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Safe Implementation of Treatments in Stroke: A study on intravenous thrombolysis in patients over 80 years of age with acute ischaemic stroke

Lookup NU author(s): Dr Anand Dixit

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).

Abstract

© Author(s) (or their employer(s)) 2025. Objectives: To investigate the safety and efficacy outcomes of intravenous thrombolysis (IVT) in patients aged >80 years with acute ischaemic stroke (AIS) after IVT was approved in this patient population in several European and non-European countries during 2018-2019. Design: This is an observational registry study using prospectively collected data from the Safe Implementation of Treatment in Stroke (SITS) registry. Comparisons will be performed between patients treated post-approval (July 2018 to December 2021) period with those treated pre-approval (June 2015 to June 2018) period using propensity score matching (PSM). Setting This is a multicentre international study in hospitals treating AIS with IVT. Participants Patients aged >80 years who otherwise followed the IVT Summary of Product Characteristics of European countries as part of the mutual recognition procedure. Primary and secondary outcomes: The main outcomes were symptomatic intracerebral haemorrhage per SITS monitoring study definition, death and functional independency as defined by a modified Rankin Scale score of 0-2 at 90 days. Results: After PSM, 614 patients remained in each group (mean age 87 years, 39% males). All baseline data were well balanced after PSM. There were no statistically significant differences in outcomes between pre- and post-approval patients for SICH (2.5% vs 2.3%, risk ratio (RR) 1.064, 95% CI 0.345-1.784), death (25.3% vs 28.4%, RR 0.889, 0.699-1.08) and functional independency at 90 days (40.3% vs 37%, RR 1.089, 0.942-1.237). Conclusions: In this observational study of IVT treatment in patients >80 years of age with AIS before and after formal approval for this treatment, we did not find any difference in outcomes between the pre- and post-approval periods.

Publication metadata

Author(s): Matusevicius M, Paiva Nunes A, Krishnan M, Egido J, Concari L, Dixit A, Reggiani M, Pages A, Danays T, Toni D, Ahmed N

Publication type: Article

Publication status: Published

Journal: BMJ Open

Year: 2025

Volume: 15

Issue: 1

Online publication date: 11/01/2025

Acceptance date: 02/01/2025

Date deposited: 27/01/2025

ISSN (print): 2044-6055

ISSN (electronic): 2044-6055

Publisher: BMJ Publishing Group

URL: https://doi.org/10.1136/bmjopen-2024-087454

DOI: 10.1136/bmjopen-2024-087454

Data Access Statement: Data are available upon reasonable request. The data that support the findings of this study are available from the corresponding author upon reasonable request.

PubMed id: 39800396

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