[Intravenous tissue-type plasminogen activator for the treatment of acute cerebral ischemia].
OBJECTIVE
Whether the risk of symptomatic hemorrhagic transformation (SHT) of cerebral infarction associated with the use of tissue plasminogen activator (t-PA) is higher in clinical practice than in clinical trials is unknown. The aim of this study was to analyze the safety profile and clinical outcome of patients with acute cerebral ischemia who received open treatment with t-PA in Spanish hospitals.


METHODS
This prospective and observational study included 155 consecutive patients with an ischemic stroke treated within 3 hours from the onset of symptoms, or within 6 hours in the absence of early signs of large cerebral infarction on CT. Intravenous t-PA was administered at 0.9 mg/kg (10% as bolus) during a 60 minutes infusion. Neurological worsening within 24-36 hours was evaluated by the NIH stroke scale (NIHSS). Primary safety and outcome variables were SHT on CT performed at 24-36 hours, mortality and independence at 90 days. Patients were treated by neurologists with expertise in acute stroke, and stroke monitoring was performed in acute stroke units.


RESULTS
Baseline median NIHSS was 16, and mean time from stroke onset to treatment was 163 minutes. SHT was found in 12 patients (7.7%; 95% CI, 4.0-13.1), and it was fatal in 7 (4.5%, 95% CI, 1.8-9.1). Overall mortality at 90 days was 16.8% (95% CI, 11.2-23.6). At 24 hours, 48% (95% CI, 39.7-55.9) of patients had improved >= 4 points in the NIHSS, and 29% (95 % CI, 22.0-36.8) showed a >= 10 points improvement or total recovery. At 3 months, 56% (95% CI, 47.9-64.1) of patients were independent.


CONCLUSIONS
In Spanish hospitals with stroke units or stroke teams, the use in the clinical practice of intravenous t-PA by experienced neurologists is safe, and it is associated with a favourable outcome similar to that observed in clinical trials.
Dávalos
Antoni
A
Servicio de Neurología y Unidad de Ictus. Hospital Universitari Josep Trueta. Girona. Spain. min.adavalos@htrueta.scs.es
Alvarez-Sabín
José
J
Martí-Vilalta
Josep Lluís
JL
Castillo
José
J
D000208:Acute Disease; D000368:Aged; D002545:Brain Ischemia / Q000150:complications / Q000000981:diagnostic imaging / Q000188:drug therapy*; D004185:Disability Evaluation; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D011446:Prospective Studies; D012307:Risk Factors; D012449:Safety; D015912:Thrombolytic Therapy / Q000009:adverse effects / Q000379:methods*; D010959:Tissue Plasminogen Activator / Q000009:adverse effects / Q000627:therapeutic use*; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator