Correspondence to Gregory J. del Zoppo, MD, Department of Molecular and Experimental Medicine, The Scripps Research Institute, 10550 N Torrey Pines Rd, SBR-17, La Jolla, CA 92037. E-mail grgdlzop{at}riscsm.scripps.edu
Background and Purpose—To test the
safety and recanalization efficacy of
intra-arterial local delivery of plasminogen
activators in acute ischemic stroke, a randomized
trial of recombinant pro-urokinase (rpro-UK) versus placebo was
undertaken in patients with angiographically documented proximal middle
cerebral artery occlusion.
Methods—After exclusion of intracranial hemorrhage by CT
scan, patients with abrupt onset of symptoms of focal ischemia
likely to receive treatment within 6 hours who satisfied all clinical
eligibility criteria underwent carotid angiography. Patients displaying
Thrombolysis in Acute Myocardial Infarction grade 0 or 1
occlusion of the M1 or M2 middle cerebral artery were randomized 2:1 to
receive rpro-UK (6 mg) or placebo over 120 minutes into the proximal
thrombus face. All patients received intravenous heparin.
Recanalization efficacy was assessed at the end of
the 2-hour infusion, and intracerebral
hemorrhage causing neurological deterioration was assessed at
24 hours.
Results—Of 105 patients who underwent angiography, 59 were
excluded from randomization. Among the 46 patients randomized, 40 were
treated with rpro-UK (n=26) or placebo (n=14) a median of 5.5 hours
from symptom onset. Recanalization was
significantly associated with rpro-UK (2P=.017).
Hemorrhagic transformation causing neurological deterioration within 24
hours of treatment occurred in 15.4% of the rpro-UK–treated patients
and 7.1% of the placebo-treated patients (2P=.64). Both
recanalization and hemorrhage frequencies
were influenced by heparin dose.
Conclusions—Intra-arterial local rpro-UK infusion was
associated with superior recanalization in acute
thrombotic/thromboembolic stroke compared with placebo. In this
regimen, heparin dose influenced hemorrhage frequency and
recanalization. Although symptomatic
hemorrhage remains a concern, this study suggests that
recanalization is enhanced with rpro-UK and
heparin.
© 1998 American Heart Association, Inc.
Original Contributions
PROACT: A Phase II Randomized Trial of Recombinant Pro-Urokinase by Direct Arterial Delivery in Acute Middle Cerebral Artery Stroke
Key Words: stroke, acute • angiography • hemorrhage • pro-urokinase • recanalization
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A. Berlis, H. Lutsep, S. Barnwell, A. Norbash, L. Wechsler, C. A. Jungreis, A. Woolfenden, G. Redekop, M. Hartmann, and M. Schumacher Mechanical Thrombolysis in Acute Ischemic Stroke With Endovascular Photoacoustic Recanalization Stroke, May 1, 2004; 35(5): 1112 - 1116. [Abstract] [Full Text] [PDF]
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W. Yoon, J. J. Seo, J. K. Kim, K. H. Cho, J. G. Park, and H. K. Kang Contrast Enhancement and Contrast Extravasation on Computed Tomography After Intra-Arterial Thrombolysis in Patients With Acute Ischemic Stroke Stroke, April 1, 2004; 35(4): 876 - 881. [Abstract] [Full Text] [PDF]
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A. J. Ringer, L. R. Guterman, and L. N. Hopkins Site-Specific Thromboembolism: A Novel Animal Model for Stroke AJNR Am. J. Neuroradiol., February 1, 2004; 25(2): 329 - 332. [Abstract] [Full Text] [PDF]
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D. Pelz, P. Lylyk, and M. Negoro Interventional Neuroradiology Stroke, February 1, 2004; 35(2): 381 - 382. [Full Text] [PDF]
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T. Neumann-Haefelin, R. du Mesnil de Rochemont, J.B. Fiebach, A. Gass, C. Nolte, T. Kucinski, J. Rother, M. Siebler, O.C. Singer, K. Szabo, et al. Effect of Incomplete (Spontaneous and Postthrombolytic) Recanalization After Middle Cerebral Artery Occlusion: A Magnetic Resonance Imaging Study Stroke, January 1, 2004; 35(1): 109 - 114. [Abstract] [Full Text] [PDF]
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 J. M. Provenzale, R. Jahan, T. P. Naidich, and A. J. Fox Assessment of the Patient with Hyperacute Stroke: Imaging and Therapy Radiology, November 1, 2003; 229(2): 347 - 359. [Abstract] [Full Text] [PDF]
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 I. Fukuda, T. Imazuru, M. Osaka, K. Watanabe, K. Meguro, and M. Wada Thrombolytic therapy for delayed, in-hospital stroke after cardiac surgery Ann. Thorac. Surg., October 1, 2003; 76(4): 1293 - 1295. [Abstract] [Full Text] [PDF]
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T. Gerriets, E. Stolz, M. Walberer, M. Kaps, G. Bachmann, and M. Fisher Neuroprotective Effects of MK-801 in Different Rat Stroke Models for Permanent Middle Cerebral Artery Occlusion: Adverse Effects of Hypothalamic Damage and Strategies for Its Avoidance Stroke, September 1, 2003; 34(9): 2234 - 2239. [Abstract] [Full Text] [PDF]
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R. T. Higashida and A. J. Furlan Trial Design and Reporting Standards for Intra-Arterial Cerebral Thrombolysis for Acute Ischemic Stroke Stroke, August 1, 2003; 34 (8): e109 - e137. [Abstract] [Full Text] [PDF]
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 M. R. Golomb, M. Rafay, D. Armstrong, P. Massicotte, R. Curtis, S. Hune, and G. A. deVeber Intra-arterial Tissue Plasminogen Activator for Thrombosis Complicating Cerebral Angiography in a 17-Year-Old Girl J Child Neurol, June 1, 2003; 18(6): 420 - 423. [Abstract] [PDF]
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G. J. Hunter, H. M. Silvennoinen, L. M. Hamberg, W. J. Koroshetz, F. S. Buonanno, L. H. Schwamm, G. A. Rordorf, and R. G. Gonzalez Whole-Brain CT Perfusion Measurement of Perfused Cerebral Blood Volume in Acute Ischemic Stroke: Probability Curve for Regional Infarction Radiology, June 1, 2003; 227(3): 725 - 730. [Abstract] [Full Text] [PDF]
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J.M. Wardlaw, P.A.G. Sandercock, and E. Berge Thrombolytic Therapy With Recombinant Tissue Plasminogen Activator for Acute Ischemic Stroke: Where Do We Go From Here? A Cumulative Meta-Analysis Stroke, June 1, 2003; 34(6): 1437 - 1442. [Abstract] [Full Text] [PDF]
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L. R. Wechsler, R. Roberts, A. J. Furlan, R. T. Higashida, W. Dillon, H. Roberts, H. A. Rowley, L. C. Pettigrew, A. S. Callahan III, A. Bruno, et al. Factors Influencing Outcome and Treatment Effect in PROACT II Stroke, May 1, 2003; 34(5): 1224 - 1229. [Abstract] [Full Text] [PDF]
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H. P. Adams Jr, R. J. Adams, T. Brott, G. J. del Zoppo, A. Furlan, L. B. Goldstein, R. L. Grubb, R. Higashida, C. Kidwell, T. G. Kwiatkowski, et al. Guidelines for the Early Management of Patients With Ischemic Stroke: A Scientific Statement From the Stroke Council of the American Stroke Association Stroke, April 1, 2003; 34(4): 1056 - 1083. [Full Text] [PDF]
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B. R. Mahon, G. M. Nesbit, S. L. Barnwell, W. Clark, T. R. Marotta, A. Weill, P. A. Teal, and A. I. Qureshi North American Clinical Experience with the EKOS MicroLysUS Infusion Catheter for the Treatment of Embolic Stroke AJNR Am. J. Neuroradiol., March 1, 2003; 24(3): 534 - 538. [Abstract] [Full Text] [PDF]
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J. D. Eastwood, M. H. Lev, and J. M. Provenzale Perfusion CT with Iodinated Contrast Material Am. J. Roentgenol., January 1, 2003; 180(1): 3 - 12. [Full Text] [PDF]
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I. Fukuda and M. Wada Intraarterial thrombolysis for perioperative stroke in patients undergoing cardiac operations Ann. Thorac. Surg., December 1, 2002; 74(6): 2227 - 2228. [Full Text] [PDF]
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H. Kassem-Moussa and C. Graffagnino Nonocclusion and Spontaneous Recanalization Rates in Acute Ischemic Stroke: A Review of Cerebral Angiography Studies Arch Neurol, December 1, 2002; 59(12): 1870 - 1873. [Abstract] [Full Text] [PDF]
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R. C. Lisboa, B. D. Jovanovic, and M. J. Alberts Analysis of the Safety and Efficacy of Intra-Arterial Thrombolytic Therapy in Ischemic Stroke Stroke, December 1, 2002; 33(12): 2866 - 2871. [Abstract] [Full Text] [PDF]
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H. J. Cloft, T. A. Tomsick, D. F. Kallmes, J. H. Goldstein, and J. J. Connors Assessment of the Interventional Neuroradiology Workforce in the United States: A Review of the Existing Data AJNR Am. J. Neuroradiol., November 1, 2002; 23(10): 1700 - 1705. [Full Text] [PDF]
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 W. F. Baker Jr Thrombolytic Therapy Clinical and Applied Thrombosis/Hemostasis, October 1, 2002; 8(4): 291 - 314. [PDF]
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A. A. Rabinstein, E. F. M. Wijdicks, and D. A. Nichols Complete Recovery after Early Intraarterial Recombinant Tissue Plasminogen Activator Thrombolysis of Carotid T Occlusion AJNR Am. J. Neuroradiol., October 1, 2002; 23(9): 1596 - 1599. [Abstract] [Full Text] [PDF]
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J. P. Broderick and W. Hacke Treatment of Acute Ischemic Stroke: Part I: Recanalization Strategies Circulation, September 17, 2002; 106(12): 1563 - 1569. [Full Text] [PDF]
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M. Arnold, G. Schroth, K. Nedeltchev, T. Loher, L. Remonda, F. Stepper, M. Sturzenegger, and H. P. Mattle Intra-Arterial Thrombolysis in 100 Patients With Acute Stroke Due to Middle Cerebral Artery Occlusion Stroke, July 1, 2002; 33(7): 1828 - 1833. [Abstract] [Full Text] [PDF]
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C. A. Molina, J. Alvarez-Sabin, J. Montaner, S. Abilleira, J. F. Arenillas, P. Coscojuela, F. Romero, and A. Codina Thrombolysis-Related Hemorrhagic Infarction: A Marker of Early Reperfusion, Reduced Infarct Size, and Improved Outcome in Patients With Proximal Middle Cerebral Artery Occlusion Stroke, June 1, 2002; 33(6): 1551 - 1556. [Abstract] [Full Text] [PDF]
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J. F. Meschia, D. A. Miller, and T. G. Brott Thrombolytic Treatment of Acute Ischemic Stroke Mayo Clin. Proc., June 1, 2002; 77(6): 542 - 551. [Abstract] [PDF]
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 S. S. Yoon and J. Byles Perceptions of stroke in the general public and patients with stroke: a qualitative study BMJ, May 4, 2002; 324(7345): 1065 - 1065. [Abstract] [Full Text] [PDF]
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P.A. Ringleb, P.D. Schellinger, C. Schranz, and W. Hacke Thrombolytic Therapy Within 3 to 6 Hours After Onset of Ischemic Stroke: Useful or Harmful? Stroke, May 1, 2002; 33(5): 1437 - 1441. [Abstract] [Full Text] [PDF]
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J. N. Fink, M. H. Selim, S. Kumar, B. Silver, I. Linfante, L. R. Caplan, and G. Schlaug Is the Association of National Institutes of Health Stroke Scale Scores and Acute Magnetic Resonance Imaging Stroke Volume Equal for Patients With Right- and Left-Hemisphere Ischemic Stroke? Stroke, April 1, 2002; 33(4): 954 - 958. [Abstract] [Full Text] [PDF]
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C. S. Kidwell, J. L. Saver, J. Carneado, J. Sayre, S. Starkman, G. Duckwiler, Y.P. Gobin, R. Jahan, P. Vespa, J.P. Villablanca, et al. Predictors of Hemorrhagic Transformation in Patients Receiving Intra-Arterial Thrombolysis * Editorial Comment Stroke, March 1, 2002; 33(3): 717 - 724. [Abstract] [Full Text] [PDF]
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H. P. Adams Jr Emergent Use of Anticoagulation for Treatment of Patients With Ischemic Stroke Stroke, March 1, 2002; 33(3): 856 - 861. [Abstract] [Full Text] [PDF]
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P. Cintas, A. P. Le Traon, and V. Larrue High Rate of Recanalization of Middle Cerebral Artery Occlusion During 2-MHz Transcranial Color-Coded Doppler Continuous Monitoring Without Thrombolytic Drug Stroke, February 1, 2002; 33(2): 626 - 628. [Abstract] [Full Text] [PDF]
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C. J. Perkins, E. Kahya, C. T. Roque, P. E. Roche, G. C. Newman, and S. Warach Fluid-Attenuated Inversion Recovery and Diffusion- and Perfusion-Weighted MRI Abnormalities in 117 Consecutive Patients With Stroke Symptoms Editorial Comment Stroke, December 1, 2001; 32(12): 2774 - 2781. [Abstract] [Full Text] [PDF]
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C. S. Kase, A. J. Furlan, L. R. Wechsler, R. T. Higashida, H. A. Rowley, R. G. Hart, G. F. Molinari, L. S. Frederick, H. C. Roberts, J. M. Gebel, et al. Cerebral hemorrhage after intra-arterial thrombolysis for ischemic stroke: The PROACT II trial Neurology, November 13, 2001; 57(9): 1603 - 1610. [Abstract] [Full Text] [PDF]
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