RT Journal Article
T1 Role of the paclitaxel-eluting stent and tirofiban in patients with ST-elevation myocardial infarction undergoing postfibrinolysis angioplasty: the GRACIA-3 randomized clinical trial.
A1 Sánchez, Pedro L
A1 Gimeno, Federico
A1 Ancillo, Pablo
A1 Sanz, Juan J
A1 Alonso-Briales, Juan Horacio
A1 Bosa, Francisco
A1 Santos, Ignacio
A1 Sanchís, Juan
A1 Bethencourt, Armando
A1 López-Messa, Juan
A1 Pérez de Prado, Armando
A1 Alonso, Joaquín J
A1 San Román, J Alberto
A1 Fernández-Avilés, Francisco
K1 tirofiban
K1 Stents Liberadores de Fármacos
K1 Electrocardiografía
K1 Femenino
K1 Estudios de Seguimiento
K1 Humanos
K1 Masculino
K1 Mediana Edad
K1 Infarto de Miocardio
K1 Tirosina
K1 Angioplastia
AB BACKGROUNDA 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.METHODS AND RESULTSWe 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).CONCLUSIONSThis 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.CLINICAL TRIAL REGISTRATIONURL: http://clinicaltrials.gov. Unique identifier: NCT00306228.
PB American Heart Association
SN 1941-7640
YR 2010
FD 2010-08
LK http://hdl.handle.net/10668/832
UL http://hdl.handle.net/10668/832
LA en
NO Sánchez PL, Gimeno F, Ancillo P, Sanz JJ, Alonso-Briales JH, Bosa F, et al. Role of the paclitaxel-eluting stent and tirofiban in patients with ST-elevation myocardial infarction undergoing postfibrinolysis angioplasty: the GRACIA-3 randomized clinical trial. Circ Cardiovasc Interv. 2010                         ; 3(4):297-307
NO Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't;
DS RISalud
RD Apr 12, 2025