Article Text

PDF
Original article
High-dose tirofiban pretreatment reduces the need for bail-out study medication in patients with ST-segment elevation myocardial infarction: results of a subgroup analysis of the On-TIME 2 trial
  1. R S Hermanides1,
  2. A A C M Heestermans2,
  3. J M ten Berg3,
  4. A T M Gosselink1,
  5. J P Ottervanger1,
  6. K G van Houwelingen4,
  7. J J E Kolkman5,
  8. P R Stella6,
  9. T Dill7,
  10. C Hamm7,
  11. A W J van 't Hof1
  1. 1Isala Klinieken, Zwolle, The Netherlands
  2. 2Medisch Centrum Alkmaar, Alkmaar, The Netherlands
  3. 3St. Antonius Ziekenhuis, Nieuwegein, The Netherlands
  4. 4Medisch Spectrum Twente, Enschede, The Netherlands
  5. 5Diagram BV, Zwolle, The Netherlands
  6. 6Universitair Medisch Centrum, Utrecht, The Netherlands
  7. 7Kerckhoff-Klinik, Bad Nauheim, Germany
  1. Correspondence to Dr Arnoud W J van 't Hof, Isala klinieken, Department of Cardiology, Groot Wezenland 20, 8011 JW Zwolle 8011, The Netherlands; v.r.c.derks{at}isala.nl

Abstract

Objective This study investigated the outcome of patients who received bail-out study medication and evaluated whether high-dose tirofiban (HDT) pretreatment may reduce the need for bail-out study medication.

Design A prespecified analysis of the multicentre, double-blind, placebo controlled, randomised On-TIME 2 trial. Bail-out use of study medication was predefined and part of the combined clinical end point.

Patients 984 patients excluded from many coronary intervention hospitals in different countries were randomly assigned to HDT or placebo. In the subgroup who received blinded bail-out treatment, patients pretreated with placebo who received bail-out HDT were compared with those pretreated with HDT who received bail-out placebo.

Interventions Routine prehospital initiation of HDT versus bail-out use of HDT.

Main Outcome Measures Electrocardiographic and clinical outcome.

Results Blinded bail-out study medication was used in 24% (237/980) of patients, with a higher rate in patients pretreated with placebo: 29% (140/492) versus 20% (97/488), p=0.002. Bail-out versus no bail-out use of study medication was associated with more residual ST deviation (5.5±7.2 vs 3.7±4.8 mm, p=0.005), and worse clinical outcome (major adverse cardiac events (MACE) at 30 days 12.2% vs 5.6%, p<0.001), mainly due to poor outcome in patients who received HDT bail-out. In patients pretreated with HDT who received placebo bail-out study medication, residual ST deviation and clinical outcome did not differ significantly compared with patients who did not receive bail-out medication (4.0±4.6 vs 3.7± 4.8 mm, p=0.703, MACE 7.2% vs 5.6%, p=0.535).

Conclusions Routine prehospital treatment with HDT significantly reduced the use of blinded bail-out study medication. The need for bail-out therapy was associated with a less favourable outcome. This analysis suggests that routine pretreatment is superior to provisional use of HDT in patients with ST-segment elevation myocardial infarction.

  • Bail-out
  • coronary angioplasty
  • glycoprotein IIb/IIIa inhibitors
  • percutaneous coronary intervention
  • STEMI

Statistics from Altmetric.com

Footnotes

  • See Systematic review, p 98

  • Linked articles 195438.

  • Funding The study was partly funded by an unrestricted grant from Merck and Co, Whitehouse Station, NJ, USA. The sponsors of the study had no role in study design, data collection, data analysis, data interpretation or writing of the report.

  • Competing interests AWJvtH has received speaker fees from Merck, Sanofi Aventis and Schering Plough. CH has received advisory board/speaker fees from Merck, Iroko, Lilly, GlaxoSmithKline, Sanofi Aventis, the Medicines Company, Roche and Abbott. All other authors declare that they have no conflict of interest.

  • Ethics approval This study was conducted with the approval of all local ethics committees involved.

  • Provenance and peer review Not commissioned; externally peer reviewed.

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Linked Articles