Clinical Study of Intravenous, Low-Dose Recombinant Tissue Plasminogen Activator for Acute Cerebral Infarction: Comparison of Treatment within 3 Hours versus 3-4.5 Hours

摘要

Background: An intravenous recombinant tissue plasminogen activator (rt-PA, alteplase.6 mg/kg) for acute cerebral infarction within 3 hours of onset was approved in Japan in 2005. The treatment window was subsequently extended to within 4.5 hours of onset. However, few Japanese studies have compared the efficacy and safety of rt-PA therapy between patients treated within 3 hours and patients treated within 3-4.5 hours. Methods: This study included 323 patients who received rt-PA for acute cerebral infarction within 3 hours or 3-4.5 hours between April 2007 and March 2017. Patients' characteristics, outcomes (modified Rankin Scale [mRS] score at 3 months), and symptomatic intracranial hemorrhage (sICH) were retrospectively investigated. Results: Of the 323 patients, 219 were treated within 3 hours and 104 were treated at 3-4.5 hours. Among patients receiving rt-PA alone, 154 were treated within 3 hours (3-hour group), and 69 were treated at 3-4.5 -hours (3-4.5-hour group). There was no difference in the sICH rate (3.9% versus 4.3%, respectively; P = 1.00) or mRS score of 0-1 (38.3% versus 40.6%, respectively; P = .76) between these groups. In patients receiving additional neuroendovascular therapy, 65 were in the 3-hour group and 35 were in the 3-4.5-hour group. There was no significant difference in the sICH rate (1.5% versus 0%, respectively; P = 1.00) or mRS score of 0-1 (30.8% versus 31.4%, respectively; P = 1.00) between these groups. Conclusions: Low-dose rt-PA treatment from either 3 or 3-4.5 hours after acute cerebral infarction has the same efficacy and safety.