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.
Keywords: Adverse drug reactions; Contrast media; Coronary angiography; Percutaneous coronary intervention.