Kutyifa Valentina, Di Biase Luigi, Prasad Karthik Venkatesh, Torres Vilma, Hesselson Aaron, McCotter Craig J, Harris Gregory, Cox Karlene, Schleede Susan, Heist E Kevin, McNitt Scott, Brown Mary W, Miller Crystal, Beck Christopher A, Poole Jeanne
Clinical Cardiovascular Research Center, University of Rochester, Medical Center, Rochester, NY, USA.
Montefiore Medical Center, Bronx, NY, USA.
EClinicalMedicine. 2025 Jul 13;86:103337. doi: 10.1016/j.eclinm.2025.103337. eCollection 2025 Aug.
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.
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).
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.
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.
BIOTRONIK Inc.
目前缺乏关于植入式心律转复除颤器（ICD）或心脏再同步治疗除颤器（CRT-D）用于非缺血性心肌病（NICM）患者的特征、药物治疗及预后的当代数据，且由于既往器械试验中女性入组率低，性别因素的作用仍未得到探索。本次对BIO-LIBRA研究预先设定的中期分析旨在按性别评估NICM患者植入ICD或CRT-D后12个月时的特征、药物治疗以及室性快速心律失常（VT/VF）或死亡率。
在这项多中心、前瞻性登记研究中，我们招募接受一级预防ICD或带家庭监测功能的CRT-D的患者，目标是女性入组率达到40%，并使用特定招募工具。每6个月评估患者器械治疗的VT或VF这一主要终点。本研究已在ClinicalTrials.gov注册（NCT03884608）。
从2019年5月9日至2021年10月1日，我们共招募了1000例患者，其中包括475例（47.5%）女性、30.4%非白人以及9.2%西班牙裔/拉丁裔患者。入组时，92%的患者使用β受体阻滞剂，80%使用ACE抑制剂/ARB，39%使用ARNI，6%使用SGLT2，且随着时间推移SGLT2的使用有所增加。女性使用利尿剂更为频繁。在12个月期间，女性发生VT/VF或死亡的风险比男性低52%（HR = 0.49，95%CI：0.31 - 0.78，p = 0.003），其中VT/VF风险低54%（HR = 0.46，95%CI：0.25 - 0.85，p = 0.003），即使在对左室射血分数（LVEF）或QRS时限进行调整后也是如此。ICD与CRT-D之间未报告显著差异。
在当代一组NICM及ICD/CRT-D患者中，我们报告女性和少数族裔入组人数增加，新型指南导向药物治疗（GDMT）的使用随时间增加，且女性在1年时发生室性心律失常或死亡的风险低于男性。
百多力公司
