Syed Mohammad K, Sheikh Hassan I, McKay Bradley, Tseng Nicholas, 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 Biomedical Sciences, University of Waterloo, Waterloo, Ontario, Canada.
CJC Open. 2021 Sep 24;3(12 Suppl):S209-S217. doi: 10.1016/j.cjco.2021.09.015. eCollection 2021 Dec.
Data are limited regarding the use of implantable cardioverter-defibrillators (ICDs) in diverse populations. This study explores cardiovascular (CV) outcomes and mortality from ICD randomized controlled trials (RCTs), by sex, race, and age.
Five electronic databases (PubMed, Emcare, Embase, MEDLINE, and Cumulative Index to Nursing & Allied Health Literature CINAHL) were searched for dates from their inception to July 12, 2021, for RCTs of ICD therapy in adult patients. Data were analyzed for clinical outcomes, including all-cause or CV death, and heart failure hospitalization (HFH).
Among 5 RCTs (mean age: 63 years; 78% male; 76% White) with moderate overall risk of bias, clinical outcomes in patients with an ICD (n = 3260) vs a control group (n = 3685) were compared. No between-group sex differences were observed for all-cause death (odds ratio [OR] 0.86, = 0.51), CV death (OR 0.98, = 0.96), HFH (OR 0.95, = 0.87), or HFH and all-cause death (OR 0.83, = 0.51) in the ICD group, in a comparison of male vs female sex. All-cause death (OR 1.20, = 0.67) did not differ for White vs Black patients receiving ICD therapy. Outcomes data for other non-White, non-Black race groups were often unreported. Most RCTs originated in North America, had male leadership, and were evenly sponsored by industry vs peer-reviewed funding.
Outcomes data are sparse, by sex, race, and age, in current RCTs evaluating ICD therapy. Although ICD patient outcomes did not significantly differ by sex or race, improved data analyses and reporting are needed to determine the relationship between these sociocultural factors and clinical outcomes among distinct ICD patient cohorts.
关于植入式心脏复律除颤器（ICD）在不同人群中的使用数据有限。本研究按性别、种族和年龄探讨了ICD随机对照试验（RCT）中的心血管（CV）结局和死亡率。
检索了五个电子数据库（PubMed、Emcare、Embase、MEDLINE和护理及联合健康文献累积索引CINAHL），从其创建到2021年7月12日，查找成人患者ICD治疗的RCT。分析了包括全因或CV死亡以及心力衰竭住院（HFH）在内的临床结局数据。
在5项偏倚总体风险为中度的RCT（平均年龄：63岁；78%为男性；76%为白人）中，比较了ICD组（n = 3260）与对照组（n = 3685）患者的临床结局。在ICD组中，男性与女性相比，全因死亡（优势比[OR] 0.86，P = 0.51）、CV死亡（OR 0.98，P = 0.96）、HFH（OR 0.95，P = 0.87）或HFH和全因死亡（OR 0.83，P = 0.51）在组间未观察到差异。接受ICD治疗的白人患者与黑人患者相比，全因死亡（OR 1.20，P = 0.67）无差异。其他非白人、非黑人种族组的结局数据通常未报告。大多数RCT起源于北美，由男性主导，行业资助与同行评审资助的比例相当。
在当前评估ICD治疗的RCT中，按性别、种族和年龄划分的结局数据较少。尽管ICD患者的结局在性别或种族上没有显著差异，但仍需要改进数据分析和报告，以确定这些社会文化因素与不同ICD患者队列临床结局之间的关系。
