Document Detail


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.
MedLine Citation:
PMID:  20510211     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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).
Authors:
Jurri?n 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;
Publication Detail:
Type:  Comment; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  55     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2010 Jun 
Date Detail:
Created Date:  2010-05-31     Completed Date:  2010-06-15     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2446-55     Citation Subset:  AIM; IM    
Affiliation:
St Antonius Hospital, Nieuwegein, the Netherlands.
Data Bank Information
Bank Name/Acc. No.:
ISRCTN/ISRCTN06195297
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Angioplasty, Transluminal, Percutaneous Coronary / methods,  mortality
Confidence Intervals
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Electrocardiography*
Emergency Medical Services / methods*
Female
Humans
Infusions, Intravenous
Male
Middle Aged
Myocardial Infarction / diagnosis*,  drug therapy*,  mortality,  therapy
Odds Ratio
Platelet Aggregation Inhibitors / administration & dosage
Probability
Prognosis
Prospective Studies
Pulse Therapy, Drug
Reference Values
Risk Assessment
Single-Blind Method
Survival Analysis
Time Factors
Treatment Outcome
Tyrosine / administration & dosage,  analogs & derivatives*
Chemical
Reg. No./Substance:
0/Platelet Aggregation Inhibitors; 144494-65-5/tirofiban; 55520-40-6/Tyrosine
Comments/Corrections
Comment On:
J Am Coll Cardiol. 2010 Jun 1;55(22):2456-8   [PMID:  20510212 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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