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Tirofiban Given in the Emergency Room Before Primary Angioplasty (TIGER-PA) Pilot Study

Tirofiban Given in the Emergency Room Before Primary Angioplasty (TIGER-PA) Pilot Study. David P. Lee, MD, Alan C. Yeung, MD, Donald Schreiber, MD, Michelle Huston, MD. GP IIb/IIIa Inhibitors in Acute MI. Key questions regarding new adjuvant therapies Can we improve reperfusion times?

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Tirofiban Given in the Emergency Room Before Primary Angioplasty (TIGER-PA) Pilot Study

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  1. Tirofiban Given in the Emergency Room Before Primary Angioplasty (TIGER-PA) Pilot Study David P. Lee, MD, Alan C. Yeung, MD, Donald Schreiber, MD, Michelle Huston, MD

  2. GP IIb/IIIa Inhibitors in Acute MI • Key questions regarding new adjuvant therapies • Can we improve reperfusion times? • Can we improve flow after reperfusion? • Can we limit infarct size and thus complications?

  3. GP IIb/IIIa Inhibitors in Acute MI • Why a GP IIb/IIIa inhibitor could work • Early potent antiplatelet therapy • Adjunctive use in PCI improves outcomes • May improve flow • Relatively safe to use

  4. RAPPORTReoPro in Acute myocardial infarction and Primary PTCA Organization Randomized Trial • N=483 • Abciximab in the ER or cath lab • 30-day MACE Any drug Int to treat (n=409) (n=483) Control 12.0 11.2 Abciximab 4.6 5.8 P value 0.005 0.038 • 6-month MACE: no difference

  5. ADMIRALAbciximab before Direct angioplasty and stenting in Myocardial Infarction Regarding Acute and Long-term follow-up Event *Abciximab Placebo (n=150) (n=150) P Death, MI, urgent TVR at 30 d 10.7% 20.0% 0.03 TIMI-3 initial 21% 10% <0.01 24 h 86% 78% <0.03 LVEF 24 h 55% 51% 30 d 63% 55% *26% received in ambulance or ER

  6. GRAPEGlycoprotein Receptor Antagonist Patency Evaluation Pilot (N=60) P < 0.0001 32% Patients With TIMI-3 Flow 23% 23% 18% 8% GRAPE(n=60) 45 min SPEED(n=26) 60 min TIMI-14A(n=31) 90 min All Abciximab(n=117) GUSTO-IIb(n=510) 115 min angio at

  7. TIGER-PAPilot • Goals • To test the safety and efficacy of tirofiban in the setting of an acute MI • To compare early adjunctive use of tirofiban before primary PCI with peri-PCI use

  8. TIGER-PAPilot • Targets • 100 patients planned • 40% power to detect a 15% difference in the TIMI frame count and flow

  9. TIGER-PAPilot • Inclusion criteria • Chest pain within 12 hours of onset • 1 mm ST-elevation in 2 or more contiguous leads or new LBBB

  10. TIGER-PAPilot • Exclusion criteria • Age <18 • Major surgery, GI or GU bleed within 30 days • CVA within 1 year or with residual deficit • Known bleeding diathesis • Known intracranial disease • Cardiogenic shock

  11. TIGER-PAPilot • Exclusion criteria • Uncontrolled HTN (SBP > 180, DBP > 100) • Prolonged CPR • Thrombolysis within 24 hours • Concomitant use of a GP IIb/IIIa inhibitor • Hemorrhagic retinopathy • PLTs < 150K

  12. TIGER-PAPilot • Study design • 1:1 open-label randomization to tirofiban in the ER (early) or in the cath lab (delayed) • No PTCA in early arm if culprit lesion <50% • Delayed tirofiban if PTCA to be performed

  13. PTCA/stent No PTCA if lesion <50% No PTCA Tirofiban if PTCA to be performed TIGER-PAPilot Acute myocardial infarction Meets inclusion criteria Tirofiban in ER No tirofiban in ER Angiogram Angiogram Final angiogram Final angiogram

  14. TIGER-PAPilot • Dosing • Tirofiban: 10 µg/kg over 3 minutes, then 0.15 µg/kg/min x 24 hours • Heparin • Early: 70 U/kg IV bolus, then 7.5 U/kg/h • Delayed: 100 U/kg IV bolus, then 10 U/kg/h • All other medications including NTG, -blockers at the investigator’s discretion

  15. TIGER-PAPilot • Laboratories Baseline 6 h 12 h 18 h 24 h Hb X - X - X Hct X - X - X PLT X - X - X CPK X X X X X CPK-MB X X X X X

  16. TIGER-PAPilot • Endpoints • Primary endpoint • TIMI flow • TIMI frame counts • Secondary endpoint • Bleeding • Minor: Hct¯ ³10% or Hb¯ ³3 g/dL • Major: Hct¯ ³15% or Hb¯ ³5 g/dL • Thrombocytopenia (PLTs< 90000)

  17. TIGER-PAPilot • Endpoints • Tertiary endpoint (30 days) • Repeat coronary revascularization • Urgent vs nonurgent • Death (from any cause) • New MI (CPK >2x normal) • Hospitalization for refractory ischemia

  18. TIGER-PAPilot • Adjuvant therapy • If a stent is placed, ticlopidine 250 mg po bid or clopidogrel 75 mg po qd x ³14 d • Heparin may be stopped temporarily for early sheath removal

  19. TIGER-PAPilot • Data analysis • Primary endpoint • Blinded observer for TIMI frame count and flow at baseline and after PTCA • Secondary endpoint • Data monitoring for CBC and CPKs • Safety monitor for bleeding events • Tertiary endpoint • Clinical follow-up by chart review and telephone

  20. INTERIM TIGER-PAPilot • N=54 30 ER, 24 cath lab • Patients to date 54 (registry=83) • Average age 65 ± 13 years • Male:female 7:2 • Anterior 22, lateral 7, inferior 25 • Mean time from ER to cath lab: 83 minutes • Mean time for tirofiban to cath lab: 34 minutes

  21. INTERIM TIGER-PAPilot Initial CTFC TGF Mean = 34 min * P=0.01 60 3 * P=0.002 40 2 CTFC TGF 20 1 0 0 ER Cath Lab ER Cath Lab

  22. INTERIM TIGER-PAPilot Initial TGF TGF 40 TIMI-3 * 30 TIMI-2 TIMI-0 or 1 20 # Patients 10 * P=0.002 0 ER Cath Lab

  23. INTERIM TIGER-PAPilot • Complications ER Cath Lab Minor bleeding 4 2 Major bleeding 1 1 30 d MACE 1 2 30-day MACE include 1 patient in each group admitted for chest pain and 1 patient who had SAT and repeat PCI at 6 days in the cath lab group with no deaths.

  24. INTERIM TIGER-PAPilot Platelet Substudy • 10 patients in the Cath Lab group underwent measurements of platelet inhibition with the Accumetrics Ultegra RPFA while in the Cath Lab • Time points: baseline, 20m, 40m, EOC

  25. TIGER-PAPilot Platelet Substudy 100 80 60 % platelet inhibition 40 20 0 Baseline Post Bolus 20 min 40 min EOC

  26. TIGER-PA • Summary • Pilot study to determine safety and efficacy of tirofiban given in the ER before primary PTCA • Tirofiban given early in the ER may lead to further improvement in TIMI flow and frame count compared with tirofiban given in the cath lab

  27. Summary • GP IIb/IIIa receptor inhibitors may be beneficial as an adjunct in acute MI • Safe and well tolerated • Further large-scale trials are needed to better delineate a long-term benefit

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