Abhinav Sharma1,2, Sana M Al-Khatib1, Justin A Ezekowitz3, Lauren B Cooper1,4, Christopher B Fordyce5, G Michael Felker1, Gust H Bardy6, Jeanne E Poole7, J Thomas Bigger8, Alfred E Buxton9, Arthur J Moss10, Daniel J Friedman1, Kerry L Lee1, Richard Steinman11, Paul Dorian12, Riccardo Cappato13,14,15, Alan H Kadish16, Peter J Kudenchuk17, Daniel B Mark1, Eric D Peterson1, Lurdes Y T Inoue18, Gillian D Sanders1. 1. Duke Clinical Research Institute, Duke University, Durham, NC, USA. 2. Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Alberta, Canada. 3. Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada. 4. Inova Heart and Vascular Institute, Falls Church, VA, USA. 5. Division of Cardiology, University of British Columbia, Vancouver, BC, Canada. 6. Seattle Institute for Cardiac Research, Seattle, WA, USA. 7. University of Washington, Seattle, WA, USA. 8. Department of Medicine, Columbia University, New York, NY, USA. 9. Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, MA, USA. 10. Heart Research Follow-up Program, University of Rochester Medical Center, Rochester, MN, USA. 11. Irving Institute for Clinical and Translational Research, Columbia University, New York, NY, USA. 12. Departments of Medicine and Cardiology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. 13. IRCCS Policlinico San Donato, Milan, Italy. 14. Humanitas Clinical And Research Center, via Manzoni 56 20089 Rozzano (Mi). 15. Humanitas University Department of Biomedical Sciences Via Rita Levi Montalcini 4 Pieve Emanuele (Mi). 16. Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. 17. Division of Cardiology, University of Washington, Seattle, WA, USA. 18. Department of Biostatistics, University of Washington, Seattle, WA, USA.
Abstract
AIM: There is limited information on the outcomes after primary prevention implantable cardioverter-defibrillator (ICD) implantation in patients with heart failure (HF) and diabetes. This analysis evaluates the effectiveness of a strategy of ICD plus medical therapy vs. medical therapy alone among patients with HF and diabetes. METHODS AND RESULTS: A patient-level combined-analysis was conducted from a combined dataset that included four primary prevention ICD trials of patients with HF or severely reduced ejection fractions: Multicenter Automatic Defibrillator Implantation Trial I (MADIT I), MADIT II, Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE), and Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). In total, 3359 patients were included in the analysis. The primary outcome of interest was all-cause death. Compared with patients without diabetes (n = 2363), patients with diabetes (n = 996) were older and had a higher burden of cardiovascular risk factors. During a median follow-up of 2.6 years, 437 patients without diabetes died (178 with ICD vs. 259 without) and 280 patients with diabetes died (128 with ICD vs. 152 without). ICDs were associated with a reduced risk of all-cause mortality among patients without diabetes [hazard ratio (HR) 0.56, 95% confidence interval (CI) 0.46-0.67] but not among patients with diabetes (HR 0.88, 95% CI 0.7-1.12; interaction P = 0.015). CONCLUSION: Among patients with HF and diabetes, primary prevention ICD in combination with medical therapy vs. medical therapy alone was not significantly associated with a reduced risk of all-cause death. Further studies are needed to evaluate the effectiveness of ICDs among patients with diabetes.
RCT Entities:
AIM: There is limited information on the outcomes after primary prevention implantable cardioverter-defibrillator (ICD) implantation in patients with heart failure (HF) and diabetes. This analysis evaluates the effectiveness of a strategy of ICD plus medical therapy vs. medical therapy alone among patients with HF and diabetes. METHODS AND RESULTS: A patient-level combined-analysis was conducted from a combined dataset that included four primary prevention ICD trials of patients with HF or severely reduced ejection fractions: Multicenter Automatic Defibrillator Implantation Trial I (MADIT I), MADIT II, Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE), and Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). In total, 3359 patients were included in the analysis. The primary outcome of interest was all-cause death. Compared with patients without diabetes (n = 2363), patients with diabetes (n = 996) were older and had a higher burden of cardiovascular risk factors. During a median follow-up of 2.6 years, 437 patients without diabetes died (178 with ICD vs. 259 without) and 280 patients with diabetes died (128 with ICD vs. 152 without). ICDs were associated with a reduced risk of all-cause mortality among patients without diabetes [hazard ratio (HR) 0.56, 95% confidence interval (CI) 0.46-0.67] but not among patients with diabetes (HR 0.88, 95% CI 0.7-1.12; interaction P = 0.015). CONCLUSION: Among patients with HF and diabetes, primary prevention ICD in combination with medical therapy vs. medical therapy alone was not significantly associated with a reduced risk of all-cause death. Further studies are needed to evaluate the effectiveness of ICDs among patients with diabetes.
Authors: Abhinav Sharma; Jingjing Wu; Haolin Xu; Adrian Hernandez; G Michael Felker; Sana Al-Khatib; Jennifer Green; Roland Matsouaka; Gregg C Fonarow; Jagmeet P Singh; Paul A Heidenreich; Justin A Ezekowitz; Adam DeVore Journal: J Am Heart Assoc Date: 2020-05-30 Impact factor: 5.501
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