RT Journal Article
SR Electronic
T1 Intravenous tenecteplase compared with alteplase for minor ischaemic stroke: a secondary analysis of the AcT randomised clinical trial
JF Stroke and Vascular Neurology
JO Stroke Vasc Neurol
FD BMJ Publishing Group Ltd
SP 604
OP 612
DO 10.1136/svn-2023-002828
VO 9
IS 6
A1 Nair, Radhika
A1 Singh, Nishita
A1 Kate, Mahesh
A1 Asdaghi, Negar
A1 Sarmiento, Robert
A1 Bala, Fouzi
A1 Coutts, Shelagh B
A1 Horn, MacKenzie
A1 Poppe, Alexandre Y
A1 Williams, Heather
A1 Ademola, Ayoola
A1 Alhabli, Ibrahim
A1 Benali, Faysal
A1 Khosravani, Houman
A1 Hunter, Gary
A1 Tkach, Aleksander
A1 Manosalva Alzate, Herbert Alejandro
A1 Pikula, Aleksandra
A1 Field, Thalia
A1 Trivedi, Anurag
A1 Dowlatshahi, Dar
A1 Catanese, Luciana
A1 Shuaib, Ashfaq
A1 Demchuk, Andrew
A1 Sajobi, Tolulope
A1 Almekhlafi, Mohammed A
A1 Swartz, Richard H
A1 Menon, Bijoy
A1 Buck, Brian H
YR 2024
UL http://svn.bmj.com/content/9/6/604.abstract
AB Background In ischaemic stroke, minor deficits (National Institutes of Health Stroke Scale (NIHSS) ≤5) at presentation are common but often progress, leaving patients with significant disability. We compared the efficacy and safety of intravenous thrombolysis with tenecteplase versus alteplase in patients who had a minor stroke enrolled in the Alteplase Compared to Tenecteplase in Patients With Acute Ischemic Stroke (AcT) trial.Methods The AcT trial included individuals with ischaemic stroke, aged >18 years, who were eligible for standard-of-care intravenous thrombolysis. Participants were randomly assigned 1:1 to intravenous tenecteplase (0.25 mg/kg) or alteplase (0.9 mg/kg). Patients with minor deficits pre-thrombolysis were included in this post-hoc exploratory analysis. The primary efficacy outcome was the proportion of patients with a modified Rankin Score (mRS) of 0–1 at 90–120 days. Safety outcomes included mortality and symptomatic intracranial haemorrhage (sICH).Results Of the 378 patients enrolled in AcT with an NIHSS of ≤5, the median age was 71 years, 39.7% were women; 194 (51.3%) received tenecteplase and 184 (48.7%) alteplase. The primary outcome (mRS score 0–1) occurred in 100 participants (51.8%) in the tenecteplase group and 86 (47.5 %) in the alteplase group (adjusted risk ratio (RR) 1.14 (95% CI 0.92 to 1.40)). There were no significant differences in the rates of sICH (2.9% in tenecteplase vs 3.3% in alteplase group, unadjusted RR 0.79 (0.24 to 2.54)) and death within 90 days (5.5% in tenecteplase vs 11% in alteplase group, adjusted HR 0.99 (95% CI 0.96 to 1.02)).Conclusion In this post-hoc analysis of patients with minor stroke enrolled in the AcT trial, safety and efficacy outcomes with tenecteplase 0.25 mg/kg were not different from alteplase 0.9 mg/kg.Data are available upon reasonable request. Data collected for the study, including de-identified individual participant data and a data dictionary defining each field in the set, can be made available to others upon reasonable request and after signing appropriate data sharing agreements by contacting the corresponding author. Such requests must be approved by the respective ethics boards and appropriate data custodians.