Background and purpose: Risks and benefits of intravenous thrombolysis for patients with stroke > 80 years of age are unclear. We examined outcomes and symptomatic intracerebral hemorrhage rates in ≤ 80- and > 80-year-old patients in the Safe Implementation of Treatment in Stroke International Stroke Thrombolysis Register.
Methods: We compared mortality and independence (modified Rankin Scale 0 to 2) at 3 months and symptomatic intracerebral hemorrhage (per Safe Implementation of Treatment in Stroke ≥ 4-point deterioration in National Institutes of Health Stroke Scale within 36 hours and Type 2 parenchymal hemorrhage and per National Institute of Neurological Disorders and Stroke [any increase in National Institutes of Health Stroke Scale and any hemorrhage]) of 1831 patients > 80 years of age with 19 411 patients ≤ 80 years of age compliant with other European licensing criteria.
Results: The > 80-year-old group (median, 83 years) had more severe strokes (median National Institutes of Health Stroke Scale 14 versus 12), lower levels of prestroke independence (modified Rankin Scale 0 to 1, 82% versus 93%), and a larger proportion of females (59% versus 39%) compared with the younger group (68 years). Symptomatic intracerebral hemorrhage was not significantly increased after adjustment for other risk factors in those >80 years of age compared with those ≤ 80 years of age (per Safe Implementation of Treatment in Stroke 1.8% versus 1.7%, P = 0.70, adjusted OR, 0.90, 95% CI, 0.73 to 1.09; P = 0.28; per National Institute of Neurological Disorders and Stroke 9.5% versus 7.8%, P < 0.005, adjusted OR, 0.96, 95% CI, 0.87 to 1.06, P = 0.42). The patients >80 years of age had a higher mortality rate (30% versus 12%; P < 0.005; adjusted OR, 1.53; 95% CI, 1.43 to 1.65; P < 0.005) and reduced independence (35% versus 57%; P < 0.005; adjusted OR, 0.73; 95% CI, 0.68 to 0.78; P < 0.005).
Conclusions: Selected patients with acute ischemic stroke > 80 years of age otherwise fulfilling the intravenous alteplase license criteria have a similar rate of symptomatic intracerebral hemorrhage compared with younger patients and are appropriate candidates for thrombolysis. The higher mortality and the poorer functional outcome are consistent with the overall worse prognosis seen in the natural history of this age group.