title: Safety and tolerability of iopromide in patients undergoing cardiac catheterization: real-world multicenter experience with 17,513 patients from the TRUST trial.
abstract: To assess the incidence of and risk factors for acute adverse drug reactions (ADRs) (occurring within 1 h) following iopromide administration in cardiac catheterization in Chinese 'real-world' practice. Acute ADRs following iopromide administration during coronary angiography or percutaneous coronary intervention (PCI) have not been systematically evaluated in China. TRUST was a prospective, multicenter, observational study conducted at 63 centers in China. Patients received iopromide (300 or 370 mgI/mL) during coronary angiography or PCI (n = 17,513). Acute ADRs occurred in 66 patients (0.38%); ADRs were mild in 58 patients (0.33%) and severe in two patients (0.01%). Most acute ADRs manifested as allergy-like symptoms such as nausea/vomiting [39 patients (0.22%)] and/or rash [15 patients (0.09%)]. The rate of acute ADRs was lower among patients who received premedication (6/3349; 0.18 %) than those who did not (60/14,164; 0.42%; p = 0.0379), and among those who did receive pre-procedural hydration (10/7993; 0.13%) compared with those who did not (56/9520; 0.59%; p < 0.0001). Age <50 years, left main coronary disease and history of ADRs to contrast media increased the risk of ADRs, while premedication with corticosteroids, pre-procedural hydration and contrast volume <100 mL versus ≥100 mL reduced the risk. Contrast quality was rated as 'Excellent' in 99.1% of patients. The incidence of acute ADRs was very low with iopromide in cardiac catheterization in China. The risk of acute ADRs increased in patients <50 years and in those with a history of ADRs to contrast media. Premedication with corticosteroids and pre-procedural hydration may prevent acute ADRs in at-risk patients.
authors.affiliation: Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences, No. 96 Dongchuan Road, Yuexiu District, Guangzhou, 510100, China. chenjiyandr@126.com.
authors.forename: Ji-Yan
authors.initials: JY
authors.lastname: Chen
authors.affiliation: Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences, No. 96 Dongchuan Road, Yuexiu District, Guangzhou, 510100, China.
authors.forename: Yong
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences, No. 96 Dongchuan Road, Yuexiu District, Guangzhou, 510100, China.
authors.forename: Ying-Ling
authors.initials: YL
authors.lastname: Zhou
authors.affiliation: Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences, No. 96 Dongchuan Road, Yuexiu District, Guangzhou, 510100, China.
authors.forename: Ning
authors.initials: N
authors.lastname: Tan
authors.affiliation: Department of Biostatistics, School of Public Health and Tropical Medicine, Southern Medical University, No. 1838 Guangzhou Road, Baiyun District, Guangzhou, 510100, China.
authors.forename: Bin
authors.initials: B
authors.lastname: Zhang
authors.affiliation: Department of Biostatistics, School of Public Health and Tropical Medicine, Southern Medical University, No. 1838 Guangzhou Road, Baiyun District, Guangzhou, 510100, China.
authors.forename: Ping-Yan
authors.initials: PY
authors.lastname: Chen
authors.affiliation: China Medical Affairs Radiology, Bayer HealthCare, Bayer Center, No. 27 Dong San Huan North Road, Chaoyang District, Beijing, 100020, China.
authors.forename: Li-Bing
authors.initials: LB
authors.lastname: Chen
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D002681:China / Q000453:epidemiology; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects*; D017023:Coronary Angiography / Q000009:adverse effects*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000453:epidemiology* / Q000517:prevention & control; D005260:Female; D005440:Fluid Therapy; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D007472:Iohexol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D003287:Contrast Media; D007472:Iohexol; C038192:iopromide
keywords: Adverse drug reactions; Contrast media; Coronary angiography; Percutaneous coronary intervention