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

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 2

Conditions: Myocardial Infarction

Treatments: Device: Left Atrial Appendage Closure Device (Watchman); Drug: Warfarin

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT02492230

241592LLAPCI

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Control Group

Active Comparator group

Description:

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.

Treatment:

Drug: Warfarin

Study Group

Experimental group

Description:

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

Treatment:

Device: Left Atrial Appendage Closure Device (Watchman)