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Circulation, Vol 90, 1631-1637, Copyright © 1994 by American Heart Association
BACKGROUND: Although intravenous heparin is routinely used in the treatment
of patients with acute coronary syndromes, this anticoagulant requires
antithrombin III as a cofactor, has no affinity to clot-bound thrombin, and
is bound or inactivated by several plasma proteins and platelet factor 4.
Recombinant hirudin, the prototypic direct thrombin inhibitor, has been
demonstrated in pilot studies to yield improved angiographic and clinical
outcomes compared with heparin. We compared these two antithrombins in a
large-scale randomized trial. METHODS AND RESULTS: At 275 participating
hospitals in 12 countries, patients within 12 hours from the onset of
ischemic chest discomfort with an abnormal ECG were randomly assigned to
receive a 72- to 120-hour infusion of heparin (5000-U bolus and 1000- to
1300-U/h infusion, adjusted to activated partial thromboplastin time (APTT)
of 60 to 90 seconds or hirudin (0.6-mg/kg bolus and 0.2-mg/kg per hour
infusion without aPTT adjustment) on a double-blind basis. Although
recruitment of 12,000 patients was planned, the trial was stopped earlier
because of an excess of intracerebral hemorrhagic events after 2564
patients were enrolled. The overall incidence of hemorrhagic stroke tended
to be higher for patients receiving hirudin (1.3%) compared with heparin
(0.7%), P = .11, but the incidence was significantly higher in patients
receiving thrombolytic therapy (1264 patients, 1.8%) compared with those
who did not (1168 patients, 0.3%), P < .001. The hemorrhagic stroke rate
varied by the thrombolytic and antithrombin combination: tissue-type
plasminogen activator and heparin, 0.9%; with hirudin, 1.7%; streptokinase
with heparin, 2.7%; with hirudin, 3.2%. All these rates are higher than the
overall incidence of hemorrhagic stroke in the patients receiving
thrombolytic therapy and intravenous heparin in the GUSTO I trial (30,892
patients with rate of 0.7%, 95% CI of 0.6 to 0.8%). Among the 26 patients
who had intracerebral hemorrhages, the aPTT was significantly elevated
compared with the event-free patients (110 +/- 46 versus 87 +/- 36 seconds
at 12 hours of therapy, respectively), P = .03. CONCLUSIONS: At the dose of
hirudin tested, there was a trend of an excess of hemorrhagic stroke
compared with heparin. Heparin, at a slightly higher dose than previously
used in a large-scale trial (approximately 20% increase) was accompanied by
a twofold risk of hemorrhagic stroke in patients receiving thrombolytic
therapy. With both thrombin inhibitors, the aPTT appears to be a useful
index for predicting risk of hemorrhagic stroke in patients receiving
thrombolytic therapy.
ARTICLES
Randomized trial of intravenous heparin versus recombinant hirudin for acute coronary syndromes. The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) IIa Investigators
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International, Randomized, Controlled Trial of Lamifiban (a Platelet Glycoprotein IIb/IIIa Inhibitor), Heparin, or Both in Unstable Angina Circulation, June 23, 1998; 97(24): 2386 - 2395. [Abstract] [Full Text] [PDF]
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P. Theroux and V. Fuster Acute Coronary Syndromes : Unstable Angina and Non–Q-Wave Myocardial Infarction Circulation, March 31, 1998; 97(12): 1195 - 1206. [Full Text] [PDF]
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D. Tanne, S. Gottlieb, A. Caspi, H. Hod, A. Palant, L. Reisin, T. Rosenfeld, B. Peled, A. T. Marmor, J. Balkin, et al. Treatment and Outcome of Patients With Acute Myocardial Infarction and Prior Cerebrovascular Events in the Thrombolytic Era: The Israeli Thrombolytic National Survey Arch Intern Med, March 23, 1998; 158(6): 601 - 606. [Abstract] [Full Text] [PDF]
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R. H. Christenson, S.-H. Duh, L. K. Newby, E. M. Ohman, R. M. Califf, C. B. Granger, S. Peck, K. S. Pieper, P. W. Armstrong, H. A. Katus, et al. Cardiac troponin T and cardiac troponin I: relative values in short-term risk stratification of patients with acute coronary syndromes Clin. Chem., March 1, 1998; 44(3): 494 - 501. [Abstract] [Full Text] [PDF]
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R. Altman Controversies in Antithrombotic Therapy in Cardiovascular Diseases Clinical and Applied Thrombosis/Hemostasis, January 1, 1998; 4(1): 11 - 24. [Abstract] [PDF]
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J. H. Chesebro Direct Thrombin Inhibition Superior to Heparin During and After Thrombolysis : Dose, Duration, and Drug Circulation, October 7, 1997; 96(7): 2118 - 2120. [Full Text]
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H. D. White, P. E. Aylward, M. J. Frey, A. A. J. Adgey, R. Nair, W. S. Hillis, Y. Shalev, M. A. Brown, J. K. French, R. Collins, et al. Randomized, Double-blind Comparison of Hirulog Versus Heparin in Patients Receiving Streptokinase and Aspirin for Acute Myocardial Infarction (HERO) Circulation, October 7, 1997; 96(7): 2155 - 2161. [Abstract] [Full Text]
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S. Syed, P. D. Schuyler, M. Kulczycky, and W. P. Sheffield Potent Antithrombin Activity and Delayed Clearance From the Circulation Characterize Recombinant Hirudin Genetically Fused to Albumin Blood, May 1, 1997; 89(9): 3243 - 3252. [Abstract] [Full Text] [PDF]
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G. Franco Gensini, A. Colella, and M. Comeglio State-of-the-Art Review: Antiplatelet Agents and Thrombin Inhibitors: Combined Modality Therapy Clinical and Applied Thrombosis/Hemostasis, April 1, 1997; 3(2): 82 - 85. [PDF]
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R. Collins, R. Peto, C. Baigent, and P. Sleight Aspirin, Heparin, and Fibrinolytic Therapy in Suspected Acute Myocardial Infarction N. Engl. J. Med., March 20, 1997; 336(12): 847 - 860. [Full Text] [PDF]
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A. H. Schmaier, E. J. Topol, R. M. Califf, F. Van de Werf, and The GUSTO IIb Investigators Heparin versus Hirudin for Acute Coronary Syndromes N. Engl. J. Med., March 6, 1997; 336(10): 730 - 731. [Full Text]
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C. Bode, S. R. Hanson, J. F. Schmedtje, E. Haber, P. Mehwald, A. B. Kelly, L. A. Harker, and M. S. Runge Antithrombotic Potency of Hirudin Is Increased in Nonhuman Primates by Fibrin Targeting Circulation, February 18, 1997; 95(4): 800 - 804. [Abstract] [Full Text]
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E. J. Topol, R. M. Califf, F. Van de Werf, M. Simoons, J. Hampton, K. L. Lee, H. White, J. Simes, and P. W. Armstrong Perspectives on Large-Scale Cardiovascular Clinical Trials for the New Millennium Circulation, February 18, 1997; 95(4): 1072 - 1082. [Full Text]
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R. P. Schwarz JR, J.-C. P. Becker, R. L. Brooks, M. J. Hursting, J. L. Joffrion, G. D. Knappenberger, T. P. Kogan, P. W. Kogan, and A. A. McKinney State-of-the-Art Review: The Preclinical and Clinical Pharmacology of Novastan (Argatroban): A Small-Molecule, Direct Thrombin Inhibitor Clinical and Applied Thrombosis/Hemostasis, January 1, 1997; 3(1): 1 - 15. [Abstract] [PDF]
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P.M. Piatti, L.D. Monti, G. Valsecchi, M. Conti, R. Nasser, B. Guazzini, E. Fochesato, C.V. Phan, A.E. Pontiroli, and G. Pozza Effects of Low-Dose Heparin Infusion on Arterial Endothelin-1 Release in Humans Circulation, December 1, 1996; 94(11): 2703 - 2707. [Abstract] [Full Text]
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E. M. Ohman, P. W. Armstrong, R. H. Christenson, C. B. Granger, H. A. Katus, C. W. Hamm, M. A. O'Hanesian, G. S. Wagner, N. S. Kleiman, F. E. Harrell, et al. Cardiac Troponin T Levels for Risk Stratification in Acute Myocardial Ischemia N. Engl. J. Med., October 31, 1996; 335(18): 1333 - 1342. [Abstract] [Full Text] [PDF]
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R. A. Lange, L. D. Hillis, C. L. Grines, R. A. Lange, L. D. Hillis, and C. L. Grines Should Thrombolysis or Primary Angioplasty Be the Treatment of Choice for Acute Myocardial Infarction? N. Engl. J. Med., October 24, 1996; 335(17): 1311 - 1312. [Full Text] [PDF]
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C. V. Jackson, J. Satterwhite, and E. Roberts Preclinical and Clinical Pharmacology of Efegatran (LY294468) : A Novel Antithrombin for the Treatment of Acute Coronary Syndromes Clinical and Applied Thrombosis/Hemostasis, October 1, 1996; 2(4): 258 - 267. [Abstract] [PDF]
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C. Gerdes, V. Faber-Steinfeld, O. Yalkinoglu, and S. Wohlfeil Comparison of the Effects of the Thrombin Inhibitor r-Hirudin in Four Animal Models of Neointima Formation After Arterial Injury Arterioscler Thromb Vasc Biol, October 1, 1996; 16(10): 1306 - 1311. [Abstract] [Full Text]
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T. J. Shetler, V. G. Crowe, B. D. Bailey, and C. V. Jackson Antithrombotic Assessment of the Effects of Combination Therapy With the Anticoagulants Efegatran and Heparin and the Glycoprotein IIb-IIIa Platelet Receptor Antagonist 7E3 in a Canine Model of Coronary Artery Thrombosis Circulation, October 1, 1996; 94(7): 1719 - 1725. [Abstract] [Full Text]
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P. Stubbs, P. Collinson, D. Moseley, T. Greenwood, and M. Noble Prognostic Significance of Admission Troponin T Concentrations in Patients With Myocardial Infarction Circulation, September 15, 1996; 94(6): 1291 - 1297. [Abstract] [Full Text]
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R. Collins, S. MacMahon, M. Flather, C. Baigent, L. Remvig, S. Mortensen, P. Appleby, J. Godwin, S. Yusuf, and R. Peto Clinical effects of anticoagulant therapy in suspected acute myocardial infarction: systematic overview of randomised trials BMJ, September 14, 1996; 313(7058): 652 - 659. [Abstract] [Full Text]
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The Global Use of Strategies to Open Occluded Coro A Comparison of Recombinant Hirudin with Heparin for the Treatment of Acute Coronary Syndromes N. Engl. J. Med., September 12, 1996; 335(11): 775 - 782. [Abstract] [Full Text] [PDF]
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J. Loscalzo Thrombin Inhibitors in Fibrinolysis: A Hobson's Choice of Alternatives Circulation, September 1, 1996; 94(5): 863 - 865. [Full Text]
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E. M. Antman Hirudin in Acute Myocardial Infarction: Thrombolysis and Thrombin Inhibition in Myocardial Infarction (TIMI) 9B Trial Circulation, September 1, 1996; 94(5): 911 - 921. [Abstract] [Full Text]
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C. B. Granger, J. Hirsh, R. M. Califf, J. Col, H. D. White, A. Betriu, L. H. Woodlief, K. L. Lee, E. G. Bovill, R. J. Simes, et al. Activated Partial Thromboplastin Time and Outcome After Thrombolytic Therapy for Acute Myocardial Infarction : Results From the GUSTO-I Trial Circulation, March 1, 1996; 93(5): 870 - 878. [Abstract] [Full Text]
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J. M. Gore, C. B. Granger, M. L. Simoons, M. A. Sloan, W. D. Weaver, H. D. White, G. I. Barbash, F. Van de Werf, P. E. Aylward, E. J. Topol, et al. Stroke After Thrombolysis : Mortality and Functional Outcomes in the GUSTO-I Trial Circulation, November 15, 1995; 92(10): 2811 - 2818. [Abstract] [Full Text]
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