Safety and Efficacy of Left Atrial Appendage Closure Versus Antithrombotic Therapy in Patients With Atrial Fibrillation Undergoing Drug-Eluting Stent Implantation Due to Complex Coronary Artery Disease

Study Overview
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Brief Summary
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Comparatively analyze the safety and validity of Amplazter Cardiac Plug (ACP) device-using percutaneous left atrial appendage closure, and the medical treatment with dabigatran plus aspirin or dabigatran plus clopidogrel after 3months triple therapy (Dabigatran plus DAPT (dual-antiplatelet therapy)) in patient with coronary artery disease treated with drug-eluting stent, accompanying atrial fibrillation. Total of 670 patients [left atrial appendage occlusion registry with 100 ACP/ 570 anti-coagulation registry: (285 Dabigatran plus aspirin) and (285 Dabigatran plus clopidogrel) therapy)] will be comparatively analyzed the safety and efficacy. Primary endpoints were a composite of death, non-fatal myocardial infarction, stroke, systemic embolism, and GUSTO bleeding (moderate to severe).

Conditions
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Atrial Fibrillation, Coronary Artery Disease

Intervention / Treatment
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* Drug: Dabigatrain plus aspirin
* Drug: Dabigatrain plus clopidogrel
* Device: Amplazter Cardiac Plug (ACP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 20 years accompanying chronic atrial fibrillation with CHADS2 score ≥2 Patients with coronary artery disease (which requires DES) should receive the 2nd generation drug-eluting stent insertion treatment Subjects and their legal representatives must understand the main purpose of this study, agree with relevant provisions, and sign to consent forms approved by IRBs of each institution. Subjects should agree with the follow-up studies as (coronary angiography) and transesophageal echocardiography, etc. Subjects should agree to follow our requests for post-operative follow-up visits. Exclusion Criteria: Patients showing any hypersensitive reaction or reason for restriction to aspirin, heparin, clopidogrel, or warfarin, or otherwise, susceptible to contrast media, and therefore, who could not use those drugs and who were pregnant or breast feeding. Comorbidities other than atrial fibrillation that required chronic warfarin use. Patients diagnosed with progressive infection condition or endocarditis. Patients who have been diagnosed with progressive gastric ulcer or upper gastrointestinal bleeding for last 3 months. Hemodynamically unstable patients who needs inotropic supports. Senile dementia patients who have experienced any cerebrovascular accident (CVA) for last 6 weeks. Patients who have been diagnosed with intracardiac mass, thrombus, or vegetation as echocardiographic findings. Patients diagnosed with severe left ventricular dysfunction (<LVEF 30%). Patients with blood disorder as followings: leucopenia (<WBC 3,000mm3), acute anemia (<Hg 9mg %), Thrombocytopenia (<100,000 platelets/mm3), or any evidence of bleeding or clotting disorders. Patients showing life expectancy less than 12 months because of noncardiac comorbidities. Patients having severe vein occlusion at femoral vein, ceiling vein, or inferior vena cava. A patent foramen ovale with atrial septal aneurysm and right-to-left shunt Symptomatic carotid artery disease Patients with severe valvular heart disease Patients who are currently participating in other clinical trials for any drug or medical device.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dabigatran plus aspirin<br>Medical treatment with dabigatran plus aspirin after 3months triple therapy (Dabigatran plus DAPT (dual-antiplatelet therapy)) | Drug: Dabigatrain plus aspirin<br>* Dabigatran (Pradaxa®) is indicated for the prevention of thrombotic events (for example stroke or heart attack) in people with atrial fibrillation. Aspirin is indicated for the prevention of stent thrombosis and myocardial infarction in patients treated with drug-eluting stents. Patients will be randomized to stop clopidogrel (maintain dabigatran + aspirin) at 3 months after PCI.<br>|
| Experimental: Dabigatran plus clopidogrel<br>medical treatment with dabigatran plus clopidogrel after 3months triple therapy (Dabigatran plus DAPT) | Drug: Dabigatrain plus clopidogrel<br>* Clopidogrel is indicated for the prevention of stent thrombosis and myocardial infarction in patients treated with drug-eluting stents. Patients will be randomized to stop aspirin (maintain dabigatran + clopidogrel) at 3 months after PCI.<br>|
| Other: Amplazter Cardiac Plug (ACP)<br>Amplazter Cardiac Plug (ACP) device-using percutaneous left atrial appendage closure | Device: Amplazter Cardiac Plug (ACP)<br>* Patients allocated to the intervention group should be received percutaneous closure of the LAA by use of the ACP device (St. Jude Medical, St Paul, MN, USA).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE (Major adverse cardiac and cerebrovascular events) |  | 5 years | 
| GUSTO bleeding |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of procedural related complications |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug eluting stent, atrial appendage closure