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

Received 16 December 2006; accepted 15 March 2007. published online 28 April 2007.

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.

Study Design

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 μg/kg over 3 minutes), followed by an infusion of 0.15 μg/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.

a Cardiology, University of Ferrara, Ferrara, Italy

b Cardiovascular Research Centre, Salvatore Maugeri Foundation, IRCCS Gussago, Brescia, Italy

c Cardiovascular Departments of San Donato Hospital, Arezzo, Italy

d Department of Biomedical and Surgical Sciences, Section of Cardiology, University of Verona, Verona, Italy

e Otamendi Hospital, Buenos Aires, Argentina

f Policlinico S. Marco, Zingonia, Bergamo, Italy

g Saint Luke's Mid America Heart Institute, Kansas City, MO

h Interventional Cardiology, University of Turin, San Giovanni Battista Hospital, Turin, Italy

i Cardiovascular Intervention Laboratory San Giovanni Bosco Hospital, Turin, Italy

j Department of Cardiology, Civic Hospital, Mirano, Venice, Italy

k Department at the University Hospital of Caen, Normandy, France

l Virga Jesseziekenhuis, Hasselt, Belgium

m Istituto di Ricovero e Cura a Carattere Scientifico, Policlinico S. Matteo, Pavia, Italy

n Department of Cardiovascular Medicine, Catholic University of the Sacred heart, Rome, Italy

o Antwerp Cardiovascular Institute Middelheim, AZ Middelheim, Antwerp, Belgium

p Medical Statistics Unit, University of Brescia, Italy

Reprint requests: Marco Valgimigli, MD, PhD, Cardiology, University of Ferrara, Cardiovascular Institute, Arcispedale S. Anna Hospital, C.rso Giovecca 203, 44100 Ferrara, Italy.

The conduct of this study was partially supported by Merck Company (Whitehouse Station, NJ).

PII: S0002-8703(07)00245-1

doi:10.1016/j.ahj.2007.03.023

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