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European Heart Journal Advance Access published online on February 25, 2005
European Heart Journal, doi:10.1093/eurheartj/ehi174
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European Heart Journal © The European Society of Cardiology 2005; all rights reserved

Clinical research

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

Albert Schömig 1*, Claus Schmitt 2, Alban Dibra 2, Julinda Mehilli 2, Christian Volmer 2, Helmut Schühlen 3, Josef Dirschinger 3, Franz Dotzer 4, Jurriën M. ten Berg 5, Franz-Josef Neumann 6, Peter B. Berger 7, Adnan Kastrati 2, and for the Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment Study Investigators

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

* To whom correspondence should be addressed.
Albert Schömig, E-mail: aschoemig{at}dhm.mhn.de


  Abstract

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.

Keywords: Angina; Angioplasty; Platelets; Stents; Thrombosis.
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