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European Heart Journal Advance Access originally published online on February 25, 2005
European Heart Journal 2005 26(14):1379-1384; doi:10.1093/eurheartj/ehi174
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© The European Society of Cardiology 2005. All rights reserved. For Permissions, please e-mail: journals.permissions@oupjournals.org

One year outcomes with abciximab vs. placebo during percutaneous coronary intervention after pre-treatment with clopidogrel{dagger}

Albert Schömig1,2,*, Claus Schmitt1, Alban Dibra1, Julinda Mehilli1, Christian Volmer1, Helmut Schühlen2, Josef Dirschinger2, Franz Dotzer3, Jurriën M. ten Berg4, Franz-Josef Neumann5, Peter B. Berger6, Adnan Kastrati1 for the Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment Study Investigators

1Deutsches Herzzentrum, Lazarettstr. 36, 80636 Munich, Germany
2Medizinische Klinik rechts der Isar, Munich, Germany
3Medizinische Klinik I, Garmisch-Partenkirchen, Germany
4St Antonius Ziekenhuis, Nieuwegein, Netherlands
5Herz-Zentrum, Bad Krozingen, Germany
6Duke University Medical Centre and Duke Clinical Research Institute, Durham, NC, USA

Received 11 October 2004; revised 13 January 2005; accepted 20 January 2005; online publish-ahead-of-print 25 February 2005.

* Corresponding author. Tel: +49 89 12184073; fax: +49 89 12184013. E-mail address: aschoemig{at}dhm.mhn.de

Aims In the Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment Trial, the use of abciximab in patients undergoing percutaneous coronary intervention (PCI) after pretreatment with 600 mg clopidogrel for >2 h was associated with no clinically measurable benefit at 30 days. We assessed whether there was any clinical benefit from abciximab at 1 year follow-up.

Methods and results After pre-treatment with 600 mg clopidogrel, a total of 2159 patients undergoing PCI for stable or unstable angina without marked ST-segment shifts or positive biomarkers were randomly assigned to receive abciximab or placebo. The occurrence of the composite endpoint of death, myocardial infarction, or target vessel revascularization was assessed at 1 year after randomization.

At 1 year, the composite endpoint occurred in 23.8% of the patients in each group [relative risk (RR), 1.01; 95% confidence interval (CI), 0.85–1.20; P=0.92]. The combined incidence of death and myocardial infarction was 6.0% in the abciximab group and 6.4% in the placebo group (RR, 0.94; 95% CI, 0.67–1.32; P=0.73). The mortality rate was 2.1% in the abciximab group and 2.4% in the placebo group (RR, 0.88; 95% CI, 0.50–1.54; P=0.66). No trend towards clinical benefit was observed with abciximab at 1 year in any subgroup analysed.

Conclusion In patients with a low-to-intermediate risk profile undergoing PCI after pre-treatment with a 600 mg clopidogrel for at least 2 h, the use of abciximab offers no additional clinical benefit at 1 year.

Key Words: Angina • Angioplasty • Platelets • Stents • Thrombosis


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