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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. Abstract: 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, non-fatal 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.
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. Abstract: 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 ref erral 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- Main Outcome Measures: The primary end point was a composite of death, non-fatal myocardial infarction, stroke, or binary restenosis at 8 months. Secondary outcomes included freedom, at day 30 Results: Cumulatively, 14 of 74 patients (19%; 95% confidence interval [CI], 10% - 28%), and month 8, from major cardiac or cerebrovascular adverse events (composite of death, reinfarction, stroke and repeat TVR) ) 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% 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.