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

https://doi.org/10.1016/j.jacc.2008.08.027Get rights and content
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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).

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

Cited by (0)

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.