Efficacy of Implantable Cardioverter Defibrillator in Nonischemic Systolic Heart Failure According to Sex: Extended Follow-Up Study of the DANISH Trial

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  • Jawad H Butt, University of Copenhagen
  • ,
  • Adelina Yafasova, University of Copenhagen
  • ,
  • Marie B Elming, University of Copenhagen
  • ,
  • Ulrik Dixen, University of Copenhagen
  • ,
  • Jens C Nielsen
  • Jens Haarbo, University of Copenhagen
  • ,
  • Lars Videbæk, University of Southern Denmark
  • ,
  • Eva Korup, Aalborg University
  • ,
  • Niels E Bruun, University of Copenhagen, Aalborg University
  • ,
  • Hans Eiskjær
  • Axel Brandes, University of Southern Denmark
  • ,
  • Anna M Thøgersen, Aalborg University
  • ,
  • Finn Gustafsson, University of Copenhagen
  • ,
  • Kenneth Egstrup, University of Southern Denmark
  • ,
  • Christian Hassager, University of Copenhagen
  • ,
  • Jesper Hastrup Svendsen, University of Copenhagen
  • ,
  • Dan E Høfsten, University of Copenhagen
  • ,
  • Christian Torp-Pedersen, University of Copenhagen
  • ,
  • Steen Pehrson, University of Copenhagen
  • ,
  • Jens Jakob Thune, University of Copenhagen
  • ,
  • Lars Køber, University of Copenhagen

BACKGROUND: Men and women may respond differently to certain therapies for heart failure with reduced ejection fraction, including implantable cardioverter defibrillators (ICD). In an extended follow-up study of the DANISH trial (Danish Study to Assess the Efficacy of ICDs in Patients With Non-Ischemic Systolic Heart Failure on Mortality), adding 4 years of additional follow-up, we examined the effect of ICD implantation according to sex.

METHODS: In the DANISH trial, 1116 patients with nonischemic systolic heart failure were randomized to receive an ICD (N=556) or usual clinical care (N=550). The primary outcome was all-cause mortality.

RESULTS: Of the 1116 patients randomized in the DANISH trial, 307 (27.5%) were women. During a median follow-up of 9.5 years, women had a lower associated rate of all-cause mortality (hazard ratio [HR], 0.60 [95% CI, 0.47-0.78]) cardiovascular death (HR, 0.62 [95% CI, 0.46-0.84]), nonsudden cardiovascular death (HR, 0.59 [95% CI, 0.42-0.85]), and a numerically lower rate of sudden cardiovascular death (HR, 0.70 [95% CI, 0.40-1.25]), compared with men. Compared with usual clinical care, ICD implantation did not reduce the rate of all-cause mortality, irrespective of sex (men, HR, 0.85 [95% CI, 0.69-1.06]; women, HR, 0.98 [95% CI, 0.64-1.50]; P for interaction=0.51). In addition, sex did not modify the effect of ICD implantation on sudden cardiovascular death (men, HR, 0.57 [95% CI, 0.36-0.92]; women, HR, 0.68 [95% CI, 0.26-1.77]; P for interaction=0.76).

CONCLUSIONS: In patients with nonischemic systolic heart failure, ICD implantation did not provide an overall survival benefit, but reduced sudden cardiovascular death, irrespective of sex.

REGISTRATION: URL: https://www.

CLINICALTRIALS: gov; Unique identifier: NCT00542945.

Original languageEnglish
JournalCirculation. Heart Failure
Volume15
Issue9
Pages (from-to)101161CIRCHEARTFAILURE122009669
ISSN1941-3289
DOIs
Publication statusPublished - Sep 2022

    Research areas

  • Death, Sudden, Cardiac/etiology, Defibrillators, Implantable, Denmark, Female, Follow-Up Studies, Heart Failure, Systolic/etiology, Heart Failure/therapy, Humans, Male, Risk Factors

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