Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms.
OBJECTIVE
We sought to determine the effects of cardiac resynchronization therapy (CRT) in New York Heart Association (NYHA) functional class II heart failure (HF) and NYHA functional class I (American College of Cardiology/American Heart Association stage C) patients with previous HF symptoms.


BACKGROUND
Cardiac resynchronization therapy improves left ventricular (LV) structure and function and clinical outcomes in NYHA functional class III and IV HF with prolonged QRS.


METHODS
Six hundred ten patients with NYHA functional class I or II heart failure with a QRS > or =120 ms and a LV ejection fraction < or =40% received a CRT device (+/-defibrillator) and were randomly assigned to active CRT (CRT-ON; n = 419) or control (CRT-OFF; n = 191) for 12 months. The primary end point was the HF clinical composite response, which scores patients as improved, unchanged, or worsened. The prospectively powered secondary end point was LV end-systolic volume index. Hospitalization for worsening HF was evaluated in a prospective secondary analysis of health care use.


RESULTS
The HF clinical composite response end point, which compared only the percent worsened, indicated 16% worsened in CRT-ON compared with 21% in CRT-OFF (p = 0.10). Patients assigned to CRT-ON experienced a greater improvement in LV end-systolic volume index (-18.4 +/- 29.5 ml/m2 vs. -1.3 +/- 23.4 ml/m2, p < 0.0001) and other measures of LV remodeling. Time-to-first HF hospitalization was significantly delayed in CRT-ON (hazard ratio: 0.47, p = 0.03).


CONCLUSIONS
The REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) trial demonstrates that CRT, in combination with optimal medical therapy (+/-defibrillator), reduces the risk for heart failure hospitalization and improves ventricular structure and function in NYHA functional class II and NYHA functional class I (American College of Cardiology/American Heart Association stage C) patients with previous HF symptoms. (REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction [REVERSE]; NCT00271154).
Linde
Cecilia
C
Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden. Electronic address: cecilia.linde@ki.se.
Abraham
William T
WT
Division of Cardiovascular Medicine and the Davis Heart and Lung Research Institute, Ohio State University, Columbus, Ohio.
Gold
Michael R
MR
Division of Cardiology, Medical University of South Carolina, Charleston, South Carolina.
St John Sutton
Martin
M
University of Pennsylvania Medical Center, Philadelphia, Pennsylvania.
Ghio
Stefano
S
Policlinico San Matteo, Pavia, Italy.
Daubert
Claude
C
Département de Cardiologie, CHU, Rennes, France.
D000368:Aged; D002304:Cardiac Pacing, Artificial / Q000379:methods*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006321:Heart / Q000502:physiology; D006333:Heart Failure / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012306:Risk; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000628:therapy*; D020257:Ventricular Remodeling