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Disclosure - I Speaker Bureau – Sanofi Aventis Bristol Myers Squibb Daichi Sankyo/Lilly

Results of CRYSTAL AMI: A Pilot Trial Before INFUSE AMI, the Concept and Evolution in Thrombus Management. Saihari Sadanandan, MD, FACC, FASE, Dip. CBNC, FSCAI Associate Professor of Clinical Medicine Director, Vascular Interventions Division of Cardiology

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Disclosure - I Speaker Bureau – Sanofi Aventis Bristol Myers Squibb Daichi Sankyo/Lilly

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  1. Results of CRYSTAL AMI: A Pilot Trial Before INFUSE AMI, the Concept and Evolution in Thrombus Management Saihari Sadanandan, MD, FACC, FASE, Dip. CBNC, FSCAIAssociate Professor of Clinical MedicineDirector, Vascular InterventionsDivision of Cardiology IU- HealthIndiana UniversityIndianapolis

  2. Disclosure - I Speaker Bureau – Sanofi Aventis Bristol Myers Squibb Daichi Sankyo/Lilly Educational Grant from Atrium Medical towards IRB fees to collect data on the case Studies CRYSTAL – AMI slide courtesy – R. Dave, MD

  3. Acute Inferior MI: Primary PCI for STEMI

  4. Primary PCI for STEMI: Predilation and Stent

  5. Distal Embolization during primary PCI for STEMI

  6. 5 year outcomes of No-reflow during Primary PCI for STEMI • N = 1406 • Pts with STEMI undergoing PCI • No reflow defined as TIMI <3 flow or • TMPG 0-1 after successful PCI • Occurred in 30% of pts • 7-14 day infarct size 15% vs. 8% p<0.001 • 5-year mortality 18.2% vs. 9.5%, p < 0.001 Ndrepepa G, et al.. J Am Coll Cardiol. 2010;55:2383-2389.

  7. Distal embolization and small distal vessel cutoff is neither infrequent nor benign!!!! • Occurs in about 15% of patients undergoing PCI for STEMI • Associated with larger infarct size, lower LVEF and • increased long term Mortality (Eur H J 2002:23-1112-17

  8. Distal embolization during Primary PCI for STEMI (Eur H J 2002:23-1112-17) (Eur H J 2002:23-1112-17

  9. Impact of myocardial blush grade

  10. TIMI Myocardial Perfusion (TMP) Grades TMP Grade 3 TMP Grade 2 TMP Grade 1 TMP Grade 0 Normal ground-glass appearance of blush. Dye mildly persistent at end of washout. No or minimal blush. Dye strongly persistent at end of washout. Gone by next injection. Stain present. Blush persists on next injection. 6.2% 5.1% 4.4% P=0.05 Mortality (%) 2.0% n=434 n=79 n=46 n=203 Adapted from Gibson CM, et al. Circulation. 2000;101:125-130.

  11. Final Blush Score (patients with final TIMI 3 flow) 100 95 3 90 Cumulative Survival(%) 2 85 Blush 1-Year Mortality 0/1 3 6.8% 80 P=0.004 2 13.2% 0/1 18.3% 75 0 2 4 6 8 10 12 Myocardial Perfusion After Primary PCI is the Strongest Predictor of Mortality independently from IRA reopening

  12. Effects of Thrombo embolization during Primary PCI

  13. Meta-Analysis of Various Devices—Mortality P = 0.050 P = 0.018 P = 0.69 Mortality, % Catheter thrombus aspiration Embolic protection Mechanical thrombectomy Bavry AA, Kumbhani D, Bhatt DL. Eur Heart J. 2008;29:2989-3001.

  14. TAPAS one year outcome: Myocardial blush grade and death Death/reinfarction P= 0.001 Myocardial blush grade Svilaas T et al. NEJM 2008;358-557 - FZ 2008-9 FZ 2008-12

  15. Burzotta et al. European Heart Journal (2009) 30, 2193-2203

  16. MORTALITY 7.4% 8% 6% 5.0% 4.8% 4% 3.3% 2% Thrombectomy±IIb/IIIa inhibitors P=0.02 IIb/IIIa inhib - Thrombectomy - IIb/IIIa inhib + Thrombectomy - IIb/IIIa inhib – Thrombectomy + IIb/IIIa inhib + Thrombectomy +

  17. Summary of Current Limitations in STEMI PCI • No optimal method of thrombus management • Once embolization occurs in primary PCI , it is a challenging scenario • Higher MACE, Infarct size with poor MBG • Aspiration catheters are good, but not uniformly effective. • There may be a synergistic effect between thrombectomy and GP-IIBIIIA receptor inhibitors

  18. How can we improve on this further iN STEMI PCI?Combine the Mechanical approach with Pharmacology -(Intracoronary drug)MINIMIZE BLEEDING & Maximize dethrombosis

  19. Meta Analysis of IC Versus IV Abciximab administration of peer reviewed studies (N=2,301) 997 STEMI, 1304 NSTEMI Hansen et al. Journal of Invasive Cardiology Vol 22; 6. June 2010. 278-282.

  20. Clearway Catheter and Intracoronary Abciximab

  21. Localized Drug Delivery via ClearWayfor Pharmacological Thrombectomy and Prevention of Distal Embolization

  22. During inflation, drug is being infused through the microporous balloon pores while blood flow is occluded, maximizing drug availability without substantial dilution by the systemic circulation. Containment of the treatment zone provides extended residence time to help local drug bioavailability, concentration and dose Occlusion Containment Controlled infusion at 1-4 ATM throughout the entire length of the targeted treatment zone provides increased residence time and uptake Infusion

  23. IC vs. Clearway Abciximab: The Coctail Study Tamburino, Capodanno, et al. J Cardiovasc Med 2009

  24. Pre ReoPro through ClearWay Post ReoPro through Clearway

  25. Coctail study: Change in Thrombus score P=0.002 N= 20 N =21 Tamburino, Capodanno, et al. J Cardiovasc Med 2009

  26. Coctail study: Final TIMI MBG P=0.24 N 21 N 20 Tamburino, Capodanno, et al. J Cardiovasc Med 2009

  27. CRYSTAL AMI: Study DesignSingle center, prospectively randomized STEMI within 6 hours, Heparin, 600mg Clopidogrel (n=50) R 1:1 IV Abciximab ClearWay™ IC Abciximab PCI as per standard of care, Evaluate MBG, TIMI flow, ST Resolution, LV Function at Discharge 30 day follow up, Echo, Resting Sestamibi

  28. CRYSTAL- AMI: Demographics (N=48)

  29. Manual/Mechanical Extraction catheter use (discretion of operator) (n = 25) (n = 23)

  30. TIMI Flow Comparison (N=48) 96% TIMI Flow (n = 25) (n = 23)

  31. Primary Endpoint: TIMI Myocardial Blush Grade (MBG) >2 (N=48) 92% of IC versus 86% of IV patients MBG (n = 25) (n = 23)

  32. In Tapas, MBG 3 was only achieved in 45% of patients in extraction arm (identical to IV Abciximab group), but was directly linked to 5 times increase in mortality. IC Abciximab Administration through ClearWay™ has resulted in 72% of patients leaving the lab with a blush score of 3. MBG 3 and ST Resolution Rates comparison 80% 70% 72% 52% (n = 25) (n = 23)

  33. Clinical Outcomes (N=48)

  34. Conclusions • Our understanding of evaluation of surrogate markers which directly correlates to Mortality and Myocardial preservation has improved significantly • Improving myocardial preservation also has profound economic impacts: low cost of care, better QOL, less need for ICD • Localized superselective drug delivery (GP 2b3a inhibitors and vasodilators) with ClearWay as a stand alone device or when combined with Aspiration devices significantly improves MBG • Series of data already promising, INFUSE AMI is underway…

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