Background
The Ambulatory Resynchronization-Defibrillation Trial for Heart Failure (RAFT) showed a greater benefit with respect to 5-year mortality among patients who received cardiac resynchronization therapy (CRT) than among those who received implantable cardioverter-defibrillators (ICDs). However, the effect of CRT on long-term survival is unknown.
Methods
We randomly assigned patients with New York Heart Association (NYHA) class II or III heart failure, a left ventricular ejection fraction of 30% or less, and an intrinsic QRS duration of 120 ms or more (or a duration of Paced QRS of 200 ms or longer) to receive an ICD alone or a CRT defibrillator (CRT-D).
We evaluated long-term outcomes among patients at the eight participating sites with the highest enrollment. The primary outcome was death from any cause; the secondary outcome was a composite of death from any cause, heart transplant, or ventricular assist device implantation.
Results
1,798 patients participated in the trial, of whom 1,050 were included in the long-term survival trial; The median duration of follow-up for the 1,050 patients was 7.7 years (interquartile range, 3.9 to 12.8), and the median duration of follow-up for those who survived was 13.9 years (range interquartile, 12.8 to 15.7).
Death occurred in 405 of 530 patients (76.4%) assigned to the ICD group and in 370 of 520 patients (71.2%) assigned to the CRT-D group. Time to death appeared to be longer for those assigned to receive a CRT-D than for those assigned to receive an ICD (acceleration factor, 0.80; 95% confidence interval, 0.69 to 0.92; P = 0.002).
A secondary outcome event occurred in 412 patients (77.7%) in the ICD group and 392 (75.4%) in the CRT-D group.
Conclusions Among patients with a reduced ejection fraction, a widened QRS complex, and NYHA class II or III heart failure, the survival benefit associated with receiving a CRT-D compared with an ICD appeared to be maintained for a median of almost 14 years of follow-up. |
(RAFT ClinicalTrials.gov number, NCT00251251)
