From the Cleveland Clinic Foundation, Cleveland, Ohio (S.J.B., D.J.M.,
E.J.T.); Midwest Heart Research, Lombard, Ill (L.A.B.); University of
Pittsburgh Medical Center, Pittsburgh, Pa (J.E.B.B.); North Shore University
Hospital, Manhasset, NY (S.K.); Riverside Methodist Hospital, Columbus, Ohio
(B.S.G.); Crozer Chester Medical Center, Upland, Pa (A.A.J.); Baptist Medical
Center, Birmingham, Ala (E.D.C.); St Joseph Hospital, Savannah, Ga (P.C.G.);
Presbyterian Health Care Center, Albuquerque, NM (H.J.W.); High Point Regional
Hospital, High Point, NC (H.B.C.); Lenox Hill Hospital, New York, NY (J.W.M.);
and Lilly Research Laboratories, Indianapolis, Ind (M.B.E.).
Correspondence to Eric J. Topol, MD, Department of Cardiology, 9500 Euclid Ave, Cleveland Clinic Foundation, Cleveland, OH 44195. E-mail topole{at}cesmtp.ccf.org
Background—The benefit of
catheter-based reperfusion for acute myocardial infarction (MI) is
limited by a 5% to 15% incidence of in-hospital major
ischemic events, usually caused by infarct artery reocclusion,
and a 20% to 40% need for repeat percutaneous or
surgical revascularization. Platelets play a
key role in the process of early infarct artery reocclusion, but
inhibition of aggregation via the glycoprotein IIb/IIIa
receptor has not been prospectively evaluated in the setting of
acute MI.
Methods and Results—Patients with acute MI of <12 hours'
duration were randomized, on a double-blind basis, to placebo or
abciximab if they were deemed candidates for primary PTCA. The primary
efficacy end point was death, reinfarction, or any (urgent or elective)
target vessel revascularization (TVR) at 6 months
by intention-to-treat (ITT) analysis. Other key prespecified
end points were early (7 and 30 days) death, reinfarction, or urgent
TVR. The baseline clinical and angiographic variables of the 483
(242 placebo and 241 abciximab) patients were balanced. There was no
difference in the incidence of the primary 6-month end point (ITT
analysis) in the 2 groups (28.1% and 28.2%,
P=0.97, of the placebo and abciximab patients,
respectively). However, abciximab significantly reduced the incidence
of death, reinfarction, or urgent TVR at all time points assessed
(9.9% versus 3.3%, P=0.003, at 7 days; 11.2% versus
5.8%, P=0.03, at 30 days; and 17.8% versus 11.6%,
P=0.05, at 6 months). Analysis by actual
treatment with PTCA and study drug demonstrated a considerable effect
of abciximab with respect to death or reinfarction: 4.7% versus 1.4%,
P=0.047, at 7 days; 5.8% versus 3.2%,
P=0.20, at 30 days; and 12.0% versus 6.9%,
P=0.07, at 6 months. The need for unplanned,
"bail-out" stenting was reduced by 42% in the abciximab group
(20.4% versus 11.9%, P=0.008). Major bleeding occurred
significantly more frequently in the abciximab group (16.6% versus
9.5%, P=0.02), mostly at the arterial
access site. There was no intracranial hemorrhage in either
group.
Conclusions—Aggressive platelet inhibition with abciximab
during primary PTCA for acute MI yielded a substantial reduction in the
acute (30-day) phase for death, reinfarction, and urgent target vessel
revascularization. However, the bleeding rates were
excessive, and the 6-month primary end point, which included elective
revascularization, was not favorably affected.
© 1998 American Heart Association, Inc.
Clinical Investigation and Reports
Randomized, Placebo-Controlled Trial of Platelet Glycoprotein IIb/IIIa Blockade With Primary Angioplasty for Acute Myocardial Infarction
Key Words: angioplasty • myocardial infarction • platelet aggregation inhibitors
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H.-K. Yip, M.-C. Chen, H.-W. Chang, C.-L. Hang, Y.-K. Hsieh, C.-Y. Fang, and C.-J. Wu Angiographic Morphologic Features of Infarct-Related Arteries and Timely Reperfusion in Acute Myocardial Infarction: Predictors of Slow-Flow and No-Reflow Phenomenon Chest, October 1, 2002; 122(4): 1322 - 1332. [Abstract] [Full Text] [PDF]
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F. Ribichini and W. Wijns ACUTE MYOCARDIAL INFARCTION: REPERFUSION TREATMENT Heart, September 1, 2002; 88(3): 298 - 305. [Full Text] [PDF]
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E. Ronner, E. Boersma, G.-J. Laarman, G. A. Somsen, R. A. Harrington, J. W. Deckers, E. J. Topol, R. M. Califf, and M. L. Simoons Early angioplasty in acute coronary syndromes without persistent st-segment elevation improves outcome but increases the need for six-month repeat revascularization: An analysis of the pursuit trial J. Am. Coll. Cardiol., June 19, 2002; 39(12): 1924 - 1929. [Abstract] [Full Text] [PDF]
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S Constantinides, T S N Lo, M Been, and M F Shiu Early experience with a helical coronary thrombectomy device in patients with acute coronary thrombosis. Heart, May 1, 2002; 87(5): 455 - 460. [Abstract] [Full Text] [PDF]
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F.W.G. Leebeek, E. Boersma, C.P. Cannon, F.J.J. van de Werf, and M.L. Simoons Oral glycoprotein IIb/IIIa receptor inhibitors in patients with cardiovascular disease: why were the results so unfavourable Eur. Heart J., March 2, 2002; 23(6): 444 - 457. [Full Text] [PDF]
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S. H. Rezkalla and R. A. Kloner No-Reflow Phenomenon Circulation, February 5, 2002; 105(5): 656 - 662. [Full Text] [PDF]
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J. Mehilli, A. Kastrati, J. Dirschinger, J. Pache, M. Seyfarth, R. Blasini, D. Hall, F.-J. Neumann, and A. Schomig Sex-Based Analysis of Outcome in Patients With Acute Myocardial Infarction Treated Predominantly With Percutaneous Coronary Intervention JAMA, January 9, 2002; 287(2): 210 - 215. [Abstract] [Full Text] [PDF]
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W. B. Batchelor, K. W. Mahaffey, P. B. Berger, E. Deutsch, S. Meier, V. Hasselblad, E. T. Fry, P. S. Teirstein, A. M. Ross, C. A. Binanay, et al. A randomized, placebo-controlled trial of enoxaparin after high-risk coronary stenting: the ATLAST trial J. Am. Coll. Cardiol., November 15, 2001; 38(6): 1608 - 1613. [Abstract] [Full Text] [PDF]
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B. A. Vakili, R. Kaplan, and D. L. Brown Volume-Outcome Relation for Physicians and Hospitals Performing Angioplasty for Acute Myocardial Infarction in New York State Circulation, October 30, 2001; 104(18): 2171 - 2176. [Abstract] [Full Text] [PDF]
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C. G. Hanratty, M. Ward, D. P. Chew, D. L. Bhatt, A. M. Lincoff, D. J. Moliterno, S. J. Brener, K. E. Wolski, and E. J. Topol Optimal Activated Clotting Time During Percutaneous Coronary Intervention Response Circulation, October 9, 2001; 104 (15): e83 - e84. [Full Text] [PDF]
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H.-K. Yip, C.-J. Wu, M.-C. Chen, H.-W. Chang, K. Y.-K. Hsieh, C.-L. Hang, and M. Fu Effect of Primary Angioplasty on Total or Subtotal Left Main Occlusion : Analysis of Incidence, Clinical Features, Outcomes, and Prognostic Determinants Chest, October 1, 2001; 120(4): 1212 - 1217. [Abstract] [Full Text] [PDF]
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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]
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S.G. Priori, E. Aliot, C. Blomstrom-Lundqvist, L. Bossaert, G. Breithardt, P. Brugada, A.J. Camm, R. Cappato, S.M. Cobbe, C. Di Mario, et al. Task Force on Sudden Cardiac Death of the European Society of Cardiology Eur. Heart J., August 2, 2001; 22(16): 1374 - 1450. [PDF]
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G. Montalescot, P. Barragan, O. Wittenberg, P. Ecollan, S. Elhadad, P. Villain, J.-M. Boulenc, M.-C. Morice, L. Maillard, M. Pansieri, et al. Platelet Glycoprotein IIb/IIIa Inhibition with Coronary Stenting for Acute Myocardial Infarction N. Engl. J. Med., June 21, 2001; 344(25): 1895 - 1903. [Abstract] [Full Text] [PDF]
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K. M. Anderson, R. M. Califf, G. W. Stone, F.-J. Neumann, G. Montalescot, D. P. Miller, J. J. Ferguson III, J. T. Willerson, H. F. Weisman, and E. J. Topol Long-term mortality benefit with abciximab in patients undergoing percutaneous coronary intervention J. Am. Coll. Cardiol., June 15, 2001; 37(8): 2059 - 2065. [Abstract] [Full Text] [PDF]
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T. M. Bashore, E. R. Bates, P. B. Berger, D. A. Clark, J. T. Cusma, G. J. Dehmer, M. J. Kern, W. K. Laskey, M. P. O'Laughlin, S. Oesterle, et al. American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards: A report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents endorsed by the American Heart Association and the Diagnostic and Interventional Catheterization Committee of the Council on Clinical Cardiology of the AHA J. Am. Coll. Cardiol., June 15, 2001; 37(8): 2170 - 2214. [Full Text] [PDF]
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S. C. Smith Jr, J. T. Dove, A. K. Jacobs, J. Ward Kennedy, D. Kereiakes, M. J. Kern, R. E. Kuntz, J. J. Popma, H. V. Schaff, D. O. Williams, et al. ACC/AHA guidelines for percutaneous coronary intervention (revision of the 1993 PTCA guidelines): A report of the American College of Cardiology/ American Heart Association Task Force on practice guidelines (Committee to revise the 1993 guidelines for percutaneous transluminal coronary angioplasty) endorsed by the Society for Cardiac Angiography and Interventions J. Am. Coll. Cardiol., June 15, 2001; 37(8): 2239 - 2239. [Full Text] [PDF]
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R. Zahn, R. Schiele, S. Schneider, A. K. Gitt, H. Wienbergen, K. Seidl, T. Voigtlander, M. Gottwik, G. Berg, E. Altmann, et al. Primary angioplasty versus intravenous thrombolysis in acute myocardial infarction: can we define subgroups of patients benefiting most from primary angioplasty?: Results from the pooled data of the maximal individual therapy in acute myocardial infarction registry and the myocardial infarction registry J. Am. Coll. Cardiol., June 1, 2001; 37(7): 1827 - 1835. [Abstract] [Full Text] [PDF]
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F. Zijlstra CORONARY DISEASE: Acute myocardial infarction: primary angioplasty Heart, June 1, 2001; 85(6): 705 - 709. [Full Text]
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F. Van de Werf New aspects of pharmacological reperfusion: from macro- to microlysis Eur. Heart J. Suppl., June 1, 2001; 3(suppl_C): C62 - C68. [Abstract] [PDF]
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E. Braunwald Foreword Eur. Heart J. Suppl., May 1, 2001; 3(suppl_A): A1 - A2. [PDF]
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G. Montalescot, R. Choussat, and J.P. Collet Glycoprotein IIb/IIIa receptors and primary stenting in acute myocardial infarction Eur. Heart J. Suppl., May 1, 2001; 3(suppl_A): A3 - A7. [Abstract] [PDF]
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H.C. Herrmann, R.H. Li, and E.M. Ohman Facilitated percutaneous coronary intervention: results from the SPEED trial Eur. Heart J. Suppl., May 1, 2001; 3(suppl_A): A26 - A34. [Abstract] [PDF]
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M. R. Le May, M. Labinaz, R. F. Davies, J.-F. Marquis, L. A. Laramee, E. R. O'Brien, W. L. Williams, R. S. Beanlands, G. Nichol, and L. A. Higginson Stenting versus thrombolysis in acute myocardial infarction trial (STAT) J. Am. Coll. Cardiol., March 15, 2001; 37(4): 985 - 991. [Abstract] [Full Text] [PDF]
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D. P. Chew, D. L. Bhatt, A. M. Lincoff, D. J. Moliterno, S. J. Brener, K. E. Wolski, and E. J. Topol Defining the Optimal Activated Clotting Time During Percutaneous Coronary Intervention : Aggregate Results From 6 Randomized, Controlled Trials Circulation, February 20, 2001; 103(7): 961 - 966. [Abstract] [Full Text] [PDF]
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H.-K. Yip, C.-J. Wu, K.-H. Yeh, C.-L. Hang, C.-Y. Fang, K. Y.-K. Hsieh, and M. Fu Unusual Complication of Retrograde Dissection to the Coronary Sinus of Valsalva During Percutaneous Revascularization : A Single-Center Experience and Literature Review Chest, February 1, 2001; 119(2): 493 - 501. [Abstract] [Full Text] [PDF]
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M. T. Roe, E. M. Ohman, A. C. P. Maas, R. H. Christenson, K. W. Mahaffey, C. B. Granger, R. A. Harrington, R. M. Califf, and M. W. Krucoff Shifting the open-artery hypothesis downstream: the quest for optimal reperfusion J. Am. Coll. Cardiol., January 1, 2001; 37(1): 9 - 18. [Abstract] [Full Text] [PDF]
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J. A. Cairns, P. Theroux, H. D. Lewis Jr., M. Ezekowitz, and T. W. Meade Antithrombotic Agents in Coronary Artery Disease Chest, January 1, 2001; 119 (2009): 228S - 252S. [Full Text] [PDF]
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A. M. Lincoff, D. B. Mark, J. E. Tcheng, R. M. Califf, M. V. Bala, K. M. Anderson, L. Davidson-Ray, J. D. Knight, C. F. Cabot, and E. J. Topol Economic Assessment of Platelet Glycoprotein IIb/IIIa Receptor Blockade With Abciximab and Low-Dose Heparin During Percutaneous Coronary Revascularization : Results From the EPILOG Randomized Trial Circulation, December 12, 2000; 102(24): 2923 - 2929. [Abstract] [Full Text] [PDF]
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D. P. Chew and D. J. Moliterno A critical appraisal of platelet glycoprotein IIb/IIIa inhibition J. Am. Coll. Cardiol., December 1, 2000; 36(7): 2028 - 2035. [Abstract] [Full Text] [PDF]
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