Comparison of intravenous and intra-arterial urokinase thrombolysis for acute ischaemic stroke

• Published in: Journal of neuroradiology 2005, Vol.32 (1), p.26-32
• Main Authors: Ducrocq, X., Bracard, S., Taillandier, L., Anxionnat, R., Lacour, J.C., Guillemin, F., Debouverie, M., Bollaert, P.E.
• Format: Article
• Language: English
• Subjects: accident vasculaire cérébral; Acute Disease; Adolescent; Adult; Aged; Brain Ischemia - drug therapy; Chi-Square Distribution; Female; Humans; Infusions, Intra-Arterial; Infusions, Intravenous; ischaemic stroke; ischémie; Male; Middle Aged; Plasminogen Activators - administration & dosage; Statistics, Nonparametric; thrombolyse; thrombolysis; Treatment Outcome; urokinase; Urokinase-Type Plasminogen Activator - administration & dosage
• ISSN: 0150-9861
• DOI: 10.1016/S0150-9861(05)83018-4

Intravenous fibrinolysis (IVF) with rt-PA (alteplase) provides significant benefits in acute ischaemic stroke when it is given within the first three hours following stroke onset. Intra-arterial fibrinolysis (IAF) with pro-urokinase in PROACT II study provides quite the same benefit in the first 6 hours. IVF and IAF have never been compared. To compare the efficacy and safety of IVF and IAF with urokinase given within the first 6 hours of acute ischaemic stroke. Patients fulfilling the selection criteria were randomly assigned to receive urokinase 900,000 units via intravenous or intra-arterial routes. This randomised monocentre study was done between December 1995 and August 1997. The primary outcome was defined as the number of patients with a modified Rankin score of 2 or less. Secondary outcomes included mortality, frequency of symptomatic intracranial haemorrhage (SIH), neurological and functional scores. Fourteen patients were given IVF and 13 IAF. The study was terminated by the National Health Authorities when 27 patients had been included because of the mortality rate. Seven patients (26%) died, 4 in the IV group (oedematous infarct in 3 and recurrence in 1), 3 in the IA group (SIH in 2, and oedematous infarct in 1). Patients given IVF were treated significantly earlier (4:16 h vs 5:24 h; p = .007). Although IA patients showed greater and earlier improvement there was no significant difference in primary and secondary outcomes. Because of premature termination, the trial was too small to provide any reliable and conclusive results. Intra-arterial fibrinolysis began significantly later than IV fibrinolysis but it gave non-significantly better results in this prematurely terminated study. La thrombolyse intraveineuse au rt-PA est efficace les trois premières heures de l’AVC ischémique cérébral. L’étude PROACT II a montré une efficacité voisine de la thrombolyse intra-artérielle dans les six premières heures. Les deux voies d’administration intraveineuse (IV) et intra-artérielle (IA) n’ont jamais été comparées. Nous avons donc réalisé une étude comparant l’efficacité de sécurité de l’Urokinase délivrée par voie intraveineuse ou intra-artérielle dans les six premières heures de l’accident ischémique cérébral. Les patients remplissant les critères d’inclusion ont été randomisés et traités par une injection de 900 000 unités d’Urokinase intraveineuse ou intra-artérielle. Le critère principal était le nombre de patients avec un score de Rankin égal ou in