PMID- 19038680 OWN - NLM STAT- MEDLINE DCOM- 20090106 LR - 20220321 IS - 1558-3597 (Electronic) IS - 0735-1097 (Linking) VI - 52 IP - 23 DP - 2008 Dec 2 TI - Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. PG - 1834-1843 LID - S0735-1097(08)02913-6 [pii] LID - 10.1016/j.jacc.2008.08.027 [doi] AB - 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 > 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). FAU - Linde, Cecilia AU - Linde C AD - Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden. Electronic address: cecilia.linde@ki.se. FAU - Abraham, William T AU - Abraham WT AD - Division of Cardiovascular Medicine and the Davis Heart and Lung Research Institute, Ohio State University, Columbus, Ohio. FAU - Gold, Michael R AU - Gold MR AD - Division of Cardiology, Medical University of South Carolina, Charleston, South Carolina. FAU - St John Sutton, Martin AU - St John Sutton M AD - University of Pennsylvania Medical Center, Philadelphia, Pennsylvania. FAU - Ghio, Stefano AU - Ghio S AD - Policlinico San Matteo, Pavia, Italy. FAU - Daubert, Claude AU - Daubert C AD - Departement de Cardiologie, CHU, Rennes, France. CN - REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) Study Group LA - eng SI - ClinicalTrials.gov/NCT00271154 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20081107 PL - United States TA - J Am Coll Cardiol JT - Journal of the American College of Cardiology JID - 8301365 SB - IM CIN - J Am Coll Cardiol. 2008 Dec 2;52(23):1844-6. PMID: 19038681 CIN - J Am Coll Cardiol. 2009 Jun 9;53(23):2198; author reply 2198-9. PMID: 19497450 CIN - J Am Coll Cardiol. 2010 Jan 19;55(3):257-8. PMID: 20117407 MH - Aged MH - Cardiac Pacing, Artificial/*methods MH - Cross-Over Studies MH - Double-Blind Method MH - Female MH - Heart/physiology MH - Heart Failure/*therapy MH - Humans MH - Male MH - Middle Aged MH - Prospective Studies MH - Risk MH - Treatment Outcome MH - Ventricular Dysfunction, Left/*therapy MH - Ventricular Remodeling EDAT- 2008/11/29 09:00 MHDA- 2009/01/07 09:00 CRDT- 2008/11/29 09:00 PHST- 2008/06/13 00:00 [received] PHST- 2008/07/31 00:00 [revised] PHST- 2008/08/14 00:00 [accepted] PHST- 2008/11/29 09:00 [pubmed] PHST- 2009/01/07 09:00 [medline] PHST- 2008/11/29 09:00 [entrez] AID - S0735-1097(08)02913-6 [pii] AID - 10.1016/j.jacc.2008.08.027 [doi] PST - ppublish SO - J Am Coll Cardiol. 2008 Dec 2;52(23):1834-1843. doi: 10.1016/j.jacc.2008.08.027. Epub 2008 Nov 7.