Danish Study to Assess the Efficacy of ICDs in Patients With Non-Ischemic Systolic Heart Failure on Mortality - DANISH
Contribution To Literature:
The DANISH trial failed to show that routine implantable cardioverter-defibrillator (ICD) implantation improved survival among patients with nonischemic cardiomyopathy.
The goal of the trial was to evaluate treatment with an ICD compared with usual care among patients with left ventricular systolic dysfunction due to nonischemic etiology.
Patients with nonischemic cardiomyopathy were randomized to ICD implantation (n = 556) versus usual care (n = 560).
- Total number of enrollees: 1,116
- Duration of follow-up: median 68 months
- Mean patient age: 64 years
- Percentage female: 27%
- Percentage diabetics: 18%
- Left ventricular ejection fraction ≤35% not due to coronary artery disease
- On optimal background medical therapy
- New York Heart Association class II or III
- N-terminal pro–B-type natriuretic peptide >200 pg/ml
- Permanent atrial fibrillation
- Awaiting heart transplant or prior major organ transplant
- Uncorrected congenital heart disease, active myocarditis, or constrictive pericarditis
- Human immunodeficiency virus positive
- On hemodialysis
- History of alcohol or illicit drug abuse
Other salient features/characteristics:
- 58% in both groups received cardiac resynchronization therapy
The primary outcome, incidence of all-cause mortality, occurred in 21.6% of the ICD group versus 23.4% of the control group (p = 0.28). Younger patients (<59 years) appeared to derive greater benefit from ICD implantation versus older patients (p for interaction = 0.009).
- Sudden cardiac death: 4.3% versus 8.2%; respectively, for ICD versus control (p = 0.005)
- Device infection: 4.9% versus 3.6%; respectively, for ICD versus control (p = 0.29)
Among patients with a nonischemic cardiomyopathy, ICD implantation did not reduce long-term mortality compared with usual care; however, there was suggestion of benefit among younger patients. Although there was lack of benefit for the primary outcome, ICD was associated with a reduction in sudden cardiac death versus usual care. Device infections were similar between the groups.
Køber L, Thune JJ, Nielsen JC, et al., on behalf of the DANISH Investigators. Defibrillator Implantation in Patients With Nonischemic Systolic Heart Failure. N Engl J Med 2016;Aug 28:[Epub ahead of print].
Editorial: McMurray JJ. The ICD in Heart Failure — Time for a Rethink? N Engl J Med 2016;Aug 28:[Epub ahead of print].
Presented by Dr. Lars Køber at the European Society of Cardiology Congress, Rome, Italy, August 28, 2016.
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