Tenecteplase Versus Alteplase for Acute Stroke: Mortality and Bleeding Complications - 20/11/23

Doi : 10.1016/j.annemergmed.2023.03.022

Luke R. Murphy, MD ^a,^⁎ , T. Preston Hill, MD ^a, Krishna Paul, BS ^a, Matthew Talbott, DO ^a, Georgiy Golovko, PhD ^b, Hashem Shaltoni, MD ^c, Dietrich Jehle, MD ^a
^a Department of Emergency Medicine, University of Texas Medical Branch, Galveston, TX
^b Department of Pharmacology and Toxicology, University of Texas Medical Branch, Galveston, TX
^c Department of Neurology, University of Texas Medical Branch, Galveston, TX

^∗Corresponding Author.

Abstract

Study objective

Intravenous thrombolysis with alteplase has been the foundation of initial treatment of acute ischemic stroke for several decades. Tenecteplase is a thrombolytic agent that offers logistical advantages in cost and administration relative to alteplase. There is evidence that tenecteplase has at least similar efficacy and safety outcomes compared with alteplase for stroke. In this study, we compared tenecteplase versus alteplase for acute stroke in a large retrospective US database (TriNetX) regarding the following 3 outcomes: (1) mortality, (2) intracranial hemorrhage, and (3) the need for acute blood transfusions.

Methods

In this retrospective study using the US cohort of 54 academic medical centers/health care organizations in the TriNetX database, we identified 3,432 patients treated with tenecteplase and 55,894 patients treated with alteplase for stroke after January 1, 2012. Propensity score matching was performed on basic demographic information and 7 previous clinical diagnostic groups, resulting in a total of 6,864 patients with acute stroke evenly matched between groups. Mortality rates, the frequency of intracranial hemorrhage, and blood transfusions (as a marker of significant blood loss) were recorded for each group over the ensuing 7- and 30-day periods. Secondary subgroup analyses were conducted on a cohort treated from 2021 to 2022 in an attempt to determine whether temporal differences in acute ischemic stroke treatment would alter the results.

Results

Patients treated with tenecteplase had a significantly lower mortality rate (8.2% versus 9.8%; risk ratio [RR], 0.832) and lower risk of major bleeding as measured by the frequency of blood transfusions (0.3% versus 1.4%; RR, 0.207) than alteplase at 30 days after thrombolysis for stroke. In the larger 10-year data set of patients with stroke treated after January 1, 2012, patients receiving tenecteplase were not found to have a statistically different incidence of intracranial hemorrhage (3.5% versus 3.0%; RR, 1.185) at 30 days after the administration of the thrombolytic agents in patients. However, a subgroup analysis of 2,216 evenly matched patients with stroke treated from 2021 to 2022 demonstrated notably better survival and statistically lower rates of intracranial hemorrhage than the alteplase group.

Conclusion

In our large retrospective multicenter study using real-world evidence from large health care organizations, tenecteplase for the treatment of acute stroke demonstrated a lower mortality rate, decreased intracranial hemorrhage, and less significant blood loss. The favorable mortality and safety profiles observed in this large study, taken together with previous randomized controlled trial data and operational advantages in rapid dosing and cost-effectiveness, all support the preferential use of tenecteplase in patients with ischemic stroke.

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Plan

Introduction

Background

Methods and Materials

Results

Limitations

Discussion

	Please see page 721 for the Editor’s Capsule Summary of this article.
	Supervising editor: William J. Meurer, MD, MS. Specific detailed information about possible conflict of interest for individual editors is available at editors.
	Author contributions: LM, PH, GG, and DJ conceived the concept and design of the study. LM, PH, KP, GG, and DJ supervised the data collection. LM, PH, KP, MT, GG, HS, and DJ undertook data acquisition, analysis, or interpretation of data. GG, DJ, and LM provided statistical advice on study design and analyzed the data. LM, PH, KP, and MT drafted the manuscript, and all authors contributed substantially to its revision. LM takes responsibility for the paper as a whole.
	Authorship: All authors attest to meeting the four ICMJE.org authorship criteria: (1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
	Funding and support: By Annals’ policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The authors have stated that no such relationships exist. This study was conducted with the support of the Institute for Translational Sciences at the University of Texas Medical Branch, supported in part by a Clinical and Translational Science Award (UL1 TR001439) from the National Center for Advancing Translational Sciences, National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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