title: 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.
abstract: BACKGROUND
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  :  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00129545.
authors: Helmsley Electrophysiology Center, The Cardiovascular Institute, Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1030, New York, NY 10029, USA. vivek.reddy@mountsinai.org
authors: Vivek Y
authors: VY
authors: Reddy
authors: Shephal K
authors: SK
authors: Doshi
authors: Horst
authors: H
authors: Sievert
authors: Maurice
authors: M
authors: Buchbinder
authors: Petr
authors: P
authors: Neuzil
authors: Kenneth
authors: K
authors: Huber
authors: Jonathan L
authors: JL
authors: Halperin
authors: David
authors: D
authors: Holmes
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use; D001241:Aspirin / Q000627:therapeutic use; D020517:Atrial Appendage / Q000187:drug effects / Q000601:surgery*; D001281:Atrial Fibrillation / Q000188:drug therapy / Q000401:mortality / Q000601:surgery*; D000077144:Clopidogrel; D004359:Drug Therapy, Combination; D004617:Embolism / Q000517:prevention & control; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D019736:Prostheses and Implants; D020521:Stroke / Q000517:prevention & control*; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D016896:Treatment Outcome; D014859:Warfarin / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D014859:Warfarin; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin