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Cardiac Resynchronization Heart Failure Study - CARE-HF
Description:
The goal of the trial was to evaluate the addition of cardiac resynchronization therapy (CRT) to optimal pharmacological therapy in patients with advanced heart failure and cardiac dyssynchrony despite standard pharmacological therapy.
Study Design
Study Design:
Patients Enrolled: 813
Mean Follow Up: 29.4 months
Mean Patient Age: 67 years
Female: 26
Patient Populations:
Age ≥18 years, LVEF ≤35%, cardiac dyssynchrony, and in sinus rhythm with New York Heart Association class III or IV heart failure despite optimal pharmacologic therapy
Exclusions:
Major cardiovascular event in the previous six weeks, conventional indications for a pacemaker or an implantable defibrillator, heart failure requiring continuous intravenous therapy, or atrial arrhythmias
Primary Endpoints:
Time to first event for the composite of hospitalization for a major cardiovascular event or all-cause mortality
Secondary Endpoints:
All-cause mortality
Drug/Procedures Used:
Patients were randomized in an open-label manner to continued standard pharmacological therapy alone (n=404) or standard pharmacological therapy combined with CRT (n=409). Patients were followed for a minimum of 18 months (mean 29.4 months) and at least 280 primary events.
Concomitant Medications:
High-dose loop diuretics, 44%; angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, 95%; beta-blocker, 72%; digoxin, 43%; and aldosterone antagonist, 56%.
Principal Findings:
Baseline clinical characteristics were similar between the treatment groups, with 46% of patients having dilated cardiomyopathy and 38% with ischemic heart disease. Mean left ventricular ejection fraction (LVEF) was 25%. Of the 409 patients randomized to the CRT device, 95% had a successful implantation.
The primary endpoint of all-cause mortality or hospitalization for a major cardiovascular event occurred less frequently in the CRT group than the medical therapy alone group (39% vs. 55%, hazard ratio [HR] 0.63, 95% confidence interval [CI] 0.51-0.77, p<0.001). The major secondary endpoint of all-cause mortality was also lower in the CRT group (20% vs. 30%, HR 0.64, 95% CI 0.48-0.85, p<0.002). The composite of death or hospitalization for worsening heart failure was also lower in the CRT group (HR 0.54, p<0.001). Patients in the CRT group had a lower New York Heart Association class (2.1 vs. 2.7, p<0.001) and a higher Euro Quality of Life score (0.70 vs. 0.63, p<0.001) at 90 days. Mean LVEF at 18 months was an average of 6.9% higher in the CRT group compared with the medical therapy alone group (p<0.001).
Interpretation:
Among patients with advanced heart failure and cardiac dyssynchrony despite standard pharmacological therapy, treatment with CRT was associated with a reduction in the primary endpoint of all-cause mortality and hospitalization for major cardiovascular events compared with standard pharmacological therapy.
Similar results were observed in the COMPANION trial, which showed a reduction in the composite endpoint of death or hospitalization through a mean 16-month follow-up in patients treated with CRT with or without an implantable defibrillator, but the reduction in mortality did not reach statistical significance (p=0.06). In the present study, which followed patients through a mean of 29 months, the reduction in mortality in the CRT was significantly lower compared with standard medical therapy alone.
References:
Cleland JG, Daubert JC, Erdmann E, et al. The Effect of Cardiac Resynchronization on Morbidity and Mortality in Heart Failure. N Engl J Med 2005 Mar 7; [Epub ahead of print].
Presented by Dr. John G. Cleland at the March 2005 ACC Annual Scientific Session, Orlando, FL.
Keywords: Myocardial Ischemia, Ventricular Function, Left, Quality of Life, Heart Failure, Stroke Volume, Hospitalization, Defibrillators, Implantable, Cardiomyopathy, Dilated, Cardiac Resynchronization Therapy
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