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

• Conditions: Atrial Fibrillation
• Interventions: Drug: New oral anticoagulants; Device: left atrial appendage occlusion

• Registration Number: NCT03108872
• Lead Sponsor: Sejong General Hospital

Brief Summary

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.

Study Timeline

• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-11
• Status Verified: 2017-05
• Study Start: 2017-05-23
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-24
• Primary Completion: 2017-09-30
• Study Completion: 2017-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Patients with atrial fibrillation, who LAAO or NOAC to prevent ischemic stroke or systemic embolism
2. Patients with CHA2DS2-VASc score >1

Exclusion Criteria

1. Patients who failed to successfully implant LAAO
2. Patients who receive new oral anticoagulant less than 6 months without clinical events
3. Patients with mitral stenosis more than mild grade
4. Patients with prosthetic heart valve

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NOAC group	New oral anticoagulants	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
LAAO group	left atrial appendage occlusion	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.

Primary Outcome Measures

Name	Time	Method
Primary effectiveness endpoint	During 4 years	The composite of cardiovascular or unexplained death, or ischemic stroke, or systemic embolism
Primary safety endpoint	During 4 years	Major bleeding or Serious device-related complications

Secondary Outcome Measures

Name	Time	Method
Cardiovascular or unexplained death	During 4 years
Serious device-related complications	During 4 years	Serious pericardial effusion need procedure or surgery, peri-procedural stroke, or device embolization
Major bleeding	During 4 years	Bleeding event that required at least 2 units of packed RBCs or Symptomatic bleeding in a critical area or organ.
Ischemic stroke or systemic embolism	During 4 years
Hemorrhagic stroke	During 4 years

Trial Locations

Locations (1)

Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu; 🇰🇷 Bucheon, Gyeonggi, Korea, Republic of