Kondapalli Lavanya, Hsia Judith, Miller Ronni, Flaig Thomas W, Bonaca Marc P
Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado, USA.
CPC Clinical Research, Aurora, Colorado, USA.
JACC CardioOncol. 2022 Dec 20;4(5):649-656. doi: 10.1016/j.jaccao.2022.09.003. eCollection 2022 Dec.
There is growing recognition of the risk of cardiovascular (CV) events, particularly myocarditis, in the context of immune checkpoint inhibitor (ICI) therapy; however, true event rates in real-world populations and in the background of CV disease remain uncertain.
The authors sought to determine CV event occurrence in ICI-treated patients and assess the accuracy of diagnosis by International Classification of Diseases (ICD) code compared with adjudication using established definitions and full-source documentation review.
Electronic medical record extraction identified potential CV events in ICI-treated patients in the University of Colorado Health system. Two cardiologists independently adjudicated events using standardized definitions. Agreement between ICD codes and adjudicated diagnoses was assessed using the kappa statistic.
The cohort comprised 1,813 ICI-treated patients with a mean follow-up of 4.6 ± 3.4 years (3.2 ± 3.2 years pre-ICI and 1.4 ± 1.4 years post-ICI). Venous thromboembolic events (VTEs) were the most common event, occurring in 11.4% of patients pre-ICI and 11.3% post-ICI therapy. Post-ICI therapy, the crude rates of myocardial infarction (MI), heart failure, and stroke were 3.0%, 2.8%, and 1.6%, respectively. Six patients (0.3%) developed myocarditis post-ICI. Agreement between the ICD code and adjudication was greater for VTE (κ = 0.82; 95% CI: 0.79-0.85) and MI (κ = 0.74; 95% CI: 0.66-0.82) and worse for myocarditis (κ = 0.50; 95% CI: 0.20-0.80) and heart failure (κ = 0.47; 95% CI: 0.40-0.54).
ICD codes correlated well with adjudicated events for VTE and MI, but correlation was worse for heart failure and myocarditis. Adjudication with standardized definitions can enhance the understanding of the incidence of CV events related to ICI therapy.
免疫检查点抑制剂（ICI）治疗会增加心血管（CV）事件风险，尤其是心肌炎，这一点已得到越来越多的认识；然而，真实世界人群中以及存在心血管疾病背景下的实际事件发生率仍不明确。
作者试图确定接受ICI治疗患者的心血管事件发生率，并通过国际疾病分类（ICD）编码评估诊断准确性，同时与采用既定定义和全面资料审查进行的判定结果作比较。
通过电子病历提取，确定科罗拉多大学健康系统中接受ICI治疗患者的潜在心血管事件。两名心脏病专家使用标准化定义独立判定事件。使用kappa统计量评估ICD编码与判定诊断之间的一致性。
该队列包括1813例接受ICI治疗的患者，平均随访4.6±3.4年（ICI治疗前3.2±3.2年，ICI治疗后1.4±1.4年）。静脉血栓栓塞事件（VTE）是最常见的事件，在ICI治疗前11.4%的患者中发生，ICI治疗后为11.3%。ICI治疗后，心肌梗死（MI）、心力衰竭和中风的粗发生率分别为3.0%、2.8%和1.6%。6例患者（0.3%）在ICI治疗后发生心肌炎。ICD编码与判定结果在VTE（κ=0.82；95%CI：0.79-0.85）和MI（κ=0.74；95%CI：0.66-0.82）方面的一致性更高，而在心肌炎（κ=0.50；95%CI：0.20-0.80）和心力衰竭（κ=0.47；95%CI：0.40-0.54）方面则较差。
ICD编码与VTE和MI的判定事件相关性良好，但与心力衰竭和心肌炎的相关性较差。采用标准化定义进行判定有助于增强对与ICI治疗相关的心血管事件发生率的理解。
