Prospective randomized evaluation of the watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: The PREVAIL trial

Journal of the American College of Cardiology

Volumn 64, Issue 1, 2014, Pages 1-12

  Holmes, David R ^a   Kar, Saibal ^b   Price, Matthew J ^c   Whisenant, Brian ^d   Sievert, Horst ^e   Doshi, Shephal K ^f   Huber, Kenneth ^g   Reddy, Vivek Y ^h  

^a MAYO CLINIC   (United States)

^b CEDARS SINAI MEDICAL CENTER   (United States)

^c SCRIPPS CLINIC   (United States)

^d INTERMOUNTAIN MEDICAL CENTER   (United States)

^e Cardiovascular   (Germany)

^f Pacific Heart Institute   (United States)

^g SAINT LUKE S MID AMERICA HEART INSTITUTE   (United States)

^h MOUNT SINAI SCHOOL OF MEDICINE   (United States)

Author keywords

atrial fibrillation; left atrial appendage; stroke prevention

Indexed keywords

WARFARIN;

AGED; ARTERIOVENOUS FISTULA; ARTICLE; BLEEDING; CARDIOVASCULAR RISK; CEREBROVASCULAR ACCIDENT; CHADS2 SCORE; CHRONIC DRUG ADMINISTRATION; CLINICAL EFFECTIVENESS; COMPARATIVE EFFECTIVENESS; CONGESTIVE HEART FAILURE; CONTROLLED STUDY; DEVICE SAFETY; DIABETES MELLITUS; DRUG EFFICACY; EMBOLISM; FEMALE; HEART TAMPONADE; HEART VENTRICLE PERFORATION; HUMAN; HYPERTENSION; LEFT ATRIAL APPENDAGE CLOSURE DEVICE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PERICARDIAL EFFUSION; PERICARDIOCENTESIS; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; TRANSIENT ISCHEMIC ATTACK;

ATRIAL FIBRILLATION; LEFT ATRIAL APPENDAGE; STROKE PREVENTION;

AGED; AGED, 80 AND OVER; ANTICOAGULANTS; ATRIAL APPENDAGE; ATRIAL FIBRILLATION; CARDIAC SURGICAL PROCEDURES; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; STROKE; TREATMENT OUTCOME; WARFARIN;

EID: 84903828960     PISSN: 07351097     EISSN: 15583597     Source Type: Journal    
DOI: 10.1016/j.jacc.2014.04.029     Document Type: Article

References (30)

1. D.M. Lloyd-Jones, T.J. Wang, and E.P. Leip et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study Circulation 110 2004 1042 1046
2. P.A. Wolf, R.D. Abbott, and W.B. Kannel Atrial fibrillation as an independent risk factor for stroke: the Framingham Study Stroke 22 1991 983 988
3. H.J. Lin, P.A. Wolf, and M. Kelly-Hayes et al. Stroke severity in atrial fibrillation. The Framingham Study Stroke 27 1996 1760 1764
4. D.A. Garcia, and E. Hylek Reducing the risk for stroke in patients who have atrial fibrillation Cardiol Clinic 26 2008 267 275
5. D.R. Holmes Atrial fibrillation and stroke management: present and future Semin Neurol 30 2010 528 536
6. The ACTIVE Writing Group on Behalf of the ACTIVE Investigators Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events (ACTIVE W): a randomised controlled trial Lancet 367 2006 1903 1912
7. S.J. Connolly, M.D. Ezekowitz, and S. Yusuf et al. Dabigatran versus warfarin in patients with atrial fibrillation N Engl J Med 361 2009 1139 1151
8. M.R. Patel, K.W. Mahaffey, and J. Garg et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation N Engl J Med 365 2011 883 891
9. S.J. Connolly, J. Eikelboom, and C. Joyner et al. Apixaban in patients with atrial fibrillation N Engl J Med 364 2011 806 817
10. J.L. Blackshear, and J.A. Odell Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation Ann Thorac Surg 61 1996 755 759
11. A.G. Dawson, S. Asopa, and J. Dunning Should patients undergoing cardiac surgery with atrial fibrillation have left atrial appendage exclusion? Interact Cardiovasc Thorac Surg 10 2010 306 311
12. A.S. Kanderian, A.M. Gillinov, and G.B. Pettersson et al. Success of surgical left atrial appendage closure: assessment by transesophageal echocardiography J Am Coll Cardiol 52 2008 924 929
13. S.H. Ostermayer, M. Reisman, and P.H. Kramer Percutaneous left atrial appendage transcatheter occlusion (PLAATO system) to prevent stroke in high risk patients with non rheumatic atrial fibrillation: results from the international multi-center feasibility trials J Am Coll Cardiol 46 2005 9 14
14. H. Sievert, M.D. Lesh, and T. Trepels et al. Percutaneous left atrial appendage transcatheter occlusion to prevent stroke in high-risk patients with atrial fibrillation - early clinical experience Circulation 105 2002 1887 1889
15. P.B. Sick, G. Schuler, and K.E. Hauptmann et al. Initial worldwide experience with the Watchman left atrial appendage system for stroke prevention in atrial fibrillation J Am Coll Cardiol 49 2007 1490 1495
16. J.W. Park, A. Bethencourt, and H. Sievert et al. Left atrial appendage closure with Amplatzer cardiac plug in atrial fibrillation: initial European experience Catheter Cardiovasc Interv 77 2011 700 706
17. D.R. Holmes, V.Y. Reddy, and Z.G. Turi et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial Lancet 374 2009 534 542
18. V.Y. Reddy, S.K. Doshi, and H. Sievert et al. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-year follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trial Circulation 127 2013 720 729
19. V.Y. Reddy, D. Holmes, and S.K. Doshi et al. The safety of percutaneous left atrial appendage closure: results from PROTECT AF and the Continued Access Registry Circulation 123 2011 417 424
20. S.J. Connolly, J. Pogue, and R.G. Hart et al. Effect of clopidogrel added to aspirin in patients with atrial fibrillation N Engl J Med 360 2009 2066 2078
21. A. Gelman, J.B. Carlin, and H.S. Stern et al. Bayesian data analysis 1995 Chapman & Hall/CRC London, UK
22. R.G. Hart, L.A. Pearce, and M.I. Aguilar Meta-analysis antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation Ann Intern Med 146 2007 857 867
23. The European Atrial Fibrillation Trial Study Group Optimal oral anticoagulant therapy in patients with nonrheumatic atrial fibrillation and recent cerebral ischemia N Engl J Med 333 1995 5 10
24. S.J. Connolly, A. Laupacis, and M. Gent et al. Canadian Atrial Fibrillation Anticoagulation (CAFA) study J Am Coll Cardiol 18 1991 349 355
25. M.D. Ezekowitz, S.L. Bridgers, and K.E. James et al. Warfarin in the prevention of stroke associated with nonrheumatic atrial fibrillation. Veterans Affairs Stroke Prevention in Nonrheumatic Atrial Fibrillation Investigators N Engl J Med 327 1992 1406 1412
26. A.S. Go, E.M. Hylek, and Y. Chang et al. Anticoagulation therapy for stroke prevention in atrial fibrillation: how well do randomized trials translate into clinical practice? JAMA 290 2003 2685 2692
27. A. Majeed, H.G. Hwang, and S.J. Connolly et al. Management and outcomes of major bleeding during treatment with dabigatran or warfarin Circulation 128 2013 2325 2332
28. C.B. Granger, and L.V. Armaganijan Newer oral anticoagulants should be used as first-line agents to prevent thromboembolism in patients with atrial fibrillation and risk factors for stroke or thromboembolism Circulation 125 2012 159 164
29. Reddy VY, Doshi SK, Sievert H, et al. Long term results of PROTECT AF: the mortality effects of left atrial appendage closure versus warfarin for stroke prophylaxis in AF. late-breaking clinical trial. Paper presented at: the Heart Rhythm Society meeting; May 8-11, 2013; Denver, CO.
30. V.Y. Reddy, S. Möbius-Winkler, and M.A. Miller et al. Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: ASA Plavix Feasibility Study with Watchman Left Atrial Appendage Closure Technology (ASAP Study) J Am Coll Cardiol 61 2013 2551 2556