Comparative Effectiveness of Left Atrial Appendage Occlusion Versus Oral Anticoagulation by Sex

Background: The comparative real-world outcomes of older patients with atrial fibrillation (AF) treated with anticoagulation compared with left atrial appendage occlusion (LAAO) may be different from those in clinical trials because of differences in anticoagulation strategies and patient demographics, including a greater proportion of women. We sought to compare real-world outcomes between older patients with AF treated with anticoagulation and those treated with LAAO by sex. Methods: Using Medicare claims data from 2015 to 2019, we identified LAAO-eligible beneficiaries and divided them into sex subgroups. Patients receiving LAAO were matched 1:1 to those receiving anticoagulation alone through propensity score matching. The risks of mortality, stroke or systemic embolism, and bleeding were compared between matched groups with adjustment for potential confounding characteristics in Cox proportional hazards models. Results: Among women, 4085 LAAO recipients were matched 1:1 to those receiving anticoagulation; among men, 5378 LAAO recipients were similarly matched. LAAO was associated with a significant reduction in the risk of mortality for women and men (hazard ratio [HR], 0.509 [95% CI, 0.447–0.580]; and HR, 0.541 [95% CI, 0.487–0.601], respectively; P<0.0001), with a similar finding for stroke or systemic embolism (HR, 0.655 [95% CI, 0.555–0.772]; and HR, 0.649 [95% CI, 0.552–0.762], respectively; P<0.0001). Bleeding risk was significantly greater in LAAO recipients early after implantation but lower after the 6-week periprocedural period for women and men (HR, 0.772 [95% CI, 0.676–0.882]; and HR, 0.881 [95% CI, 0.784–0.989], respectively; P<0.05). Conclusions: In a real-world population of older Medicare beneficiaries with AF, compared with anticoagulation, LAAO was associated with a reduction in the risk of death, stroke, and long-term bleeding among women and men. These findings should be incorporated into shared decision-making with patients considering strategies for reduction in AF-related stroke.

[1]  P. Noseworthy,et al.  Percutaneous Left Atrial Appendage Occlusion in Comparison to Non‐Vitamin K Antagonist Oral Anticoagulant Among Patients With Atrial Fibrillation , 2022, Journal of the American Heart Association.

[2]  M. Price,et al.  Antithrombotic Therapy After Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation. , 2022, Journal of the American College of Cardiology.

[3]  S. Al‐Khatib,et al.  Coverage with evidence development: where are we now? , 2019, The American journal of managed care.

[4]  P. Neužil,et al.  Left Atrial Appendage Closure versus Non-Warfarin Oral Anticoagulation in Atrial Fibrillation: 4-Year Outcomes of PRAGUE-17. , 2021, Journal of the American College of Cardiology.

[5]  Frederick T. Han,et al.  Sex Differences in Procedural Outcomes Among Patients Undergoing Left Atrial Appendage Occlusion: Insights From the NCDR LAAO Registry. , 2021, JAMA cardiology.

[6]  M. Alkhouli.  Moving the Needle Forward for More Relevant Evidence on Left Atrial Appendage Occlusion. , 2021, JACC. Cardiovascular interventions.

[7]  H. Diener,et al.  Clinical Outcomes Associated With Left Atrial Appendage Occlusion Versus Direct Oral Anticoagulation in Atrial Fibrillation. , 2021, JACC. Cardiovascular interventions.

[8]  E. Michos,et al.  Sex‐stratified analysis of the safety of percutaneous left atrial appendage occlusion , 2020, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[9]  P. Neužil,et al.  Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation. , 2020, Journal of the American College of Cardiology.

[10]  S. Windecker,et al.  Left atrial appendage closure versus medical therapy for atrial fibrillation: the APPLY study. , 2020, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[11]  M. Price,et al.  The NCDR Left Atrial Appendage Occlusion Registry. , 2020, Journal of the American College of Cardiology.

[12]  D. Delurgio,et al.  Long-Term Safety and Efficacy in Continued Access Left Atrial Appendage Closure Registries. , 2019, Journal of the American College of Cardiology.

[13]  S. Kische,et al.  Evaluating Real-World Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology: Final 2-Year Outcome Data of the EWOLUTION Trial Focusing on History of Stroke and Hemorrhage , 2019, Circulation. Arrhythmia and electrophysiology.

[14]  Hugh Calkins,et al.  2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. , 2019, Heart rhythm.

[15]  Hugh Calkins,et al.  2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. , 2019, Journal of the American College of Cardiology.

[16]  A. Natale,et al.  Sex differences in complications of catheter ablation for atrial fibrillation: results on 85,977 patients , 2018, Journal of Interventional Cardiac Electrophysiology.

[17]  S. Kische,et al.  Incidence of pericardial effusion after left atrial appendage closure: The impact of underlying heart rhythm—Data from the EWOLUTION study , 2018, Journal of cardiovascular electrophysiology.

[18]  Saibal Kar,et al.  5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. , 2017, Journal of the American College of Cardiology.

[19]  Christopher X. Wong,et al.  Atrial fibrillation as risk factor for cardiovascular disease and death in women compared with men: systematic review and meta-analysis of cohort studies , 2016, British Medical Journal.

[20]  M. Price,et al.  Bleeding Outcomes After Left Atrial Appendage Closure Compared With Long-Term Warfarin: A Pooled, Patient-Level Analysis of the WATCHMAN Randomized Trial Experience. , 2015, JACC. Cardiovascular interventions.

[21]  A. Russo,et al.  Gender and outcomes after primary prevention implantable cardioverter-defibrillator implantation: Findings from the National Cardiovascular Data Registry (NCDR). , 2015, American heart journal.

[22]  Saibal Kar,et al.  Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. , 2014, JAMA.

[23]  M. Price,et al.  Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. , 2014, Journal of the American College of Cardiology.

[24]  V. Prasad,et al.  Falsification end points for observational studies--reply. , 2013, JAMA.

[25]  Lesley H. Curtis,et al.  Incidence and Prevalence of Atrial Fibrillation and Associated Mortality Among Medicare Beneficiaries: 1993–2007 , 2012, Circulation. Cardiovascular quality and outcomes.

[26]  Maurice Buchbinder,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 , 2009, The Lancet.

[27]  D. Rubin,et al.  Constructing a Control Group Using Multivariate Matched Sampling Methods That Incorporate the Propensity Score , 1985 .