Abstract 1898: CRT In Patients With Asymptomatic And Mildly Symptomatic Heart Failure: Baseline Characteristics Of The Resynchronization Reverses Remodeling In Systolic Left Ventricular Dysfunction (reverse) Study Population.
Background Little is known about the effects of cardiac resynchronization therapy (CRT) in NYHA I-II patients. The REVERSE study is assessing the efficacy of CRT in patients with previously symptomatic (ACC/AHA stage C, NYHA I) and mildly symptomatic (NYHA II) heart failure (HF), an LVEF ≤40%, sinus rhythm, QRS ≥120 ms and on stable optimal medical therapy. The baseline characteristics of patients in this first large, randomized trial evaluating CRT±ICD are reported here.
Methods REVERSE is an international, multicenter, prospective, randomized, double blind, controlled study in North America and Europe to assess whether CRT±ICD compared to no CRT can attenuate disease progression and reverse left ventricular remodelling over 12 months. Eligible patients had an LVEF ≤40%, sinus rhythm, QRS ≥120 ms, and were on stable optimal medical therapy. The primary endpoint is the HF clinical composite response, with LVESVi as the principal secondary endpoint.
Results REVERSE enrollment was completed in September 2006. Enrollment ended with 648 patients (US: n=366, Canada: n=5, Europe: n=277) completing baseline (610 were randomized). Implant success rate was 96.7%. Baseline characteristics for the randomized patients are presented in the table⇓ (mean ± SD, or %).
Conclusion: Compared to previous randomized CRT trials mainly in NYHA III-IV patients, the REVERSE study patients are younger and have a narrower QRS. Despite the higher use of recommended HF medical therapy compared to previous trials, LV dysfunction is of similar magnitude to that of NYHA III-IV patients, indicating a potential to reverse left ventricular remodeling by CRT in these NYHA I-II patients. The results may give insight into the demographics of NYHA I-II patients, a potential new population for CRT. The overall results of the REVERSE study will be reported in 2008.