Intravenous tenecteplase compared with alteplase for minor ischaemic stroke: a secondary analysis of the AcT randomised clinical trial

Author:

Nair Radhika,Singh Nishita,Kate MaheshORCID,Asdaghi Negar,Sarmiento Robert,Bala FouziORCID,Coutts Shelagh B,Horn MacKenzieORCID,Poppe Alexandre Y,Williams Heather,Ademola Ayoola,Alhabli Ibrahim,Benali Faysal,Khosravani Houman,Hunter Gary,Tkach Aleksander,Manosalva Alzate Herbert AlejandroORCID,Pikula Aleksandra,Field ThaliaORCID,Trivedi Anurag,Dowlatshahi DarORCID,Catanese Luciana,Shuaib AshfaqORCID,Demchuk Andrew,Sajobi Tolulope,Almekhlafi Mohammed A,Swartz Richard H,Menon Bijoy,Buck Brian HORCID

Abstract

BackgroundIn 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.MethodsThe 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).ResultsOf 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)).ConclusionIn 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.

Funder

Alberta Strategy for Patient Oriented Research Support Unit

Canadian Institutes of Health Research

Publisher

BMJ

Subject

Cardiology and Cardiovascular Medicine,Neurology (clinical)

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