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免疫检查点抑制剂相关的急性冠状动脉综合征:致命不良事件的概念验证病例和药物警戒分析。

Acute Coronary Syndrome With Immune Checkpoint Inhibitors: A Proof-of-Concept Case and Pharmacovigilance Analysis of a Life-Threatening Adverse Event.

机构信息

University Mediterranean Centre of Cardio-Oncology, Assistance Publique-Hôpitaux de Marseille, Aix-Marseille University, and Unit of Heart Failure and Valvular Heart Diseases, Department of Cardiology, Hôpital Nord, Marseille, France; Groupe Méditerranéen de Cardio-Oncologie, Marseille, France; Centre for Cardiovascular and Nutrition Research, Aix-Marseille University, INSERM 1263, INRA 1260, Marseille, France.

Department of Clinical Pharmacology and Pharmacovigilance, Regional Pharmacovigilance Centre of Marseille Provence Corse, Marseille, France.

出版信息

Can J Cardiol. 2020 Apr;36(4):476-481. doi: 10.1016/j.cjca.2019.11.035. Epub 2019 Dec 11.

DOI:10.1016/j.cjca.2019.11.035
PMID:32144037
Abstract

Isolated cases of acute coronary syndrome (ACS) associated with immune checkpoint inhibitors (ICIs) have been described without the establishment of a formal cause-and-effect relationship between treatment and adverse event. We reported a case of ACS after the first administration of an ICI and with a fatal recurrence in another coronary area immediately after readministration. According to guidelines, causality was considered to be certain. Subsequently, we queried the French pharmacovigilance database and found 4 cases of ACS with coronary artery thrombosis. Causality was probable in those patients. These data suggest that ACS may be another life-threatening cardiac adverse event occurring with ICI exposure.

摘要

已经描述了与免疫检查点抑制剂(ICI)相关的孤立急性冠状动脉综合征(ACS)病例,但尚未在治疗与不良事件之间建立正式的因果关系。我们报告了一例 ICI 首次给药后发生 ACS 的病例,并且在再次给药后立即在另一个冠状动脉区域发生致命性复发。根据指南,因果关系被认为是确定的。随后,我们查询了法国药物警戒数据库,发现了 4 例 ACS 合并冠状动脉血栓形成病例。在这些患者中,因果关系被认为是很可能的。这些数据表明,ACS 可能是 ICI 暴露时发生的另一种危及生命的心脏不良事件。

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