title: Left Atrial Appendage Closure as an Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation: A Patient-Level Meta-Analysis.
abstract: BACKGROUND
  The risk-benefit ratio of left atrial appendage closure (LAAC) versus systemic therapy (warfarin) for prevention of stroke, systemic embolism, and cardiovascular death in nonvalvular atrial fibrillation (NVAF) requires continued evaluation.
  
  
  OBJECTIVE
  This study sought to assess composite data regarding left atrial appendage closure (LAAC) in 2 randomized trials compared to warfarin for prevention of stroke, systemic embolism, and cardiovascular death in patients with nonvalvular AF.
  
  
  METHODS
  Our meta-analysis included 2,406 patients with 5,931 patient-years (PY) of follow-up from the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) and PREVAIL (Prospective Randomized Evaluation of the Watchman LAA Closure Device In Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) trials, and their respective registries (Continued Access to PROTECT AF registry and Continued Access to PREVAIL registry).
  
  
  RESULTS
  With mean follow-up of 2.69 years, patients receiving LAAC with the Watchman device had significantly fewer hemorrhagic strokes (0.15 vs. 0.96 events/100 patient-years [PY]; hazard ratio [HR]: 0.22; p = 0.004), cardiovascular/unexplained death (1.1 vs. 2.3 events/100 PY; HR: 0.48; p = 0.006), and nonprocedural bleeding (6.0% vs. 11.3%; HR: 0.51; p = 0.006) compared with warfarin. All-cause stroke or systemic embolism was similar between both strategies (1.75 vs. 1.87 events/100 PY; HR: 1.02; 95% CI: 0.62 to 1.7; p = 0.94). There were more ischemic strokes in the device group (1.6 vs. 0.9 and 0.2 vs. 1.0 events/100 PY; HR: 1.95 and 0.22, respectively; p = 0.05 and 0.004, respectively). Both trials and registries identified similar event rates and consistent device effect in multiple subsets.
  
  
  CONCLUSIONS
  In patients with NVAF at increased risk for stroke or bleeding who are candidates for chronic anticoagulation, LAAC resulted in improved rates of hemorrhagic stroke, cardiovascular/unexplained death, and nonprocedural bleeding compared to warfarin.
authors.affiliation: Mayo Clinic, Rochester, Minnesota. Electronic address: holmes.david@mayo.edu.
authors.forename: David R
authors.initials: DR
authors.lastname: Holmes
authors.affiliation: St. John's Health Center, Santa Monica, California.
authors.forename: Shephal K
authors.initials: SK
authors.lastname: Doshi
authors.affiliation: Cedars Sinai Medical Center, Los Angeles, California.
authors.forename: Saibal
authors.initials: S
authors.lastname: Kar
authors.affiliation: Scripps Clinic, La Jolla, California.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Price
authors.affiliation: Mercy Hospital, St. Louis, Missouri.
authors.forename: Jose M
authors.initials: JM
authors.lastname: Sanchez
authors.affiliation: Cardiovascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany.
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.affiliation: Methodist Hospital, Houston, Texas.
authors.forename: Miguel
authors.initials: M
authors.lastname: Valderrabano
authors.affiliation: Mount Sinai School of Medicine, New York, New York.
authors.forename: Vivek Y
authors.initials: VY
authors.lastname: Reddy
mesh_terms: D000925:Anticoagulants / Q000008:administration & dosage*; D020517:Atrial Appendage / Q000473:pathology / Q000601:surgery*; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000188:drug therapy* / Q000601:surgery*; D005500:Follow-Up Studies; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D020521:Stroke / Q000175:diagnosis / Q000517:prevention & control*; D016896:Treatment Outcome; D014859:Warfarin / Q000008:administration & dosage*
chemical_list: D000925:Anticoagulants; D014859:Warfarin
keywords: appendage occlusion; long-term warfarin; stroke prevention; thromboembolism; warfarin alternative