Longer-term effects of cardiac resynchronization therapy on mortality in heart failure [the CArdiac REsynchronization-Heart Failure (CARE-HF) trial extension phase].
By J. Cleland, J. Daubert, E. Erdmann, N. Freemantle, D. Gras, L. Kappenberger, L. Tavazzi. European Heart Journal, 2006
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AIMS The CArdiac REsynchronization-Heart Failure study randomized patients with left ventricular ejection fraction < or =35%, markers of cardiac dyssynchrony, and persistent moderate or severe symptoms of heart failure despite pharmacological therapy, to implantation of a cardiac resynchronization therapy (CRT) device or not. The main study observed substantial benefits on morbidity and mortality during a mean follow-up of 29.4 months [median 29.6, interquartile range (IQR) 23.6-34.6]. Prior to study closure, an extension phase lasting a further 8 months (allowing time for data analysis and presentation) was declared during which cross-over was discouraged. METHODS AND RESULTS This was an extension of the already reported open-label randomized trial described above. The primary outcome of the extension phase was all-cause mortality from the time of randomization to completion of the extension phase. The secondary outcome was mode of death. The mean follow-up was 37.4 months (median 37.6, IQR 31.5-42.5, range 26.1-52.6 months). There were 154 deaths (38.1%) in 404 patients assigned to medical therapy and 101 deaths (24.7%) in 409 patients assigned to CRT (hazard ratio 0.60, 95% CI 0.47-0.77, P<0.0001) without evidence of heterogeneity in pre-specified subgroups. A reduction in the risk of death due to heart failure (64 vs. 38 deaths; hazard ratio 0.55, 95% CI 0.37-0.82, P=0.003) and sudden death was observed (55 vs. 32; hazard ratio 0.54, 95% CI 0.35-0.84, P=0.005). CONCLUSION The benefits of CRT observed in the main trial persist or increase with longer follow-up. Reduction in mortality was due to fewer deaths both from worsening heart failure and from sudden death.
Subfields: Cardiology and Cardiovascular Medicine, Surgery
View Paper: https://www.semanticscholar.org/paper/74c7458ae69e2c600b1f62c437f29d5eee2540e0
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Citations in the corpus
- 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the preventionof sudden cardiac death (2015, positive): “001].(335) COMPANION and CARE-HF together provide strong evidence favouring the use of CRT (CRT-P or CRT-D) in HFrEF patients with moderate to severe symptoms who have a prolonged QRS duration, especially in those with LBBB morphology.”
- Targeted left ventricular lead placement to guide cardiac resynchronization therapy: the TARGET study: a randomized, controlled trial. (2012, background): “993 13 (13) 14 (13) 4 (4) 3 (3) 5 (5) 6 (6) 1 (1) 1 (1) 1 (1) 1 (1) 1 (1) 1 (1) 1 (1) 2 (2)”
- Cardiac resynchronization therapy for patients with left ventricular systolic dysfunction: a systematic review. (2007, positive): “Consequently, although our meta-analysis demonstrated a number needed to treat to prevent 1 death of 29 patients at 6 months, the CARE-HF trial follow-up data demonstrated the numbers needed to treat to prevent 1 death of 13 patients at 2 years and 9 patients at 3 years.(137) The long-term impact of”