Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study: A randomized controlled trial

Anthony Furlan, Randall Higashida, Lawrence Wechsler, Michael Gent, Howard Rowley, Carlos Kase, Michael Pessin, Arvind Ahuja, Fred Callahan, Wayne M. Clark, Frank Silver, Frank Rivera

Research output: Contribution to journalArticle

2577 Scopus citations

Abstract

Context: Intravenous tissue-type plasminogen activator can be beneficial to some patients when given within 3 hours of stroke onset, but many patients present later after stroke onset and alternative treatments are needed. Objective: To determine the clinical efficacy and safety of intra-arterial (IA) recombinant prourokinase (r-proUK) in patients with acute stroke of less than 6 hours' duration caused by middle cerebral artery (MCA) occlusion. Design: PROACT II (Prolyse in Acute Cerebral Thromboembolism II), a randomized, controlled, multicenter, open-label clinical trial with blinded follow-up conducted between February 1996 and August 1998. Setting: Fifty- four centers in the United States and Canada. Patients: A total of 180 patients with acute ischemic stroke of less than 6 hours' duration caused by angiographically proven occlusion of the MCA and without hemorrhage or major early infarction signs on computed tomographic scan Intervention: Patients were randomized to receive 9 mg of IA r-proUK plus heparin (n = 121) or heparin only (n = 59). Main Outcome Measures: The primary outcome, analyzed by intention-to-treat, was based on the proportion of patients with slight or no neurological disability at 90 days as defined by a modified Rankin score of 2 or less. Secondary outcomes included MCA recanalization, the frequency of intracranial hemorrhage with neurological deterioration, and mortality. Results: For the primary analysis, 40% of r-proUK patients and-25% of control patients had a modified Rankin score of 2 or less (P = .04). Mortality was 25% for the r-proUK group and 27% for the control group. The recanalization rate was 66% for the r-proUK group and 18% for the control group (P<.001). Intracranial hemorrhage with neurological deterioration within 24 hours occurred in 10% of r-proUK patients and 2% of control patients (P = .06). Conclusion: Despite an increased frequency of early symptomatic intracranial hemorrhage, treatment with IA r-proUK within 6 hours of the onset of acute ischemic stroke caused by MCA occlusion significantly improved clinical outcome at 90 days.

Original languageEnglish (US)
Pages (from-to)2003-2011
Number of pages9
JournalJournal of the American Medical Association
Volume282
Issue number21
DOIs
StatePublished - Dec 1 1999

ASJC Scopus subject areas

  • Medicine(all)

Fingerprint Dive into the research topics of 'Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study: A randomized controlled trial'. Together they form a unique fingerprint.

  • Cite this

    Furlan, A., Higashida, R., Wechsler, L., Gent, M., Rowley, H., Kase, C., Pessin, M., Ahuja, A., Callahan, F., Clark, W. M., Silver, F., & Rivera, F. (1999). Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study: A randomized controlled trial. Journal of the American Medical Association, 282(21), 2003-2011. https://doi.org/10.1001/jama.282.21.2003