title: Two-by-two factorial comparison of high-bolus-dose tirofiban followed by standard infusion versus abciximab and sirolimus-eluting versus bare-metal stent implantation in patients with acute myocardial infarction: design and rationale for the MULTI-STRATEGY trial.
abstract: BACKGROUND
  Current treatment standards for patients undergoing primary percutaneous coronary intervention support early infusion of abciximab, followed by bare-metal stent (BMS) implantation. Whether the use of sirolimus-eluting stent (SES) would result in a further improvement of clinical outcomes remains to be proven. Similarly, whether tirofiban administered at high-bolus dose (HBD) followed by standard infusion is a valuable alternative to abciximab in the setting of ST-segment elevation myocardial infarction remains uncertain.
  
  
  METHODS
  Multicentre evaluation of single high-bolus dose tirofiban versus abciximab and sirolimus-eluting versus bare metal stent in acute myocardial infarction (MULTI-STRATEGY) is a phase III, open-label, multinational investigator-driven clinical trial evaluating, with a 2-by-2 factorial design, the safety/efficacy profile of 4 interventional strategies of reperfusion: tirofiban given at HBD (bolus of 25 microg/kg over 3 minutes), followed by an infusion of 0.15 microg/kg per minute for 18 to 24 hours versus abciximab and SES, as compared to BMS implantation in primary percutaneous coronary intervention. The coprimary objectives are (i) the evaluation of the effect of SES versus BMS on the incidence of major adverse cardiac events within 8 months of the index procedure and (ii) the degree of ST-segment resolution obtained after the mechanical intervention for the comparison of HBD tirofiban versus abciximab. The protocol mandates clinical follow-up for 5 years.
  
  
  CONCLUSIONS
  MULTI-STRATEGY will evaluate the role of SES and HBD tirofiban versus BMS and abciximab in the acute management of patients presenting with ST-segment elevation myocardial infarction.
authors.affiliation: Cardiology, University of Ferrara, Ferrara, Italy. vlgmrc@unife.it
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.forename: Leonardo
authors.initials: L
authors.lastname: Bolognese
authors.forename: Maurizio
authors.initials: M
authors.lastname: Anselmi
authors.forename: Gianluca
authors.initials: G
authors.lastname: Campo
authors.forename: Alfredo E
authors.initials: AE
authors.lastname: Rodriguez
authors.forename: Nicoletta
authors.initials: N
authors.lastname: de Cesare
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.forename: Imad
authors.initials: I
authors.lastname: Sheiban
authors.forename: Salvatore
authors.initials: S
authors.lastname: Colangelo
authors.forename: Giampaolo
authors.initials: G
authors.lastname: Pasquetto
authors.forename: Martial
authors.initials: M
authors.lastname: Hamon
authors.forename: Pascal
authors.initials: P
authors.lastname: Vranckx
authors.forename: Maurizio
authors.initials: M
authors.lastname: Ferrario
authors.forename: Francesco
authors.initials: F
authors.lastname: Prati
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Agostoni
authors.forename: Patrizia
authors.initials: P
authors.lastname: Malagutti
authors.forename: Chiara
authors.initials: C
authors.lastname: Arcozzi
authors.forename: Giovanni
authors.initials: G
authors.lastname: Parrinello
authors.forename: Corrado
authors.initials: C
authors.lastname: Vassanelli
authors.forename: Roberto
authors.initials: R
authors.lastname: Ferrari
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Percoco
mesh_terms: D000077284:Abciximab; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D017326:Clinical Trials, Phase III as Topic; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage*; D007262:Infusions, Intravenous; D008670:Metals; D009203:Myocardial Infarction / Q000628:therapy*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D000077466:Tirofiban; D014443:Tyrosine / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D008670:Metals; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D014443:Tyrosine; D000077466:Tirofiban; D020123:Sirolimus; D000077284:Abciximab