Journal article
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
EClinicalMedicine, Vol.86, 103337
08/01/2025
DOI: 10.1016/j.eclinm.2025.103337
PMCID: PMC12281065
PMID: 40697957
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.
Details
- Title: Subtitle
- 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
- Creators
- Valentina KutyifaLuigi Di Biase - Montefiore Medical CenterKarthik Venkatesh Prasad - Cardiology Associates Research, Tupelo, MS, USAVilma Torres - University of FloridaAaron Hesselson - University of KentuckyCraig J. McCotter - Central Baptist HospitalGregory Harris - Heart Rhythm Associates, Greenville, NC, USAKarlene Cox - BIOTRONIK Inc., Lake Oswego, OR, USASusan Schleede - University of Rochester Medical CenterE. Kevin Heist - Massachusetts General HospitalScott McNitt - University of Rochester Medical CenterMary W. Brown - University of Rochester Medical CenterCrystal Miller - BIOTRONIK Inc., Lake Oswego, OR, USAChristopher A. Beck - University of Rochester Medical CenterJeanne Poole - University of WashingtonKarthik PrasadDavid FrazierKristin EllisonJonathan DukesJihn HanPaul GerczukGery TomassoniMatthew SellersTheofanie MelaStavros MountantonakisBryan FrainParash PokharelSrinivas RajshekerGeorge ThomasJ. Matt BrunsonOmar KahalySamuel JohnstonLuis GarciaRakesh LatchamsettyDavid HuangZaid AzizDavid RodakSoraya SamiiJonathan HobsonSherry SaxonhouseVipul ShahHarish ManyamRobert P Robichaux JrChristopher PierceRichard VestChristian NgoMichael YarnozNatalie BradfordRajasekhar NekkantiMargot VlokaUma SrivatsaChandra BommaKhaled AwadSei IwaiShane RowanMatthew SevensmaMichael DruckerToshimasa OkabeAnthony OchoaLeon FeldmanGioia Turitto
- Resource Type
- Journal article
- Publication Details
- EClinicalMedicine, Vol.86, 103337
- DOI
- 10.1016/j.eclinm.2025.103337
- PMID
- 40697957
- PMCID
- PMC12281065
- NLM abbreviation
- EClinicalMedicine
- ISSN
- 2589-5370
- eISSN
- 2589-5370
- Publisher
- Elsevier
- Grant note
- BIOTRONIK Inc.
The BIO-LIBRA study is supported by an unrestricted research grant from BIOTRONIK Inc. to the University of Rochester Medical Center, Rochester, NY. Devices in the study have been used per standard guideline-based indications. There has been no AI used for the preparation of this manuscript.
- Language
- English
- Date published
- 08/01/2025
- Academic Unit
- Internal Medicine
- Record Identifier
- 9984865438702771
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