|Effect of early, pre-hospital initiation of high bolus dose tirofiban in patients with ST-segment elevation myocardial infarction on short- and long-term clinical outcome.|
|PMID: 20510211 Owner: NLM Status: MEDLINE|
|OBJECTIVES: The purpose of this trial was to study the effect of a high bolus dose (HBD) of tirofiban on clinical outcome in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI).
BACKGROUND: The On-TIME 2 (Ongoing Tirofiban In Myocardial infarction Evaluation 2) placebo-controlled, double-blind, randomized trial showed that early administration of HBD tirofiban in the ambulance improves ST-segment resolution in patients with STEMI undergoing primary percutaneous coronary intervention. The effect of early tirofiban treatment on clinical outcome is unclear.
METHODS: The On-TIME 2 trial consisted of 2 phases: an open-label phase, followed by a double-blind, placebo-controlled phase. STEMI patients were randomized to either HBD tirofiban or no tirofiban (phase 1) or placebo (phase 2) in addition to aspirin, heparin, and high-dose clopidogrel. The protocol pre-specified a pooled analysis of the 2 study phases to assess the incidence of major adverse cardiac events at the 30-day follow-up and on total mortality at the 1-year follow-up.
RESULTS: During a 3-year period, 1,398 patients were randomized, 414 in phase 1 and 984 in phase 2. Major adverse cardiac events at 30 days were significantly reduced (5.8% vs. 8.6%, p = 0.043). There was a strong trend toward a decrease in mortality (2.2% vs. 4.1%, p = 0.051) in patients who were randomized to tirofiban pre-treatment, which was maintained during the 1-year follow-up (3.7% vs. 5.8%, p = 0.08). No clinically relevant difference in bleeding was observed.
CONCLUSIONS: Early, pre-hospital initiation of HBD tirofiban, in addition to high-dose clopidogrel, improves the clinical outcome after primary percutaneous coronary intervention in patients with STEMI. (Ongoing 2b/3a inhibition In Myocardial infarction Evaluation; ISRCTN06195297).
|Jurriën M ten Berg; Arnoud W J van 't Hof; Thorsten Dill; Ton Heestermans; Jochem W van Werkum; Arend Mosterd; Gert van Houwelingen; Petra C Koopmans; Pieter R Stella; Eric Boersma; Christian Hamm;|
|Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't|
|Title: Journal of the American College of Cardiology Volume: 55 ISSN: 1558-3597 ISO Abbreviation: J. Am. Coll. Cardiol. Publication Date: 2010 Jun|
|Created Date: 2010-05-31 Completed Date: 2010-06-15 Revised Date: 2014-06-23|
Medline Journal Info:
|Nlm Unique ID: 8301365 Medline TA: J Am Coll Cardiol Country: United States|
|Languages: eng Pagination: 2446-55 Citation Subset: AIM; IM|
|Data Bank Information|
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Aged, 80 and over
Angioplasty, Balloon, Coronary / methods, mortality
Dose-Response Relationship, Drug
Drug Administration Schedule
Emergency Medical Services / methods*
Myocardial Infarction / diagnosis*, drug therapy*, mortality, therapy
Platelet Aggregation Inhibitors / administration & dosage
Pulse Therapy, Drug
Tyrosine / administration & dosage, analogs & derivatives*
|0/Platelet Aggregation Inhibitors; 144494-65-5/tirofiban; 42HK56048U/Tyrosine|
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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