(Stroke. 1999;30:2598.)
© 1999 American Heart Association, Inc.
Original Contributions |
Combined Intravenous and Intra-Arterial r-TPA Versus Intra-Arterial Therapy of Acute Ischemic Stroke
Emergency Management of Stroke (EMS) Bridging Trial
From Henry Ford Health Sciences Center, Department of Emergency Medicine (C.A.L.); Emory University, Department of Neurology (M.F.); University of Cincinnati, Departments of Radiology, Division of Neuroradiology (T.A.T.), Neurology (J.B.), Emergency Medicine (J.S.), and Environmental Health (J.K.); Barrow Neurological Institute (J.F.), Oregon Health Sciences University, Department of Neurology (W.C.); University of California Los Angeles, Departments of Emergency Medicine and Neurology (S.S.); University of Texas Houston, Department of Neurology (J.G.); and Mayo Clinic Jacksonville, Department of Neurology (T.B.).
Correspondence to Thomas Brott, MD, Mayo Clinic Jacksonville, Department of Neurology, 4500 San Pablo Rd, Jacksonville, FL 32224. E-mail Brott.thomas{at}mayo.edu
Background and Purpose—The purpose of this study was to test the feasibility, efficacy, and safety of combined intravenous (IV) and local intra-arterial (IA) recombinant tissue plasminogen activator (r-TPA) therapy for stroke within 3 hours of onset of symptoms.
Methods—This was a double-blind, randomized, placebo-controlled multi-center Phase I study of IV r-TPA or IV placebo followed by immediate cerebral arteriography and local IA administration of r-TPA by means of a microcatheter. Treatment activity was assessed by improvement on the National Institutes of Health Stroke Scale Score (NIHSSS) at 7 to 10 days. The Barthel Index, modified Rankin Scale, and the Glasgow Outcome Scale measured 3-month functional outcome. Arterial recanalization rates and their relation to total r-TPA dose and time to lysis were measured. Rates of life-threatening bleeding, intracerebral hemorrhage (ICH), or other bleeding complications assessed safety.
Results—Thirty-five patients were randomly assigned, 17 into the IV/IA group and 18 into the placebo/IA group. There was no difference in the 7- to 10-day or the 3-month outcomes, although there were more deaths in the IV/IA group. Clot was found in 22 of 34 patients. Recanalization was better (P=0.03) in the IV/IA group with TIMI 3 flow in 6 of 11 IV/IA patients versus 1 of 10 placebo/IA patients and correlated to the total dose of r-TPA (P=0.05). There was no difference in the median treatment intervals from time of onset to IV treatment (2.6 vs 2.7 hours), arteriography (3.3 vs 3.0 hours), or clot lysis (6.3 vs 5.7 hours) between the IV/IA and placebo/IA groups, respectively. A direct relation between NIHSSS and the likelihood of the presence of a clot was identified. Eight ICHs occurred; all were hemorrhagic infarctions. There were no parenchymal hematomas. Symptomatic ICH within 24 hours occurred in 1 placebo/IA patient only. Beyond 24 hours, symptomatic ICH occurred in 2 IV/IA patients only. Life-threatening bleeding complications occurred in 2 patients, both in the IV/IA group. Moderate to severe bleeding complications occurred in 2 IV/IA patients and 1 placebo/IA patient.
Conclusions—This pilot study demonstrates combined IV/IA treatment is feasible and provides better recanalization, although it was not associated with improved clinical outcomes. The presence of thrombus on initial arteriography was directly related to the baseline NIHSSS. This approach is technically feasible. The numbers of symptomatic ICH were similar between the 2 groups, which suggests that this approach may be safe. Further study is needed to determine the safety and effectiveness of this new method of treatment. Such studies should address not only efficacy and safety but also the cost-benefit ratio and quality of life, given the major investment in time, personnel, and equipment required by combined IV and IA techniques.
Key Words: cerebral ischemia • cerebrovascular disorders • drug therapy, combination • stroke, acute • tissue plasminogen activator • thrombolytic therapy
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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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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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A. V. Alexandrov and J. C. Grotta Arterial reocclusion in stroke patients treated with intravenous tissue plasminogen activator Neurology, September 24, 2002; 59(6): 862 - 867. [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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O. O. Zaidat, J. I. Suarez, C. Santillan, J. L. Sunshine, R. W. Tarr, V. H. Paras, W. R. Selman, D. M.D. Landis, and D. D. Tong Response to Intra-Arterial and Combined Intravenous and Intra-Arterial Thrombolytic Therapy in Patients With Distal Internal Carotid Artery Occlusion * Editorial Comment Stroke, July 1, 2002; 33(7): 1821 - 1827. [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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R. A. Felberg, N. J. Okon, A. El-Mitwalli, W. S. Burgin, J. C. Grotta, and A. V. Alexandrov Early Dramatic Recovery During Intravenous Tissue Plasminogen Activator Infusion: Clinical Pattern and Outcome in Acute Middle Cerebral Artery Stroke Stroke, May 1, 2002; 33(5): 1301 - 1307. [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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C. S. Kidwell, J. L. Saver, J. P. Villablanca, G. Duckwiler, A. Fredieu, K. Gough, M. C. Leary, S. Starkman, Y. P. Gobin, R. Jahan, et al. Magnetic Resonance Imaging Detection of Microbleeds Before Thrombolysis: An Emerging Application Stroke, January 1, 2002; 33(1): 95 - 98. [Abstract] [Full Text] [PDF]
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P. Verro, L. N. Tanenbaum, N. M. Borden, S. Sen, and N. Eshkar CT Angiography in Acute Ischemic Stroke: Preliminary Results Stroke, January 1, 2002; 33(1): 276 - 278. [Abstract] [Full Text] [PDF]
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M. D. Hill, P. A. Barber, A. M. Demchuk, N. J. Newcommon, A. Cole-Haskayne, K. Ryckborst, L. Sopher, A. Button, W. Hu, M. E. Hudon, et al. Acute Intravenous-Intra-Arterial Revascularization Therapy for Severe Ischemic Stroke Stroke, January 1, 2002; 33(1): 279 - 282. [Abstract] [Full Text] [PDF]
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W.S. Burgin, L. Staub, W. Chan, PhD;, T.H. Wein, R.A. Felberg, J.C. Grotta, A.M. Demchuk, S.L. Hickenbottom, and L.B. Morgenstern Acute stroke care in non-urban emergency departments Neurology, December 11, 2001; 57(11): 2006 - 2012. [Abstract] [Full Text] [PDF]
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C. S. Kidwell, J. L. Saver, J. Mattiello, S. Starkman, F. Vinuela, G. Duckwiler, Y.P. Gobin, R. Jahan, P. Vespa, J. P. Villablanca, et al. Diffusion-perfusion MRI characterization of post-recanalization hyperperfusion in humans Neurology, December 11, 2001; 57(11): 2015 - 2021. [Abstract] [Full Text] [PDF]
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Intra-arterial Thrombolysis AJNR Am. J. Neuroradiol., September 1, 2001; 22(2007): 18S - 21S. [Full Text] [PDF]
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J. L. Saver Intra-arterial thrombolysis Neurology, September 1, 2001; 57(90002): S58 - 60. [Abstract] [Full Text]
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A. M. Demchuk, D. Tanne, M. D. Hill, S. E. Kasner, S. Hanson, M. Grond, and S. R. Levine Predictors of good outcome after intravenous tPA for acute ischemic stroke Neurology, August 14, 2001; 57(3): 474 - 480. [Abstract] [Full Text] [PDF]
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L. Derex, T. A. Tomsick, T. G. Brott, C. A. Lewandowski, M. R. Frankel, W. Clark, S. Starkman, J. Spilker, G. J. Udsten, J. Khoury, et al. Outcome of Stroke Patients without Angiographically Revealed Arterial Occlusion within Four Hours of Symptom Onset AJNR Am. J. Neuroradiol., April 1, 2001; 22(4): 685 - 690. [Abstract] [Full Text]
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D. T. Cross III, C. P. Derdeyn, and C. J. Moran Bleeding Complications after Basilar Artery Fibrinolysis with Tissue Plasminogen Activator AJNR Am. J. Neuroradiol., March 1, 2001; 22(3): 521 - 525. [Abstract] [Full Text]
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W. Scott Burgin and A. V. Alexandrov Deterioration following improvement with tPA therapy: Carotid thrombosis and reocclusion Neurology, February 27, 2001; 56(4): 568 - 570. [Full Text] [PDF]
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V. Keris, S. Rudnicka, V. Vorona, G. Enina, B. Tilgale, and J. Fricbergs Combined Intraarterial/Intravenous Thrombolysis for Acute Ischemic Stroke AJNR Am. J. Neuroradiol., February 1, 2001; 22(2): 352 - 358. [Abstract] [Full Text] [PDF]
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E. COMMITTEE OF THE ASITN Intraarterial Thrombolysis: Ready for Prime Time? AJNR Am. J. Neuroradiol., January 1, 2001; 22(1): 55 - 58. [Full Text] [PDF]
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R. Ernst, A. Pancioli, T. Tomsick, B. Kissela, D. Woo, D. Kanter, E. Jauch, J. Carrozzella, J. Spilker, and J. Broderick Combined Intravenous and Intra-Arterial Recombinant Tissue Plasminogen Activator in Acute Ischemic Stroke Stroke, November 1, 2000; 31(11): 2552 - 2557. [Abstract] [Full Text] [PDF]
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J. P. Broderick, M. Lu, R. Kothari, S. R. Levine, P. D. Lyden, E. C. Haley, T. G. Brott, J. Grotta, B. C. Tilley, J. R. Marler, et al. Finding the Most Powerful Measures of the Effectiveness of Tissue Plasminogen Activator in the NINDS tPA Stroke Trial Stroke, October 1, 2000; 31(10): 2335 - 2341. [Abstract] [Full Text] [PDF]
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 T. Brott and J. Bogousslavsky Treatment of Acute Ischemic Stroke N. Engl. J. Med., September 7, 2000; 343(10): 710 - 722. [Full Text] [PDF]
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T. A. Tomsick Tick Tock, Doc: The Rapid Evaluation of Acute Stroke to Direct Therapy and Improve Patient Outcome AJNR Am. J. Neuroradiol., July 1, 2000; 21(7): 1177 - 1179. [Full Text] [PDF]
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W. S. Burgin, M. Malkoff, R. A. Felberg, A. M. Demchuk, I. Christou, J. C. Grotta, and A. V. Alexandrov Transcranial Doppler Ultrasound Criteria for Recanalization After Thrombolysis for Middle Cerebral Artery Stroke Stroke, May 1, 2000; 31(5): 1128 - 1132. [Abstract] [Full Text] [PDF]
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 P. T. Akins, S. Schneweis, D. Tirschwell, A. Furlan, L. Wechsler, M. Gent, R. Higashida, and R. Roberts Intra-arterial Prourokinase for Acute Ischemic Stroke JAMA, April 26, 2000; 283(16): 2102 - 2104. [Full Text] [PDF]
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J. P. Mohr Thrombolytic Therapy for Ischemic Stroke: From Clinical Trials to Clinical Practice JAMA, March 1, 2000; 283(9): 1189 - 1191. [Full Text] [PDF]
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