Biton Yitschak, Zareba Wojciech, Goldenberg Ilan, Klein Helmut, McNitt Scott, Polonsky Bronislava, Moss Arthur J, Kutyifa Valentina
Heart Research Follow-up Program, Division of Cardiology, Department of Medicine, University of Rochester Medical Center, Rochester, NY (Y.B., W.Z., I.G., H.K., S.M.N., B.P., A.J.M., V.K.).
J Am Heart Assoc. 2015 Jun 29;4(7):e002013. doi: 10.1161/JAHA.115.002013.
Previous studies have shown conflicting results regarding the benefit of cardiac resynchronization therapy (CRT) by sex and QRS duration.
In the Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy (MADIT-CRT), we evaluated long-term clinical outcome of heart failure (HF) or death, death, and HF alone by sex and QRS duration (dichotomized at 150 ms) in left bundle-branch block patients with CRT with defibrillator backup (CRT-D) versus implantable cardioverter-defibrillator (ICD) only. There were 394 women (31%) and 887 men with left bundle-branch block. During the median follow-up of 5.6 years, women derived greater clinical benefit from CRT-D compared with implantable cardioverter-defibrillator only, with a significant 71% reduction in HF or death (hazard ratio [HR] 0.29, P<0.001) and a 77% reduction in HF alone (HR 0.23, P<0.001) compared with men, who had a 41% reduction in HF or death (HR 0.59, P<0.001) and a 50% reduction in HF alone (HR 0.50, P<0.001) (all sex-by-treatment interaction P<0.05). Men and women had similar reduction in long-term mortality with CRT-D versus implantable cardioverter-defibrillator only (men: HR 0.70, P=0.03; women: HR 0.59, P=0.04). The incremental benefit of CRT-D in women for HF or death and HF alone was consistent with QRS <150 or >150 ms.
During long-term follow-up of mild HF patients with left ventricular dysfunction and wide QRS, both women and men with left bundle-branch block derived sustained benefit from CRT-D versus implantable cardioverter-defibrillator only, with significant reduction in HF or death, HF alone, and all-cause mortality regardless of QRS duration. There is an incremental benefit with CRT-D in women for the end points of HF or death and HF alone.
URL: https://clinicaltrials.gov/. Unique identifiers: NCT00180271, NCT01294449, and NCT02060110.
先前的研究在心脏再同步治疗(CRT)按性别和QRS波时限分层的获益方面得出了相互矛盾的结果。
在心脏再同步治疗的多中心自动除颤器植入试验(MADIT-CRT)中,我们评估了在有除颤器备用的心脏再同步治疗(CRT-D)与单纯植入式心律转复除颤器(ICD)的左束支传导阻滞患者中,按性别和QRS波时限(以150毫秒为界分为两组)分层的心力衰竭(HF)或死亡、全因死亡以及单纯HF的长期临床结局。共有394名女性(31%)和887名男性存在左束支传导阻滞。在5.6年的中位随访期内,与单纯植入式心律转复除颤器相比,CRT-D使女性获得了更大的临床获益,与男性相比,女性HF或死亡显著降低71%(风险比[HR]0.29,P<0.001),单纯HF降低77%(HR 0.23,P<0.001),而男性HF或死亡降低41%(HR 0.59,P<0.001),单纯HF降低50%(HR 0.50,P<0.001)(所有性别与治疗的交互作用P<0.05)。与单纯植入式心律转复除颤器相比,CRT-D使男性和女性的长期死亡率均有相似程度的降低(男性:HR 0.70,P=0.03;女性:HR 0.59,P=0.04)。CRT-D在女性中对HF或死亡以及单纯HF的额外获益在QRS波时限<150毫秒或>150毫秒时均一致。
在左心室功能障碍和QRS波增宽的轻度HF患者的长期随访中,存在左束支传导阻滞的男性和女性与单纯植入式心律转复除颤器相比,均从CRT-D中持续获益,无论QRS波时限如何,HF或死亡、单纯HF以及全因死亡率均显著降低。CRT-D在女性中对HF或死亡以及单纯HF这些终点具有额外获益。
网址:https://clinicaltrials.gov/。唯一标识符:NCT00180271、NCT01294449和NCT02060110。