article159

DANISH

"ICD in Patients with Nonischemic Systolic Heart Failure and the Risk of Sudden Cardiac Death". The New England Journal of Medicine. 2016. DOI: 10.1056/NEJMoa1608029.

Clinical Question

Does prophylactic ICD implantation reduce the long-term mortality in patients with symptomatic systolic heart failure not caused by coronary artery disease compared to usual clinical care?

Bottom Line

Prophylactic ICD implantation in patients with symptomatic systolic heart failure not caused by coronary artery disease did not significantly lower the long-term rate of death from any cause when compared to usual clinical care, although it halved the risk of sudden cardiac death.

Major Points

Guidelines

At the time of the study, guidelines suggested class 1 recommendations for ICD implantation in patients with symptomatic systolic heart failure, with stronger evidence for ischemic versus nonischemic causes.

Design

- Multicenter, randomized, controlled trial
- N = 1,116 patients with symptomatic systolic heart failure not due to coronary artery disease
- Randomized to ICD (n = 556) vs usual clinical care (n = 560)
- Median follow-up: 67.6 months
- Trial conducted in Denmark

Population

- Inclusion criteria: Patients with symptomatic systolic heart failure (LVEF ≤ 35%), not due to coronary artery disease, and NT-proBNP > 200 pg/mL
- Exclusion criteria: Permanent atrial fibrillation with resting heart rate > 100 bpm, renal failure requiring dialysis

Interventions

- ICD group (n = 556)
- Usual clinical care (control) group (n = 560)
- 58% of patients received CRT in both groups

Outcomes

- The primary outcome was death from any cause.
- Secondary outcomes were sudden cardiac death and cardiovascular death.
- Sudden cardiac death occurred less frequently in the ICD group (4.3% vs 8.2%, HR 0.50; P=0.005).
- No significant difference in all-cause mortality (HR 0.87; P=0.28)
- Device infection occurred in 4.9% of ICD group and 3.6% of control group (P=0.29).

Criticisms

- Unblinded design.

Funding

- Funded by Medtronic, St. Jude Medical, TrygFonden, and the Danish Heart Foundation.