5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials
Language English Country United States Media print-electronic
Document type Journal Article, Multicenter Study, Randomized Controlled Trial
PubMed
29103847
DOI
10.1016/j.jacc.2017.10.021
PII: S0735-1097(17)41187-9
Knihovny.cz E-resources
- Keywords
- Watchman *, atrial fibrillation *, left atrial appendage *, left atrial appendage closure *, oral anticoagulation *, stroke prevention *, warfarin *,
- MeSH
- Time Factors MeSH
- Stroke etiology prevention & control MeSH
- Echocardiography, Transesophageal MeSH
- Atrial Fibrillation diagnosis surgery MeSH
- Cardiac Surgical Procedures methods MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Prospective Studies MeSH
- Aged MeSH
- Atrial Appendage diagnostic imaging surgery MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
BACKGROUND: 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. OBJECTIVES: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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).
Boston Scientific Inc St Paul Minnesota
Cardiovascular Medicine Department Mayo Clinic Rochester Minnesota
Department of Cardiology Homolka Hospital Prague Czech Republic
Division of Cardiology Cedars Sinai Medical Center Los Angeles California
Division of Cardiology Saint Luke's Mid America Heart Institute Kansas City Missouri
Division of Cardiology Scripps Clinic La Jolla California
Division of Cardiology St John's Health Center Santa Monica California
Division of Cardiology Texas Cardiac Arrhythmia Institute Austin Texas
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