Percutaneous Left Atrial Appendage Closure for Stroke Prophylaxis in Patients With Atrial Fibrillation: 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) Trial

• Published in: Circulation (New York, N.Y.) Vol. 127; no. 6; pp. 720 - 729
• Main Authors: REDDY, Vivek Y, DOSHI, Shephal K, SIEVERT, Horst, BUCHBINDER, Maurice, NEUZIL, Petr, HUBER, Kenneth, HALPERIN, Jonathan L, HOLMES, David
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 12.02.2013
• Subjects: Aged; Aged, 80 and over; Anticoagulants - therapeutic use; Aspirin - therapeutic use; Atrial Appendage - drug effects; Atrial Appendage - surgery; Atrial Fibrillation - drug therapy; Atrial Fibrillation - mortality; Atrial Fibrillation - surgery; Biological and medical sciences; Blood and lymphatic vessels; Cardiology. Vascular system; Cardiovascular system; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous; Drug Therapy, Combination; Embolism - prevention & control; Female; Follow-Up Studies; Humans; Male; Medical sciences; Pharmacology. Drug treatments; Prostheses and Implants; Stroke - prevention & control; Ticlopidine - analogs & derivatives; Ticlopidine - therapeutic use; Treatment Outcome; Vasodilator agents. Cerebral vasodilators; Warfarin - therapeutic use; Arrhythmia; Coumarine derivatives; anticoagulation; Catheter; Cardiovascular disease; Anticoagulant; Left atrium; Percutaneous route; Vascular disease; Prevention; Antivitamin K; Heart disease; left atrial appendage; catheters; Cerebrovascular disease; Human; Nervous system diseases; Stroke; Warfarin; Atrial fibrillation; Excitability disorder; Cerebral disorder; Pericardial Effusion; Central nervous system disease; Pericardial disease; stroke prevention
• ISSN: 0009-7322; 1524-4539
• DOI: 10.1161/CIRCULATIONAHA.112.114389

The multicenter PROTECT AF study (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) was conducted to determine whether percutaneous left atrial appendage closure with a filter device (Watchman) was noninferior to warfarin for stroke prevention in atrial fibrillation. Patients (n=707) with nonvalvular atrial fibrillation and at least 1 risk factor (age >75 years, hypertension, heart failure, diabetes, or prior stroke/transient ischemic attack) were randomized to either the Watchman device (n=463) or continued warfarin (n=244) in a 2:1 ratio. After device implantation, warfarin was continued for ≈45 days, followed by clopidogrel for 4.5 months and lifelong aspirin. Study discontinuation rates were 15.3% (71/463) and 22.5% (55/244) for the Watchman and warfarin groups, respectively. The time in therapeutic range for the warfarin group was 66%. The composite primary efficacy end point included stroke, systemic embolism, and cardiovascular death, and the primary analysis was by intention to treat. After 1588 patient-years of follow-up (mean 2.3±1.1 years), the primary efficacy event rates were 3.0% and 4.3% (percent per 100 patient-years) in the Watchman and warfarin groups, respectively (relative risk, 0.71; 95% confidence interval, 0.44%-1.30% per year), which met the criteria for noninferiority (probability of noninferiority >0.999). There were more primary safety events in the Watchman group (5.5% per year; 95% confidence interval, 4.2%-7.1% per year) than in the control group (3.6% per year; 95% confidence interval, 2.2%-5.3% per year; relative risk, 1.53; 95% confidence interval, 0.95-2.70). The "local" strategy of left atrial appendage closure is noninferior to "systemic" anticoagulation with warfarin. PROTECT AF has, for the first time, implicated the left atrial appendage in the pathogenesis of stroke in atrial fibrillation. : URL: http://www.clinicaltrials.gov. Unique identifier: NCT00129545.