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

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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.

authors

  • Nair, Radhika
  • Singh, Nishita
  • Kate, Mahesh
  • Asdaghi, Negar
  • Sarmiento, Robert
  • Bala, Fouzi
  • Coutts, Shelagh B
  • Horn, MacKenzie
  • Poppe, Alexandre Y
  • Williams, Heather
  • Ademola, Ayoola
  • Alhabli, Ibrahim
  • Benali, Faysal
  • Khosravani, Houman
  • Hunter, Gary
  • Tkach, Aleksander
  • Manosalva Alzate, Herbert Alejandro
  • Pikula, Aleksandra
  • Field, Thalia
  • Trivedi, Anurag
  • Dowlatshahi, Dar
  • Catanese, Luciana
  • Shuaib, Ashfaq
  • Demchuk, Andrew
  • Sajobi, Tolulope
  • Almekhlafi, Mohammed A
  • Swartz, Richard H
  • Menon, Bijoy
  • Buck, Brian H

publication date

  • January 31, 2024