Atrial Fibrillation
Conditions
Keywords
Anticoagulants, Atrial Appendage, Stroke
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.
Interventions
DEVICEleft atrial appendage occlusion
Percutaneous exclusion of left atrial appendage with Watchman or ACP devices
DRUGNew oral anticoagulants
Include dabigatran, rivaroxaban, apixaban and edoxaban
Sponsors
Korea University Anam Hospital
Yonsei University
Gachon University Gil Medical Center
Ulsan University Hospital
Sejong General Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Hemorrhagic stroke | During 4 years | — |
| 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 | — |
Countries
South Korea
Contacts
Primary ContactHyun Jong Lee, MD
Outcome results
None listed