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. 2025 Jul 13:86:103337.
doi: 10.1016/j.eclinm.2025.103337. eCollection 2025 Aug.

Contemporary medical therapy, sex-specific characteristics, and outcomes of patients with non-ischemic cardiomyopathy: a prespecified interim analysis of the BIO-LIBRA study

Valentina Kutyifa  1 , Luigi Di Biase  2 , Karthik Venkatesh Prasad  3 , Vilma Torres  4 , Aaron Hesselson  5 , Craig J McCotter  6 , Gregory Harris  7 , Karlene Cox  8 , Susan Schleede  1 , E Kevin Heist  9 , Scott McNitt  1 , Mary W Brown  1 , Crystal Miller  8 , Christopher A Beck  1 , Jeanne Poole  10 ; BIO-LIBRA Investigators
Collaborators, Affiliations

Contemporary medical therapy, sex-specific characteristics, and outcomes of patients with non-ischemic cardiomyopathy: a prespecified interim analysis of the BIO-LIBRA study

Valentina Kutyifa et al. EClinicalMedicine. .

Abstract

Background: Contemporary data on characteristics, medical therapy, and outcomes in non-ischemic cardiomyopathy (NICM) with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) are lacking, and the role of sex remains unexplored due to historical low enrollment of females in device trials. The purpose of this pre-specified interim analysis of the BIO-LIBRA study was to assess characteristics, medical therapy, and ventricular tachyarrhythmias (VT/VF) or mortality at 12 months in NICM patients with ICD or CRT-D, by sex.

Methods: In this multicenter, prospective, registry study, we recruited patients with primary prevention ICD or CRT-Ds with Home Monitoring®, aiming for 40% female enrollment, utilizing specific recruitment tools. Patients were assessed for the primary endpoint of device-treated VT or VF every 6 months. This study is registered with ClinicalTrials.gov (NCT03884608).

Findings: From May 9, 2019 to October 1, 2021, we enrolled 1000 patients, including 475 (47.5%) females, 30.4% non-white, and 9.2% Hispanic/Latino patients. Beta-blockers were prescribed in 92%, ACE-Inhibitor/ARB in 80%, ARNI in 39%, and SGLT2 in 6% at enrollment with increase in SGLT2 use over time. Diuretics were more frequently prescribed in females. Females had a 52% lower risk of VT/VF or death as compared to men through 12 months (HR = 0.49, 95% CI: 0.31-0.78, p = 0.003), driven by a 54% lower risk of VT/VF (HR = 0.46, 95% CI: 0.25-0.85, p = 0.003), even after adjustments for LVEF or QRS duration. No significant differences were reported by ICD vs. CRT-D.

Interpretation: In a contemporary cohort of patients with NICM and ICD/CRT-D, we report an increased enrollment of females and minorities, an increase in the use of novel guideline-directed medical therapy (GDMT) over time, and a lower risk of ventricular arrhythmias or death in females as compared to men at one year.

Funding: BIOTRONIK Inc.

Keywords: Cardiac resynchronization therapy; Implantable cardioverter defibrillator; Left ventricular dysfunction; Sex differences; Ventricular tachyarrhythmias.

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Conflict of interest statement

Valentina Kutyifa MD, PhD: research grants from Boston Scientific, BIOTRONIK, NIH, Spire Inc., speaker fee from Medtronic, Abbott Medical, consultant fees from Medtronic, Abbott Medical, Biotronik, PIVATAL NIH trial DSMB, AHA CSSP committee. Luigi Di Biase MD, PhD: consultant for Medtronic, Abbott Medical, Biotronik, Zoll, Boston Scientific, Baylis, Zoll, Biosense Webster, Stereotaxis, I rhythm, Zoll, Atricure and has received speaker honoraria/travel from Medtronic, Abbott Medical, Biotronik, Zoll, Boston Scientific, Baylis, Zoll, Biosense Webster, Stereotaxis, I rhythm, Zoll, Atricure and travel support from Medtronic, Abbott Medical, Biotronik, Zoll, Boston Scientific, Baylis, Zoll, Biosense Webster, Stereotaxis, I rhythm, Zoll, Atricure. Karthik Venkatesh Prasad MD: none. Vilma Torres MD: received consultant fees from Biotronik. Aaron Hesselson MD: payment or honoraria from Medtronic and Abbott. Craig J. McCotter MD: none. Gregory Harris MD: received speaker honoraria/travel from Biotronik. Karlene Cox BS–employee of Biotronik Inc. Susan Schleede MS: none. Kevin Heist MD, PhD: consultant: Biotronik, Boston Scientific, and HRS Membership Committee Chair. Scott McNitt MS: none. Mary W. Brown MS: none. Crystal Miller MS–employee of Biotronik Inc. Christopher A. Beck PhD: grants from Boston Scientific, BIOTRONIK, NIH. Jeanne Poole MD–Research contracts direct to institution from: Biotronik, Boston Scientific, AtriCure, Kestra Medical.

Figures

Fig. 1
Fig. 1
Overview of BIO-LIBRA Site Locations across the United States.
Fig. 2
Fig. 2
A. Sex-Difference in GDMT in BIO-LIBRA. B. Utilization and Changes of Novel GDMT, ARNI and SGLT2 in BIO-LIBRA over Time. C. Utilization and Changes of Novel GDMT, ARNI and SGLT2 in BIO-LIBRA over Time by Sex. ∗ p-values for SGLT2 use between men and women (Chi-sq cont adj): Baseline: 0.482, 12 Month: 1.000, 24 Month: 0.204. p-values for SGLT2 use between men and women (Chi-sq cont adj): Baseline: 0.328, 12 Month: 0.218, 24 Month: 0.674.
Fig. 3
Fig. 3
A. Cumulative Probability of VT/VF or Death by Sex. B. Cumulative Probability of VT/VF by Sex. C. Cumulative Probability of VT/VF or Death by ICD/CRT-D. D. Cumulative Probability of VT/VF by ICD/CRT-D.
See this image and copyright information in PMC

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