ArticleEClinicalMedicine2025
Contemporary medical therapy, sex-specific characteristics, and outcomes of patients with non-ischemic cardiomyopathy: a prespecified interim analysis of the BIO-LIBRA study.
Article in EClinicalMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03884608 (BIO-LIBRA Clinical Study), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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BIO-LIBRA Clinical Study
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16 authors.
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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.
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