Incidence of Major Adverse Cardiovascular and Cerebrovascular Events in Chinese Patients Undergoing Percutaneous Coronary Intervention with Iodixanol: An Observational Postauthorization Study

Abstract

Objective: This study aimed to evaluate the major adverse cardiovascular and cerebrovascular events (MACCEs) and overall safety profile associated with iodixanol in Chinese patients undergoing percutaneous coronary intervention (PCI). Methods: Patients at 30 centers in China registered in the OpenClinic v3.6 database from October 30, 2013, to October 7, 2015, were included in the study. The primary endpoint was in-hospital MACCEs including target lesion revascularization (TLR), stroke, stent thrombosis, cardiac death, and PCI-related myocardial infarction (MI) within 72 h post-PCI. Secondary endpoints were MACCEs from 72 h to 30 d post-PCI and other safety events within 30 d post-PCI. Results: A total of 3,042 patients were enrolled. The incidence of MACCEs within 72 h post-PCI was 2.33% (n = 71), including cardiac death (0.03%, n = 1) and PCI-related MI (2.30%, n = 70). The incidence of MACCEs from 72 h to 30 d post-PCI was 0.16% (n = 5), including cardiac death (0.10%, n = 3), PCI-related MI (0.03%, n = 1), and TLR for stent thrombosis (0.03%, n = 1). The incidence of composite angiographic or procedural complications was 2.86% (n = 87); 233 (7.86%) patients had results suggesting contrast-induced acute kidney injury. Conclusions: These findings indicate that the use of iodixanol in Chinese patients undergoing PCI is associated with a low incidence of MACCEs, confirming its safety in this population.