Sex-specific response to cardiac resynchronization therapy: the BIO|WOMEN trial
- PMID: 40543624
- DOI: 10.1016/j.ijcard.2025.133526
Sex-specific response to cardiac resynchronization therapy: the BIO|WOMEN trial
Abstract
Background: Variable evidence exists about the efficacy of Cardiac resynchronization therapy (CRT) in women vs. men with reduced left ventricular ejection fraction (LVEF) and wide QRS complex. Current guidelines, hindered by underrepresentation of women in clinical trials, lack definitive recommendations. The present study was designed to achieve an equal distribution of women and men to prospectively evaluate sex-specific response to CRT.
Methods: The primary endpoint was the absolute increase in core-lab-assessed LVEF 12 months after de novo implantation of a CRT device. Estimation was adjusted by several baseline confounders to correct sex-specific effect of CRT. Secondary endpoints were further echocardiographic changes including responder rate (LVEF increase ≥5 %); change in NYHA class, 6-min walk distance, quality of life, a clinical composite score (CCS) and the composite of death or HF hospitalization.
Results: We enrolled 230 women and 244 men at 25 sites in eight countries. A larger improvement in LVEF (+14.7 % vs. +11.5 %, p ≤ 0.01) in women remained after adjustment for baseline variables (absolute increase attributed to female sex +2.53 %, P = 0.023). Furthermore, a better improvement was observed in reverse remodeling, responder rate (∆LVEF ≥5 %: 83.3 % vs. 70.6 %; p = 0.003), quality of life and HF symptoms in women compared to men. The CCS and the composite of death or HF hospitalization were better in women than in men after CRT.
Conclusions: The effect of CRT remained superior in women regarding echocardiographic outcomes even after adjusting for baseline variables. Our results confirm the importance of recognizing sex-specific differences when screening patients for CRT.
Keywords: Biventricular pacing; Cardiac resynchronization therapy; Dyssynchrony; Heart failure; Left ventricular ejection fraction; Sex differences.
Copyright © 2025 The Authors. Published by Elsevier B.V. All rights reserved.
Conflict of interest statement
Declaration of competing interest Dr. Zamorano received support from Biotronik for the present manuscript and for the Echo Core Lab in the BIO|WOMEN study (Estudios y Proyectos Cardiologicos S.L.) and received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events (Bayer, Pfizer, Novartis). Dr. Calvi received grants or contracts (Boston Italia S.p.A.). Dr. Quesada received modest consulting fees (Abbott, Boston Scientific, Medtronic) and support for attending meetings or/and travel (Abbott). Dr. Vernooy received grants or contracts with payments made to the institution (Medtronic: consultant, educational, and research grant; Abbott: consultant; Boston Scientific: consultant; Biosense Webster: consultant) and has a leadership or fiduciary role (Educational committee EHRA, Digital committee ESC, Device committee Netherlands). Dr. Martinez received consulting fees (Abbott), payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events (Daiichi-Sankyo, Boston Scientific), and support for attending meetings or/and travel (Daiichi-Sankyo). Dr. Maas received consulting fees (Boston Scientific, Medtronic; all payments went to the Research Department) and has a leadership or fiduciary role (Dutch Heart Registration). Dr. Merino received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events (Abbott, Milestone Pharmaceuticals and AstraZeneca paid to the institution, while Biotronik, Microport and Zoll paid to Dr. Merino), received personal support for attending meetings or/and travel (Bayer, Zoll), and has participated on a Data Safety Monitoring Board or Advisory Board for personal payment (Medtronic, Sanofi). Dr. Tönnis received consulting fees (Medtronic, Boston Scientific, Pfizer) and has participated on Advisory Board (Medtronic, Pfizer). N.G.C., received personal grants or contracts (Medtronic, Boston Scientific, Abbott, Biotronik, AstraZeneca, Novartis), personal consulting fees (Medtronic, Abbott), personal payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events (Medtronic, Boston Scientific, Abbott, Biotronik, AstraZeneca, Novartis), and has participated on a Data Safety Monitoring Board or Advisory Board for personal payment (Medtronic, Abbott). Dr. Nürnberg received consulting fees (Abbott), payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events (Abbott, Biotronik, Microport), and support for attending meetings or/and travel (Biotronik). Dr. Ruiz-Granell received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events (Biotronik, Abbott, Microport, Medtronic, Boston Scientific) and has participated on a Data Safety Monitoring Board or Advisory Board (Medtronic, Boston Scientific, Abbott, Biotronik, Microport). Dr. Prinzen received a research grant from Biotronik (for work as ECG Core Lab in the BIO|WOMEN study), received other research grants (Abbott), and has minority stock options (FutureCardia start-up). Miss Moreno and Dr. Pinart are employees of Biotronik SE & Co. KG (the sponsor of the trial), and Dr. Ver Heyen is employee of Biotronik Belgium NV a subsidiary of Biotronik SE & Co. KG (the sponsor of the trial). Dr. Van Erven received a consulting fee from Biotronik for work as Coordinating Clinical Investigator of the BIO|WOMEN study (payment made to the institution) has participated on Medtronic European Product Planning and Advisory Board and has a leadership or fiduciary role (Device committee Netherlands). The remaining authors have nothing to disclose.
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