Five-year outcome of patients with acute myocardial infarction enrolled in a randomised trial assessing the value of abciximab during coronary artery stenting

Eur Heart J. 2004 Sep;25(18):1635-40. doi: 10.1016/j.ehj.2004.04.031.

Abstract

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 (401 patients) was followed up for 5 years after enrollment. 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 enrollment. On the basis of the Kaplan-Meier 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, 0.73-1.96]; P=0.47). 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, 0.70-1.33]; P=0.83). Multivariable analysis showed no significant independent association of abciximab with 5-year mortality (adjusted hazard ratio, 1.16 [95% confidence interval, 0.70-1.92]; P=0.55).

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Abciximab
  • Antibodies, Monoclonal / therapeutic use*
  • Disease-Free Survival
  • Female
  • Humans
  • Immunoglobulin Fab Fragments / therapeutic use*
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Myocardial Infarction / drug therapy*
  • Platelet Aggregation Inhibitors / therapeutic use*
  • Proportional Hazards Models
  • Prospective Studies
  • Recurrence
  • Stents*
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal
  • Immunoglobulin Fab Fragments
  • Platelet Aggregation Inhibitors
  • Abciximab