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

Sponsor

Sejong General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03108872

Collaborator

Korea University Anam Hospital (Other), Yonsei University (Other), Gachon University Gil Medical Center (Other), Ulsan University Hospital (Other)

300

Enrollment

Location

5.3

Anticipated Duration (Months)

57.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: left atrial appendage occlusion Drug: New oral anticoagulants

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Long Term Clinical Outcomes of Left Atrial Appendage Occlusion Versus New Oral Anticoagulants for Stroke Prevention in Patients With Non-valvular Atrial Fibrillation; From Korean Multicenter Registry

Actual Study Start Date :

May 23, 2017

Anticipated Primary Completion Date :

Sep 30, 2017

Anticipated Study Completion Date :

Oct 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
LAAO group 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.	Device: left atrial appendage occlusion Percutaneous exclusion of left atrial appendage with Watchman or ACP devices
NOAC group 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	Drug: New oral anticoagulants Include dabigatran, rivaroxaban, apixaban and edoxaban

Arm

Intervention/Treatment

LAAO group

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.

Device: left atrial appendage occlusion

Percutaneous exclusion of left atrial appendage with Watchman or ACP devices

NOAC group

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

Drug: New oral anticoagulants

Include dabigatran, rivaroxaban, apixaban and edoxaban

Outcome Measures

Primary Outcome Measures

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

Cardiovascular or unexplained death [During 4 years]
Ischemic stroke or systemic embolism [During 4 years]
Hemorrhagic stroke [During 4 years]
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.
Serious device-related complications [During 4 years]
Serious pericardial effusion need procedure or surgery, peri-procedural stroke, or device embolization

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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