1 / 34

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?

karena
Download Presentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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. Improved TIMI-grade Flow with Early IIb/IIIa in Acute MI % with TIMI-3 flow N 60 300 888

  8. 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

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

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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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)

  18. 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

  19. 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

  20. TIGER-PAPilot • Data analysis • Primary endpoint • Blinded observers for TIMI frame count, myocardial perfusion 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

  21. TIGER-PAPilot Demographics • N=100 50 ER, 50 cath lab • Patients screened 157 • Declined enrollment 32 • Shock/IABP 9 • Signif comorbities 14 • Recent IIb/IIIa 2

  22. TIGER-PAPilot Demographics

  23. TIGER-PAPilot Demographics 33 minute mean from drug-to-balloon

  24. TIGER-PAPilot Angiographic Outcomes

  25. TIGER-PAPilot Angiographic Outcomes

  26. Initial TIMI-Grade Flow * P < 0.007 50 10% 32% 8% 40 TIMI-3 30 TIMI-2 14% # Patients TIMI-0 or 1 20 10 0 Early Late TIGER-PAPilot

  27. Initial CTFC * P = 0.005 80 60 CTFC 66 ± 23 40 44 ± 20 20 0 Early Late TIGER-PAPilot

  28. * P < 0.001 50 6% 32% 12% 40 TMPG-3 30 TMPG-2 16% # Patients TMPG-0 or 1 20 10 0 Early Late TIGER-PAPilot Initial TIMI-Myocardial Perfusion Grade

  29. TIGER-PAPilot Clinical Outcomes

  30. TIGER-PAPilot Clinical Outcomes ER Cath Lab p *Minor bleeding 10% 6% NS *Major bleeding 2% 2% NS Transfusions 10% 8% NS PLT < 100K 4% 0% NS * TIMI-defined

  31. 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

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

  33. TIGER-PAPilot • 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, frame count, and blush when compared with tirofiban given in the cath lab • Earlier reperfusion may translate into better clinical outcomes

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

More Related