Tirofiban and Sirolimus-Eluting Stent vs Abciximab and Bare-Metal Stent for Acute Myocardial Infarction STRATEGY Trial Journal of the American Medical Association May 4, 2005 Marco Valgimigli, et al. Marco Valgimigli, et al.

www. Clinical trial results.org Sirolimus-eluting stent + Tirofiban Single, high-dose bolus of tirofiban (25 µg/kg over 3 minutes) n=74 Sirolimus-eluting stent + Tirofiban Single, high-dose bolus of tirofiban (25 µg/kg over 3 minutes) n=74 Endpoints:  Primary – Composite of death, MI, stroke, or binary restenosis at 8 months.  Secondary – 30 day and 8 month freedom from major adverse cardiac or cerebrovascular events (death, reinfarction, stroke, repeat TVR) Endpoints:  Primary – Composite of death, MI, stroke, or binary restenosis at 8 months.  Secondary – 30 day and 8 month freedom from major adverse cardiac or cerebrovascular events (death, reinfarction, stroke, repeat TVR) STRATEGY Trial JAMA 2005 Bare-metal stent + Abciximab Standard-dose abciximab n=74 Bare-metal stent + Abciximab Standard-dose abciximab n= patients with STEMI or new left bundle-branch block single-blind, randomized, single-center mean age 63 years 175 patients with STEMI or new left bundle-branch block single-blind, randomized, single-center mean age 63 years

www. Clinical trial results.org STRATEGY Trial The primary composite endpoint of 8-month death, MI, stroke, or target vessel revascularization was significantly lower in the tirofiban and sirolimus-eluting stent group than in the absiximab and bare-metal stent group The over-all reduction in the primary composite endpoint was driven by a reduction in the rate of TVR Primary Composite Endpoint of Death, Reinfarction, Stroke, or TVR at 8 months p = 0.04 JAMA 2005

www. Clinical trial results.org STRATEGY Trial % JAMA 2005 p=0.78 p=0.60 p=0.01 p=>0.99 The individual components of the primary endpoint were equivalent between the two groups, with the exception of TVR which was significantly lower in the tirofiban + SES arm than in the abciximab + BMS arm.

www. Clinical trial results.org STRATEGY Trial: Summary Among patients with STEMI or new left bundle-branch block, treatment with tirofiban and a sirolimus-eluting stent was associated with a reduction in the primary composite endpoint of death, nonfatal MI, stroke, and TVR at 8 months, compared to treatment with abciximab and a bare-metal stent. All individual components of the primary endpoint were equivalent between the two groups with the exception of TVR, which was significantly lower in the tirofiban + SES group than in the abciximab + BMS group. Drug-eluting stents have been associated with significant reductions in target-vessel revascularization compared to bare metal stents, but the cost of treatment with a sirolimus-eluting stent plus the GP IIb/IIa inhibitor abciximab exceeds the average reimbursement in Europe. Tirofiban is a less-costly GP IIb/IIa inhibitor, and in the head-to- head TARGET trial was assiciated with a higher rate of periprocedural MI than abciximab. However, the TARGET trial used a lower bolus dose than the one used this trial (10 μg/kg vs. 25 μg/kg). The cost of treatment with a sirolimus-eluting stent and tirofiban is comparable to the cost of treatment with a bare-metal stent and abciximab The large, ongoing TENACITY trial is comparing treatment with a high-dose bolus of tirofiban with abciximab in patients undergoing PCI. Additionally, a larger, multicenter trial is currently underway to further test the efficacy and safety of SES + tirofiban therapy. Among patients with STEMI or new left bundle-branch block, treatment with tirofiban and a sirolimus-eluting stent was associated with a reduction in the primary composite endpoint of death, nonfatal MI, stroke, and TVR at 8 months, compared to treatment with abciximab and a bare-metal stent. All individual components of the primary endpoint were equivalent between the two groups with the exception of TVR, which was significantly lower in the tirofiban + SES group than in the abciximab + BMS group. Drug-eluting stents have been associated with significant reductions in target-vessel revascularization compared to bare metal stents, but the cost of treatment with a sirolimus-eluting stent plus the GP IIb/IIa inhibitor abciximab exceeds the average reimbursement in Europe. Tirofiban is a less-costly GP IIb/IIa inhibitor, and in the head-to- head TARGET trial was assiciated with a higher rate of periprocedural MI than abciximab. However, the TARGET trial used a lower bolus dose than the one used this trial (10 μg/kg vs. 25 μg/kg). The cost of treatment with a sirolimus-eluting stent and tirofiban is comparable to the cost of treatment with a bare-metal stent and abciximab The large, ongoing TENACITY trial is comparing treatment with a high-dose bolus of tirofiban with abciximab in patients undergoing PCI. Additionally, a larger, multicenter trial is currently underway to further test the efficacy and safety of SES + tirofiban therapy.