Niaz Ahmed1, Kennedy R Lees2, Peter A Ringleb2, Christopher Bladin2, David Collas2, Danilo Toni2, Gary A Ford2. 1. From the Department of Clinical Neuroscience (N.A.), Karolinska Institutet; Department of Neurology (N.A.), Karolinska University Hospital, Stockholm, Sweden; Institute of Cardiovascular & Medical Sciences (K.R.L.), University of Glasgow, UK; Department of Neurology (P.A.R.), University Hospital Heidelberg, Germany; Department Neurosciences (Eastern Health) (C.B.), Box Hill Hospital, Monash University, Melbourne, Australia; Department of Medicine (D.C.), West Hertfordshire Hospitals NHS Trust, Watford, UK; Hospital Policlinico Umberto I (D.T.), Deptartment of Neurology and Psychiatry, "Sapienza" University Viale del Policlinico, Rome, Italy; Oxford University Hospitals NHS Foundation Trust (G.A.F.); and Radcliffe Department of Medicine (G.A.F.), Oxford University, UK. niaz.ahmed@ki.se. 2. From the Department of Clinical Neuroscience (N.A.), Karolinska Institutet; Department of Neurology (N.A.), Karolinska University Hospital, Stockholm, Sweden; Institute of Cardiovascular & Medical Sciences (K.R.L.), University of Glasgow, UK; Department of Neurology (P.A.R.), University Hospital Heidelberg, Germany; Department Neurosciences (Eastern Health) (C.B.), Box Hill Hospital, Monash University, Melbourne, Australia; Department of Medicine (D.C.), West Hertfordshire Hospitals NHS Trust, Watford, UK; Hospital Policlinico Umberto I (D.T.), Deptartment of Neurology and Psychiatry, "Sapienza" University Viale del Policlinico, Rome, Italy; Oxford University Hospitals NHS Foundation Trust (G.A.F.); and Radcliffe Department of Medicine (G.A.F.), Oxford University, UK.
Abstract
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.
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.
Authors: Louise E Craig; Sandy Middleton; Helen Hamilton; Fern Cudlip; Victoria Swatzell; Andrei V Alexandrov; Elizabeth Lightbody; Dame Caroline Watkins; Sheeba Philip; Dominique A Cadilhac; Elizabeth McInnes; Simeon Dale; Anne W Alexandrov Journal: Interv Neurol Date: 2018-09-25