Martin Stockburger1, Arthur J Moss2, Brian Olshansky3, Helmut Klein2, Scott McNitt2, Claudio Schuger4, James P Daubert5, Ilan Goldenberg2, Anne-Christine H Ruwald2, Bela Merkely6, Wojciech Zareba2, Valentina Kutyifa7. 1. Experimental and Clinical Research Center, a Joint Cooperation Between the Charité Medical Faculty and the Max-Delbrueck Center for Molecular Medicine, Berlin, Germany Havelland Kliniken, Nauen, Germany. 2. University of Rochester Medical Center, 265 Crittenden Blvd., Box 653, Rochester, NY 14642, USA. 3. Department of Medicine, University of Iowa Health Care, Iowa City, IA, USA. 4. Department of Electrophysiology, The Henry Ford Hospital, Detroit, MI, USA. 5. Electrophysiology Department, Duke Medical Center, Durham, NC, USA. 6. Semmelweis University, Heart Center, Budapest, Hungary. 7. University of Rochester Medical Center, 265 Crittenden Blvd., Box 653, Rochester, NY 14642, USA valentina.kutyifa@heart.rochester.edu.
Abstract
AIMS: Data on the time-dependent benefit of cardiac resynchronization therapy with defibrillator (CRT-D) compared with a dual-chamber implantable cardioverter-defibrillator (ICD) to reduce death or ventricular tachycardia (VT) or ventricular fibrillation (VF) are limited. We aimed to evaluate the time-related risk of death or sustained VT or VF in patients receiving CRT-D vs. ICD in the MADIT-RIT trial. METHODS AND RESULTS: Kaplan-Meier survival analyses and multivariate Cox regression models were utilized to compare the incidence and the risk of death or sustained VT/VF in the CRT-D and ICD subgroups by the elapsed time after device implantation (6 months). Of the ICD (n = 742) and CRT-D (n = 757) patients enrolled, the risk of death was lower in CRT-D vs. in ICD early after device implantation [hazard ratio (HR) = 0.42, 95% confidence interval (CI): 0.17-1.03, P = 0.058] and beyond 6 months of follow-up (HR = 0.39, 95% CI: 0.21-0.73, P = 0.004), with the 6-month interaction P = 0.899. The overall risk of sustained VT/VF was reduced in CRT-D vs. ICD patients (HR = 0.73, 95% CI: 0.52-1.03, P = 0.07). However, the risk was similar in the first 6 months (HR = 1.00, 95% CI: 0.62-1.62, P = 0.988), and a lower risk emerged 6 months after CRT-D implantation (HR = 0.58, 95% CI: 0.38-0.88, P = 0.011), with the 6-month interaction P = 0.059. CONCLUSION: The reduced mortality risk of CRT-D compared with an ICD alone began early after device implantation and was sustained during long-term follow-up; the reduced risk for ventricular tachyarrhythmias did not emerge until 6 months after device implantation. CLINICAL TRIAL REGISTRATION: http://clinicaltrials.gov/ct2/show/NCT00947310. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: Data on the time-dependent benefit of cardiac resynchronization therapy with defibrillator (CRT-D) compared with a dual-chamber implantable cardioverter-defibrillator (ICD) to reduce death or ventricular tachycardia (VT) or ventricular fibrillation (VF) are limited. We aimed to evaluate the time-related risk of death or sustained VT or VF in patients receiving CRT-D vs. ICD in the MADIT-RIT trial. METHODS AND RESULTS: Kaplan-Meier survival analyses and multivariate Cox regression models were utilized to compare the incidence and the risk of death or sustained VT/VF in the CRT-D and ICD subgroups by the elapsed time after device implantation (6 months). Of the ICD (n = 742) and CRT-D (n = 757) patients enrolled, the risk of death was lower in CRT-D vs. in ICD early after device implantation [hazard ratio (HR) = 0.42, 95% confidence interval (CI): 0.17-1.03, P = 0.058] and beyond 6 months of follow-up (HR = 0.39, 95% CI: 0.21-0.73, P = 0.004), with the 6-month interaction P = 0.899. The overall risk of sustained VT/VF was reduced in CRT-D vs. ICDpatients (HR = 0.73, 95% CI: 0.52-1.03, P = 0.07). However, the risk was similar in the first 6 months (HR = 1.00, 95% CI: 0.62-1.62, P = 0.988), and a lower risk emerged 6 months after CRT-D implantation (HR = 0.58, 95% CI: 0.38-0.88, P = 0.011), with the 6-month interaction P = 0.059. CONCLUSION: The reduced mortality risk of CRT-D compared with an ICD alone began early after device implantation and was sustained during long-term follow-up; the reduced risk for ventricular tachyarrhythmias did not emerge until 6 months after device implantation. CLINICAL TRIAL REGISTRATION: http://clinicaltrials.gov/ct2/show/NCT00947310. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Leonard Bergau; Tobias Tichelbäcker; Barbora Kessel; Lars Lüthje; Thomas H Fischer; Tim Friede; Markus Zabel Journal: PLoS One Date: 2017-10-17 Impact factor: 3.240