Abstract 160: Final Results of the Thrombolysis for Minor Ischemic Stroke With Proven Acute Symptomatic Occlusion Using TNK-tPA (TEMPO-1) Trial
Background: Minor stroke and TIA with an intracranial occlusion are associated with a 20-30% risk of neurological deterioration and subsequent disability. TNK-tPA compared to alteplase is easier to administer, has a longer half-life, higher fibrin specificity and possibly a lower rate of intracranial hemorrhage. Therefore, it may be an ideal thrombolytic agent for recanalization in this population.
Methods: TEMPO-1 was a multi-centre, prospective cohort, TNK-tPA dose-escalation, safety and feasibility trial. Patients with an NIHSS < 6, intracranial arterial occlusion on CTA, with no sign of well-evolved infarction who were treated within a 12h treatment window were enrolled. 50 patients were enrolled. The first 25 patients were treated at a dose of 0.1 mg/kg, and a second cohort of 25 patients treated at a dose of 0.25 mg/kg. Primary outcome was the rate of symptomatic intracranial (SICH) and extracranial hemorrhage. SICH was defined as a new ICH with ≥ 2 points worsening on the NIHSS. SITS-MOST definition of SICH was also assessed. Secondary outcomes include complete neurological (NIHSS 0-1) and functional (mRS 0-1) recovery at 90 days, recanalization at 4-8 h on CTA and minor bleeding.
Results: Median baseline NIHSS was 2 (SD 1.24) and median age was 71 years (SD 18). Site of intracranial occlusions were: MCA-M1 (13), MCA-M2 (21), MCA-M3 (8), PCA-P1 (1), PCA-P2 (1) branches, vertebral artery/PICA (3) and undetermined (3). There was one SICH seen [2% (1/50), CI95 0.5%-10.6%], which was in the 0.25mg/Kg dose tier. There were no SICH by the SITS-MOST definition. For the 0.1mg/Kg dose tier recanalization between 4-8 hours post drug was complete in 21.7%, partial in 26.1% and no recanalization was seen in 52.2%. For the 0.25mg/Kg dose tier recanalization between 4-8 hours post drug was complete in 56.6%, partial in 13% and no recanalization was seen in 30.4%. 90-day disability and neurological outcome assessment will be available at the time of the International Stroke Conference.
Conclusion: We have shown the safety and feasibility of thrombolysis with TNK-tPA in a minor stroke with intracranial occlusion population. Rates of recanalization are high in the 0.25mg/Kg tier and we have chosen this dose to proceed with a randomized controlled trial in this population.
Author Disclosures: S.B. Coutts: None. V. Dubuc: None. J.L. Mandzia: None. C. Kenney: None. S. Patil: None. M. Goyal: None. M.D. Hill: None. F. TEMPO-1 Investigators: None.
- © 2015 by American Heart Association, Inc.