BACKGROUND: Data are limited regarding whether the presence of diabetes mellitus (DM) influences the benefit of cardiac resynchronization with defibrillator therapy (CRT-D) in heart failure (HF) patients. METHODS AND RESULTS: The effect of CRT-D was evaluated in 1817 patients who were enrolled in the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT). Patients were minimally symptomatic (New York Heart Association class I or II), with ejection fraction ≤0.30 and QRS ≥130 ms. We used Cox regression to determine hazard ratio (HR) of CRT-D versus implantable cardioverter-defibrillator (ICD) therapy for the risk of HF event or death, whichever came first (MADIT-CRT primary end point), in DM (n=552) and non-DM (n=1265) patients. Compared with the non-DM patients, those with DM had more coronary risk factors. During an average follow-up of 2.4 years, DM patients had significantly more primary end point events than non-DM patients (26.6% versus 18%, P<0.001). CRT-D was associated with a significant reduction in risk of primary end point in both DM (HR=0.56, P<0.001) and non-DM patients (HR=0.67, P=0.003). Compared with non-DM patients, CRT-D:ICD HRs in DM patients were lower in the total population, and in subgroups with ischemic cardiomyopathy (0.63 versus 0.64), nonischemic cardiomyopathy (0.39 versus 0.73), and left bundle-branch block (0.36 versus 0.50). There were no significant differences in ventricular remodeling, arrhythmia events, or device-related complications between DM and non-DM patients. CONCLUSIONS:Patients with diabetes, left ventricular dysfunction, mildly symptomatic HF, and wide QRS complex derive similar benefit from CRT-D compared with patients without diabetes. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00180271.
RCT Entities:
BACKGROUND: Data are limited regarding whether the presence of diabetes mellitus (DM) influences the benefit of cardiac resynchronization with defibrillator therapy (CRT-D) in heart failure (HF) patients. METHODS AND RESULTS: The effect of CRT-D was evaluated in 1817 patients who were enrolled in the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT). Patients were minimally symptomatic (New York Heart Association class I or II), with ejection fraction ≤0.30 and QRS ≥130 ms. We used Cox regression to determine hazard ratio (HR) of CRT-D versus implantable cardioverter-defibrillator (ICD) therapy for the risk of HF event or death, whichever came first (MADIT-CRT primary end point), in DM (n=552) and non-DM (n=1265) patients. Compared with the non-DMpatients, those with DM had more coronary risk factors. During an average follow-up of 2.4 years, DMpatients had significantly more primary end point events than non-DMpatients (26.6% versus 18%, P<0.001). CRT-D was associated with a significant reduction in risk of primary end point in both DM (HR=0.56, P<0.001) and non-DMpatients (HR=0.67, P=0.003). Compared with non-DMpatients, CRT-D:ICD HRs in DMpatients were lower in the total population, and in subgroups with ischemic cardiomyopathy (0.63 versus 0.64), nonischemic cardiomyopathy (0.39 versus 0.73), and left bundle-branch block (0.36 versus 0.50). There were no significant differences in ventricular remodeling, arrhythmia events, or device-related complications between DM and non-DMpatients. CONCLUSIONS:Patients with diabetes, left ventricular dysfunction, mildly symptomatic HF, and wide QRS complex derive similar benefit from CRT-D compared with patients without diabetes. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00180271.
Authors: Jenie George; Alon Barsheshet; Arthur J Moss; David Martin; Gregory Ouellet; Scott McNitt; Ilan Goldenberg Journal: Ann Noninvasive Electrocardiol Date: 2012-01 Impact factor: 1.468
Authors: Ravi V Shah; Robert K Altman; Mi Young Park; Jodi Zilinski; Jordan Leyton-Mange; Mary Orencole; Michael H Picard; Conor D Barrett; E Kevin Heist; Gaurav Upadhyay; Ranendra Das; Jagmeet P Singh; Saumya Das Journal: Am J Cardiol Date: 2012-05-25 Impact factor: 2.778
Authors: Ulas Höke; Joep Thijssen; Rutger J van Bommel; Lieselot van Erven; Enno T van der Velde; Eduard R Holman; Martin J Schalij; Jeroen J Bax; Victoria Delgado; Nina Ajmone Marsan Journal: Diabetes Care Date: 2012-12-05 Impact factor: 19.112