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The EPIC Investigators: Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high-risk coronary angioplasty. N Engl J Med 1994, 330:956-961. The EPIC trial was the first trial to reveal a significant 35% reduction in death, myocardial infarction, and urgent revascularization in patients undergoing high-risk angioplasty who were treated with abciximab.
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Topol EJ, Califf RM, Weisman HF, Ellis SG, Tcheng JE, Worley S, Ivanhoe R, George BS, Fintel D, Weston M, Sigmon K, Anderson DM, Lee KL, Willerson JT, on behalf of the EPIC investigators: Randomized trial of coronary intervention with antibody against platelet IIb/IIIa integrin for reduction of clinical restenosis: results at six months. Lancet 1994, 343:881-886.
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Aguirre FV, Topol EJ, Ferguson JJ, Anderson K, Blankenship JC, Heuser RR, Sigmon K, Taylor M, Gottlieb R, Hanovich G, et al.: Bleeding complications with the chimeric antibody to platelet glycoprotein IIb/IIIa integrin in patients undergoing percutaneous coronary intervention. Circulation 1995, 91:2882-2890.
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Lincoff AM, Tcheng JE, Califf RM, Cabot CF, Miller DP, Booth JE, Montague EA, Anderson KM, Topol EJ: Abciximab with reduced heparin dosing during coronary intervention: final results of the EPILOG trial [abstract]. J Am Coll Cardiol 1997, 29:187A. The EPILOG trial, which revealed a 56% reduction in death, myocardial infarction, and urgent revascularization in all patients undergoing angioplasty, was also stopped due to early positive results, and extended the beneficial effects of abciximab to all patients undergoing angioplasty.
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Tcheng JE, Lincoff AM, Miller DP, Booth JE, Rund MM, Cabot CF, Weisman HF, Califf RM, Topol EJ: Benefits of abciximab accrue in the full spectrum of coronary interventional patients: insights from the EPILOG trial [abstract]. J Am Coll Cardiol 1997, 29:276A.
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Van de Werf F: More evidence for a beneficial effect of platelet glycoprotein IIb/IIIa-blockade during coronary interventions: latest results from the EPILOG and CAPTURE trials. Eur Heart J 1996, 17:325-326
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Horrigan MCG, Tcheng JE, Califf RM, Kitt M, Lorenz T, Sigmon K, Lincoff AM, Topol EJ for the IMPACT-II Investigators: Maximal benefit of integrelin platelet IIb/IIIa blockade 6-24 hours after therapy: results of the IMPACT-II trial [abstract]. J Am Coll Cardiol 1996, 27:55A.
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The IMPACT-II Investigators: Effect of competitive platelet glycoprotein IIb/IIIa inhibition with Integrilin in reducing complications of percutaneous coronary interventions: results of the randomized clinical trial IMPACT-II. Lancet 1997, 349:1422-1428. This trial of the glycoprotein IIb/IIIa antagonist Integrilin in patients undergoing angioplasty did not document significant durable benefit at the dose studied.
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Schulman SP, Goldschmidt-Clermont PJ, Topol EJ, Califf RM, Navetta FI, Willerson JT, Chandra NC, Guerci AD, Ferguson JJ, Harrington RA, Lincoff AM, et al.: Effects of Integrelin, a platelet glycoprotein IIb/IIIa receptor antagonist, in unstable angina. Circulation 1996, 94:2083-2089.
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Ohman EM, Kleiman NS, Gacioch G, Worley S, Talley JD, Navetta FI, Talley JD, Anderson HV, Ellis SG, Cohen M, Spriggs D, Miller M, , Dereiakes D, Yakubov S, Kitt MM, Sigmon KN, Califf RM, Krucoff M, Topol EJ. for the IMPACT-AMI Investigators: Combined accelerated tissue-plasminogen activator and platelet glycoprotein IIb/IIIa integrin receptor blockade with Integrilin in acute myocardial infarction: results of a randomized, placebo-controlled, dose-ranging trial. Circulation 1997, 98:846-854. Integrilin to Manage Platelet Activation to Prevent Coronary Thrombosis in Acute Myocardial Infarction I (IMPACT-AMI), a dose-finding trial of the short-acting glycoprotein IIb/IIIa inhibitor Integrilin, documented improved TIMI 3 flow in patients with acute myocardial infarction who were treated with Integrilin in conjuction with thrombolysis.
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Harrington RA, Moliterno DJ, Van de Werf F, Keech A, Kleiman N, Bhapkar M, Rames A, Peek M, Topol EJ, Califf RM, Armstrong PW, for the PARAGON Investigators: Delaying and preventing ischemic events in patients with acute coronary syndromes using the platelet glycoprotein IIb/IIIa inhibitor lamifiban [abstract]. J Am Coll Cardiol 1997, 29:409A. In PARAGON-A, a dose-finding trial of lamifiban in patients with unstable angina and non-Q wave myocardial infarction, there was no singificant benefit seen at 30 days; however, there was a significant reduction in death or myocardial reinfarction seen at 6-month follow-up.
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Moliterno DJ, Harrington RA, Califf RM, Rapold HJ, Topol EJ, for the PARADIGM Investigators: Randomized, placebo-controlled study of lamifiban with thrombolytic therapy for the treatment of acute myocardial infarction: rationale and design for the Platelet Aggregation Receptor Antagonist Dose Investigation and reperfusion Gain in Myocardial infarction (PARADIGM) study. J Thromb Thrombol 1995, 2:165-169.
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Moliterno DJ, Harrington RA, Krucoff MW, Armstrong PW, Van de Werf F, Kristinsson A, Hui W, Paraschos A, Bhapkar M, Rames A, Topol J, for the PARADIGM Investigators: More complete and stable reperfusion with platelet IIb/IIIa antagonism plus thrombolysis for AMI: the PARADIGM trial [abstract]. Circulation 1996, 94(suppl):I-553.
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Topol EJ, Califf RM, Van de Werf F, Simoons M, Hampton J, Lee KL, White H, Simes J, Armstrong PW, for the Virtual Coordinating Center for Global Collaborative Cardiovascular Research (VIGOUR) Group: Perspectives on large-scale cardiovascular clinical trials for the new millennium. Circulation 1997, 95:1072-1082. Reviews the importance of large randomized clinical trials for documenting the efficacy of new therapies in cardiovascular disease.
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Simpfendorfer C, Kottke-Marchant K, Topol EJ: First experience with chronic platelet GPIIb/IIIa receptor blockade: a pilot study of xemlofiban an orally active antagonist in unstable angina patients eligible for PTCA [abstract]. J Am Coll Cardiol 1996, 27:242A.
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Ryan TJ, Anderson JL, Antman EM, Braniff BA, Brooks NH, Califf RM, Hillis LD, Hiratzka LF, Rapaport E, Riegel BJ, Russell RO, Smith EE, Weaver WD, Ritchie JL, Cheitlin MD, Eagle KA, Gardner TJ, Garson A, Gibbons RJ, Lewis RP, Orourke RA: 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. J Am Coll Cardiol 1996, 28:1328-1419.
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Karsch KR, Preisack MB, Rainer B, Eschenfelder V, Foley D, Garcia EJ, Kaltenback M, Meisner C, Selbmann HK, Serruys PW, Shiu MF, Sujatta M, Bonan R, for the REDUCE Trial Group: Low molecular weight heparin (Reviparin) in percutaneous transluminal coronary angioplasty: results of a randomized, double-blind, unfractionated heparin and placebo controlled, multicenter trial (REDUCE Trial). J Am Coll Cardiol 1996, 28:1437-1443.
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Fragmin During Instability in Coronary Artery Disease (FRISC) Study Group: Low-molecular weight heparin during instability in coronary artery disease. Lancet 1996, 347:561-568. Documented a significant early reduction in death or myocardial infarction, which was attenuated at 40 days, in patients with unstable angina treated with dalteparin.
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Ferguson JJ, Fox R: Meeting highlights. Circulation 1997, 95:763. Reviews the presentation of the ESSENCE trial results showing a significant reduction in death, MI, and recurrent angina in patients with unstable angina or non-Q wave myocardial infarction who were treated with enoxaparin.
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Serruys PW, Herrman JR, Simon R, Rutsch W, Bode C, Laarman GJ, Dijk RV, Van Den Bos AA, Umans VAWM, Fox KAA, Close P, Deckers JW, for the HELVETICA Investigators: A comparison of hirudin with heparin in the prevention of restenosis after coronary angioplasty. N Engl J Med 1995, 333:757-763. In HELVETICA, although patients receiving hirudin had a significant reduction in early death, myocardial infarction, or revascularization, there was no benefit seen at 7-month follow-up.
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The Global Use Of Strategies To Open Occluded Coronary Arteries (GUSTO) IIa Investigators: Randomized trial of intravenous heparin versus recombinant hirudin for acute coronary syndromes. Circulation 1996, 90:1631-1637. This trial, along with HIT-III (Neuhaus er al.: Circulation 1994, 90:1638-1642) and TIMI-9A (Antman et al.: Circulation 1994, 90:1624-1630) documented the narrow therapeutic window of the antithrombins hirudin and heparin, with aggressive dosing being associated with an increased risk of bleeding.
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