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

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

Summary: 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 hist...

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Main Authors: Valentina Kutyifa, Luigi Di Biase, Karthik Venkatesh Prasad, Vilma Torres, Aaron Hesselson, Craig J. McCotter, Gregory Harris, Karlene Cox, Susan Schleede, E. Kevin Heist, Scott McNitt, Mary W. Brown, Crystal Miller, Christopher A. Beck, Jeanne Poole, Karthik Prasad, David Frazier, Kristin Ellison, Jonathan Dukes, Jihn Han, Paul Gerczuk, Gery Tomassoni, Matthew Sellers, Theofanie Mela, Stavros Mountantonakis, Mountantonakis, Bryan Frain, Parash Pokharel, Srinivas Rajsheker, George Thomas, J. Matt Brunson, Omar Kahaly, Samuel Johnston, Luis Garcia, Rakesh Latchamsetty, David Huang, Zaid Aziz, David Rodak, Soraya Samii, Jonathan Hobson, Sherry Saxonhouse, Vipul Shah, Harish Manyam, Robert P. Robichaux, Jr., Christopher Pierce, Richard Vest, Christian Ngo, Michael Yarnoz, Natalie Bradford, Rajasekhar Nekkanti, Margot Vloka, Uma Srivatsa, Chandra Bomma, Khaled Awad, Sei Iwai, Shane Rowan, Matthew Sevensma, Michael Drucker, Toshimasa Okabe, Anthony Ochoa, Leon Feldman, Gioia Turitto
Format: Article
Language:English
Published: Elsevier 2025-08-01
Series:EClinicalMedicine
Subjects:
Ventricular tachyarrhythmias
Sex differences
Left ventricular dysfunction
Implantable cardioverter defibrillator
Cardiac resynchronization therapy
Online Access:http://www.sciencedirect.com/science/article/pii/S258953702500269X
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Summary:Summary: 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.
ISSN:2589-5370

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