Left Atrial Appendage Closure Compared to Standard Antiplatelet Therapy in Patients With AF Who Underwent PCI

Study Overview
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Brief Summary
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The objective of Left atrial appendage closure compared to standard antiplatelet therapy in patients with AF who underwent percutaneous coronary intervention (LLA-PCI) study is to evaluate the safety and efficacy of implantation of left atrial appendage closure compared to standard antiplatelet therapy for prevention of thromboembolic events and stent thrombosis in subjects with AF who underwent PCI.

Detailed Description
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This will be prospective randomized (1:1) open label pilot study. Patients with unstable angina and non-ST-elevation ACS and history of AF will be included in this study. After PCI and DES implantation TEE will be performed for assessing LAA anatomy and size eligible for left atrial appendage closure device implantation. After screening all patients will be randomized in two groups. The first (control) group will receive standard antiplatelet and anticoagulation therapy according to the guidelines (2), the second group of patients will undergo left atrial appendage closure device implantation. After the PCI the first group will take Triple therapy (warfarin + clopidogrel+aspirin) during 45 days and after combination of warfarin+clopidogrel to 6 months after procedure and then only warfarin. The second group will take Triple therapy (warfarin+clopidogrel+aspirin) during 45 days following PCI and after control TEE, warfarin will be discontinued. Then patients from the second group will take DAPT combination (clopidogrel+aspirin) to 6 months after procedure and then only aspirin. Patients will be followed at 45 day, and every 3 months during 12 months of follow up (Figure 1). At each follow-up visits the data regarding clinical events and healthcare utilization will be collected.

Official Title
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Left Atrial Appendage Closure Compared to Standard Antiplatelet Therapy in Patients With AF Who Underwent Percutaneous Coronary Intervention

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Device: Left Atrial Appendage Closure Device (Watchman)
* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: age > 18 years old Acute coronary syndrome without ST elevation and unstable angina 2 weeks before enrolment Successful PCI procedure with DES History of atrial fibrillation (paroxysmal, persistent or permanent) with ECG documentation within previous 12 month CHA2DS2-VASC ≥ 2 HAS-BLED ≥ 3 LAA eligible for left atrial appendage closure device implantation (TEE data) Exclusion criteria: age <18 or >80 years old INR >3 recurrent myocardial infarction myocardial infarction with ST elevation EF<50% severe comorbidities Cardiogenic shock (within 72 hours of randomization), as defined by the need for intraaortic balloon support or the requirement for intravenous inotropic support. anemia < 100 g/l uncontrolled hypertension thrombocytopenia oncology obesity, BMI>40 LAA thrombosis Women of childbearing potential (unless post-menopausal or surgically sterile)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>After successful PCI the control group will take Triple therapy (warfarin + clopidogrel+aspirin) during 45 days and after combination of warfarin+clopidogrel to 6 months after procedure and then only warfarin. Patients will be followed at 45 day, and every 3 months during 12 months of follow up. | Drug: Warfarin<br>* Warfarin dose adjusted to maintain INR 2.0-3.0 for all period of study; Aspirin dose-75mg for 45 days after randomization; Clopidogrel dose-75mg for 6 months after procedure. All drugs will be started before PCI procedure. Low molecular weight heparins will be used before procedure and will be stopped when INR reach 1.8-2.0.<br>* Other names: PCI;|
| Experimental: Study Group<br>Left Atrial Appendage Closure Device will be implanted immediately after successful PCI procedure. It will be implanted via a trans-septal approach by use of a catheter based delivery system to seal the ostium of the LAA. The implantation will be guided by fluoroscopy and TEE to verify proper positioning and stability. The study group will take Triple therapy (warfarin+clopidogrel+aspirin) during 45 days following PCI and after control TEE, warfarin will be discontinued. Then patients from the study group will take DAPT combination (clopidogrel+aspirin) to 6 months after procedure and then only aspirin. Patients will be followed at 45 day, and every 3 months during 12 months of follow up | Device: Left Atrial Appendage Closure Device (Watchman)<br>* This device is a self-expanding nickel titanium (nitinol) frame structure with fixation barbs and a permeable polyester fabric cover. The device ranges in diameter from 21 mm to 33 mm to accommodate varying LAA anatomy and size. It will be implanted via a trans-septal approach by use of a catheter based delivery system to seal the ostium of the LAA. The implantation will be guided by fluoroscopy and TEE to verify proper positioning and stability. The dose of warfarin will be adjusted to maintain INR 2.0 - 3.0 for 45 days. If TEE data shows no additional flow in LAA, warfarin will be discontinued: Aspirin dose: 75 mg for all period of study; Clopidogrel dose: 75 mg for 6 months after procedure.<br>* Other names: PCI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with bleeding according TIMI and GUSTO scales |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular death |  | 12 month | 
| Sudden cardiac death |  | 12 month | 
| Death due to heart failure |  | 12 month | 
| Death due to stroke |  | 12 month | 
| Death due to cardiovascular procedures |  | 12 month | 
| Death due to CV hemorrhage |  | 12 month | 
| Death due to other CV causes |  | 12 month | 
| Periprocedural complications on first FU visit |  | 1,5 month | 
| All neurologic events with documented diagnosis of stroke or transient ischemic attack |  | 12 month | 
| Definite stent thrombosis |  | 12 month |