DALLAS – Cardiac resynchronization therapy demonstrated a robust cost-effectiveness of $18,275 per quality-adjusted life-year gained in an analysis from the landmark REVERSE trial.
REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) was the first large, international, randomized, double-blind clinical trial to establish that cardiac resynchronization therapy (CRT) is clinically beneficial in patients with mild heart failure (J. Am. Coll. Cardiol. 2008;52:1834-43). The incremental cost-effectiveness ratio (ICER) of $18,275 per quality-adjusted life-year (QALY) gained in the new secondary analysis is well under the figure of $50,000 per QALY gained generally accepted as the benchmark defining cost-effectiveness, Dr. Michael R. Gold noted at the American Heart Association scientific sessions.
Dr. Michael R. Gold
He presented an analysis based on an economic model that utilized 5-year follow-up data from REVERSE to predict the impact of CRT on life-years and costs out to 10 years. REVERSE included 610 patients with New York Heart Association (NYHA) class I or II heart failure, a QRS interval of 120 milliseconds or more, and a left ventricular ejection fraction of 40% or less, all of whom were on optimal medical therapy. Participants were implanted with a CRT device, which was placed in either the on or off position for the first year in North American patients or the first 2 years in Europeans, after which everyone’s device was switched on for the remainder of follow-up.
The model projected that patients with CRT turned on would gain an extra 0.83 years of life compared with those without active CRT. The ICER ratio of $18,275 per QALY gained through CRT was determined by applying costs based on national Medicare rates to the reduced heart failure hospitalization rate resulting from the device therapy, explained Dr. Gold, professor of medicine and director of cardiology at the Medical University of South Carolina, Charleston.
CRT was found to be highly cost effective in all patient subgroups examined in the analysis. For example, the projected ICER with cardiac resynchronization therapy switched on in patients with heart failure of ischemic etiology was $15,648 per QALY. In those with left bundle branch block, it was $22,086 per QALY.
Significantly fewer patients were projected to progress to NYHA class III heart failure over the course of 10 years with CRT on than off, by a margin of 18.7% to 28.1%. From the 5-year follow-up data, it was estimated that at 10 years 31% of the CRT-on group would be in NYHA class I, compared with 22.3% of controls with CRT off.
A combined CRT/implantable cardioverter-defibrillator (CRT-D) with both functions switched on had an ICER of $13,050 per QALY gained compared with CRT only.
On the basis of the results of REVERSE and the Resynchronization/Defibrillation in Ambulatory Heart Failure Trial (RAFT, N. Engl. J. Med. 2010;363:2385-95), in 2012 the Food and Drug Administration expanded the indication for Medtronic’s CRT-D device to include the treatment of patients with NYHA class II heart failure with a left ventricular ejection fraction of 30% or less, left bundle branch block, and a QRS duration of at least 130 milliseconds. The new secondary analysis of REVERSE demonstrates that CRT is not only clinically effective in patients with mild heart failure, as recognized by the FDA, it is highly cost effective as well, according to Dr. Gold.
The REVERSE trial was sponsored by Medtronic. Dr. Gold is a consultant to Medtronic and Boston Scientific.