy. In four pivotal phase 3 clinical trials and their meta-analysis, NOACs have been shown to significantly reduce ischemic stroke, intracranial hemorrhage, and mortality, and had similar major bleeding as for warfarin in patients with non-valvular atrial fibrillation (NVAF). Another new treatment strategy for prevention of stroke is left atrial appendage occlusion (LAAO). Left atrial appendage has been considered to be an origin of thrombi more than 90% of cases. The concept that exclusion of LAA from the circulation reduces the risk of stroke in patients with NVAF is therefore being tested in clinical studies. LAAO with Watchman device and only aspirin were proved to be non-inferior to warfarin for ischemic stroke prevention or systemic embolism. And, LAAO reduced significantly cardiac death and hemorrhagic stroke compared to warfarin in a long-term follow up. Up to date, there was no study to compare long-term clinical outcomes between LAAO and NOACs, which are two new treatment strategies for stroke prevention in patients with NVAF.

Conditions

Interventions

  • Left Atrial Appendage Occlusion Device
    Intervention Desc: Percutaneous exclusion of left atrial appendage with Watchman or ACP devices
    ARM 1: Kind: Experimental
    Label: LAAO group
    Description: One-hundred consecutive patients who underwent left atrial appendage occlusion from October 2010 to March 2015 in 5 Korean tertiary cardiovascular centers will be retrospectively registered.
  • New oral anticoagulants Drug
    Intervention Desc: Include dabigatran, rivaroxaban, apixaban and edoxaban
    ARM 1: Kind: Experimental
    Label: NOAC group
    Description: Two-hundred age-, sex-, CHA2DS2-VASc score- and HAS-BLED score- matched control will be selected with a 1:2 ratio among all patients treated with new oral anticoagulants to prevent ischemic events from 5 centers during same periods

Trial Population

Atrial fibrillation with high risk of ischemic stroke or systemic embolism

Outcomes

Type Measure Time Frame Safety Issue
Primary Primary effectiveness endpoint During 4 years
Primary Primary safety endpoint During 4 years
Secondary Cardiovascular or unexplained death During 4 years
Secondary Ischemic stroke or systemic embolism During 4 years
Secondary Hemorrhagic stroke During 4 years
Secondary Major bleeding During 4 years
Secondary Serious device-related complications During 4 years

Sponsors