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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.
Authors: Sánchez, Pedro L
Gimeno, Federico
Ancillo, Pablo
Sanz, Juan J
Alonso-Briales, Juan Horacio
Bosa, Francisco
Santos, Ignacio
Sanchís, Juan
Bethencourt, Armando
López-Messa, Juan
Pérez de Prado, Armando
Alonso, Joaquín J
San Román, J Alberto
Fernández-Avilés, Francisco
metadata.dc.contributor.authoraffiliation: [Sánchez,PL; Fernández-Avilés,F] Hospital General Universitario Gregorio Marañón, Madrid, Spain. [Gimeno,F; San Román,JA] Hospital Clínico de Valladolid, Spain. [Ancillo,P] Hospital General de Segovia, Spain. [Sanz,JJ] Hospital Río Hortega, Valladolid, Spain. [Alonso Briales,JH] Hospital Universitario Virgen de la Victoria, Málaga. Spain. [Bosa,F] Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain. [Santos,I] Hospital Universitario de Salamanca, Spain. [Sanchís,J] Hospital Clínico Universitario, Valencia, Spain. [Bethencourt,A] Hospital Son Dureta, Palma de Mallorca, Spain. [López-Messa,J] Hospital Río Carrión, Palencia, Spain. [Pérez de Prado,A] Complejo Hospitalario de León, Spain. [Alonso,JJ] Hospital de Fuenlabrada, Madrid, Spain. The GRACIA-3 (Grupo de Análisis de la Cardiopatía Isquémica Aguda)
Keywords: tirofiban;Stents Liberadores de Fármacos;Electrocardiografía;Femenino;Estudios de Seguimiento;Humanos;Masculino;Mediana Edad;Infarto de Miocardio;Tirosina;Angioplastia
metadata.dc.subject.mesh: Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Equipment and Supplies::Prostheses and Implants::Stents::Drug-Eluting Stents
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Electrodiagnosis::Electrocardiography
Medical Subject Headings::Check Tags::Female
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Longitudinal Studies::Follow-Up Studies
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Check Tags::Male
Medical Subject Headings::Named Groups::Persons::Age Groups::Adult::Middle Aged
Medical Subject Headings::Diseases::Cardiovascular Diseases::Heart Diseases::Myocardial Ischemia::Myocardial Infarction
Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Hydrocarbons::Hydrocarbons, Cyclic::Hydrocarbons, Alicyclic::Cycloparaffins::Cyclodecanes::Taxoids::Paclitaxel
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcome
Medical Subject Headings::Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Amino Acids::Amino Acids, Cyclic::Amino Acids, Aromatic::Tyrosine
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Catheterization::Angioplasty
Issue Date: Aug-2010
Publisher: American Heart Association
Citation: 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
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. METHODS AND 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. CLINICAL TRIAL REGISTRATION URL: Unique identifier: NCT00306228.
Description: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't;
metadata.dc.identifier.doi: 10.1161/CIRCINTERVENTIONS.109.920868
ISSN: 1941-7632 (Online)
1941-7640 (Print)
Appears in Collections:01- Artículos - Hospital Virgen de la Victoria

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