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PROTECT AF – percutaneous LAA closure superior to warfarin

Percutaneous left atrial appendage (LAA) closure is superior to warfarin for preventing the combined outcome of stroke, systemic embolism, and cardiovascular death, as well as for cardiovascular and all-cause mortality, in patients with non-valvular atrial fibrillation (AF) at elevated risk for stroke, according to results form the PROTECT AF trial published recently in the Journal of the American Medical Association.1

707 patients with nonvalvular AF and at least 1 additional stroke risk factor (CHADS2 score ≥1) were enrolled from 59 hospitals between February 2005 and June 2008. The study included 4-year follow-up through October 2012. Non-inferiority required a posterior probability greater than 97.5% and superiority a probability of 95% or greater; the non-inferiority margin was a rate ratio of 2.0 comparing event rates between treatment groups.

LAA closure with the device (Watchman™, Boston Scientific) was performed in 463 patients, and warfarin in 244. The composite efficacy end point included stroke, systemic embolism, and cardiovascular/unexplained death, analysed by intention-to-treat.

6 - Fwd_ PROTECT AF 4-Years Results_ WATCHMAN™ LAA Closure Device vs Warfarin for Atrial FibrillationAt a mean (SD) follow-up of 3.8 (1.7) years (2,621 patient-years), there were 39 events among 463 patients (8.4%) in the device group for a primary event rate of 2.3 events per 100 patient-years, compared with 34 events among 244 patients (13.9%) for a primary event rate of 3.8 events per 100 patient-years with warfarin, meeting prespecified criteria for both noninferiority (posterior probability, >99.9%) and superiority (posterior probability, 96.0%).

Patients in the device group demonstrated lower rates of both cardiovascular mortality (1.0 events per 100 patient-years for the device group vs. 2.4 events per 100 patient-years with warfarin) and all-cause mortality (3.2 events per 100 patient-years for the device group vs. 4.8 events per 100 patient-years with warfarin).

References

1. Reddy VY, Sievert H, Halperin J, et al. Percutaneous left atrial appendage closure vs. warfarin for atrial fibrillation: a randomized clinical trial. JAMA 2014;312:1988–98. http://dx.doi.org/10.1001/jama.2014.15192

Published on: December 19, 2014

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ENDORSED BY

  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association
 

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