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 Clark, Frank Silver, Frank Rivera

Research output: Contribution to journalArticle

2562 Citations (Scopus)

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

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

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saruplase
Randomized Controlled Trials
Stroke
Middle Cerebral Artery Infarction
Heparin
Control Groups
Mortality
Intracranial Hemorrhages
Thromboembolism
Middle Cerebral Artery
Tissue Plasminogen Activator

ASJC Scopus subject areas

  • Medicine(all)

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Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study : A randomized controlled trial. / Furlan, Anthony; Higashida, Randall; Wechsler, Lawrence; Gent, Michael; Rowley, Howard; Kase, Carlos; Pessin, Michael; Ahuja, Arvind; Callahan, Fred; Clark, Wayne; Silver, Frank; Rivera, Frank.

In: Journal of the American Medical Association, Vol. 282, No. 21, 01.12.1999, p. 2003-2011.

Research output: Contribution to journalArticle

Furlan, A, Higashida, R, Wechsler, L, Gent, M, Rowley, H, Kase, C, Pessin, M, Ahuja, A, Callahan, F, Clark, W, 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, vol. 282, no. 21, pp. 2003-2011. https://doi.org/10.1001/jama.282.21.2003
Furlan, Anthony ; Higashida, Randall ; Wechsler, Lawrence ; Gent, Michael ; Rowley, Howard ; Kase, Carlos ; Pessin, Michael ; Ahuja, Arvind ; Callahan, Fred ; Clark, Wayne ; Silver, Frank ; Rivera, Frank. / Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study : A randomized controlled trial. In: Journal of the American Medical Association. 1999 ; Vol. 282, No. 21. pp. 2003-2011.
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AU - Gent, Michael

AU - Rowley, Howard

AU - Kase, Carlos

AU - Pessin, Michael

AU - Ahuja, Arvind

AU - Callahan, Fred

AU - Clark, Wayne

AU - Silver, Frank

AU - Rivera, Frank

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N2 - 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

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