CLINICAL STUDIES
Effect of glycoprotein IIb/IIIa receptor blockade with abciximab on clinical and angiographic restenosis rate after the placement of coronary stents following acute myocardial infarction
Franz-Josef Neumann, MDa,
Adnan Kastrati, MDa,
Claus Schmitt, MDa,
Rudolf Blasini, MDa,
Martin Hadamitzky, MDa,
Julinda Mehilli, MDa,
Meinrad Gawaz, MDa,
Michael Schleefa,
Melchior Seyfarth, MDa,
Josef Dirschinger, MDa and
Albert Schömig, MDa
a Deutsches Herzzentrum und 1. Medizinische Klinik der Technischen Universität München, Munich, Germany
Manuscript received July 8, 1999;
revised manuscript received October 26, 1999,
accepted December 2, 1999.
Reprint requests and correspondence: Dr. Franz-Josef Neumann, 1. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität, Ismaningerstr. 22, 81675 München, Germany
neumann{at}med1.med.tu-muenchen.de
OBJECTIVES
In the Intracoronary Stenting and Antithrombotic Regimen-2 trial (ISAR-2), we sought to investigate the effect of abciximab on angiographic and clinical restenosis after stenting following acute myocardial infarction (AMI). We also intended to assess the impact of abciximab on clinical outcome in this setting.
BACKGROUND
It is unclear whether abciximab reduces neointima formation after stenting. Such an effect may be particularly prominent in thrombus-containing lesions.
METHODS
Patients undergoing stenting within 48 h after onset of AMI were randomly assigned to receive either standard-dose heparin or abciximab plus reduced-dose heparin. Of 401 patients randomized, 366 without 30-day adverse events were eligible for six-month angiographic follow-up. Scheduled angiography was performed in 80% of these patients.
RESULTS
By 30 days, the composite clinical end point of death, reinfarction, and target lesion revascularization (TLR) was reached in 5.0% of the abciximab group and in 10.5% of the control group (p = 0.038). At one year, absolute reduction in the composite clinical end point by abciximab was still 5.7% but had lost its statistical significance. Our primary end point, late lumen loss, was 1.26 ± 0.85 mm with abciximab and 1.21 ± 0.74 mm with standard heparin (p = 0.61), and binary angiographic restenosis rates were 31.1% and 30.6%, respectively (p = 0.92).
CONCLUSIONS
In patients undergoing stenting following AMI, abciximab exerted beneficial effects by substantially reducing the 30-day rate of major adverse cardiac events. During one-year follow-up, there was no additional benefit from a reduction in TLR nor did abciximab reduce angiographic restenosis.
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Abbreviations and Acronyms
| | AMI | = acute myocardial infarction | | CABG | = coronary artery bypass surgery | | EPISTENT | = Evaluation of IIb/IIIa Platelet Inhibition for Stenting | | MLD | = minimal luminal diameter | | PTCA | = percutaneous transluminal coronary angiography | | RAPPORT | = ReoPro in Acute MI Primary PTCA Organization and Randomized Trial | | TIMI | = thrombolysis in myocardial infarction | | TLR | = target lesion revascularization |
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H. C. Herrmann, G. W. Stone, C. L. Grines, and J. E. Tcheng
Comparison of Angioplasty with Stenting in Acute Myocardial Infarction
N. Engl. J. Med.,
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M. Sakakibara, S. Goto, K. Eto, N. Tamura, T. Isshiki, and S. Handa
Application of Ex Vivo Flow Chamber System for Assessment of Stent Thrombosis
Arterioscler Thromb Vasc Biol,
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22(8):
1360 - 1364.
[Abstract]
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Comparison of Angioplasty with Stenting, with or without Abciximab, in Acute Myocardial Infarction
N. Engl. J. Med.,
March 28, 2002;
346(13):
957 - 966.
[Abstract]
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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.,
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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;
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[Abstract]
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H. Schuhlen, A. Kastrati, J.u. Pache, J. Dirschinger, and A. Schomig
Incidence of thrombotic occlusion and major adverse cardiac events between two and four weeks after coronary stent placement: analysis of 5,678 patients with a four-week ticlopidine regimen
J. Am. Coll. Cardiol.,
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[Abstract]
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E. Braunwald
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G. Montalescot, R. Choussat, and J.P. Collet
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Eur. Heart J. Suppl.,
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F.-J. Neumann
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J. J. Popma, E. M. Ohman, J. Weitz, A. M. Lincoff, R. A. Harrington, and P. Berger
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Abciximab Fails to Reduce Restenosis After MI
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T. A. Waldmann, R. Levy, and B. S. Coller
Emerging Therapies: Spectrum of Applications of Monoclonal Antibody Therapy
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