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(Circulation. 1998;98:2829-2835.)
© 1998 American Heart Association, Inc.
Clinical Investigation and Reports* |
Clinical Outcomes of Therapeutic Agents That Block the Platelet Glycoprotein IIb/IIIa Integrin in Ischemic Heart Disease
From the Duke Clinical Research Institute, Durham, NC (D.F.K., R.M.C., R.A.H., J.E.T., V.H.); the Cleveland Clinic Foundation, Cleveland, Ohio (D.P.M., D.J.M., A.M.L., E.J.T.); and Green Lane Hospital, Auckland, New Zealand (H.D.W.).
Correspondence to Robert M. Califf, MD, Duke Clinical Research Institute, 2024 W Main St, Durham, NC 27705. E-mail calif001{at}onyx.mc.duke.edu
Background—Several platelet glycoprotein (GP) IIb/IIIa receptor antagonists have been evaluated in clinical trials. We conducted a systematic overview (meta-analysis) to assess the effect of these compounds on death, myocardial infarction (MI), and revascularization.
Methods and Results—ORs were calculated for 16 randomized, controlled trials of GP IIb/IIIa inhibitors. An empirical Bayesian random-effects model combined the outcomes of 32 135 patients. There was a significant mortality reduction by GP IIb/IIIa inhibitors at 48 to 96 hours, with an OR of 0.70 (95% CI, 0.51 to 0.96; P<0.03), equivalent to a reduction of 1 death per 1000 patients treated. Mortality benefits at 30 days (OR, 0.87; 95% CI, 0.74 to 1.02; P=0.08) and 6 months (OR, 0.97; 95% CI, 0.86 to 1.10; P=0.67) were not statistically significant. For the combined end point of death or MI, there was a highly significant (P<0.001) benefit for GP IIb/IIIa inhibitors at each time point. The 30-day OR was 0.76 (95% CI, 0.66 to 0.87), or 20 fewer events per 1000 patients treated. For the composite end point of death, MI, or revascularization, there was also a highly significant (P<0.001) benefit for GP IIb/IIIa inhibitors. At 30 days, the OR was 0.77 (95% CI, 0.68 to 0.86), or 30 fewer events per 1000 patients treated. The risk differences for death, death or MI, and composite outcomes were similar at 6 months, indicating a sustained absolute improvement. Similar benefit was seen when trials were subgrouped by therapeutic indication (percutaneous intervention versus acute coronary syndromes).
Conclusions—Application of this new therapeutic class to clinical practice promises substantial benefit for both indications.
Key Words: platelet aggregation inhibitors • meta-analysis • myocardial infarction • mortality • revascularization
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E. M. Ohman, R. A. Harrington, C. P. Cannon, G. Agnelli, J. A. Cairns, and J.W. Kennedy Intravenous Thrombolysis in Acute Myocardial Infarction Chest, January 1, 2001; 119 (2009): 253S - 277S. [Full Text] [PDF]
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R. Curtin and D.J. Fitzgerald A cold start for oral glycoprotein IIb/IIIa antagonists Eur. Heart J., December 2, 2000; 21(24): 1992 - 1994. [PDF]
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P.W. Armstrong Reperfusion synergism: will it be both sustained and safe? Eur. Heart J., December 1, 2000; 21(23): 1913 - 1916. [PDF]
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D. Cox, R. Smith, M. Quinn, P. Theroux, P. Crean, and D. J. Fitzgerald Evidence of platelet activation during treatment with a GPIIb/IIIa antagonist in patients presenting with acute coronary syndromes J. Am. Coll. Cardiol., November 1, 2000; 36(5): 1514 - 1519. [Abstract] [Full Text] [PDF]
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D. L. Bhatt and E. J. Topol Current Role of Platelet Glycoprotein IIb/IIIa Inhibitors in Acute Coronary Syndromes JAMA, September 27, 2000; 284(12): 1549 - 1558. [Abstract] [Full Text] [PDF]
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E Ronner, H.A.M van Kesteren, P Zijnen, E Altmann, P.G Molhoek, L.R van der Wieken, C.A Cuffie-Jackson, K.L Neuhaus, and M.L Simoons Safety and efficacy of eptifibatide vs placebo in patients receiving thrombolytic therapy with streptokinase for acute myocardial infarction. A phase II dose escalation, randomized, double-blind study Eur. Heart J., September 2, 2000; 21(18): 1530 - 1536. [Abstract] [PDF]
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S. G. Goodman, M. Cohen, F. Bigonzi, E. P. Gurfinkel, D. R. Radley, V. Le Iouer, G. J. Fromell, C. Demers, A. G. G. Turpie, R. M. Califf, et al. Randomized trial of low molecular weight heparin (enoxaparin) versus unfractionated heparin for unstable coronary artery disease: One-year results of the essence study J. Am. Coll. Cardiol., September 1, 2000; 36(3): 693 - 698. [Abstract] [Full Text] [PDF]
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E. Braunwald, E. M. Antman, J. W. Beasley, R. M. Califf, M. D. Cheitlin, J. S. Hochman, R. H. Jones, D. Kereiakes, J. Kupersmith, T. N. Levin, et al. ACC/AHA guidelines for the management of patients with unstable angina and non-st-segment elevation myocardial infarction: A report of the american college of cardiology/ american heart association task force on practice guidelines (committee on the management of patients with unstable angina) J. Am. Coll. Cardiol., September 1, 2000; 36(3): 970 - 1062. [Full Text] [PDF]
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E. M. Ohman, C. B. Granger, R. A. Harrington, and K. L. Lee Risk Stratification and Therapeutic Decision Making in Acute Coronary Syndromes JAMA, August 16, 2000; 284(7): 876 - 878. [Full Text] [PDF]
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R. A. Harrington, P. W. Armstrong, C. Graffagnino, F. Van de Werf, D. J. Kereiakes, K. N. Sigmon, T. Card, D. M. Joseph, R. Samuels, J. Granett, et al. Dose-Finding, Safety, and Tolerability Study of an Oral Platelet Glycoprotein IIb/IIIa Inhibitor, Lotrafiban, in Patients With Coronary or Cerebral Atherosclerotic Disease Circulation, August 15, 2000; 102(7): 728 - 735. [Abstract] [Full Text] [PDF]
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W Kubler Treatment of cardiac diseases: evidence based or experience based medicine? Heart, August 1, 2000; 84(2): 134 - 136. [Full Text] [PDF]
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W. S. Weintraub, T. D. Thompson, S. Culler, S. J. Boccuzzi, E. R. Becker, A. S. Kosinski, and E. Mahoney Targeting Patients Undergoing Angioplasty for Thrombus Inhibition : A Cost-Effectiveness and Decision Support Model Circulation, July 25, 2000; 102(4): 392 - 398. [Abstract] [Full Text] [PDF]
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C. P. Cannon, C. H. McCabe, R. G. Wilcox, A. Langer, A. Caspi, P. Berink, J. Lopez-Sendon, J. Toman, A. Charlesworth, R. J. Anders, et al. Oral Glycoprotein IIb/IIIa Inhibition With Orbofiban in Patients With Unstable Coronary Syndromes (OPUS-TIMI 16) Trial Circulation, July 11, 2000; 102(2): 149 - 156. [Abstract] [Full Text] [PDF]
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K. A A Fox CORONARY DISEASE: Acute coronary syndromes: presentation---clinical spectrum and management Heart, July 1, 2000; 84(1): 93 - 93. [Full Text] [PDF]
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E. Boersma, K. S. Pieper, E. W. Steyerberg, R. G. Wilcox, W.-C. Chang, K. L. Lee, K. M. Akkerhuis, R. A. Harrington, J. W. Deckers, P. W. Armstrong, et al. Predictors of Outcome in Patients With Acute Coronary Syndromes Without Persistent ST-Segment Elevation : Results From an International Trial of 9461 Patients Circulation, June 6, 2000; 101(22): 2557 - 2567. [Abstract] [Full Text] [PDF]
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R. A. Harrington Cardiac enzyme elevations after percutaneous coronary intervention: myonecrosis, the coronary microcirculation and mortality J. Am. Coll. Cardiol., April 1, 2000; 35(5): 1142 - 1144. [Full Text] [PDF]
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E. J. Topol and J. S. Yadav Recognition of the Importance of Embolization in Atherosclerotic Vascular Disease Circulation, February 8, 2000; 101(5): 570 - 580. [Full Text] [PDF]
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D. B. Mark, R. A. Harrington, A. M. Lincoff, R. M. Califf, C. L. Nelson, A. A. Tsiatis, H. Buell, K. W. Mahaffey, L. Davidson-Ray, and E. J. Topol Cost-Effectiveness of Platelet Glycoprotein IIb/IIIa Inhibition With Eptifibatide in Patients With Non-ST-Elevation Acute Coronary Syndromes Circulation, February 1, 2000; 101(4): 366 - 371. [Abstract] [Full Text] [PDF]
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J. H. Alexander, R. A. Sparapani, K. W. Mahaffey, J. W. Deckers, L. K. Newby, E. M. Ohman, R. Corbalan, S. L. Chierchia, J. B. Boland, M. L. Simoons, et al. Association Between Minor Elevations of Creatine Kinase-MB Level and Mortality in Patients With Acute Coronary Syndromes Without ST-Segment Elevation JAMA, January 19, 2000; 283(3): 347 - 353. [Abstract] [Full Text] [PDF]
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E. Boersma, K. M. Akkerhuis, P. Theroux, R. M. Califf, E. J. Topol, and M. L. Simoons Platelet Glycoprotein IIb/IIIa Receptor Inhibition in Non-ST-Elevation Acute Coronary Syndromes : Early Benefit During Medical Treatment Only, With Additional Protection During Percutaneous Coronary Intervention Circulation, November 16, 1999; 100(20): 2045 - 2048. [Abstract] [Full Text] [PDF]
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K.A.A. Fox Specific antithrombins in the context of current treatment for acute coronary syndromes Eur. Heart J., November 1, 1999; 20(21): 1519 - 1521. [PDF]
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C. P. Cannon Overcoming thrombolytic resistance: Rationale and initial clinical experience combining thrombolytic therapy and glycoprotein IIb/IIIa receptor inhibition for acute myocardial infarction J. Am. Coll. Cardiol., November 1, 1999; 34(5): 1395 - 1402. [Abstract] [Full Text] [PDF]
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T. J. Ryan, E. M. Antman, N. H. Brooks, R. M. Califf, L. D. Hillis, L. F. Hiratzka, E. Rapaport, B. Riegel, R. O. Russell, E. E. Smith III, et al. 1999 update: ACC/AHA guidelines for the management of patients with acute myocardial infarction: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Acute Myocardial Infarction) J. Am. Coll. Cardiol., September 1, 1999; 34(3): 890 - 911. [Full Text] [PDF]
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