McKay Bradley, Tseng Nicholas W H, Sheikh Hassan I, Syed Mohammad K, Pakosh Maureen, Caterini Jessica E, Sharma Abhinav, Colella Tracey J F, Konieczny Kaja M, Connelly Kim A, Graham Michelle M, McDonald Michael, Banks Laura, Randhawa Varinder Kaur
Faculty of Health Sciences, Ontario Tech University, Oshawa, Ontario, Canada.
Faculty of Sciences, University of Waterloo, Waterloo, Ontario, Canada.
CJC Open. 2021 Sep 15;3(12 Suppl):S192-S201. doi: 10.1016/j.cjco.2021.09.005. eCollection 2021 Dec.
Cardiac resynchronization therapy (CRT) is beneficial in patients who have heart failure with reduced ejection fraction or arrhythmic events. However, most randomized controlled trials (RCTs) showing survival benefits primarily enrolled older white men. This study aims to evaluate CRT efficacy by sex, race, and age in RCTs.
Five electronic databases (CINAHL, Embase, Emcare, Medline, and PubMed) were searched from inception to July 12, 2021 for RCTs with CRT in adult patients. Data were analyzed for clinical outcomes including all-cause or cardiovascular (CV) death, worsening heart failure (HF), and HF hospitalization (HFH) according to sex, race, and age.
Among six RCTs with up to moderate risk of bias, 54% (n = 3,630 of 6,682; mean age 64 years, 22% female, 8% black patients) had CRT device implantation. All-cause death (odds ratio [OR], 0.51; = 0.053) was reduced in female versus male CRT patients, whereas CV death, HFH, or all-cause death with worsening HF or HFH did not differ significantly. No difference was seen in CRT patients for all-cause death and worsening HF (OR, 1.32; = 0.46) among white vs black patients or for all-cause death and HFH (OR, 1.19; = 0.55) among ≥ 65 versus < 65 years.
Whereas all-cause death was lower in female CRT patients, other reported outcomes did not significantly differ by sex, race, or age. Only 6 studies partially reported outcomes. Thus, enhanced reporting and analyses are required to overcome such paucity of data to evaluate the impact of these factors on clinical outcomes in distinct patient cohorts with CRT indication.
心脏再同步治疗（CRT）对射血分数降低的心力衰竭患者或心律失常事件患者有益。然而，大多数显示生存获益的随机对照试验（RCT）主要纳入的是老年白人男性。本研究旨在评估RCT中按性别、种族和年龄分组的CRT疗效。
检索了五个电子数据库（CINAHL、Embase、Emcare、Medline和PubMed），从建库至2021年7月12日，查找纳入成年患者CRT的RCT。根据性别、种族和年龄，对包括全因死亡或心血管（CV）死亡、心力衰竭恶化（HF）和心力衰竭住院（HFH）在内的临床结局数据进行分析。
在六项偏倚风险为中度及以下的RCT中，54%（6682例中的3630例；平均年龄64岁，22%为女性，8%为黑人患者）植入了CRT设备。与男性CRT患者相比，女性患者的全因死亡（优势比[OR]，0.51；P = 0.053）有所降低，而CV死亡、HFH或伴有HF恶化或HFH的全因死亡无显著差异。在CRT患者中，白人患者与黑人患者的全因死亡和HF恶化（OR，1.32；P = 0.46）之间以及≥65岁与<65岁患者的全因死亡和HFH（OR，1.19；P = 0.55）之间均未观察到差异。
虽然女性CRT患者的全因死亡较低，但其他报告的结局在性别、种族或年龄方面无显著差异。仅有6项研究部分报告了结局。因此，需要加强报告和分析，以克服此类数据匮乏的问题，从而评估这些因素对有CRT适应证的不同患者队列临床结局的影响。
