2004 25(10):837-846; doi:10.1016/j.ehj.2004.04.003
Copyright © 2004 by the European Society of Cardiology.
Clinical research
Facilitation of primary coronary angioplasty by early start of a glycoprotein 2b/3a inhibitor: results of the ongoing tirofiban in myocardial infarction evaluation (On-TIME) trial
a Isala Klinieken, Locatie Weezenlanden, Department of Cardiology, Groot Wezenland 20, 8011 JW Zwolle, The Netherlands
b Academic Medical Centre, Department of Cardiology, Amsterdam, The Netherlands
c Erasmus Medical Centre, Department of Cardiology, Rotterdam, The Netherlands
d Merck & Co., Inc., Whitehouse Station, NJ, USA
e Ospedale di Cisanello, University Hospital, Department of Cardiology, Pisa, Italy
f Gelre Ziekenhuizen, Department of Cardiology, Apeldoorn, The Netherlands
g Ambulance Dienst, Regio IJsselvecht, Zwolle, The Netherlands
Received March 24, 2004;
revised April 5, 2004;
accepted April 6, 2004
* Corresponding author. Tel.: +31-384242198; fax: +31-384243222
E-mail address: v.r.c.derks{at}isala.nl
See page 807 for the editorial comment on this article.1
Aim Although primary angioplasty is effective despite additional transportation delay, improved patency before PCI might be obtained by starting pharmacological pre-treatment before transportation.
Methods and Results From June 2001 to November 2002, 507 patients with acute myocardial infarction, who were transferred to a PCI centre, were randomised to early, pre-hospital initiation of Tirofiban (Early) or to initiation in the catheterisation laboratory (Late). The primary end-point was TIMI flow grade 3 of the infarct-related vessel (IRV) at initial angiography, as assessed by an independent core-lab. The effect of Tirofiban on each TIMI flow component, the presence of thrombus at initial angiography and pre-PCI myocardial blush grade were secondary end-points. A large proportion of patients (41%) was diagnosed and randomised in the ambulance, without intervention of a physician. In the Early group, Tirofiban was administered a median of 59 min (range 11178 min) earlier than in the Late group. At initial angiography, TIMI 3 flow was present in 19% the Early group and in 15% in the Late group (
). The combined incidence of TIMI 2 or 3 flow was present in 43% in the Early group and in 34% in the Late group, respectively (
). Thrombus or a fresh occlusion was present in 60% and 73% in the Early and Late group, respectively (
). A pre-PCI myocardial blush grades 2 or 3 was more often present in the Early group (30% vs. 22%,
). However, no difference in TIMI 3 flow or myocardial blush grade was found between the groups, post-PCI. At one-year follow-up, the combined incidence of death or recurrent MI was not different between the groups (7.0% vs. 7.0%,
).
Conclusion Early initiation of Tirofiban did not improve initial TIMI 3 flow of the IRV significantly. Despite a better patency (TIMI 2 or 3 flow), a lower prevalence of thrombus or fresh occlusion and a better myocardial perfusion in the infarct-related region pre-PCI, no beneficial effect on post-PCI angiographic or clinical outcome was found, as compared to initiation of Tirofiban in the catheterisation laboratory.
Key Words: Primary angioplasty Anti-platelet therapy Reperfusion
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