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(Circulation. 1999;99:2720-2732.)
© 1999 American Heart Association, Inc.

Clinical Investigation and Reports

Abciximab Facilitates the Rate and Extent of Thrombolysis

Results of the Thrombolysis In Myocardial Infarction (TIMI) 14 Trial

Elliott M. Antman, MD; Robert P. Giugliano, MD, SM; C. Michael Gibson, MS, MD; Carolyn H. McCabe, BS; Patrick Coussement, MD; Neal S. Kleiman, MD; Alec Vahanian, MD; A. A. Jennifer Adgey, MD; Ian Menown, MD; Hans-Jürgen Rupprecht, MD; R. Van der Wieken, MD; John Ducas, MD; Joel Scherer, MD; Keaven Anderson, PhD; Frans Van de Werf, MD, PhD; Eugene Braunwald, MD; for the TIMI 14 Investigators¹

From Brigham and Women's Hospital (E.M.A., R.P.G., C.H.M., E.B.), Boston, Mass; Allegheny General Hospital (C.M.G.), Pittsburgh, Pa; Universitair Ziekenhuis Gasthuisberg (P.C., F.V.d.W.), Leuven, Belgium; Methodist Hospital (N.S.K.), Houston, Tex; Hopital Tenon (A.V.), Paris, France; Royal Victoria Hospital (A.A.J.A., I.M.), Belfast, United Kingdom; Medizinische Klinik II (H.-J.R.), Mainz, Germany; OLVG afdeling Cardiologie (R.V.d.W.), Amsterdam, Netherlands; University of Manitoba Health Sciences Centre (J.D.), Winnipeg, Canada; Eli Lilly, Inc (J.S.), Indianapolis, Ind; and Centocor (K.A.), Malvern, Pa.

Correspondence to Elliott M. Antman, MD, Cardiovascular Division, Brigham and Women's Hospital, 75 Francis St, Boston, MA 02115. E-mail eantman{at}bustoff.bwh.harvard.edu

Background—The TIMI 14 trial tested the hypothesis that abciximab, the Fab fragment of a monoclonal antibody directed to the platelet glycoprotein (GP) IIb/IIIa receptor, is a potent and safe addition to reduced-dose thrombolytic regimens for ST-segment elevation MI.

Methods and Results—Patients (n=888) with ST-elevation MI presenting <12 hours from onset of symptoms were treated with aspirin and randomized initially to either 100 mg of accelerated-dose alteplase (control) or abciximab (bolus 0.25 mg/kg and 12-hour infusion of 0.125 µg · kg^-1 · min^-1) alone or in combination with reduced doses of alteplase (20 to 65 mg) or streptokinase (500 000 U to 1.5 MU). Control patients received standard weight-adjusted heparin (70-U/kg bolus; infusion of 15 U · kg^-1 · h^-1), whereas those treated with a regimen including abciximab received low-dose heparin (60-U/kg bolus; infusion of 7 U · kg^-1 · h^-1). The rate of TIMI 3 flow at 90 minutes for patients treated with accelerated alteplase alone was 57% compared with 32% for abciximab alone and 34% to 46% for doses of streptokinase between 500 000 U and 1.25 MU with abciximab. Higher rates of TIMI 3 flow at both 60 and 90 minutes were observed with increasing duration of administration of alteplase, progressing from a bolus alone to a bolus followed by either a 30- or 60-minute infusion (P<0.02). The most promising regimen was 50 mg of alteplase (15-mg bolus; infusion of 35 mg over 60 minutes), which produced a 76% rate of TIMI 3 flow at 90 minutes and was tested subsequently in conjunction with either low-dose or very-low-dose (30-U/kg bolus; infusion of 4 U · kg^-1 · h^-1) heparin. TIMI 3 flow rates were significantly higher in the 50-mg alteplase plus abciximab group versus the alteplase-only group at both 60 minutes (72% versus 43%; P=0.0009) and 90 minutes (77% versus 62%; P=0.02). The rates of major hemorrhage were 6% in patients receiving alteplase alone (n=235), 3% with abciximab alone (n=32), 10% with streptokinase plus abciximab (n=143), 7% with 50 mg of alteplase plus abciximab and low-dose heparin (n=103), and 1% with 50 mg of alteplase plus abciximab with very-low-dose heparin (n=70).

Conclusions—Abciximab facilitates the rate and extent of thrombolysis, producing early, marked increases in TIMI 3 flow when combined with half the usual dose of alteplase. This improvement in reperfusion with alteplase occurred without an increase in the risk of major bleeding. Substantial reductions in heparin dosing may reduce the risk of bleeding even further. Modest improvements in TIMI 3 flow were seen when abciximab was combined with streptokinase, but there was an increased risk of bleeding.

Key Words: thrombolysis • myocardial infarction • platelet aggregation inhibitors • platelets

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				E. Braunwald Personal reflections on efforts to reduce ischemic myocardial damage Cardiovasc Res, December 1, 2002; 56(3): 332 - 338. [Full Text] [PDF]

				A. M. Lincoff, R. M. Califf, F. Van de Werf, J. T. Willerson, H. D. White, P. W. Armstrong, V. Guetta, W. B. Gibler, J. S. Hochman, C. Bode, et al. Mortality at 1 Year With Combination Platelet Glycoprotein IIb/IIIa Inhibition and Reduced-Dose Fibrinolytic Therapy vs Conventional Fibrinolytic Therapy for Acute Myocardial Infarction: GUSTO V Randomized Trial JAMA, November 6, 2002; 288(17): 2130 - 2135. [Abstract] [Full Text] [PDF]

				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]

				W. F. Baker Jr Thrombolytic Therapy Clinical and Applied Thrombosis/Hemostasis, October 1, 2002; 8(4): 291 - 314. [PDF]

				E. Ronner, R.T. van Domburg, M.J.B.M. van den Brand, P.J. de Feyter, D.P. Foley, W.J. van der Giessen, P.W. Serruys, and M.L. Simoons Platelet GP IIb/IIIa receptor blockers for failed thrombolysis in acute myocardial infarction, alone or as adjunct to other rescue therapies. A single centre retrospective analysis of 548 consecutive patients with acute myocardial infarction Eur. Heart J., October 1, 2002; 23(19): 1529 - 1537. [Abstract] [Full Text] [PDF]

				F. Ribichini and W. Wijns ACUTE MYOCARDIAL INFARCTION: REPERFUSION TREATMENT Heart, September 1, 2002; 88(3): 298 - 305. [Full Text] [PDF]

				H. D. White Further evidence that antithrombotic therapy is beneficial with streptokinase: improved early ST resolution and late patency with enoxaparin Eur. Heart J., August 2, 2002; 23(16): 1233 - 1237. [PDF]

				S. M. Inverso Combination Glycoprotein IIb/IIIa Receptor Antagonists With Thrombolytics in Acute Myocardial Infarction Journal of Pharmacy Practice, August 1, 2002; 15(4): 344 - 355. [Abstract] [PDF]

				F. Van de Werf and D. S. Baim Reperfusion for ST-Segment Elevation Myocardial Infarction: An Overview of Current Treatment Options Circulation, June 18, 2002; 105(24): 2813 - 2816. [Full Text] [PDF]

				F. van de Werf ASSENT-3: implications for future trial design and clinical practice Eur. Heart J., June 2, 2002; 23(12): 911 - 912. [Full Text] [PDF]

				M. Aschermann and P. Widimsky I have an acute myocardial infarction: open my coronary artery, stent it and keep full flow! Eur. Heart J., June 2, 2002; 23(12): 913 - 916. [Full Text] [PDF]

				E.M. Antman, H.A. Cooper, C.M. Gibson, J.A. de Lemos, C.H. McCabe, R.P. Giugliano, P. Coussement, S. Murphy, J. Scherer, K. Anderson, et al. Determinants of improvement in epicardial flow and myocardial perfusion for ST elevation myocardial infarction. Insights from TIMI 14 and InTIME-II Eur. Heart J., June 2, 2002; 23(12): 928 - 933. [Abstract] [Full Text] [PDF]

				B. Eckert, C. Koch, G. Thomalla, J. Roether, and H. Zeumer Acute Basilar Artery Occlusion Treated With Combined Intravenous Abciximab and Intra-arterial Tissue Plasminogen Activator: Report of 3 Cases Stroke, May 1, 2002; 33(5): 1424 - 1427. [Abstract] [Full Text] [PDF]

				E. Braunwald Reperfusion therapy for acute myocardial infarction: historical context and future promise Eur. Heart J. Suppl., May 1, 2002; 4(suppl_E): E10 - E14. [Abstract] [PDF]

				F.J. Van de Werf, E.M. Antman, and M.L. Simoons Managing ST elevation myocardial infarction Eur. Heart J. Suppl., May 1, 2002; 4(suppl_E): E15 - E23. [Abstract] [PDF]

				S.H. Baird, I.B.A. Menown, S.J. Mcbride, T.G. Trouton, and C. Wilson Randomized comparison of enoxaparin with unfractionated heparin following fibrinolytic therapy for acute myocardial infarction Eur. Heart J., April 2, 2002; 23(8): 627 - 632. [Abstract] [Full Text] [PDF]

				H. Luciardi, S. Berman, J. Muntaner, F. De La Serna, and R. Altman Facilitated Thrombolysis: Dethrombosis? Clinical and Applied Thrombosis/Hemostasis, April 1, 2002; 8(2): 133 - 138. [Abstract] [PDF]

				O-K. Kwon, K. J. Lee, M. H. Han, C.-W. Oh, D. H. Han, and Y. C. Koh Intraarterially Administered Abciximab as an Adjuvant Thrombolytic Therapy: Report of Three Cases AJNR Am. J. Neuroradiol., March 1, 2002; 23(3): 447 - 451. [Abstract] [Full Text] [PDF]

				S. J. Brener, U. Zeymer, A. A. J. Adgey, T. R. Vrobel, S. G. Ellis, K.-L. Neuhaus, N. Juran, T. B. Ivanc, E. M. Ohman, J. Strony, et al. Eptifibatide and low-dose tissue plasminogen activator in acute myocardial infarction: The integrilin and low-dose thrombolysis in acute myocardial infarction (INTRO AMI) trial J. Am. Coll. Cardiol., February 6, 2002; 39(3): 377 - 386. [Abstract] [Full Text] [PDF]

				I. Ott, V. Malcouvier, A. Schomig, and F.-J. Neumann Proteolysis of Tissue Factor Pathway Inhibitor-1 by Thrombolysis in Acute Myocardial Infarction Circulation, January 22, 2002; 105(3): 279 - 281. [Abstract] [Full Text] [PDF]

				B. G. Angeja, M. Gunda, S. A. Murphy, B. E. Sobel, A. C. Rundle, M. Syed, A. Asfour, S. Borzak, S. G. Gourlay, H. V. Barron, et al. TIMI Myocardial Perfusion Grade and ST Segment Resolution: Association With Infarct Size as Assessed by Single Photon Emission Computed Tomography Imaging Circulation, January 22, 2002; 105(3): 282 - 285. [Abstract] [Full Text] [PDF]

				J. A. Barrabes, D. Garcia-Dorado, M. Mirabet, R.-M. Lidon, B. Soriano, M. Ruiz-Meana, P. Pizcueta, J. Blanco, Y. Puigfel, and J. Soler-Soler Lack of effect of glycoprotein IIb/IIIa blockade on myocardial platelet or polymorphonuclear leukocyte accumulation and on infarct size after transient coronary occlusion in pigs J. Am. Coll. Cardiol., January 2, 2002; 39(1): 157 - 165. [Abstract] [Full Text] [PDF]

				J. A. de Lemos and E. Braunwald ST segment resolution as a tool for assessing the efficacy of reperfusion therapy J. Am. Coll. Cardiol., November 1, 2001; 38(5): 1283 - 1294. [Abstract] [Full Text] [PDF]

				H. J. Cloft, O. B. Samuels, F. C. Tong, and J. E. Dion Use of Abciximab for Mediation of Thromboembolic Complications of Endovascular Therapy AJNR Am. J. Neuroradiol., October 1, 2001; 22(9): 1764 - 1767. [Abstract] [Full Text] [PDF]

				S. P. SCHULMAN and H. E. FESSLER Management of Acute Coronary Syndromes Am. J. Respir. Crit. Care Med., September 15, 2001; 164(6): 917 - 922. [Full Text] [PDF]

				P. W. Armstrong New advances in the management of acute coronary syndromes: 2. Fibrinolytic therapy for acute ST-segment elevation myocardial infarction Can. Med. Assoc. J., September 1, 2001; 165(6): 791 - 797. [Full Text] [PDF]

				G MANOHARAN and A A J ADGEY Glycoprotein IIb/IIIa inhibitors and acute coronary syndromes: summary report of the full submission to NICE, and beyond Heart, September 1, 2001; 86(3): 259 - 261. [Full Text] [PDF]

				J. Bogousslavsky and J. R. Leclerc Platelet glycoprotein IIb/IIIa antagonists for acute ischemic stroke Neurology, September 1, 2001; 57(90002): S53 - 57. [Abstract] [Full Text]

				J. E. Tcheng, D. J. Kereiakes, A. M. Lincoff, B. S. George, N. S. Kleiman, D. C. Sane, D. B. Cines, R. E. Jordan, M. A. Mascelli, M. A. Langrall, et al. Abciximab Readministration: Results of the ReoPro Readministration Registry Circulation, August 21, 2001; 104(8): 870 - 875. [Abstract] [Full Text] [PDF]

				C. P. Cannon Importance of TIMI 3 Flow Circulation, August 7, 2001; 104(6): 624 - 626. [Full Text] [PDF]