TY - JOUR
T1 - Left Atrial Appendage Closure as an Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation
T2 - A Patient-Level Meta-Analysis
AU - Holmes, David R.
AU - Doshi, Shephal K.
AU - Kar, Saibal
AU - Price, Matthew J.
AU - Sanchez, Jose M.
AU - Sievert, Horst
AU - Valderrabano, Miguel
AU - Reddy, Vivek Y.
N1 - Funding Information:
Dr. Holmes and the Mayo Clinic have a financial interest in technology related to this research; the technology has been licensed to Boston Scientific. Dr. Doshi has received research grants and consultant fees from Boston Scientific, St. Jude Medical, Coherex, and SentreHeart; and is the national principal Investigator of the Continuous Access Registry (CAP2). Dr. Kar has received research grants from Boston Scientific , St. Jude Medical , and Abbott Vascular ; is a member of the advisory board for left atrial appendage closure; is the national principal investigator of the Continuous Access Registries (CAP and CAP2) has served as a proctor for Boston Scientific; owns equity in Coherex; and is a consultant for Abbott Vascular. Dr. Price has received consulting honoraria from Boston Scientific, St. Jude Medical, Janssen Pharmaceuticals, Daiichi-Sankyo, Terumo, and W.L. Gore; and his institution receives research support from Boston Scientific , St. Jude Medical, and SentreHeart . Dr. Sanchez has received consulting fees from Boston Scientific. Dr. Sievert has received study honoraria, travel expenses, consulting fees <25,000 € from Abbott, Access Closure, AGA, Angiomed, Aptus, Atrium, Avinger, Bard, Biosense Webster, Boston Scientific, Bridgepoint, Carag, Cardiac Dimensions, CardioKinetix, CardioMEMS, Cardiox, Celonova, CGuard, Coherex, Contego, Covidien, CSI, CVRx, EndoCross, ev3, FlowCardia, Gardia, Gore, GTIMD Medical, Guided Delivery Systems, Hemoteq, InSeal Medical, InspireMD, Lumen Biomedical, HLT, Lifetech, Lutonix, Maya Medical, Medtronic, NDC, Occlutech, Osprey, Ostial, PendraCare, pfm Medical, Recor, ResMed, Rox Medical, SentreHeart, Spectranetics, SquareOne, Svelte Medical Systems, Tendyne, Trireme, Trivascular, Valtech, Vascular Dynamics, Venus Medical, Veryan, and Vessix; has received research grant support <25,000 € from Cook , and St. Jude Medical ; and owns stock options <25,000 € from Cardiokinetix, Access Closure, Velocimed, Lumen Biomedical, Coherex, and SMT. Dr. Valderrabano has received consulting fees from Boston Scientific, St. Jude Medical, Biosense Webster, Hansen Medical, and SentreHeart. Dr. Reddy has received research grant support from and has been a consultant for Atritech/Boston Scientific. Noel Boyle, MD, PhD, served as Guest Editor for this paper.
Publisher Copyright:
© 2015 American College of Cardiology Foundation.
PY - 2015/6/23
Y1 - 2015/6/23
N2 - 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. Objectives 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.
AB - 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. Objectives 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.
KW - appendage occlusion
KW - long-term warfarin
KW - stroke prevention
KW - thromboembolism
KW - warfarin alternative
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U2 - 10.1016/j.jacc.2015.04.025
DO - 10.1016/j.jacc.2015.04.025
M3 - Article
C2 - 26088300
AN - SCOPUS:84931026720
SN - 0735-1097
VL - 65
SP - 2614
EP - 2623
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 24
M1 - 21282
ER -