Patient-Level Analysis of Watchman Left Atrial Appendage Occlusion in Practice Versus Clinical Trials |
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| Institution: | 1. Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA;2. Division of Cardiology, Duke University School of Medicine, Durham, North Carolina, USA;3. Center for Outcomes Research and Evaluation, Yale New Haven Health, New Haven, Connecticut, USA;4. Division of Cardiology, University of Colorado School of Medicine, Denver, Colorado, USA;5. Cardiology Section, VA Eastern Colorado Health Care System, Aurora, Colorado, USA;6. Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota, USA;7. Division of Cardiology, Icahn School of Medicine at Mount Sinai, New York, New York, USA;8. Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, California, USA |
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| Abstract: | ObjectivesThe aim of this study was to compare outcomes among patients from the PROTECT-AF (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation) and PREVAIL (Evaluation of the WATCHMAN Left Atrial Appendage LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) left atrial appendage occlusion (LAAO) trials with matched patients from the National Cardiovascular Data Registry LAAO Registry using patient-level data.BackgroundPatients undergoing LAAO in clinical practice generally have more comorbidities than trial participants.MethodsPropensity-matched analyses, with up to 3 registry patients matched to each trial patient, were performed using Cox proportional hazards and Fine-Gray models.ResultsA total of 1,904 registry patients were matched to 667 trial LAAO patients; 1,010 registry patients were matched to 348 warfarin patients. Compared with registry patients, trial LAAO patients experienced more pericardial effusion requiring intervention (3.8% vs 0.6%, P < 0.001), periprocedural ischemic stroke (0.9% vs 0.2%, P = 0.005), and failed device implantation (7.5% vs 3.6%, P < 0.001). The 425-day risk of ischemic stroke in trial LAAO patients was higher than in registry patients (2.70% vs 1.21%; HR: 1.951; P = 0.03); warfarin patients had comparable rates of ischemic stroke compared with registry patients (1.15% vs 1.29%; HR: 0.728; P = 0.57). Hemorrhagic stroke risk was similar among trial LAAO and registry patients (P = 0.88). Hemorrhagic stroke risk was greater among warfarin patients versus registry patients (1.44% vs 0.20%; HR: 5.871, P = 0.03). Mortality was lower in trial LAAO patients than in registry patients (2.92% vs 6.23%; HR: 0.477; P = 0.004), a difference attributable to noncardiovascular deaths. Mortality was similar (P = 0.44) among trial warfarin (4.48%) and registry (5.86%) patients.ConclusionIn clinical practice, patients who meet trial criteria and undergo LAAO experience a lower risk of ischemic stroke, a similar risk of hemorrhagic stroke, and a higher risk of death after implant versus LAAO trial patients. (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation PROTECT-AF], NCT00129545; Evaluation of the WATCHMAN Left Atrial Appendage LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy PREVAIL], NCT01182441) |
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| Keywords: | atrial fibrillation clinical trials left atrial appendage occlusion FDA"} {"#name":"keyword" "$":{"id":"kwrd0030"} "$$":[{"#name":"text" "_":"Food and Drug Administration LAA"} {"#name":"keyword" "$":{"id":"kwrd0050"} "$$":[{"#name":"text" "_":"left atrial appendage LAAO"} {"#name":"keyword" "$":{"id":"kwrd0060"} "$$":[{"#name":"text" "_":"left atrial appendage occlusion NCDR"} {"#name":"keyword" "$":{"id":"kwrd0070"} "$$":[{"#name":"text" "_":"National Cardiovascular Data Registry TIA"} {"#name":"keyword" "$":{"id":"kwrd0080"} "$$":[{"#name":"text" "_":"transient ischemic attack |
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