Danish Study to Assess the Efficacy of ICDs in Patients With Non-Ischemic Systolic Heart Failure on Mortality - DANISH

Aug 28, 2016
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Presenter/Author:
Lars Kober, DSc
Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Medtronic
Date Presented:
08/28/2016
Date Published:
08/28/2016
Original Posted Date:
08/28/2016
References

Contribution To Literature:

The DANISH trial failed to show that routine implantable cardioverter-defibrillator (ICD) implantation improved survival among patients with nonischemic cardiomyopathy.

Description:

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.

Study Design

  • Randomized
  • Parallel

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%

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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

Principal Findings:

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).

Secondary outcomes:

  • 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)

Interpretation:

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.

References:

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.

Keywords: Arrhythmias, Cardiac, Cardiac Resynchronization Therapy, Cardiomyopathies, Death, Sudden, Cardiac, Defibrillators, Implantable, ESC Congress, Heart Failure, Heart Failure, Systolic, Natriuretic Peptide, Brain, Secondary Prevention, Stroke Volume, Ventricular Dysfunction, Left, ESC Congress


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