Incidence of significant adverse events within 24 h following administration of tenecteplase or alteplase for treatment of acute ischemic stroke: A multi-center, single-enterprise, retrospective study.

PURPOSE: This study aims to evaluate differences in the safety profile between alteplase or tenecteplase for suspected acute ischemic stroke (AIS) at Cleveland Clinic Health System (CCHS) facilities in Ohio and Florida.

METHODS

This was a multi-center, single-enterprise, retrospective review of patients that received alteplase (January 1, 2020 - January 10, 2022) or tenecteplase (February 1, 2022 - September 20, 2023) for suspected AIS at CCHS Ohio or Florida. The composite primary outcome consisted of conversion to intracranial hemorrhage (ICH), angioedema, and/or non-ICH critical site bleeding at 24 h post-treatment, and in-hospital all-cause mortality. Secondary outcomes include incidence of symptomatic ICH, any ICH, angioedema, or critical site bleed within 24 h, and in-hospital all-cause mortality.

RESULTS

A total of 863 patients were identified with 476 receiving alteplase and 387 receiving tenecteplase. Total, 115 total patients (13 %) experienced the primary safety composite outcome (95 % CI = 0.2 [-4.4 to 4.8]), and 64 patients (7 %) experienced any ICH with 42 (5 %) being symptomatic. Of total ICH transformations, 37 (8 %) received alteplase and 27 (7 %) received tenecteplase (95 % CI = -0.8 [-4.3 to 2.7]; however, symptomatic ICH included 26 patients (5 %) treated with alteplase and 16 (4 %) with tenecteplase (95 % CI = -1.3 [-4.2 to 1.5]).

CONCLUSION

No statistical difference was observed in the primary composite outcome when treated with tenecteplase and alteplase for AIS treatment. There was no observed safety risk between tenecteplase and alteplase in patients treated for AIS at CCHS in Florida and Ohio.

DISCLOSURE: The individuals involved do not have anything to disclose concerning potential or actual financial or personal relationships with commercial entities (or their competitors) that may be referenced in this study.

MESH TERMS: Tissue plasminogen activator, tenecteplase, ischemic stroke, intracranial hemorrhage, retrospective studies.