Abstract
ObjectivesThe benefit of intravenous recombinant tissue plasminogen activator (rt-PA) therapy for very old patients with acute ischemic stroke remains unclear. The aim of this study was to elucidate the efficacy and safety of intravenous rt-PA therapy for patients over 80 years old.MethodsOf 13,521 stroke patients registered in the Fukuoka Stroke Registry in Japan from June 1999 to February 2013, 953 ischemic stroke patients who were over 80 years old, hospitalized within 3 h of onset, and not treated with endovascular therapy were included in this study. Among them, 153 patients were treated with intravenous rt-PA (0.6 mg/kg). For propensity score (PS)-matched case-control analysis, 148 patients treated with rt-PA and 148 PS-matched patients without rt-PA therapy were selected by 1∶1 matching with propensity for using rt-PA. Clinical outcomes were neurological improvement, good functional outcome at discharge, in-hospital mortality, and hemorrhagic complications (any intracranial hemorrhage [ICH], symptomatic ICH, and gastrointestinal bleeding).ResultsIn the full cohort of 953 patients, rt-PA use was associated positively with neurological improvement and good functional outcome, and negatively with in-hospital mortality after adjustment for multiple confounding factors. In PS-matched case-control analysis, patients treated with rt-PA were still at lower risk for unfavorable clinical outcomes than non-treated patients (neurological improvement, odds ratio 2.67, 95% confidence interval 1.61–4.40; good functional outcome, odds ratio 2.23, 95% confidence interval 1.16–4.29; in-hospital mortality, odds ratio 0.30, 95% confidence interval 0.13–0.65). There was no significant association between rt-PA use and risk of hemorrhagic complications in the full and PS-matched cohorts.ConclusionsIntravenous rt-PA therapy was associated with improved clinical outcomes without significant increase in risk of hemorrhagic complications in very old patients (aged>80 years) with acute ischemic stroke.
Highlights
Thrombolysis with intravenous recombinant tissue plasminogen activator is currently the most effective therapy to improve clinical outcomes in patients with acute ischemic stroke [1]
Most previous studies have shown no significant difference in the occurrence of intracranial hemorrhage (ICH) after recombinant tissue plasminogen activator (rt-PA) therapy between very old and young patients [2]–[10], [12]–[18], a recent study using the National Impatient Sample Database revealed a PLOS ONE | www.plosone.org rt-PA for Stroke Patients over 80 Years Old significantly higher risk of ICH after thrombolysis in very old versus younger patients [11]
The Third International Stroke Trial (IST-3) enrolled ischemic stroke patients up to 6 h from onset without upper age limit to determine whether intravenous thrombolysis with rt-PA is beneficial to a wider range of patients [19]
Summary
Thrombolysis with intravenous recombinant tissue plasminogen activator (rt-PA) is currently the most effective therapy to improve clinical outcomes in patients with acute ischemic stroke [1]. A large number of studies have reported that functional outcome and in-hospital mortality are unfavorable after thrombolytic therapy in very old patients compared with those in younger patients [2]–[13]. Regarding the safety, it remains unclear whether thrombolysis is associated with an increased risk of adverse events, such as intracranial hemorrhage (ICH), in older patients. The frequencies of hemorrhagic complications, including any ICH, symptomatic ICH, and gastrointestinal bleeding were not statistically different between rt-PA-treated and PS-matched non-treated patients
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