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.
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.
['Deguchi|Ichiro|I|', 'Tanahashi|Norio|N|', 'Takao|Masaki|M|']
D000208:Acute Disease D000368:Aged D000369:Aged, 80 and over D002544:Cerebral Infarction D003131:Combined Modality Therapy D004185:Disability Evaluation D057510:Endovascular Procedures D005260:Female D005343:Fibrinolytic Agents D006801:Humans D007262:Infusions, Intravenous D020300:Intracranial Hemorrhages D007564:Japan D008297:Male D008875:Middle Aged D011994:Recombinant Proteins D020127:Recovery of Function D012189:Retrospective Studies D015912:Thrombolytic Therapy D013997:Time Factors D010959:Tissue Plasminogen Activator D016896:Treatment Outcome
recombinant tissue plasminogen activator neuroendovascular therapy Acute ischemic stroke low dose