Author + information
- Received June 13, 2008
- Revision received July 31, 2008
- Accepted August 14, 2008
- Published online December 2, 2008.
- Cecilia Linde, MD, PhD⁎,⁎ (, )
- William T. Abraham, MD, FACC†,
- Michael R. Gold, MD, PhD‡,
- Martin St. John Sutton, MD§,
- Stefano Ghio, MD¶,
- Claude Daubert, MD∥,
- REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) Study Group
- ↵⁎Reprint requests and correspondence:
Dr. Cecilia Linde, Department of Cardiology, Karolinska University Hospital, S-17176 Stockholm, Sweden
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).
- cardiac resynchronization therapy
- heart failure
- randomized controlled trial
- biventricular pacing
- reverse remodeling
Dr. Linde reports research grants, speaker honoraria, and consulting fees from Medtronic and speaker honoraria and consulting fees from St. Jude Medical. Dr. Abraham reports research grants, speaker honoraria, and consulting fees from Medtronic, St. Jude Medical, and Biotronik. Dr. Gold reports consulting fees from Medtronic and Boston Scientific and lecture fees and research grants from Medtronic, Boston Scientific, and St. Jude Medical. Dr. St. John Sutton reports research grant support, speaker honoraria, and consulting fees from Medtronic as well as research support from Paracore. Dr. Ghio reports consulting fees from Medtronic. Dr. Daubert reports speaker honoraria and consulting fees from Medtronic and St. Jude Medical.
- Received June 13, 2008.
- Revision received July 31, 2008.
- Accepted August 14, 2008.
- 2008 American College of Cardiology Foundation