Document Detail


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.
MedLine Citation:
PMID:  20962338     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
R S Hermanides; A A C M Heestermans; J M Ten Berg; A T M Gosselink; J P Ottervanger; K G van Houwelingen; J J E Kolkman; P R Stella; T Dill; C Hamm; A W J van 't Hof
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-10-20
Journal Detail:
Title:  Heart (British Cardiac Society)     Volume:  97     ISSN:  1468-201X     ISO Abbreviation:  Heart     Publication Date:  2011 Jan 
Date Detail:
Created Date:  2010-12-17     Completed Date:  2011-03-09     Revised Date:  2011-07-07    
Medline Journal Info:
Nlm Unique ID:  9602087     Medline TA:  Heart     Country:  England    
Other Details:
Languages:  eng     Pagination:  106-11     Citation Subset:  AIM; IM    
Affiliation:
Isala Klinieken, Zwolle, The Netherlands.
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MeSH Terms
Descriptor/Qualifier:
Angioplasty, Balloon, Coronary / methods
Double-Blind Method
Emergency Medical Services
Female
Humans
Male
Middle Aged
Myocardial Infarction / drug therapy*
Platelet Aggregation Inhibitors / administration & dosage*
Preoperative Care / methods
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 In:
Heart. 2011 Jun;97(12):1026; author reply 1026   [PMID:  21586427 ]

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


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