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OBJECTIVE: To determine outcomes and risks of IV thrombolysis (IVT) in patients with acute ischemic stroke (AIS) >80 years of age within 3 hours compared to >3 to 4.5 hours recorded in the Safe Implementation of Treatment in Stroke (SITS) International Stroke Thrombolysis Registry. METHODS: A total of 14,240 (year 2003-2015) patients >80 years of age with AIS were treated with IVT ≤4.5 hours of stroke onset (3,558 in >3-4.5 hours). Of these, 8,658 (2,157 in >3-4.5 hours) were treated otherwise according to the European Summary of Product Characteristics (EU SmPC) criteria for alteplase. Outcomes were 3-month functional independence (modified Rankin Scale score 0-2), mortality, and symptomatic intracerebral hemorrhage (SICH)/SITS. Results were compared between the groups treated in >3 to 4.5 and ≤3 hours. RESULTS: Median age was 84 years; 61% were female in both groups. Median NIH Stroke Scale score was 12 vs 14 in the >3- to 4.5- and ≤3-hour group, respectively. Three-month functional independence was 34% vs 35% (adjusted odds ratio [aOR] 0.78, 95% confidence interval [CI] 0.69-0.89, p < 0.001); mortality was 31% vs 32% (aOR 1.10, 95% CI 0.97-1.25, p = 0.13); and SICH/SITS was 2.7% vs 1.6% (aOR 1.72, 95% CI 1.25-2.35, p = 0.001). In EU SmPC-compliant patients, 3-month functional independence was 36 vs 37% (aOR 0.79, 95% CI 0.68-0.92, p = 0.002), mortality was 29% vs 29.6% (aOR 1.10, 95% CI 0.95-1.28, p = 0.20), and SICH/SITS was 2.7% vs 1.6% (aOR 1.62, 95% CI 1.12-2.34, p = 0.01). CONCLUSIONS: In this observational study, unselected patients >80 years of age treated with IVT after 3 hours vs earlier had a slightly higher rate of SICH and similar unadjusted functional outcome but poorer adjusted outcome. The absolute difference between the treatment groups is small, and elderly patients should not be denied IVT in the later time window solely because of age without other contraindications.

Original publication




Journal article



Publication Date





1561 - 1568


Aged, 80 and over, Cerebral Hemorrhage, Europe, Female, Fibrinolytic Agents, Humans, Male, Outcome Assessment (Health Care), ROC Curve, Registries, Retrospective Studies, Stroke, Time Factors, Tissue Plasminogen Activator, Treatment Outcome