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

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

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

1 Citation (Scopus)


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]; Pinteraction=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]; Pinteraction=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.

Original languageEnglish
JournalCirculation. Heart Failure
Issue number9
Pages (from-to)e009669
Publication statusPublished - Sept 2022


  • Death, Sudden, Cardiac/etiology
  • Defibrillators, Implantable
  • Denmark
  • Female
  • Follow-Up Studies
  • Heart Failure, Systolic/etiology
  • Heart Failure/therapy
  • Humans
  • Male
  • Risk Factors
  • clinical trial
  • heart failure
  • mortality
  • defibrillator, implantable
  • women


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