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M. Valgimigli University of Ferrara Italy

ESC Congress 2007. Three-year clinical follow-up after sirolimus-eluting versus bare metal stent implantation assisted by systematic GP IIb/IIIa infusion in patients with MI . M. Valgimigli University of Ferrara Italy. MI = myocardial infarction . Vienna 2nd September 07.

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M. Valgimigli University of Ferrara Italy

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  1. ESC Congress 2007 Three-year clinical follow-up after sirolimus-eluting versus bare metal stent implantation assisted by systematic GP IIb/IIIa infusion in patients with MI M. Valgimigli University of Ferrara Italy MI = myocardial infarction Vienna 2nd September 07

  2. Study Design • Inclusion criteria: STEMI all comers: shock, elderly included • Exclusion criteria: Contraindications to GP IIb/IIIa Tirofiban SHDB Cypher STEMI UFH - ASA Clopidogrel BMS Abciximab standard regimen CCU Cath-Lab ASA = acetylsalicylic acid, BMS = bare metal stent, GP = glycoprotein, STEMI = ST-segment elevation myocardial infarction, UFH = unfractioned heparin. Valgimigli M et al. Cardiovasc Drugs Ther 04; 18: 225-30.

  3. BMS and abciximab display a synergistic role in primary PCI setting and… “should be currently regarded as the gold standard for STEMI” B M S D E S Abciximab Tirofiban BMS = bare metal stent, DES = drug-eluting stent, PCI = percutaneous coronary intervention, STEMI = ST-segment elevation myocardial infarction. Medical Costs

  4. 84 PTCA 3 POBA 74 SES 7 BMS Study Profile 219 Assessed for Eligibility 44 Excluded • 34 Not Meeting Inclusion Criteria • 10 Refused to Participate 175 Randomized 1:1 SHDB Tirofiban (n = 87) Abciximab (n = 88) 88% 85% 83 PTCA 5 No PCI 3 No PCI 4 POBA 77 BMS 2 SES 75% 77% 3 4 3 74 7 77 2 5 Clinical Follow-up Angiographic Follow-up Pts not eligible Refused to participate 1 1 0 62 4 64 1 0 2 3 3 6 0 4 0 5 0 0 0 6 3 9 1 0 BMS = bare metal stent, PCI = percutaneous coronary intervention, POBA = plain old balloon angioplasty, PTCA = percutaneous transluminal coronary angioplasty, SES = sirolimus-eluting stent, SHDB = single high dose bolus. Valgimigli M et al. JAMA 2005; 293: 2109-17.

  5. 30-Day Outcome(n = 175) Abciximab+BMS Tirofiban+SES *in 1 pt SES was implanted as protocol violation % p > 0.99 p = 0.62 p = 0.62 p > 0.99 AMI = acute myocardial infarction, BMS = bare metal stent, SES = sirolimus-eluting stent, ST = sinus tachycardia, TVR = target vessel revascularization. Valgimigli M et al. JAMA 2005; 293: 2109-17.

  6. 41% 15% 8-Month Outcome(n = 175) p = 0.0002 Abciximab+BMS p = 0.004 Tirofiban+SES * In all recruited pts % p = 0.8 p = 0.6 p > 0.99 Death MI CVA BR 1° Endpoint* BMS = bare metal stent, BR = binary restenosis, SES = sirolimus-eluting stent, ST = sinus tachycardia, TVR = target vessel revascularization. Valgimigli M et al. JAMA 2005; 293: 2109-17.

  7. Death/MI/TVR at 8 Months p=0.043 HR 0.53 [95% CI: 0.28-0.92] Valgimigli M et al. JAMA 2005; 293: 2109-17.

  8. Duration of Dual Antiplatelet Tx • 5 pts (4 tirofiban+SES) re-started clopidogrel beyond the 2 year follow-up BMS = bare metal stent, SES = sirolimus-eluting stent, Tx = treatment.

  9. Primary EP at 3 years * No lost to Follow-up 70 Abciximab+BMS Tirofiban+SES 60 P=0.008 50 % 49% 40 30 29% 20 1° EP: composite of death, MI, CVA and binary restenosis *: in all recruited patients

  10. All Cause Mortality at 3 Years 16% 15% BMS = bare metal stent, SES = sirolimus-eluting stent.

  11. Death/MI at 3 Years 23% 20% P=0.57 at log rank test BMS = bare metal stent, SES = sirolimus-eluting stent.

  12. TVR at 3 Years 25% 10% BMS = bare metal stent, SES = sirolimus-eluting stent, TVR = target vessel revascularization

  13. MACE Rate at 3 Years 41% 29% BMS = bare metal stent, CI = confidence interval, SES = sirolimus-eluting stent, TVR = target vessel revascularization.

  14. Stent Thrombosis at 3 Years 6.8% 5.7% BMS = bare metal stent, SES = sirolimus-eluting stent.

  15. Conclusions • At 3 year Follow-up the composite of death MI CVA and BR was lower in tirofiban+SES arm • This difference was driven by an improvement in angiographic outcome leading to lower TVR • There was no difference in terms of death, MI or cumulative probability of stent thrombosis according to ARC classification

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