Real-world comparative safety and efficacy of tenecteplase versus alteplase in acute ischemic stroke patients with large vessel occlusion

Klearchos Psychogios; Lina Palaiodimou; Aristeidis H Katsanos; Georgios Magoufis; Apostolos Safouris; Odysseas Kargiotis; Stavros Spiliopoulos; Ermioni Papageorgiou; Aikaterini Theodorou; Konstantinos Voumvourakis; Elias Broutzos; Elefterios Stamboulis; Georgios Tsivgoulis

doi:10.1177/1756286420986727

Real-world comparative safety and efficacy of tenecteplase versus alteplase in acute ischemic stroke patients with large vessel occlusion

Ther Adv Neurol Disord. 2021 Jan 12:14:1756286420986727. doi: 10.1177/1756286420986727. eCollection 2021.

Affiliations

¹ Acute Stroke Unit, Metropolitan Hospital, Ethnarhou Makariou 9, Athens, Piraeus 18547, Greece.
² Second Department of Neurology, Attikon University Hospital, School of Medicine, University of Athens, Athens, Greece.
³ Division of Neurology, McMaster University/Population Health Research Institute, Hamilton, Canada.
⁴ Department of Interventional Neuroradiology, Metropolitan Hospital, Piraeus, Greece.
⁵ Acute Stroke Unit, Metropolitan Hospital, Piraeus, Greece.
⁶ Second Department of Radiology, Division of Interventional Radiology, School of Medicine, National and Kapodistrian University of Athens, Attikon University General Hospital, Athens, Greece.

Abstract

Background and aims: Tenecteplase has recently emerged as an alternative thrombolytic agent in acute ischemic stroke (AIS) patients with large vessel occlusion (LVO), possibly superior in achieving early reperfusion compared with alteplase. We aimed to compare the safety and efficacy of intravenous tenecteplase with intravenous alteplase for AIS patients with LVO in everyday clinical practice settings.

Methods: We prospectively evaluated patients with AIS due to LVO, treated with intravenous thrombolysis (IVT) with or without mechanical thrombectomy in two tertiary stroke centers. Patients were treated with standard-dose alteplase (0.9 mg/kg) or 0.25 mg/kg tenecteplase. Safety outcomes included prevalence of symptomatic intracranial hemorrhage (sICH) and mortality. Efficacy outcomes included averted thrombectomy, major neurological improvement at 24 h (defined as decrease in baseline NIHSS score of 8 points or greater) and functional status on discharge and on 3 months assessed by modified Rankin Scale (mRS).

Results: Nineteen AIS patients with LVO received tenecteplase and 39 received alteplase. We observed a non-significant higher rate of averted thrombectomies (32% versus 18%, p = 0.243) and a non-significant higher rate of sICH (16% versus 5%, p = 0.201) in the tenecteplase group. The rate of 24 h major neurological improvement was higher in the tenecteplase group (64% versus 33%, p = 0.046) but this was marginally attenuated in multivariable analyses (adjusted OR 10.22, 95% CI: 0.73-142.98; p = 0.084). Discharge mRS, 3-months mRS, and 3-month functional independence (mRS scores of 0-2) did not differ (p > 0.2) between the two groups. The rates of 3-month mortality (11% versus 18%, p = 0.703) were similar in the two groups. No independent association between thrombolytic agent and safety or efficacy outcomes emerged in multivariable regression analyses.

Conclusion: The present pilot observational study highlights that AIS patients with LVO treated with 0.25 mg/kg bolus administration of tenecteplase had increased likelihood to achieve early neurological improvement compared with AIS patients treated with alteplase, but this association was attenuated after adjustment for potential confounders. There were no significant differences in 3-month functional or safety outcomes between the two groups. This preliminary real-world observation requires independent confirmation in larger, multicenter studies.

Keywords: alteplase; intravenous thrombolysis; large vessel occlusion; mechanical thrombectomy; stroke; tenecteplase.