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Does cardiac resynchronisation therapy benefit patients with NYHA I–II heart failure?
Cardiac resynchronisation therapy (CRT) is an effective addition to pharmacological treatment in reducing the hospitalisation rate of symptomatic patients with advanced (NYHA III–IV) heart failure symptoms, ejection fraction (EF) <35% and an intraventricular conduction delay of >120 ms. The MADIT-CRT trial (Multicentre Automatic Defibrillator Implantation Trial with Cardiac Resynchronisation Therapy) was designed to assess whether prophylactic CRT in combination with an implantable cardioverter-defibrillator (ICD) would reduce the risk of death or non-fatal heart failure events in patients with an EF <30%, QRS duration >130 ms but NYHA I–II symptoms, as compared with ICD implantation alone.
Over a 4-year period from December 2004, 1820 patients were enrolled at 110 hospitals in the United States, Canada and Europe. Patients were seen in clinic at 1 month after randomisation and then every 3 months until trial termination. Baseline assessment included an echocardiogram and 6 min walk test. Patients were randomised in a 3:2 fashion to either CRT with an ICD (CRT-ICD), n = 1089 or an ICD alone (n = 731). Further echocardiographic assessment was performed at 1 year to assess changes in the LV volumes and EF. The primary end point was death from any cause or non-fatal heart failure events—whichever came first.
Follow-up was for an average of 2.4 years. The primary end point occurred in 17.2% in the CRT-ICD arm and 25.3% in the ICD arm (HR = 0.66, 95% CI 0.52 to 0.84, p = 0.001). The benefit did not differ significantly between patients with ischaemic or non-ischaemic cardiomyopathy. The superiority of CRT was driven by a 41% reduction in the risk of heart failure events; this was evident primarily in a prespecified subgroup of patients with a QRS duration of ⩾150 ms. …
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