Safety outcomes of Alteplase among acute ischemic stroke patients with special characteristics

Background Although tissue plasminogen activator (tPA) has been approved for use in acute ischemic stroke, concerns linger regarding its safety. We analyzed whether patients in special subgroups (i.e., age > 70 years, baseline National Institute of Health Stroke Scale (NIHSS) score > 20, diabetes, congestive heart failure (CHF), and of Hispanic origin) have a higher risk of symptomatic intracerebral hemorrhage (SICH) than patients without these characteristics. Methods Four prospective observational studies of acute ischemic stroke patients treated within 3 h with Alteplase were identified and individual patient data were pooled for this analysis. These included the Standard Treatment with Alteplase to Reverse Stroke Study [STARS, N = 389], Epidemiology Study of Ischemic Stroke [ESIS, N = 236], University Of Texas Houston Stroke Study [UT, N = 241], and Canadian Activase For Stroke Effectiveness Study [CASES, N = 1100]. The risk of SIGH was calculated for all patients and for each of five subgroups. Results A total of 1966 patients were studied. Overall the risk of symptomatic ICH was 4.7% (95%CI, 3.8-5.8%) and the risk was similar among patients with and without each of the five characteristics. Patients with advanced age, baseline NIHSS score > 20, CHF or diabetes had increased mortality and significantly lower rate of functional recovery. Conclusions The present study suggests that these specified subgroups of patients are not at increased risk of SICH after stroke thrombolysis compared to those without these characteristics.