ESC Congress 2016 - 13

ESC CONGRESS 2016 IN REVIEW clINIcAl TRIAl HIgHlIgHTs Prophylactic Use of ICD in Patients With Nonischemic Heart Failure: Results From the DANISH Study Written by Maria Vinall Results from the DANISH study [Køber L et al. N Engl J Med. 2016] reported by Lars Køber, MD, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark, failed to show a significant reduction in all-cause mortality with the prophylactic use of implantable cardioverter defibrillator (ICD) devices in patients with symptomatic systolic heart failure (HF) not caused by coronary artery disease. DANISH was a randomized, controlled, multicenter trial to determine whether ICDs reduce all-cause mortality in patients with symptomatic systolic HF of nonischemic origin. The study comprised patients with NYHA class II to III (IV for those with planned cardiac resynchronization therapy [CRT]), left ventricular ejection fraction ≤ 35%, and NT-proBNP > 200 pg/mL (23.6 pmol/L) who were on optimal medical treatment. Participants received a prophylactic ICD (n = 556) or usual care (n = 560). The primary study endpoint was all-cause mortality. The secondary outcomes were cardiovascular death and sudden cardiac death. Patients had a mean age of 64 years (range, 56-72), mean left ventricular ejection fraction of 25%, and mean duration of HF of about 19 months; 28% were women. Approximately 92% of patients were taking a ß-blocker, 97% were taking an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, and 58% were taking a mineralocorticoid receptor antagonist; 58% were scheduled to receive CRT. Patients were followed for a median of 67.6 months. The primary outcome of death from any cause occurred in 120 patients in the ICD group and 131 patients in the control group (HR, 0.87; 95% CI, 0.68 to 1.12; P = .28; Figure 1). Official Peer-Reviewed Highlights From 0.0 Cumulative Event Rate 0.2 0.4 0.6 0.8 1.0 Figure 1. Primary Outcome: All-Cause Mortality HR, 0.87 (95% CI, 0.68 to 1.12) P = .28 Controls ICD 0 1 2 3 560 556 540 540 517 526 438 451 4 Years 344 358 5 6 7 248 272 169 186 88 107 8 12 Controls 17 ICD ICD, implantable cardioverter defibrillator. Reproduced from New England Journal of Medicine, Køber L et al. A Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure. N Engl J Med. 2016;DOI: 10.1056/NEJMoa1608029. Copyright © 2016 Massachusetts Medical Society. Reprinted with permission from the Massachusetts Medical Society. Official Peer-Reviewed Highlights From ESC Congress 2016 13

Table of Contents for the Digital Edition of ESC Congress 2016