TY - JOUR
T1 - Clinical effectiveness of CRT and ICD therapy in heart failure patients by racial/ethnic classification
T2 - Insights from the improve HF registry
AU - Ziaeian, Boback
AU - Zhang, Yan
AU - Albert, Nancy M.
AU - Curtis, Anne B.
AU - Gheorghiade, Mihai
AU - Heywood, J. Thomas
AU - Mehra, Mandeep R.
AU - O'Connor, Christopher M.
AU - Reynolds, Dwight
AU - Walsh, Mary Norine
AU - Yancy, Clyde W.
AU - Fonarow, Gregg C.
N1 - Funding Information:
The IMPROVE HF registry and this study are supported by Medtronic, Inc . Outcome Sciences performed data abstraction and checks, stored site-specific and aggregate data, and provided benchmarked quality-of-care reports to participating sites with funding from Medtronic . This paper was submitted to Medtronic prior to submission for publication, and all authors have read and agreed to the written content. Dr. Ziaeian’s brother is a clinical specialist for Biotronik. Dr. Zhang is an employee of Medtronic, Inc. Dr. Curtis has received research honoraria from Medtronic, Inc. and St. Jude Medical; and has served on the advisory board of Sanofi-Aventis, St. Jude Medical, Biosense Webster, Janssen Pharmaceuticals, Bristol-Myers-Squibb, Pfizer, Inc., and Daiichi Sankyo. Dr. Mehra has served as a consultant to Thoratec, Medtronic, Inc., Johnson & Johnson, St. Jude Medical, Boston Scientific, and Abbott Vascular; has received grants/research support from the National Institutes of Health / National Heart, Lung, and Blood Institute and American Board of Internal Medicine ; and serves as editor-in-chief of the Journal of Heart and Lung Transplantation. Dr. Gheorghiade has served as a consultant to Abbott Laboratories, Astellas, AstraZeneca, Bayer Schering Pharma AG, CorThera, Inc., Cytokinetics, Inc., DebioPharm SA, Errekappa Terapeutici, GlaxoSmithKline, Johnson & Johnson, Medtronic, Inc., Merck, Novartis Pharma AG, Otsuka Pharmaceuticals, Pericor Therapeutics, Protein Design Laboratories, Sanofi-Aventis, Sigma Tau, Solvay Pharmaceuticals, and Takeda. Dr. Heywood has received research grants from Biosite , Medtronic, Inc. , and St. Jude Medical; has served on the Speaker’s Bureau of or received honoraria from GlaxoSmithKline, Medtronic, AstraZeneca, Novartis, Actelion, St. Jude Medical, Otsuka, Biotronik, and Boston Scientific; and has served as a consultant to or on the advisory board of Emerge, Medtronic, Inc., Biotronik, and Actelion. Dr. O’Connor has served as a consultant to Forest, Medtronic, Inc., Amgen, Medpace, Impulse Dynamics, Actelion, Cytokinetics, Roche, and Trevena. Dr. Reynolds has received research grants from Medtronic and Biotronik ; has served on the Speakers' Bureau of Medtronic and Sorin; and has served as a consultant to Medtronic. Dr. Walsh has served on the scientific advisory board for United HealthCare; and has served as a consultant to Eli Lilly, United HealthCare, and Novartis. Dr. Fonarow has received research support from the National Institutes of Health and AHRQ ; and has served as a consultant to Medtronic, Novartis, Johnson & Johnson, Takeda, The Medicines Company, and Gambro. Drs. Albert and Yancy have reported that they have no relationships relevant to the contents of this paper to disclose.
PY - 2014/8/26
Y1 - 2014/8/26
N2 - BACKGROUND: Clinical trials have demonstrated benefit for cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillator (ICD) therapies in patients with heart failure with reduced ejection fraction (HFrEF); yet, questions have been raised with regard to the benefit of device therapy for minorities. OBJECTIVES: The purpose of this study was to determine the clinical effectiveness of CRT and ICD therapies as a function of race/ethnicity in outpatients with HFrEF (ejection fraction ≤35%). METHODS: Data from IMPROVE HF (Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting) were analyzed by device status and race/ethnicity among guideline-eligible patients for mortality at 24 months. Multivariate Generalized Estimating Equations analyses were conducted, adjusting for patient and practice characteristics. RESULTS: The ICD/cardiac resynchronization defibrillator (CRT-D)-eligible cohort (n = 7,748) included 3,391 (44%) non-Hispanic white, 719 (9%) non-Hispanic black, and 3,638 (47%) other racial/ethnic minorities or race-not-documented patients. The cardiac resynchronization pacemaker (CRT-P)/CRT-D-eligible cohort (n = 1,188) included 596 (50%) non-Hispanic white, 99 (8%) non-Hispanic black, and 493 (41%) other/not-documented patients. There was clinical benefit associated with ICD/CRT-D therapy (adjusted odds ratio: 0.64, 95% confidence interval: 0.52 to 0.79, p = 0.0002 for 24-month mortality), which was of similar proportion in white, black, and other minority/not-documented patients (device-race/ethnicity interaction p = 0.7861). For CRT-P/CRT-D therapy, there were also associated mortality benefits (adjusted odds ratio: 0.55, 95% confidence interval: 0.33 to 0.91, p = 0.0222), and the device-race/ethnicity interaction was not significant (p = 0.5413). CONCLUSIONS: The use of guideline-directed CRT and ICD therapy was associated with reduced 24-month mortality without significant interaction by racial/ethnic group. Device therapies should be offered to eligible heart failure patients, without modification based on race/ethnicity.
AB - BACKGROUND: Clinical trials have demonstrated benefit for cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillator (ICD) therapies in patients with heart failure with reduced ejection fraction (HFrEF); yet, questions have been raised with regard to the benefit of device therapy for minorities. OBJECTIVES: The purpose of this study was to determine the clinical effectiveness of CRT and ICD therapies as a function of race/ethnicity in outpatients with HFrEF (ejection fraction ≤35%). METHODS: Data from IMPROVE HF (Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting) were analyzed by device status and race/ethnicity among guideline-eligible patients for mortality at 24 months. Multivariate Generalized Estimating Equations analyses were conducted, adjusting for patient and practice characteristics. RESULTS: The ICD/cardiac resynchronization defibrillator (CRT-D)-eligible cohort (n = 7,748) included 3,391 (44%) non-Hispanic white, 719 (9%) non-Hispanic black, and 3,638 (47%) other racial/ethnic minorities or race-not-documented patients. The cardiac resynchronization pacemaker (CRT-P)/CRT-D-eligible cohort (n = 1,188) included 596 (50%) non-Hispanic white, 99 (8%) non-Hispanic black, and 493 (41%) other/not-documented patients. There was clinical benefit associated with ICD/CRT-D therapy (adjusted odds ratio: 0.64, 95% confidence interval: 0.52 to 0.79, p = 0.0002 for 24-month mortality), which was of similar proportion in white, black, and other minority/not-documented patients (device-race/ethnicity interaction p = 0.7861). For CRT-P/CRT-D therapy, there were also associated mortality benefits (adjusted odds ratio: 0.55, 95% confidence interval: 0.33 to 0.91, p = 0.0222), and the device-race/ethnicity interaction was not significant (p = 0.5413). CONCLUSIONS: The use of guideline-directed CRT and ICD therapy was associated with reduced 24-month mortality without significant interaction by racial/ethnic group. Device therapies should be offered to eligible heart failure patients, without modification based on race/ethnicity.
KW - cardiac resynchronization therapy
KW - clinical effectiveness
KW - heart failure
KW - mortality
KW - race/ethnicity
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U2 - 10.1016/j.jacc.2014.05.060
DO - 10.1016/j.jacc.2014.05.060
M3 - Article
C2 - 25145524
AN - SCOPUS:84907958163
VL - 64
SP - 797
EP - 807
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
SN - 0735-1097
IS - 8
ER -