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STRATEGY Trial

STRATEGY Trial. Tirofiban and Sirolimus-Eluting Stent vs Abciximab and Bare-Metal Stent for Acute Myocardial Infarction . Journal of the American Medical Association May 4, 2005 Marco Valgimigli , et al. . STRATEGY Trial. 175 patients with STEMI or new left bundle-branch block

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STRATEGY Trial

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

  2. STRATEGY Trial 175patients with STEMI or new left bundle-branch block single-blind, randomized, single-center mean age 63 years Sirolimus-eluting stent + Tirofiban Single, high-dose bolus of tirofiban (25 µg/kg over 3 minutes) n=74 Bare-metal stent + Abciximab Standard-dose abciximab 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) JAMA 2005

  3. STRATEGY Trial Primary Composite Endpoint of Death, Reinfarction, Stroke, or TVR at 8 months p = 0.04 • 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 JAMA 2005

  4. STRATEGY Trial 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. p=0.01 p=0.78 p=0.60 % p=>0.99 JAMA 2005

  5. 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.

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