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European Heart Journal Advance Access originally published online on December 23, 2007
European Heart Journal 2008 29(4):455-461; doi:10.1093/eurheartj/ehm562
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2007. For permissions please email: journals.permissions@oxfordjournals.org

One-year clinical outcomes with abciximab vs. placebo in patients with non-ST-segment elevation acute coronary syndromes undergoing percutaneous coronary intervention after pre-treatment with clopidogrel: results of the ISAR-REACT 2 randomized trial{dagger}

Gjin Ndrepepa1, Adnan Kastrati1,*, Julinda Mehilli1, Franz-Josef Neumann2, Jurriën ten Berg3, Olga Bruskina1, Franz Dotzer4, Melchior Seyfarth1, Jürgen Pache1, Josef Dirschinger5, Peter B. Berger6 and Albert Schömig1,5

1 Deutsches Herzzentrum, Technische Universität, Lazarettstrasse 36, 80636 Munich, Germany
2 Herz-Zentrum, Bad Krozingen, Germany
3 St Antonius Ziekenhuis, Nieuwegein, The Netherlands
4 Klinikum Garmisch-Partenkirchen, Germany
5 1. Medizinische Klinik rechts der Isar, Technische Universität, Munich, Germany
6 Geisinger Clinic, Danville, PA, USA

Received 31 July 2007; revised 26 October 2007; accepted 5 November 2007; online publish-ahead-of-print 23 December 2007.

* Corresponding author. Tel: +49 89 12184577, Fax: +49 89 12184053. Email: kastrati{at}dhm.mhn.de

See page 429 for the editorial comment on this article (doi:10.1093/eurheartj/ehm624)

Aims: The aim of this study is to investigate whether the benefit of abciximab in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACSs) undergoing percutaneous coronary intervention (PCI) after pre-treatment with 600 mg clopidogrel is sustained at 1 year.

Methods and results: We performed 1-year follow-up of 2022 high-risk patients with NSTE-ACS undergoing urgent PCI, who were randomized to abciximab or placebo after pre-treatment with 600 mg clopidogrel in the Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 2 trial. The combined incidence of death, myocardial infarction, or target vessel revascularization at 1 year was the primary outcome analysis. At 1 year, the primary outcome was reached in 23.3% of patients allocated to abciximab vs. 28.0% of patients allocated to placebo [relative risk (RR) 0.80, 95% confidence interval (CI) 0.67–0.95, P = 0.012]. The combined incidence of death or myocardial infarction was 11.6% in patients allocated to abciximab vs. 15.3% in patients allocated to placebo (RR 0.74, 95% CI 0.59–0.94, P = 0.015).

Conclusion: In high-risk patients with NSTE-ACS undergoing a PCI after pre-treatment with 600 mg clopidogrel, adverse events occurred less frequently with abciximab and the early benefit was maintained at 1 year after administration.

Key Words: Abciximab • Acute coronary syndrome • Clopidogrel • Percutaneous coronary intervention

{dagger} Presented at the Clinical Trial Update Sessions of the Congress of the European Society of Cardiology. 1–5 September 2007, Vienna, Austria. Trial Registration ClinicalTrials.gov Identifier: NCT00133003 [ClinicalTrials.gov] .


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