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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2025-08-01
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S258953702500269X |
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| author | 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 Luigi Di Biase Karthik Prasad David Frazier Vilma Torres 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 |
| author_facet | 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 Luigi Di Biase Karthik Prasad David Frazier Vilma Torres 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 |
| author_sort | Valentina Kutyifa |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-a46fc57cce8d48c2ae07771d310a4709 |
| institution | Kabale University |
| issn | 2589-5370 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EClinicalMedicine |
| spelling | doaj-art-a46fc57cce8d48c2ae07771d310a47092025-08-20T03:27:25ZengElsevierEClinicalMedicine2589-53702025-08-018610333710.1016/j.eclinm.2025.103337Contemporary medical therapy, sex-specific characteristics, and outcomes of patients with non-ischemic cardiomyopathy: a prespecified interim analysis of the BIO-LIBRA studyResearch in contextValentina Kutyifa0Luigi Di Biase1Karthik Venkatesh Prasad2Vilma Torres3Aaron Hesselson4Craig J. McCotter5Gregory Harris6Karlene Cox7Susan Schleede8E. Kevin Heist9Scott McNitt10Mary W. Brown11Crystal Miller12Christopher A. Beck13Jeanne Poole14Luigi Di BiaseKarthik PrasadDavid FrazierVilma TorresKristin EllisonJonathan DukesJihn HanPaul GerczukGery TomassoniMatthew SellersTheofanie MelaStavros Mountantonakis MountantonakisBryan FrainParash PokharelSrinivas RajshekerGeorge ThomasJ. Matt BrunsonOmar KahalySamuel JohnstonLuis GarciaRakesh LatchamsettyDavid HuangZaid AzizDavid RodakSoraya SamiiJonathan HobsonSherry SaxonhouseVipul ShahHarish ManyamRobert P. Robichaux, Jr.Christopher PierceRichard VestChristian NgoMichael YarnozNatalie BradfordRajasekhar NekkantiMargot VlokaUma SrivatsaChandra BommaKhaled AwadSei IwaiShane RowanMatthew SevensmaMichael DruckerToshimasa OkabeAnthony OchoaLeon FeldmanGioia TurittoClinical Cardiovascular Research Center, University of Rochester, Medical Center, Rochester, NY, USA; Corresponding author. Clinical Cardiovascular Research Center, Cardiology Division, University of Rochester Medical Center, 265 Crittenden Blvd., Box 653, Rochester, NY, 14642, USA.Montefiore Medical Center, Bronx, NY, USACardiology Associates Research, Tupelo, MS, USAUniversity of Florida, Gainesville, FL, USAUniversity of Kentucky, Lexington, KY, USABaptist Health, Lexington, KY, USAHeart Rhythm Associates, Greenville, NC, USABIOTRONIK Inc., Lake Oswego, OR, USAClinical Cardiovascular Research Center, University of Rochester, Medical Center, Rochester, NY, USAMassachusetts General Hospital, Boston, MA, USAClinical Cardiovascular Research Center, University of Rochester, Medical Center, Rochester, NY, USAClinical Cardiovascular Research Center, University of Rochester, Medical Center, Rochester, NY, USABIOTRONIK Inc., Lake Oswego, OR, USAClinical Cardiovascular Research Center, University of Rochester, Medical Center, Rochester, NY, USAUniversity of Washington, Seattle, WA, USASummary: 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.http://www.sciencedirect.com/science/article/pii/S258953702500269XVentricular tachyarrhythmiasSex differencesLeft ventricular dysfunctionImplantable cardioverter defibrillatorCardiac resynchronization therapy |
| spellingShingle | 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 Luigi Di Biase Karthik Prasad David Frazier Vilma Torres 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 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 Ventricular tachyarrhythmias Sex differences Left ventricular dysfunction Implantable cardioverter defibrillator Cardiac resynchronization therapy |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Ventricular tachyarrhythmias Sex differences Left ventricular dysfunction Implantable cardioverter defibrillator Cardiac resynchronization therapy |
| url | http://www.sciencedirect.com/science/article/pii/S258953702500269X |
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