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J Am Coll Cardiol, doi:10.1016/j.jacc.2008.08.027 (Published online 17 September 2008)
© 2008 by the American College of Cardiology Foundation
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EXPEDITED PUBLICATION

Randomized Trial of Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in Asymptomatic Patients With Left Ventricular Dysfunction and Previous Heart Failure Symptoms

Cecilia Linde, MD, PhD*,*, William T. Abraham, MD, FACC{dagger}, Michael R. Gold, MD, PhD{ddagger}, Martin St. John Sutton, MD§, Stefano Ghio, MD, Claude Daubert, MD|| on behalf of the REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) Study Group

* Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden
{dagger} Division of Cardiovascular Medicine and the Davis Heart and Lung Research Institute, Ohio State University, Columbus, Ohio
{ddagger} Division of Cardiology, Medical University of South Carolina, Charleston, South Carolina
§ University of Pennsylvania Medical Center, Philadelphia, Pennsylvania
Policlinico San Matteo, Pavia, Italy
|| Département de Cardiologie, CHU, Rennes, France

Manuscript received June 13, 2008; revised manuscript received July 31, 2008, accepted August 14, 2008.

* Reprint requests and correspondence: Dr. Cecilia Linde, Department of Cardiology, Karolinska University Hospital, S-17176 Stockholm, Sweden (Email: cecilia.linde{at}ki.se).

Objectives: 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 ≥120 ms and a LV ejection fraction ≤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 [ClinicalTrials.gov] ).

Key Words: cardiac resynchronization therapy • heart failure • randomized controlled trial • biventricular pacing • reverse remodeling

Abbreviations and Acronyms
  AEAC = Adverse Event Advisory/Endpoint Committee
  CRT = cardiac resynchronization therapy
  HF = heart failure
  ICD = implantable cardioverter-defibrillator
  LV = left ventricular
  LVESVi = left ventricular end-systolic volume index
  NYHA = New York Heart Association






 
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