title: Tirofiban and sirolimus-eluting stent vs abciximab and bare-metal stent for acute myocardial infarction: a randomized trial.
abstract: BACKGROUND
  Bare-metal stenting with abciximab pretreatment is currently considered a reasonable reperfusion strategy for acute ST-segment elevation myocardial infarction (STEMI). Sirolimus-eluting stents significantly reduce the need for target-vessel revascularization (TVR) vs bare-metal stents but substantially increase procedural costs. At current European list prices, the use of tirofiban instead of abciximab would absorb the difference in cost between stenting with sirolimus-eluting vs bare-metal stents.
  
  
  OBJECTIVE
  To evaluate the clinical and angiographic impact of single high-dose bolus tirofiban plus sirolimus-eluting stenting vs abciximab plus bare-metal stenting in patients with STEMI.
  
  
  METHODS
  Prospective, single-blind, randomized controlled study (Single High Dose Bolus Tirofiban and Sirolimus Eluting Stent vs Abciximab and Bare Metal Stent in Myocardial Infarction [STRATEGY]) of 175 patients (median age, 63 [interquartile range, 55-72] years) presenting to a single referral center in Italy with STEMI or presumed new left bundle-branch block and randomized between March 6, 2003, and April 23, 2004.
  
  
  METHODS
  Single high-dose bolus tirofiban regimen plus sirolimus-eluting stenting (n = 87) vs standard-dose abciximab plus bare-metal stenting (n = 88).
  
  
  METHODS
  The primary end point was a composite of death, nonfatal myocardial infarction, stroke, or binary restenosis at 8 months. Secondary outcomes included freedom, at day 30 and month 8, from major cardiac or cerebrovascular adverse events (composite of death, reinfarction, stroke, and repeat TVR).
  
  
  RESULTS
  Cumulatively, 14 of 74 patients (19%; 95% confidence interval [CI], 10%-28%) in the tirofiban plus sirolimus-eluting stent group and 37 of 74 patients (50%; 95% CI, 44%-56%) in the abciximab plus bare-metal stent group reached the primary end point (hazard ratio, 0.33; 95% CI, 0.18-0.60; P<.001 [P<.001 by Fischer exact test]). The cumulative incidence of death, reinfarction, stroke, or TVR was significantly lower in the tirofiban plus sirolimus-eluting stent group (18%) vs the abciximab plus bare-metal stent group (32%) (hazard ratio, 0.53; 95% CI, 0.28-0.92; P = .04), predominantly reflecting a reduction in the need for TVR. Binary restenosis was present in 6 of 67 (9%; 95% CI, 2%-16%) and 24 of 66 (36%; 95% CI, 26%-46%) patients in the tirofiban plus sirolimus-eluting stent and abciximab plus bare-metal stent groups, respectively (P = .002).
  
  
  CONCLUSIONS
  Tirofiban-supported sirolimus-eluting stenting of infarcted arteries holds promise for improving outcomes while limiting health care expenditure in patients with myocardial infarction undergoing primary intervention.
authors.affiliation: Chair of Cardiology, University of Ferrara, Cardiovascular Institute, Arcispedale S. Anna, Italy. vlgmrc@unife.it
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Percoco
authors.forename: Patrizia
authors.initials: P
authors.lastname: Malagutti
authors.forename: Gianluca
authors.initials: G
authors.lastname: Campo
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Ferrari
authors.forename: Dario
authors.initials: D
authors.lastname: Barbieri
authors.forename: Giordano
authors.initials: G
authors.lastname: Cicchitelli
authors.forename: Eugène P
authors.initials: EP
authors.lastname: McFadden
authors.forename: Fabia
authors.initials: F
authors.lastname: Merlini
authors.forename: Lucia
authors.initials: L
authors.lastname: Ansani
authors.forename: Gabriele
authors.initials: G
authors.lastname: Guardigli
authors.forename: Alessandro
authors.initials: A
authors.lastname: Bettini
authors.forename: Giovanni
authors.initials: G
authors.lastname: Parrinello
authors.forename: Eric
authors.initials: E
authors.lastname: Boersma
authors.forename: Roberto
authors.initials: R
authors.lastname: Ferrari
mesh_terms: D000077284:Abciximab; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D000077466:Tirofiban; D014443:Tyrosine / Q000031:analogs & derivatives* / Q000627:therapeutic use*
chemical_list: D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D007166:Immunosuppressive Agents; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D014443:Tyrosine; D000077466:Tirofiban; D020123:Sirolimus; D000077284:Abciximab