Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Korea University Anam Hospital | OTHER |
| Yonsei University | OTHER |
| Gachon University Gil Medical Center | OTHER |
| Ulsan University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| left atrial appendage occlusion | Device | Percutaneous exclusion of left atrial appendage with Watchman or ACP devices |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary effectiveness endpoint | The composite of cardiovascular or unexplained death, or ischemic stroke, or systemic embolism | During 4 years |
| Primary safety endpoint | Major bleeding or Serious device-related complications | During 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular or unexplained death | During 4 years | |
| Ischemic stroke or systemic embolism | During 4 years | |
| Hemorrhagic stroke |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Atrial fibrillation with high risk of ischemic stroke or systemic embolism
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyun Jong Lee, MD | Contact | 82-10-6217-9315 | untouchables@sejongh.co.kr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu | Recruiting | Bucheon-si | Gyeonggi-do | 422-711 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26984716 | Background | Kim JS, Lee H, Suh Y, Pak HN, Hong GR, Shim CY, Yu CW, Lee HJ, Kang WC, Shin ES, Choi RK, Kar S, Park JW, Lim DS, Jang Y. Left Atrial Appendage Occlusion in Non-Valvular Atrial Fibrillation in a Korean Multi-Center Registry. Circ J. 2016 Apr 25;80(5):1123-30. doi: 10.1253/circj.CJ-15-1134. Epub 2016 Mar 17. |
Not provided
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
| New oral anticoagulants | Drug | Include dabigatran, rivaroxaban, apixaban and edoxaban |
|
| During 4 years |
| Major bleeding | Bleeding event that required at least 2 units of packed RBCs or Symptomatic bleeding in a critical area or organ. | During 4 years |
| Serious device-related complications | Serious pericardial effusion need procedure or surgery, peri-procedural stroke, or device embolization | During 4 years |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000097546 | Left Atrial Appendage Closure |
| ID | Term |
|---|---|
| D006328 | Cardiac Catheterization |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
Not provided
Not provided