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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Efficacy of Implantable Cardioverter Defibrillator in Nonischemic Systolic Heart Failure According to Sex : Extended Follow-Up Study of the DANISH Trial. / Butt, Jawad H.; Yafasova, Adelina; Elming, Marie B.; Dixen, Ulrik; Nielsen, Jens C.; Haarbo, Jens; Videbæk, Lars; Korup, Eva; Bruun, Niels E.; Eiskjær, Hans; Brandes, Axel; Thøgersen, Anna M.; Gustafsson, Finn; Egstrup, Kenneth; Hassager, Christian; Svendsen, Jesper Hastrup; Høfsten, Dan E.; Torp-Pedersen, Christian; Pehrson, Steen; Thune, Jens Jakob; Køber, Lars.
I: Circulation. Heart failure, Bind 15, Nr. 9, e009669, 2022.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Efficacy of Implantable Cardioverter Defibrillator in Nonischemic Systolic Heart Failure According to Sex
T2 - Extended Follow-Up Study of the DANISH Trial
AU - Butt, Jawad H.
AU - Yafasova, Adelina
AU - Elming, Marie B.
AU - Dixen, Ulrik
AU - Nielsen, Jens C.
AU - Haarbo, Jens
AU - Videbæk, Lars
AU - Korup, Eva
AU - Bruun, Niels E.
AU - Eiskjær, Hans
AU - Brandes, Axel
AU - Thøgersen, Anna M.
AU - Gustafsson, Finn
AU - Egstrup, Kenneth
AU - Hassager, Christian
AU - Svendsen, Jesper Hastrup
AU - Høfsten, Dan E.
AU - Torp-Pedersen, Christian
AU - Pehrson, Steen
AU - Thune, Jens Jakob
AU - Køber, Lars
PY - 2022
Y1 - 2022
N2 - 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. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT00542945.
AB - 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. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT00542945.
KW - clinical trial
KW - defibrillator, implantable
KW - heart failure
KW - mortality
KW - women
U2 - 10.1161/CIRCHEARTFAILURE.122.009669
DO - 10.1161/CIRCHEARTFAILURE.122.009669
M3 - Journal article
C2 - 35942877
AN - SCOPUS:85138458179
VL - 15
JO - Circulation: Heart Failure
JF - Circulation: Heart Failure
SN - 1941-3289
IS - 9
M1 - e009669
ER -
ID: 321312222