Tenecteplase versus standard care for minor ischaemic stroke according to the baseline occlusion status in TEMPO-2 trial

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Abstract
Introduction: Patients with minor ischaemic stroke (NIHSS ≤ 5) and intracranial occlusion or focal perfusion abnormality ≤ 12 h of onset did not benefit from intravenous tenecteplase compared to non-thrombolytic standard care (control) in the Tenecteplase vs Standard of Care for Minor Ischaemic Stroke with Proven Occlusion (TEMPO-2) trial. We tested whether tenecteplase was associated with better outcomes in subgroups defined by baseline vessel occlusion status. Patients and methods: In this secondary analysis of the randomised, controlled, blinded TEMPO-2 trial, patients were divided into 3 subgroups: complete occlusion (revised arterial occlusive lesion score 0), near occlusion (score 1) and no visible occlusion (focal perfusion abnormality present). The primary outcome was return to pre-stroke neurological functioning or better, assessed with 90-day mRS. Outcomes were analysed using a generalised linear model adjusted for age, sex, onset-to-randomisation time and baseline stroke severity. Results: Of 881 patients, complete occlusion was present in 218 in the control and 216 in the tenecteplase arm, near occlusion in 102 and 92 and no visible occlusion in 130 and 123, respectively. At baseline, there were longer treatment delays in the control arm with near occlusion, and older age, more hypertension and higher creatinine levels in the tenecteplase arm with complete occlusion. We found no difference in the primary outcome between tenecteplase and control in any subgroup (no visible occlusion: adjusted RR 1.03 [95% CI, 0.90–1.18]; near occlusion: adjusted RR 0.85 [95% CI, 0.71–1.01]; complete occlusion: adjusted RR 1.00 [95% CI, 0.89–1.12]). Discussion and conclusion: There was no difference in outcome between tenecteplase and standard care for patients with mild stroke based on their baseline vessel occlusion status. Trial registration: Clinicaltrials.gov: NCT02398656.
Funding Information
  • Canadian Institutes of Health Research
  • Heart and Stroke Foundation of Canada
  • British Heart Foundation and drug
  • University of Calgary

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