title: Role of the paclitaxel-eluting stent and tirofiban in patients with ST-elevation myocardial infarction undergoing postfibrinolysis angioplasty: the GRACIA-3 randomized clinical trial.
abstract: BACKGROUND
  A catheter-based approach after fibrinolysis is recommended if fibrinolysis is likely to be successful in patients with acute ST-elevation myocardial infarction. We designed a 2x2 randomized, open-label, multicenter trial to evaluate the efficacy and safety of the paclitaxel-eluting stent and tirofiban administered after fibrinolysis but before catheterization to optimize the results of this reperfusion strategy.
  
  
  RESULTS
  We randomly assigned 436 patients with acute ST-elevation myocardial infarction to (1) bare-metal stent without tirofiban, (2) bare-metal stent with tirofiban, (3) paclitaxel-eluting stent without tirofiban, and (4) paclitaxel-eluting stent with tirofiban. All patients were initially treated with tenecteplase and enoxaparin. Tirofiban was started 120 minutes after tenecteplase in those patients randomly assigned to tirofiban. Cardiac catheterization was performed within the first 3 to 12 hours after inclusion, and stenting (randomized paclitaxel or bare stent) was applied to the culprit artery. The primary objectives were the rate of in-segment binary restenosis of paclitaxel-eluting stent compared with that of bare-metal stent and the effect of tirofiban on epicardial and myocardial flow before and after mechanical revascularization. At 12 months, in-segment binary restenosis was similar between paclitaxel-eluting stent and bare-metal stent (10.1% versus 11.3%; relative risk, 1.06; 95% confidence interval, 0.74 to 1.52; P=0.89). However, late lumen loss (0.04+/-0.055 mm versus 0.27+/-0.057 mm, P=0.003) was reduced in the paclitaxel-eluting stent group. No evidence was found of any association between the use of tirofiban and any improvement in the epicardial and myocardial perfusion. Major bleeding was observed in 6.1% of patients receiving tirofiban and in 2.7% of patients not receiving it (relative risk, 2.22; 95% confidence interval, 0.86 to 5.73; P=0.14).
  
  
  CONCLUSIONS
  This trial does not provide evidence to support the use of tirofiban after fibrinolysis to improve epicardial and myocardial perfusion. Compared with bare-metal stent, paclitaxel-eluting stent significantly reduced late loss but appeared not to reduce in-segment binary restenosis.
  
  
  BACKGROUND
  URL: http://clinicaltrials.gov. Unique identifier: NCT00306228.
authors: Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors: Pedro L
authors: PL
authors: Sánchez
authors: Federico
authors: F
authors: Gimeno
authors: Pablo
authors: P
authors: Ancillo
authors: Juan J
authors: JJ
authors: Sanz
authors: Juan H
authors: JH
authors: Alonso-Briales
authors: Francisco
authors: F
authors: Bosa
authors: Ignacio
authors: I
authors: Santos
authors: Juan
authors: J
authors: Sanchis
authors: Armando
authors: A
authors: Bethencourt
authors: Juan
authors: J
authors: López-Messa
authors: Armando Pérez
authors: AP
authors: de Prado
authors: Joaquin J
authors: JJ
authors: Alonso
authors: J Alberto
authors: JA
authors: San Román
authors: Francisco
authors: F
authors: Fernández-Avilés
mesh_terms: D017130:Angioplasty; D054855:Drug-Eluting Stents; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D017239:Paclitaxel / Q000627:therapeutic use*; D000077466:Tirofiban; D016896:Treatment Outcome; D014443:Tyrosine / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D014443:Tyrosine; D000077466:Tirofiban; D017239:Paclitaxel