Adverse events during administration of alteplase for acute ischemic stroke

doi:10.19803/j.1672-8629.20260561

Abstract

Abstract: Objective To characterize adverse drug events (ADE) during administration of recombinant tissue plasminogen activator (rt-PA) in patients with acute ischemic stroke (AIS) and evaluate the actual rt-PA dose administered in order to contribute to safe medication during thrombolysis. Methods Patients with AIS who received intravenous thrombolysis with rt-PA in 2016-2025 were retrospectively identified and included. Patients were divided into the ADE and non-ADE groups according to the occurrence of ADE during rt-PA administration. The type, severity, and clinical management methods of ADE were described. Baseline characteristics and actual rt-PA doses administered were compared between the two groups. Univariable and multivariable logistic regression analyses were performed to identify contributors to ADE. Results A total of 1 012 patients were included, 373 (36.9%) of whom experienced ADE during rt-PA administration that were mostly mild or moderate non-intracranial bleeding events, but no deaths attributable to ADE were observed. Among these 373 patients, rt-PA administration was discontinued in 206 (55.2%). The actual rt-PA dose administered was significantly lower in the ADE group than in the non-ADE group (P<0.001). Multivariable logistic regression analysis showed that being female (OR=1.383 5, 95%CI: 1.052 3-1.818 8), prior lipid-lowering medications (OR=1.969 4, 95%CI: 1.248 0-3.107 6), prior antihypertensive medications (OR=1.382 0, 95%CI: 1.057 8-1.805 7), and higher D-dimer levels (OR=1.076 1, 95%CI: 1.016 4-1.139 3) could increase the odds of ADE (all P<0.05) while higher platelet counts were associated with lower chance of ADE (OR=0.997 5, 95%CI: 0.995 5-0.999 6; P<0.05). Conclusion ADE during rt-PA administration in patients with AIS might impact the completion of rt-PA administration and the actual dose administered. The incidence is associated with gender, prior medications, and hemostasis-related laboratory parameters. Monitoring during rt-PA administration and appropriate management according to the types and severity of ADE are warranted to ensure safe medication.

Key words: Acute Ischemic Stroke(AIS), Alteplase, Intravenous Thrombolysis, Administered Dose, Adverse Drug Event

CLC Number:

Zhang Jialin, Hu Jia, Xu Yinqiu, Jiang Chenxiao, Li Li. Adverse events during administration of alteplase for acute ischemic stroke[J]. Chinese Journal of Pharmacovigilance, 2026, 23(10): 1164-1170.

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