Medicines

Major trial backs Aussie guidance for tenecteplase in stroke thrombolysis


A landmark stroke thrombolysis study has backed new Australian recommendations for tenecteplase to be use as an alternative to alteplase within 4.5 hours of stroke onset.

The Canadian AcT study is the first randomised controlled trial to provide solid evidence that tenecteplase 0·25 mg/kg is equally safe and effective as alteplase 0·9 mg/kg in patients with acute ischaemic stroke, according to international stroke researchers writing in The Lancet.

They said findings should be practice changing because tenecteplase may be administered as a single immediate dose whereas alteplase delivery takes up to an hour and requires an infusion pump that needs to be monitored, a major drawback when transporting a patient.

The study was a pragmatic, multicentre, open-label trial comparing tenecteplase with alteplase in 1577  patients with acute ischaemic stroke presenting within 4·5 hours of symptom onset.

Conducted across 22 stroke centres, the study showed that for the primary endpoint of excellent functional outcome (modified Rankin Scale score of 0–1) at 90–120 days, tenecteplase treatment was non-inferior to alteplase ( (36·9% vs 34·8%).

There were also no differences between the treatment groups in the secondary efficacy endpoints, such as return to baseline function at 90 days, door-to-needle time, proportion of patients given endovascular therapy,  cognition and length of hospital stay.

Likewise the two treatments showed no differences in safety endpoints, with 3·4% patients in the tenecteplase group and 3·2% in the alteplase group had 24 hour symptomatic intracerebral haemorrhage and 15·3% vs 15·4% died within 90 days of starting treatment.

The study authors concluded that the AcT trial results provide “robust empirical evidence that tenecteplase is comparable to alteplase in patients presenting with acute ischaemic stroke, with similar function, quality of life, and safety outcomes.”

“Given the ease of administration of tenecteplase compared with alteplase, these results provide a compelling rationale to support switching the standard-of-care intravenous thrombolytic agent for acute ischaemic stroke from alteplase to tenecteplase at a dose of 0·25 mg/kg.”

An accompanying commentary in The Lancet supported this conclusion, stating: “with regard to patients presenting within 4·5 h of symptom onset, it is time for action and modification of the current intravenous thrombolysis guidelines and protocols.”

However, the authors said research was now needed on teneceteplase for thrombolysis beyond 4.5 hours of stroke onset.

In May 2022, Australia’s living guidelines for a stroke were updated to include two new recommendations for the use of tenecteplase as an alternative to alteplase within 4.5 hours of stroke onset, and for use in large vessel occlusions.

The updates to the Australian and New Zealand Clinical Guidelines for Stroke Management reflect current evidence and are supported by the Stroke Foundation, the authors said in the MJA.

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