DANISH Trial Shows ICD in Nonischemic HF Does Not Reduce Long-Term Mortality
Prophylactic implantable cardioverter defibrillator (ICD) implantation in patients with symptomatic systolic heart failure (HF) not caused by coronary artery disease did not “significantly lower long-term rate of death from any cause” as compared to usual care, according to results from the DANISH Trial presented Aug. 28 at ESC Congress 2016 in Rome and published simultaneously in the New England Journal of Medicine.
The trial, led by Lars Kober, MD, DMSc, et al., randomly assigned 1,116 patients to receive an ICD (556 patients) vs. usual care (560 patients). In both groups, 58 percent of patients received CRT. Results showed that at after 5.6 years, the primary outcome of death from any cause occurred in 120 patients in the ICD group vs. 131 patients in the usual care group (hazard ratio, 0.87; 95 percent confidence interval, 0.68 to 1.12; P=0.28). The secondary endpoint of sudden cardiac death occurred in 24 patients in the ICD group vs. 46 patients in the usual care group (P=0.005).
The authors explain that they saw an “important interaction with age that suggested that younger patients may have a survival benefit in association with an ICD implantation.” They add that they didn’t find a difference “in the relative effect of an ICD between patients who received CRT and patients who did not.”
In a related editorial comment, John J.V. McMurray, MD, FACC, explains that the results “probably represent the most optimistic estimate of the benefit of ICD therapy in patients with nonischemic HF who receive evidence-based treatment.” He adds that “these considerations highlight the need to target ICDs to the patients most likely to benefit … those that remain at high absolute risk for sudden cardiac death despite receiving the best available pharmacologic and device therapy.”
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