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DANISH: Prophylactic ICD implantation not superior to usual care in some patients with systolic HF

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In patients with symptomatic systolic HF not due to CAD, prophylactic implantation of an implantable cardioverter defibrillator did not improve outcomes compared with the usual care, according to the results of the DANISH study.

The researchers conducted a randomized controlled trial of 1,116 patients with symptomatic systolic HF, all of whom had left ventricular ejection fraction 35%. Patients were assigned an ICD (n = 556; median age, 64 years; 27% women) or the usual care (n = 560; median age, 63 years; 28% women). In both groups, cardiac resynchronization therapy was used in 58% of patients.

The primary outcome was all-cause mortality. Secondary outcomes were CV death and sudden cardiac death. Median follow-up was 67.6 months.

Lars Køber, MD, DMSc, from the department of cardiology at Rigshospitalet, University Hospital, Copenhagen, Denmark, and colleagues found that during the study period, the primary outcome occurred in 21.6% of patients assigned an ICD and in 23.4% of those assigned the usual care (HR = 0.87; 95% CI, 0.68-1.12).

There was no significant difference in CV death (ICD group, 13.8%; controls, 17%; HR = 0.77; 95% CI, 0.57-1.05), according to the researchers.

However, Køber and colleagues wrote, sudden cardiac death occurred less often in the ICD group (4.3% vs. 8.2%; HR = 0.5; 95% CI, 0.31-0.82).

The rate of device infection was 4.9% in the ICD group and 3.6% in the control group.

“There was an important interaction with age that suggested that younger patients may have a survival benefit in association with ICD implantation,” the researchers wrote. “The side effects associated with device implantation in our trial were not trivial.” – by Erik Swain

References:

Køber L, et al. Hot Line: Heart failure and innovative approaches. Presented at: European Society of Cardiology Congress; Aug. 27-31, 2016; Rome.

Køber L, et al. N Engl J Med. 2016;doi:10.1056/NEJMoa1608029.

Disclosure: The study was funded in part by Medtronic, St. Jude Medical and TrygFonden. Køber reports receiving lecture fees from Novartis and Sanofi. Please see the full study for a list of the other researchers’ relevant financial disclosures.