Key result
Cardiac resynchronization with defibrillator therapy reduced the risk of heart failure events or death compared to ICD therapy in both diabetic (HR 0.56, P<0.001) and non-diabetic patients.
Why the study?
Does CRT-D reduce the risk of heart failure events or death in patients with minimally symptomatic heart failure and wide QRS, regardless of diabetes status, compared to ICD therapy?
RCT (n=1,817)
Yes
Does CRT-D reduce the risk of heart failure events or death in patients with minimally symptomatic heart failure and wide QRS, regardless of diabetes status, compared to ICD therapy?
Hazard Ratio: 0.56
p-value: p=<0.001
CRT-D provides a similar reduction in the risk of heart failure events or death in patients with mildly symptomatic heart failure and wide QRS, regardless of whether they have diabetes.
CRT-D was associated with lower HF/death risk regardless of diabetes; extends observational data but leaves open need for randomized confirmation.
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.
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Martin et al. (2011) conducted an RCT in Heart failure (n=1,817). Cardiac resynchronization with defibrillator therapy (CRT-D) vs. Implantable cardioverter-defibrillator (ICD) therapy was evaluated on Heart failure event or death, whichever came first (HR 0.56, p=<0.001). Cardiac resynchronization with defibrillator therapy reduced the risk of heart failure events or death compared to ICD therapy in both diabetic (HR 0.56, P<0.001) and non-diabetic patients.
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