Left Atrial Appendage Occlusion Device and Novel Oral Anticoagulants Versus Warfarin for Stroke Prevention in Nonvalvular Atrial Fibrillation Systematic Review and Meta-Analysis of Randomized Controlled Trials

被引:23
作者
Briceno, David F. [1 ]
Villablanca, Pedro [1 ]
Cyrille, Nicole [1 ]
Massera, Daniele [1 ]
Bader, Eric [1 ]
Manheimer, Eric [1 ]
Aagaard, Philip [1 ]
Ferrick, Kevin [1 ]
Gross, Jay [1 ]
Kim, Soo Gyum [1 ]
Krumerman, Andrew [1 ]
Palma, Eugen [1 ]
Guttenplan, Nils [1 ]
Romero, Jorge [1 ]
Fisher, John [1 ]
Garcia, Mario [1 ]
Natale, Andrea [2 ,3 ,4 ,5 ,6 ,7 ,8 ]
Di Biase, Luigi [1 ,2 ,3 ,9 ]
机构
[1] Albert Einstein Coll Med, Montefiore Med Ctr, Montefiore Einstein Ctr Heart & Vasc Care, Dept Med,Div Cardiol, New York, NY USA
[2] St Davids Med Ctr, Texas Cardiac Arrhythmia Inst, Austin, TX USA
[3] Univ Texas Austin, Dept Biomed Engn, Austin, TX 78712 USA
[4] Stanford Univ, Div Cardiol, Palo Alto, CA 94304 USA
[5] Case Western Reserve Univ, Div Cardiovasc Med, Cleveland, OH 44106 USA
[6] Scripps Clin, Intervent Electrophysiol, San Diego, CA USA
[7] Dell Med Sch, Austin, TX USA
[8] Calif Pacific Med Ctr, San Francisco, CA USA
[9] Univ Foggia, Dept Cardiol, Foggia, Italy
关键词
anticoagulants; atrial appendage; atrial fibrillation; stroke; warfarin; CLOSURE; RIVAROXABAN; DABIGATRAN; EFFICACY; SAFETY; BIAS;
D O I
10.1161/CIRCEP.115.002993
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background Nonvalvular atrial fibrillation is the most common arrhythmia. Patients with nonvalvular atrial fibrillation are at increased risk of stroke; therefore, we evaluated the efficacy and safety of different approaches to prevent this major complication. Methods and Results We conducted electronic database searches of phase III randomized controlled trials. The groups were novel oral anticoagulants, Watchman left atrial appendage occlusion device (DEVICE), and warfarin. Efficacy outcomes were stroke or systemic embolism, and all-cause mortality. Safety outcome was major bleeding and procedure-related complications. A subgroup analysis of the elderly population was done. We used random-effects model to compare pooled outcomes and tested for heterogeneity. Odds ratios (ORs) and 95% confidence intervals (CIs) were computed for each outcome. Seven randomized controlled trials (n=73978) were included. There was a significant difference favoring novel oral anticoagulants for systemic embolism (OR, 0.84; 95% CI, 0.72-0.97; P=0.01), all-cause mortality (OR, 0.89; 95% CI, 0.84-0.94; P<0.001), and safety outcomes (OR, 0.79; 95% CI, 0.65-0.97; P=0.026) compared with warfarin. No difference was seen between DEVICE and warfarin for efficacy end points; however, DEVICE had more complications (OR, 1.85; 95% CI, 1.14-3.01; P=0.012). In the elderly (6 randomized controlled trials, n=30699), systemic embolism was favored with novel oral anticoagulants over warfarin (OR, 0.77; 95% CI, 0.68-0.87; P0.001). No evidence of significant publication bias was found. Conclusions Novel oral anticoagulants is superior to warfarin for stroke prevention in nonvalvular atrial fibrillation. This benefit was also observed in the elderly population. DEVICE is a reasonable noninferior alternative to warfarin for stroke prevention, but cautious use is essential given safety concerns.
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收藏
页码:1057 / 1064
页数:8
相关论文
共 25 条
[1]  
[Anonymous], COCHRANE HDB SYSTEMA
[2]   Percutaneous Left Atrial Appendage Occlusion for Stroke Prophylaxis in Nonvalvular Atrial Fibrillation A Systematic Review and Analysis of Observational Studies [J].
Bajaj, Navkaranbir Singh ;
Parashar, Akhil ;
Agarwal, Shikhar ;
Sodhi, Nishtha ;
Poddar, Kanhaiya Lal ;
Garg, Aatish ;
Tuzcu, E. Murat ;
Kapadia, Samir R. .
JACC-CARDIOVASCULAR INTERVENTIONS, 2014, 7 (03) :296-304
[3]   Percutaneous Left Atrial Appendage Suture Ligation Using the LARIAT Device in Patients With Atrial Fibrillation Initial Clinical Experience [J].
Bartus, Krzysztof ;
Han, Frederick T. ;
Bednarek, Jacek ;
Myc, Jacek ;
Kapelak, Boguslaw ;
Sadowski, Jerzy ;
Lelakowski, Jacek ;
Bartus, Stanislaw ;
Yakubov, Steven J. ;
Lee, Randall J. .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2013, 62 (02) :108-118
[4]   PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) for prevention of cardioembolic stroke in non-anticoagulation eligible atrial fibrillation patients: results from the European PLAATO study [J].
Bayard, Yves-Laurent ;
Omran, Heyder ;
Neuzil, Petr ;
Thuesen, Leif ;
Pichler, Maximilian ;
Rowland, Edward ;
Ramondo, Angelo ;
Ruzyllo, Witold ;
Budts, Werner ;
Montalescot, Gilles ;
Brugada, Pedro ;
Serruys, Patrick W. ;
Vahanian, Alec ;
Piechaud, Jean-Francois ;
Bartorelli, Antonio ;
Marco, Jean ;
Probst, Peter ;
Kuck, Karl-Heinz ;
Ostermayer, Stefan H. ;
Buescheck, Franziska ;
Fischer, Evelyn ;
Leetz, Michaela ;
Sievert, Horst .
EUROINTERVENTION, 2010, 6 (02) :220-226
[5]   OPERATING CHARACTERISTICS OF A BANK CORRELATION TEST FOR PUBLICATION BIAS [J].
BEGG, CB ;
MAZUMDAR, M .
BIOMETRICS, 1994, 50 (04) :1088-1101
[6]   Dabigatran versus Warfarin in Patients with Atrial Fibrillation. [J].
Connolly, Stuart J. ;
Ezekowitz, Michael D. ;
Yusuf, Salim ;
Eikelboom, John ;
Oldgren, Jonas ;
Parekh, Amit ;
Pogue, Janice ;
Reilly, Paul A. ;
Themeles, Ellison ;
Varrone, Jeanne ;
Wang, Susan ;
Alings, Marco ;
Xavier, Denis ;
Zhu, Jun ;
Diaz, Rafael ;
Lewis, Basil S. ;
Darius, Harald ;
Diener, Hans-Christoph ;
Joyner, Campbell D. ;
Wallentin, Lars .
NEW ENGLAND JOURNAL OF MEDICINE, 2009, 361 (12) :1139-1151
[7]   Efficacy and Safety of the Novel Oral Anticoagulants in Atrial Fibrillation A Systematic Review and Meta-Analysis of the Literature [J].
Dentali, Francesco ;
Riva, Nicoletta ;
Crowther, Mark ;
Turpie, Alexander G. G. ;
Lip, Gregory Y. H. ;
Ageno, Walter .
CIRCULATION, 2012, 126 (20) :2381-+
[8]   Random-effects model for meta-analysis of clinical trials: An update [J].
DerSimonian, Rebecca ;
Kacker, Raghu .
CONTEMPORARY CLINICAL TRIALS, 2007, 28 (02) :105-114
[9]   Trim and fill: A simple funnel-plot-based method of testing and adjusting for publication bias in meta-analysis [J].
Duval, S ;
Tweedie, R .
BIOMETRICS, 2000, 56 (02) :455-463
[10]   Bias in meta-analysis detected by a simple, graphical test [J].
Egger, M ;
Smith, GD ;
Schneider, M ;
Minder, C .
BMJ-BRITISH MEDICAL JOURNAL, 1997, 315 (7109) :629-634