Left Atrial Appendage Closure as an Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation
Open accessAbstract
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.
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LAA occlusion was non-inferior to VKA treatment for the prevention of stroke in AF patients with moderate stroke risk, with a possibility of lower bleeding rates in patients who continued follow-up.
“In these data sets, LAA occlusion was non-inferior to VKA treatment for the prevention of stroke in AF patients with moderate stroke risk, with a possibility of lower bleeding rates in the patients who continued follow-up. 452,453”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [453]
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Cites
Gelman, A., Carlin, J. B., Stern, H. S., Dunson, D. B., Vehtari, A., & Rubin, D. B. (2013) · doi:10.1201/b16018 · Cited by 27,276 · see citing works
Dabigatran versus warfarin in patients with atrial fibrillation
Connolly, S. J., Ezekowitz, M. D., Yusuf, S., Eikelboom, J., Oldgren, J., Parekh, A., Pogue, J., Reilly, P. A., Themeles, E., Varrone, J., et al. (2009) · New England Journal of Medicine · doi:10.1056/nejmoa0905561 · Cited by 11,215 · see citing works
Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
Patel, M. R., Mahaffey, K. W., Garg, J., Pan, G., Singer, D. E., Hacke, W., Breithardt, G., Halperin, J. L., Hankey, G. J., Piccini, J. P., et al. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1009638 · Cited by 9,430 · see citing works
Apixaban versus warfarin in patients with atrial fibrillation
Granger, C. B., Alexander, J. H., McMurray, J. J. V., Lopes, R. D., Hylek, E. M., Hanna, M., Al-Khalidi, H. R., Ansell, J., Atar, D., Avezum, A., et al. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1107039 · Cited by 8,943 · see citing works
2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation
January, C. T., Wann, L. S., Alpert, J. S., Calkins, H. G., Cigarroa, J. E., Cleveland, J. C., CONTI, J. B., Ellinor, P. T., Ezekowitz, M. D., Field, M. E., et al. (2014) · Circulation · doi:10.1161/cir.0000000000000041 · Cited by 7,119 · see citing works
Edoxaban versus warfarin in patients with atrial fibrillation
Giugliano, R. P., Ruff, C. T., Braunwald, E., Murphy, S. A., Wiviott, S. D., Halperin, J. L., Waldo, A. L., Ezekowitz, M. D., Weitz, J. I., Špinar, J., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1310907 · Cited by 5,164 · see citing works
Ruff, C. T., Giugliano, R. P., Braunwald, E., Hoffman, E. B., Deenadayalu, N., Ezekowitz, M. D., Camm, A. J., Weitz, J. I., Lewis, B. S., Parkhomenko, A., et al. (2014) · The Lancet · doi:10.1016/s0140-6736(13)62343-0 · Cited by 5,051 · see citing works
Gage, B. F., Waterman, A. D., Shannon, W., Boechler, M., Rich, M. W., & Radford, M. J. (2001) · JAMA · doi:10.1001/jama.285.22.2864 · Cited by 4,832 · see citing works
2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation
January, C. T., Wann, L. S., Alpert, J. S., Calkins, H., Cigarroa, J. E., Cleveland, J. C., Conti, J. B., Ellinor, P. T., Ezekowitz, M. D., Field, M. E., et al. (2014) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2014.03.022 · Cited by 2,955 · see citing works
Holmes, D. R., Reddy, V. Y., Turi, Z. G., Doshi, S. K., Sievert, H., Buchbinder, M., Mullin, C. M., & Sick, P. B. (2009) · The Lancet · doi:10.1016/s0140-6736(09)61343-x · Cited by 2,242 · see citing works
Self-citationSubclinical atrial fibrillation and the risk of stroke
Healey, J. S., Connolly, S. J., Gold, M. R., Israel, C. W., Van Gelder, I. C., Capucci, A., Lau, C. P., Fain, E., Yang, S., Bailleul, C., et al. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1105575 · Cited by 2,100 · see citing works
Lifetime Risk for Development of Atrial Fibrillation: The Framingham Heart Study
Lloyd-Jones, D. M., Wang, T. J., Leip, E. P., Larson, M. G., Levy, D., Vasan, R. S., D’Agostino, R. B., Massaro, J. M., Beiser, A., Wolf, P. A., et al. (2004) · Circulation · doi:10.1161/01.cir.0000140263.20897.42 · Cited by 2,041 · see citing works
Holmes, D. R., Kar, S., Price, M. J., Whisenant, B. K., Sievert, H., Doshi, S. K., Huber, K., & Reddy, V. Y. (2014) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2014.04.029 · Cited by 1,850 · see citing works
Self-citationEmergency hospitalizations for adverse drug events in older Americans.
Budnitz, D., Lovegrove, M., Shehab, N., & Richards, C. (2011) · New England Journal of Medicine · doi:10.1056/nejmsa1103053 · Cited by 1,748 · see citing works
Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation
Blackshear, J. L., & Odell, J. A. (1996) · The Annals of Thoracic Surgery · doi:10.1016/0003-4975(95)00887-x · Cited by 1,686 · cited 13× · see citing works
“Although all 4 Watchman studies excluded these contraindicated patients, in the Aspirin Plavix Registry (8), the devicewas implanted in 150 NVAF patients ineligible for warfarin.”
BackgroundInfluentialAtrial Fibrillation: A Major Contributor to Stroke in the Elderly
Wolf, P. A. (1987) · Archives of Internal Medicine · doi:10.1001/archinte.147.9.1561 · Cited by 1,526 · see citing works
Fearn, T., Gelman, A., Carlin, J., Stern, H., & Rubin, D. B. (1996) · Biometrics · doi:10.2307/2533081 · Cited by 1,322 · see citing works
Atrial Fibrillation: A Major Contributor to Stroke in the Elderly: The Framingham Study
Wolf, P. A. (1987) · Archives of Internal Medicine · doi:10.1001/archinte.1987.00370090041008 · Cited by 1,108 · see citing works
Lip, G. Y. H., Frison, L., Halperin, J. L., & Lane, D. A. (2010) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2010.09.024 · Cited by 1,077 · see citing works
Reddy, V. Y., Sievert, H., Halperin, J., Doshi, S. K., Buchbinder, M., Neuzil, P., Huber, K., Whisenant, B., Kar, S., Swarup, V., et al. (2014) · JAMA · doi:10.1001/jama.2014.15192 · Cited by 1,018 · see citing works
Self-citationSafety of Percutaneous Left Atrial Appendage Closure
Reddy, V. Y., Holmes, D. R., Doshi, S. K., Neužil, P., & Kar, S. (2011) · Circulation · doi:10.1161/circulationaha.110.976449 · Cited by 863 · see citing works
Self-citationReddy, V. Y., Möbius-Winkler, S., Miller, M. A., Neuzil, P., Schuler, G., Wiebe, J., Sick, P., & Sievert, H. (2013) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2013.03.035 · Cited by 727 · see citing works
Reddy, V. Y., Doshi, S. K., Sievert, H., Buchbinder, M., Neužil, P., Huber, K., Halperin, J. L., & Holmes, D. R. (2013) · Circulation · doi:10.1161/circulationaha.112.114389 · Cited by 677 · see citing works
Self-citationViles-González, J. F., Kar, S., Douglas, P. S., Dukkipati, S. R., Feldman, T. E., Horton, R., Holmes, D. R., & Reddy, V. Y. (2012) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2011.11.028 · Cited by 545 · see citing works
Self-citationLane, D. A., & Lip, G. Y. H. (2012) · Circulation · doi:10.1161/circulationaha.111.060061 · Cited by 389 · see citing works
Attitudes of physicians regarding anticoagulation for atrial fibrillation: a systematic review
Pugh, D., Pugh, J., & Mead, G. E. (2011) · Age and Ageing · doi:10.1093/ageing/afr097 · Cited by 243 · see citing works
Fountain, R. B., Holmes, D. R., Chandrasekaran, K., Packer, D. L., Asirvatham, S. J., Tassel, R. A. V., & Turi, Z. G. (2006) · American Heart Journal · doi:10.1016/j.ahj.2006.02.005 · Cited by 233 · see citing works
Self-citationThe Epidemiology of Atrial Fibrillation in Elderly Persons: The Tip of the Iceberg
Go, A. S. (2005) · The American Journal of Geriatric Cardiology · doi:10.1111/j.1076-7460.2005.02278.x · Cited by 114 · see citing works
Baker, W. L., & Phung, O. J. (2012) · Circulation Cardiovascular Quality and Outcomes · doi:10.1161/circoutcomes.112.966572 · Cited by 111 · see citing works
Emergency Hospitalizations for Adverse Drug Events
Cm, H., de Lemos, J., & Laban, R. B. A. (2012) · New England Journal of Medicine · doi:10.1056/nejmc1114768 · Cited by 111 · see citing works
Bajaj, N. S., Parashar, A., Agarwal, S., Sodhi, N., Poddar, K. L., Garg, A., Tuzcu, E. M., & Kapadia, S. R. (2014) · JACC: Cardiovascular Interventions · doi:10.1016/j.jcin.2013.11.010 · Cited by 96 · see citing works
Gangireddy, S. R., Halperin, J. L., Fuster, V., & Reddy, V. Y. (2012) · European Heart Journal · doi:10.1093/eurheartj/ehs292 · Cited by 83 · see citing works
Self-citationLewalter, T., Kanagaratnam, P., Schmidt, B., Rosenqvist, M., Nielsen‐Kudsk, J. E., Ibrahim, R., Albers, B., & Camm, A. J. (2014) · EP Europace · doi:10.1093/europace/euu069 · Cited by 41 · see citing works
Patients’ Preferences in Anticoagulant Therapy
Najafzadeh, M., Gagne, J. J., Choudhry, N. K., Polinski, J. M., Avorn, J., & Schneeweiß, S. (2014) · Circulation Cardiovascular Quality and Outcomes · doi:10.1161/circoutcomes.114.001013 · Cited by 37 · see citing works
Pharmacotherapy in Medicare beneficiaries with atrial fibrillation
Piccini, J. P., Mi, X., DeWald, T. A., Go, A. S., Hernandez, A. F., & Curtis, L. H. (2012) · Heart Rhythm · doi:10.1016/j.hrthm.2012.04.031 · Cited by 26 · see citing works
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2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure
Ponikowski, P., Voors, A. A., Anker, S. D., Bueno, H., Cleland, J. G. F., Coats, A. J. S., Falk, V., González-Juanatey, J. R., Harjola, V.-P., Jankowska, E. A., et al. (2016) · European Heart Journal · doi:10.1093/eurheartj/ehw128 · Cited by 11,429 · see citing works
2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS
Kirchhof, P., Benussi, S., Kotecha, D., Ahlsson, A., Atar, D., Casadei, B., Castella, M., Diener, H.-C., Heidbuchel, H., Hendriks, J., et al. (2016) · European Heart Journal · doi:10.1093/eurheartj/ehw210 · Cited by 6,418 · see citing works
2016 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure
Ponikowski, P., Voors, A. A., Anker, S. D., Bueno, H., Cleland, J. G. F., Coats, A. J. S., Falk, V., González-Juanatey, J. R., Harjola, V.-P., Jankowska, E. A., et al. (2016) · European Journal of Heart Failure · doi:10.1002/ejhf.592 · Cited by 5,866 · see citing works
January, C. T., Wann, L. S., Calkins, H., Chen, L. Y., Cigarroa, J. E., Cleveland, J. C., Ellinor, P. T., Ezekowitz, M. D., Field, M. E., Furie, K. L., et al. (2019) · Circulation · doi:10.1161/cir.0000000000000665 · Cited by 2,744 · see citing works
2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS
Kirchhof, P., Benussi, S., Kotecha, D., Ahlsson, A., Atar, D., Casadei, B., Castella, M., Diener, H.-C., Heidbuchel, H., Hendriks, J., et al. (2016) · European Journal of Cardio-Thoracic Surgery · doi:10.1093/ejcts/ezw313 · Cited by 1,403 · see citing works
- Authors
- Holmes, D. R., Doshi, S. K., Kar, S., Price, M. J., Sanchez, J. M., Sievert, H., Valderrabano, M., & Reddy, V. Y.
- Affiliations
- Mayo Clinic (US)
- Saint John's Health Center (US)
- Cedars-Sinai Medical Center (US)
- Scripps Clinic (US)
- Cardiovascular Center Frankfurt (DE)
- Icahn School of Medicine at Mount Sinai (US)
- Corresponding author
- Holmes, David R.
- Venue
- Journal of the American College of Cardiology
- Publisher
- Elsevier BV
- Published
- 2015-06
- Volume
- 65
- Issue
- 24
- Pages
- 2614-2623
- ISSN
- 0735-1097 (ISSN-L)
- OpenAlex
- W620992480
- Cited by
- 543
- References
- 35
- Citations by year
- 2026: 20 · 2025: 21 · 2024: 33 · 2023: 42 · 2022: 42 · 2021: 57 · 2020: 42 · 2019: 56 · 2018: 62 · 2017: 86 · 2016: 55 · 2015: 22 · 2014: 1 · 2013: 1 · 2012: 1
- FWCI
- 54.54
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of the American College of Cardiology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Boston Scientific Corporation
- St. Jude Medical
- Abbott Vascular
- National Heart, Lung, and Blood Institute (R01HL115003)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Cardiovascular and Diving-Related Complications
- Health Sciences › Medicine › Epidemiology › Acute Ischemic Stroke Management
- Keywords
- left atrial appendage closure, non-valvular atrial fibrillation, warfarin, stroke prevention, systemic embolism, Watchman device, hemorrhagic stroke, cardiovascular mortality, ischemic stroke, risk-benefit comparison, anticoagulation alternatives
- MeSH terms
- Anticoagulants, Atrial Fibrillation, Follow-Up Studies, Humans, Warfarin, Randomized Controlled Trials as Topic, Treatment Outcome, Atrial Appendage, Stroke
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