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5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials

Journal of the American College of Cardiology, 2017-12, Vol.70 (24), p.2964-2975 [Peer Reviewed Journal]

Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved. ;Copyright Elsevier Limited Dec 19, 2017 ;ISSN: 0735-1097 ;EISSN: 1558-3597 ;DOI: 10.1016/j.jacc.2017.10.021 ;PMID: 29103847

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Title:
5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials
Author: Reddy, Vivek Y ; Doshi, Shephal K ; Kar, Saibal ; Gibson, Douglas N ; Price, Matthew J ; Huber, Kenneth ; Horton, Rodney P ; Buchbinder, Maurice ; Neuzil, Petr ; Gordon, Nicole T ; Holmes, Jr, David R
Subjects: Age ; Aged ; Anticoagulants ; Atrial Appendage - diagnostic imaging ; Atrial Appendage - surgery ; Atrial Fibrillation - diagnosis ; Atrial Fibrillation - surgery ; Bleeding ; Cardiac arrhythmia ; Cardiac Surgical Procedures - methods ; Cardiovascular disease ; Clinical outcomes ; Clinical trials ; Complications ; Conditional probability ; Death ; Echocardiography, Transesophageal ; Embolism ; Embolisms ; Evaluation ; Female ; Fibrillation ; Follow-Up Studies ; Heart failure ; Heart surgery ; Hemorrhage ; Humans ; Hypertension ; Ischemia ; Male ; Medical research ; Mortality ; Patients ; Prospective Studies ; Statistical analysis ; Stroke ; Stroke - etiology ; Stroke - prevention & control ; Therapy ; Time Factors ; Treatment Outcome ; Warfarin
Is Part Of: Journal of the American College of Cardiology, 2017-12, Vol.70 (24), p.2964-2975
Description: The PROTECT AF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trial demonstrated that left atrial appendage closure (LAAC) with the Watchman device (Boston Scientific, St. Paul, Minnesota) was equivalent to warfarin for preventing stroke in atrial fibrillation, but had a high rate of complications. In a second randomized trial, PREVAIL (Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy), the complication rate was low. The warfarin cohort experienced an unexpectedly low ischemic stroke rate, rendering the efficacy endpoints inconclusive. However, these outcomes were based on relatively few patients followed for a relatively short time. The final results of the PREVAIL trial, both alone and as part of a patient-level meta-analysis with the PROTECT AF trial, are reported with patients in both trials followed for 5 years. PREVAIL and PROTECT AF are prospective randomized clinical trials with patients randomized 2:1 to LAAC or warfarin; together, they enrolled 1,114 patients for 4,343 patient-years. Analyses are by intention-to-treat, and rates are events per 100 patient-years. For the PREVAIL trial, the first composite coprimary endpoint of stroke, systemic embolism (SE), or cardiovascular/unexplained death did not achieve noninferiority (posterior probability for noninferiority = 88.4%), whereas the second coprimary endpoint of post-procedure ischemic stroke/SE did achieve noninferiority (posterior probability for noninferiority = 97.5%); the warfarin arm maintained an unusually low ischemic stroke rate (0.73%). In the meta-analysis, the composite endpoint was similar between groups (hazard ratio [HR]: 0.820; p = 0.27), as were all-stroke/SE (HR: 0.961; p = 0.87). The ischemic stroke/SE rate was numerically higher with LAAC, but this difference did not reach statistical significance (HR: 1.71; p = 0.080). However, differences in hemorrhagic stroke, disabling/fatal stroke, cardiovascular/unexplained death, all-cause death, and post-procedure bleeding favored LAAC (HR: 0.20; p = 0.0022; HR: 0.45; p = 0.03; HR: 0.59; p = 0.027; HR: 0.73; p = 0.035; HR: 0.48; p = 0.0003, respectively). These 5-year outcomes of the PREVAIL trial, combined with the 5-year outcomes of the PROTECT AF trial, demonstrate that LAAC with Watchman provides stroke prevention in nonvalvular atrial fibrillation comparable to warfarin, with additional reductions in major bleeding, particularly hemorrhagic stroke, and mortality. (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation; NCT00129545; and Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy; NCT01182441).
Publisher: United States: Elsevier Limited
Language: English
Identifier: ISSN: 0735-1097
EISSN: 1558-3597
DOI: 10.1016/j.jacc.2017.10.021
PMID: 29103847
Source: Geneva Foundation Free Medical Journals at publisher websites
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5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials

Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved. ;Copyright Elsevier Limited Dec 19, 2017 ;ISSN: 0735-1097 ;EISSN: 1558-3597 ;DOI: 10.1016/j.jacc.2017.10.021 ;PMID: 29103847

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