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(Stroke. 2004;35:904.)
© 2004 American Heart Association, Inc.
Original Contributions |
From University of Cincinnati, Cincinnati, Ohio.
Correspondence to Dr Joseph Broderick, Professor and Chair, Department of Neurology, University of Cincinnati, 231 Bethesda Avenue, PO Box 670525, Cincinnati, OH 45267-0525. E-mail joseph.broderick{at}uc.edu
Background and Purpose To investigate the feasibility and safety of a combined intravenous (IV) and intra-arterial (IA) approach to recanalization in patients with ischemic stroke.
Materials and Methods Subjects ages 18 to 80 with an NIH Stroke Scale (NIHSS)
10 at baseline had IV recombinant tissue plasminogen activator (rt-PA) started (0.6 mg/kg, 60 mg maximum over 30 minutes) within 3 hours of onset. Additional rt-PA was then administered via microcatheter at the site of the thrombus up to a total dose of 22 mg over 2 hours of infusion or until thrombolysis. Primary comparisons were with similar subsets of placebo and rt-PAtreated subjects from the NINDS rt-PA Stroke Trial.
Results The 80 subjects had a median baseline NIHSS score of 18. The median time to initiation of IV rt-PA was 140 minutes as compared with 108 minutes for placebo and 90 minutes for rt-PAtreated subjects in the NINDS rt-PA Stroke Trial. The 3-month mortality in Interventional Management Study (IMS) subjects (16%) was numerically lower but not statistically different than the mortality of placebo (24%) and rt-PAtreated subjects (21%) in the NINDS rt-PA Stroke Trial. The rate of symptomatic intracerebral hemorrhage (6.3%) in IMS subjects was similar to that of rt-PAtreated subjects (6.6%) but higher than the rate in placebo-treated subjects (1.0%, P=0.018) in the NINDS rt-PA Stroke Trial. IMS subjects had a significantly better outcome at 3 months than NINDS placebo-treated subjects for all outcome measures (odds ratios
2).
Conclusions A randomized trial of standard IV rt-PA as compared with a combined IV and IA approach is needed.
Key Words: tissue plasminogen activator thrombolytic therapy controlled clinical trials
Related Article:
Stroke 2004 35: 911-912.
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