Copyright © 2004 by the European Society of Cardiology.
Clinical research
Five-year outcome of patients with acute myocardial infarction enrolled in a randomised trial assessing the value of abciximab during coronary artery stenting
a Deutsches Herzzentrum and Medizinische Klinik rechts der Isar, Technische Universität, Lazarettstr 36, 80636 Munich, Germany
b Herz-Zentrum, Bad Krozingen, Germany
Received February 20, 2004;
revised April 20, 2004;
accepted April 29, 2004
* Corresponding author. Tel.: +49-89-12184577; fax: +49-89-12184593
kastrati{at}dhm.mhn.de
See page 1562 for the editorial comment on this article1
Aims The aim of the study was to investigate the long-term (five years) efficacy of glycoprotein IIb/IIIa inhibition with abciximab given as an adjunct therapy to coronary stenting in patients with acute myocardial infarction (MI) using the patient cohort of the Intracoronary Stenting and Antithrombotic Regimen-2 (ISAR-2) randomised trial.
Methods and results The patient cohort of ISAR-2 trial (401patients) was followed up for 5 years after enrolment. There were 201 patients in the abciximab group (stenting plus abciximab) and 200 patients in the control group (stenting without abciximab). The primary end-point of the study was mortality at 5 years. Recurrent MI and target vessel re-vascularisation were also assessed at 5 years after enrolment. On the basis of the KaplanMeier analyses, the 5-year mortality was 17.8% (35 patients) in the group with abciximab and 14.6% (29 patients) in the control group (relative risk, 1.20 [95% confidence interval, 0.731.96];
). The 5-year combined incidence of death, recurrent MI and target vessel re-vascularisation was 38.2% (76 patients) in the group of abciximab and 37.7% (75 patients) in the control group (relative risk, 0.97 [95% confidence interval, 0.701.33];
). Multivariable analysis showed no significant independent association of abciximab with 5-year mortality (adjusted hazard ratio, 1.16 [95% confidence interval, 0.701.92];
).
Conclusion These findings are not in support of a sustained clinical benefit at 5 years with the use of abciximab during coronary artery stenting in patients with acute MI.
Key Words: Abciximab Mortality Myocardial infarction Stents
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