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The PROACT II Study: A Randomized Controlled Trial

Anthony Furlan, MD; Randall Higashida, MD; Lawrence Wechsler, MD; Michael Gent, DSc; Howard Rowley, MD; Carlos Kase, MD; Michael Pessin, MD; Arvind Ahuja, MD; Fred Callahan, MD; Wayne M. Clark, MD; Frank Silver, MD; Frank Rivera, MD; for the PROACT Investigators

JAMA. 1999;282:2003-2011.

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.

Author Affiliations: Cerebrovascular Center, Department of Neurology, Cleveland Clinic Foundation, Cleveland, Ohio (Dr Furlan). Department of Neuroradiology, University of California, San Francisco (Drs Higashida and Rowley); Stroke Institute, University of Pittsburgh, Pittsburgh, Pa (Dr Wechsler); Department of Clinical Epidemiology and Biostatistics, McMaster University and Clinical Trials Methodology Group, Hamilton Civic Hospital Research Center, Hamilton, Ontario (Dr Gent); Department of Neurology, Boston University School of Medicine (Dr Kase), Department of Neurology, New England Medical Center (Dr Pessin), Boston, Mass; Department of Neurosurgery, St Lukes' Medical Center, Milwaukee, Wis (Dr Ahuja); Neurologic Consultants PC, Centennial Medical Center, Nashville, Tenn (Dr Callahan); Department of Neurology, Oregon Health Sciences University, Portland (Dr Clark); Department of Neurology, The Toronto Hospital–Western Division, Toronto, Ontario (Dr Silver); and Department of Vascular and Interventional Radiology, Baylor University Medical Center, Dallas, Tex (Dr Rivera). Dr Pessin is deceased.

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RELATED LETTER

Intra-arterial Prourokinase for Acute Ischemic Stroke
Paul T. Akins, Susanne Schneweis, David Tirschwell, Anthony Furlan, Lawrence Wechsler, Michael Gent, Randall Higashida, and Robin Roberts
JAMA. 2000;283(16):2102-2104.
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JAMA. 1999;282(21):2087-2088.
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