Intravenous Thrombolysis in Patients Older Than Age 80 Years
To the Editor:
Congratulations to Dr Meretoja et al1 on their recent article about off-label use of intravenous thrombolysis from 1995 to 2008 at the Helsinki University Central Hospital. They raise concerns about use in patients older than age 80 years, a criterion that falls outside the European product license and is thus off-label in their study. They state, “Although the National Institute of Neurological Disorders and Stroke study2 also included patients older than age 80 years, their outcome has not been reported separately. No other randomized trial has been published on this age group.” Although we had difficulty finding a publisher, we have reported the outcomes in this subgroup from the National Institute of Neurological Disorders and Stroke study.3 Compared with younger patients (n=580), older patients (n=44) were 2.87-times more likely to experience a symptomatic intracranial hemorrhage within 36 hours of intravenous tissue plasminogen activator (95% confidence interval, 1.04–7.93). Older patients had worse outcomes on all 4 outcome measures and did not show the obvious benefit with intravenous tissue plasminogen activator that was evident in younger patients. Concern about the use of intravenous thrombolysis in patients older than age 80 years seems justified.
Meretoja A, Putaala J, Tatlisumak T, Atula S, Artto V, Curtze S, Häppölä O, Lindsberg PJ, Mustanoja S, Piironen K, Pitkäniemi J, Rantanen K, Sairanen T, Salonen O, Silvennoinen H, Soinne L, Strbian D, Tiainen M, Kaste M. Off-label thrombolysis is not associated with poor outcome in patients with stroke. Stroke. 2010; 41: 1450–1458.