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A Randomized Trial

Marco Valgimigli, MD; Gianfranco Percoco, MD; Patrizia Malagutti, MD; Gianluca Campo, MD; Fabrizio Ferrari, MD; Dario Barbieri, MD; Giordano Cicchitelli, MD; Eugène P. McFadden, MD, FRCPI; Fabia Merlini, MD; Lucia Ansani, MD; Gabriele Guardigli, MD; Alessandro Bettini, MD; Giovanni Parrinello, PhD; Eric Boersma, PhD; Roberto Ferrari, MD, PhD; for the STRATEGY Investigators

JAMA. 2005;293:2109-2117.

Context  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.

Design, Setting, and Patients  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.

Intervention  Single high-dose bolus tirofiban regimen plus sirolimus-eluting stenting (n = 87) vs standard-dose abciximab plus bare-metal stenting (n = 88).

Main Outcome Measures  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).

Conclusion  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.

Author Affiliations: Chair of Cardiology, University of Ferrara, Italy (Drs Valgimigli, Percoco, Malagutti, Campo, F. Ferrari, Barbieri, Cicchitelli, Merlini, Ansani, Guardigli, and R. Ferrari); Cardiovascular Research Centre, Salvatore Maugeri Foundation, IRCCS Gussago (BS), Italy (Drs Valgimigli, Bettini, and R. Ferrari); Medical Statistics Unit, University of Brescia, Italy (Dr Parrinello); Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands (Drs McFadden and Boersma).

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