European Heart Journal Advance Access originally published online on January 24, 2007
European Heart Journal 2007 28(4):443-449; doi:10.1093/eurheartj/ehl472
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Abciximab in primary coronary stenting of ST-elevation myocardial infarction: a European meta-analysis on individual patients' data with long-term follow-up
1 Institute of Cardiology (APHP) and INSERM unit #856, Pitié-Salpêtrière University Hospital, 47 Boulevard de l'Hôpital, 75013 Paris, France
2 Division of Cardiology, Careggi Hospital, Florence, Italy
3 Deutsches Herzzentrum, Technische Universität München, Munich, Germany
4 Herz-Zentrum, Bad Grozingen, Germany
5 Unité de Recherche Clinique (Statistics department), Lariboisière University Hospital, Paris, France
Received 2 June 2006; revised 14 December 2006; accepted 21 December 2006; online publish-ahead-of-print 24 January 2007.
* Corresponding author. Tel: +33 1 42 16 30 06; fax: +33 1 42 16 29 31. E-mail address: gilles.montalescot{at}psl.aphp.fr
Aims Varying results have been reported in studies evaluating glycoprotein (GP) IIb/IIIa inhibition in primary coronary stenting of acute ST-elevation myocardial infarction (STEMI), usually with limited clinical follow-up. We performed a meta-analysis on case specific data of primary stenting in STEMI with a long-term evaluation.
Methods and results For this meta-analysis, studies of rescue percutaneous coronary intervention (PCI) after failed lytic therapy, plain balloon angioplasty studies and studies with an angiographic selection of patients were excluded. The ISAR-2, ADMIRAL, and ACE studies fulfilled inclusion criteria and all individual data were analysed together. The primary endpoint was the composite of death or re-infarction up to 3 years of follow-up. A total of 1101 patients, presenting for primary PCI and stenting of STEMI were randomized to abciximab (n = 550) or placebo (n = 551). This population had high-risk characteristics with 41% of anterior MI, 30% with a prior history of MI, 8.4% of cardiogenic shock, and 3.1% of previous coronary artery bypass graft (CABG). The primary endpoint of death or re-infarction was significantly reduced from an estimated cumulative hazard rate of 19.0% with placebo to 12.9% with abciximab [RR(95% IC): 0.633 (0.452; 0.887), P = 0.008]. The mortality rate was reduced from an estimated cumulative hazard rate of 14.3% in the placebo arm to 10.9% in the abciximab arm [0.695 (0.482; 1.003), P = 0.052]. Re-infarction was reduced from an estimated cumulative hazard rate of 5.5% with placebo to 2.3% with abciximab [0.41 (0.203; 0.831), P = 0.013]. Major bleedings were 2.5 and 2% with and without abciximab, respectively (NS). In the control arm, both the death or MI cumulative hazard rate (54 vs. 13.5%) and mortality rate (39.7 vs. 10.1%) were four-fold higher in diabetics when compared with non-diabetics. Abciximab provided a significant benefit on the primary endpoint for diabetics [0.525 (0.303; 0.911), P = 0.022].
Conclusion Abciximab has a strong and persistent impact on hard clinical endpoints in patients undergoing primary stenting for STEMI.
Key Words: Primary percutaneous coronary intervention • Stent • GP IIb/IIIa inhibitors • Abciximab • Myocardial infarction
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