Bente Thommessen1, Halvor Næss2,3, Nicola Logallo4, Christopher E Kvistad2,5, Ulrike Waje-Andreassen2, Hege Ihle-Hansen6,7, Håkon Ihle-Hansen6,8, Lars Thomassen2,5, Ole Morten Rønning1,8. 1. Department of Neurology, Division of Medicine, Akershus University Hospital, Lorenskog, Norway. 2. Department of Neurology, Haukeland University Hospital, Bergen, Norway. 3. Center for Age-Related Medicine, Stavanger University Hospital, Stavanger, Norway. 4. Department of Neurosurgery, Haukeland University Hospital, Bergen, Norway. 5. Institute of Clinical Medicine, University of Bergen, Bergen, Norway. 6. Department of Internal Medicine, Bærum Hospital, Drammen, Norway. 7. Department of Neurology, Oslo University Hospital, Oslo, Norway. 8. Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Abstract
BACKGROUND:Stroke prevalence is increasing with age. Alteplase is the only agent approved for thrombolytic treatment for patients with ischemic stroke, including patients ≥80 years. In the present study, the aim was to compare efficacy and safety of tenecteplase and alteplase in patients ≥80 years. METHODS: Data from the Norwegian Tenecteplase Stroke Trial, a randomized controlled trial comparing alteplase and tenecteplase, were assessed. RESULTS: Of the 273 patients ≥80 years included, mean age was 85.5 years.In the intention-to-treat analyses, 43.1% receiving tenecteplase and 39.9% receiving alteplase reached excellent functional outcome (modified Rankin Scale score 0-1) after 3 months (odds ratio (OR) 1.14, 95% confidence interval (CI) 0.70-1.85, p=0.59). No significant differences among patients in the two treatment groups regarding frequency of symptomatic intracranial hemorrhage during the first 48 h were identified (11 (8.5%) in the tenecteplase group, 10 (7.0%) in the alteplase group, OR 1.23, 95% CI 0.50-3.00, p 0.65). Death within 3 months occurred in 18 patients (14.3%) in the tenecteplase group and in 21 (15.3%) in the alteplase group (p 0.84). After excluding stroke mimics, the proportion of patients with excellent functional outcome was 44.1% in the tenecteplase group and 34.4% in the alteplase group (OR 1.50 CI 0.90-2.52, p 0.12). CONCLUSION: No differences in the efficacy and safety of tenecteplase versus alteplase in patients ≥80 years were identified. TRIAL REGISTRATION: Clinicaltrials.gov (NCT01949948).
RCT Entities:
BACKGROUND:Stroke prevalence is increasing with age. Alteplase is the only agent approved for thrombolytic treatment for patients with ischemic stroke, including patients ≥80 years. In the present study, the aim was to compare efficacy and safety of tenecteplase and alteplase in patients ≥80 years. METHODS: Data from the Norwegian Tenecteplase Stroke Trial, a randomized controlled trial comparing alteplase and tenecteplase, were assessed. RESULTS: Of the 273 patients ≥80 years included, mean age was 85.5 years.In the intention-to-treat analyses, 43.1% receiving tenecteplase and 39.9% receiving alteplase reached excellent functional outcome (modified Rankin Scale score 0-1) after 3 months (odds ratio (OR) 1.14, 95% confidence interval (CI) 0.70-1.85, p=0.59). No significant differences among patients in the two treatment groups regarding frequency of symptomatic intracranial hemorrhage during the first 48 h were identified (11 (8.5%) in the tenecteplase group, 10 (7.0%) in the alteplase group, OR 1.23, 95% CI 0.50-3.00, p 0.65). Death within 3 months occurred in 18 patients (14.3%) in the tenecteplase group and in 21 (15.3%) in the alteplase group (p 0.84). After excluding stroke mimics, the proportion of patients with excellent functional outcome was 44.1% in the tenecteplase group and 34.4% in the alteplase group (OR 1.50 CI 0.90-2.52, p 0.12). CONCLUSION: No differences in the efficacy and safety of tenecteplase versus alteplase in patients ≥80 years were identified. TRIAL REGISTRATION: Clinicaltrials.gov (NCT01949948).
Entities:
Keywords:
Tenecteplase; alteplase; ischemic stroke; old age; thrombolysis