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The Additive Value of Tirofiban Administered With

Explore the additive value of Tirofiban in preventing ischemic complications during high-risk coronary angioplasty. Detailed trial findings, patient characteristics, and implications for clinical practice.

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The Additive Value of Tirofiban Administered With

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  1. Department of Cardiology University of Ferrara M. Valgimigli University of Ferrara Italy Erasmus MC, Thoraxcenter The Netherlands The Additive Value of Tirofiban Administered With the High-Dose Bolus in the Prevention of Ischemic Complications During High-Risk Coronary Angioplasty The ADVANCE Trial

  2. p = 0.002 8,5 p = 0.32 5,8 5,6 4,5 acs pts non acs pts 30-day composite events (death, MI, urgent TVR) by clinical status Tirofiban p = 0.032 9,0 Abciximab 7,59 8,0 7,0 6,01 6,0 5,0 4,0 3,0 2,0 1,0 0,0 all pts

  3. Dr Schneider’s Hypothesis • Baseline platelet reactivity is not uniform in patients undergoing PCI • The higher the baseline value, the worse the outcome • Baseline platelet reactivity is proportional to the clinical status, lower in elective pts, higher in NSTEACS and highest in STEMI pts • Tirofiban, at Restore regimen, is just enough, soon after the bolus, to control platelet reactivity in elective patients Circ 01; 104: 18; AJC 02; 90: 1421; AJC 03; 91: 334; AJC 03; 91: 872; Frossard Circ 04; 110

  4. AIM • To re-assess the efficacy of Tirofiban when given at SHDB on top of ADP receptor blockers in: • Elective patients • NSTE-ACS patients

  5. AIM • To re-assess the efficacy of Tirofiban when given at SHDB on top of ADP receptor blockers in High-Risk: • Elective patients • Multivessel treatment • Diabetes • NSTE-ACS patients • High-risk features (ESC guidelines)

  6. PCI Indications ACS Silent Ischemia Viability SA

  7. NSTE-ACS Population (n=111) 79% • 73% Troponin positive • 55% ST >0.5 mm 2 leads • 23% Diabetes

  8. Study Protocol 160-325mg ASA 500mg ticlidopine bolus + 250mg bid or 300mg clopidogrel bolus + 75mg daily 100U/kg bolus UFH + Bolus to maintain 300s ACT 50-70U/kg bolus UFH + Bolus to maintain 200s ACT Placebo 25mcg/kg bolus tirofiban + 0.15mcg/kg/min infusion for 24-48 hours Valgimigli et al. (2004) JACC 44:14-19

  9. Primary Endpoint Death, nonfatal MI, TVR and thrombotic bailout GP IIb/IIIa Secondary Endpoints Each component of the primary endpoint Effect of drug on troponin I levels Effects in prespecified subgroups Diabetics Patients with ACS TIMI major and minor bleeding Endpoints ≈199 Patients 30% events Controls 40% events reduction β-error 0.8 α-error .05 Valgimigli et al. (2004) JACC 44:14-19

  10. Characteristics Placebo (n=101) HDB Tirofiban (n=101) P-Value Age (yr) 687 699 NS Male sex (%) 66 69 NS Diabetes (%) 45 53 NS 15 19 NS Previous PCI (%) 45 50 NS Pervious MI (%) 21 19 NS Creatinine (mg/dl) 1.10.3 1.00.2 NS Baseline Characteristics Heart failure (%) Valgimigli et al. (2004) JACC 44:14-19

  11. Characteristics Placebo (n=101) HDB Tirofiban (n=101) P-Value Age (yr) 687 699 NS Male sex (%) 66 69 NS Diabetes (%) 45 53 NS 15 19 NS Previous PCI (%) 45 50 NS Pervious MI (%) 21 19 NS Creatinine (mg/dl) 1.10.3 1.00.2 NS Baseline Characteristics Heart failure (%) Valgimigli et al. (2004) JACC 44:14-19

  12. Characteristics Placebo (n=101) HDB Tirofiban (n=101) P-Value Age (yr) 687 699 NS Male sex (%) 66 69 NS Diabetes (%) 45 53 NS 15 19 NS Previous PCI (%) 45 50 NS Pervious MI (%) 21 19 NS Creatinine (mg/dl) 1.10.3 1.00.2 NS Baseline Characteristics Heart failure (%) Valgimigli et al. (2004) JACC 44:14-19

  13. Characteristics Placebo (n=101) HDB Tirofiban (n=101) P-Value Age (yr) 687 699 NS Male sex (%) 66 69 NS Diabetes (%) 45 53 NS 15 19 NS Previous PCI (%) 45 50 NS Pervious MI (%) 21 19 NS Creatinine (mg/dl) 1.10.3 1.00.2 NS Baseline Characteristics Heart failure (%) Valgimigli et al. (2004) JACC 44:14-19

  14. Characteristics Placebo (n=101) HDB Tirofiban (n=101) P-Value Age (yr) 687 699 NS Male sex (%) 66 69 NS Diabetes (%) 45 53 NS 15 19 NS Previous PCI (%) 45 50 NS Pervious MI (%) 21 19 NS Creatinine (mg/dl) 1.10.3 1.00.2 NS Baseline Characteristics Heart failure (%) Valgimigli et al. (2004) JACC 44:14-19

  15. Characteristics Placebo (n=101) HDB Tirofiban (n=101) P-Value Age (yr) 687 699 NS Male sex (%) 66 69 NS Diabetes (%) 45 53 NS 15 19 NS Previous PCI (%) 45 50 NS Pervious MI (%) 21 19 NS Creatinine (mg/dl) 1.10.3 1.00.2 NS Baseline Characteristics Heart failure (%) Valgimigli et al. (2004) JACC 44:14-19

  16. Characteristics Placebo (n=101) HDB Tirofiban (n=101) P-Value Age (yr) 687 699 NS Male sex (%) 66 69 NS Diabetes (%) 45 53 NS 15 19 NS Previous PCI (%) 45 50 NS Pervious MI (%) 21 19 NS Creatinine (mg/dl) 1.10.3 1.00.2 NS Baseline Characteristics Heart failure (%) Valgimigli et al. (2004) JACC 44:14-19

  17. Characteristics Placebo (n=101) HDB Tirofiban (n=101) P-Value Age (yr) 687 699 NS Male sex (%) 66 69 NS Diabetes (%) 45 53 NS 15 19 NS Previous PCI (%) 45 50 NS Pervious MI (%) 21 19 NS Creatinine (mg/dl) 1.10.3 1.00.2 NS Baseline Characteristics Heart failure (%) Valgimigli et al. (2004) JACC 44:14-19

  18. 1° End-point 100 90 20% 80 P=0,01 70 35% 60 Tirofiban SHDB Suirvival Probability % Placebo 50 40 30 20 10 0 0 50 100 150 200 250 300 350 400 Days Valgimigli et al. (2004) JACC 44:14-19

  19. Clinical Outcome 0.01 0.048 n.s. % 0.052 n.s. TVR 1°Endpoint MI MACE Death Valgimigli et al. (2004) JACC 44:14-19

  20. Troponin I and CK-MB P<0. 01 P=0.001 ng/ml Troponin I CK-MB Valgimigli et al. (2004) JACC 44:14-19

  21. Subgroup Analysis Acute Coronary Syndrome Yes No Diabetes Yes No 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 Tirofiban Better Placebo Better Valgimigli et al. (2004) JACC 44:14-19

  22. Safety Results • No incidence of major bleeding • No RBC transfusions • No severe thrombocytopenia • One mild thrombocytopenia in each group Placebo 20 Tirofiban 18 16 14 P=0.19 12 10 # Patients 8 6 4 2 0 Minor Bleeding Valgimigli et al. (2004) JACC 44:14-19

  23. CONCLUSIONS • Tirofiban when given at SHDB, immediately before high-risk PCIs, to patients who have been pre-treated with thienopyridines was: • As safe as • More effective than UFH alone in the prevention of periprocedural ischemic complications • Our current findings, based on a limited and selected sample size, should be viewed as preliminary, thus giving input for further research in this field. Valgimigli et al. (2004) JACC 44:14-19

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