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The Effect of Cangrelor and Access Site on Ischemic and Bleeding Events – Insights from CHAMPION PHOENIX.

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  1. The Effect of Cangrelor and Access Site on Ischemic and Bleeding Events – Insights from CHAMPION PHOENIX J. Antonio Gutierrez, MD, MHS, Robert A. Harrington, MD, James C. Blankenship, MD, Gregg W. Stone, MD, Ph. Gabriel Steg, MD, C. Michael Gibson, MS, MD, Christian W. Hamm, MD, Matthew J. Price, MD, Philippe Genereux, MD, Jayne Prats, PhD, Efthymios N. Deliargyris, MD, Kenneth W. Mahaffey, MD, Harvey D. White, DSc, Deepak L. Bhatt, MD, MPH, on Behalf of the CHAMPION PHOENIX Investigators

  2. Disclosures • Dr. Antonio Gutierrez is a consultant for Boehringer-Ingelheim • The CHAMPION PHOENIX trial was sponsored by The Medicines Company

  3. Background • Periprocedural bleeding (PCI) • Increased morbidity and mortality • Bleeding reduction strategies • Access site • Femoral • Radial •  Bleeding •  Access site complications Valgimigli M, et al. Lancet. 2015 Jun 20;385(9986):2465-76

  4. Objectives • Evaluate the efficacy and safety of cangrelor vs. clopidogrel according to PCI access site • Explore the effect of PCI access site (radial vs. femoral) on ischemic and bleeding events

  5. Background • Cangrelor • Potent intravenous adenosine diphosphate (ADP) receptor antagonist • Rapidly acting • 2 minutes • Reversible • Return of normal platelet function within 1 hour Bhatt DL et al. N Engl J Med. 2013 Jul 25;369(4):393-4

  6. Background CHAMPION PHOENIX OR Placebo oral (right before PCI or right after, per physician) SA/ NSTE-ACS/ STEMI Patients requiring PCI P2Y12 inhibitor naïve Cangrelor bolus & infusion (30ug/kg; 4ug/kg/min) Clopidogrel 600 mg oral PCI ~30’ Rand Placebo bolus & infusion Placebo oral OR Clopidogrel (600 mg or 300 mg oral, per physician) 0 1 2 to 4 hours Bhatt DL et al. N Engl J Med. 2013 Jul 25;369(4):393-4

  7. Background CHAMPION PHOENIX: Primary efficacy outcomes Bhatt DL et al. N Engl J Med. 2013 Jul 25;369(4):393-4

  8. Methods • Cangrelor vs. Clopidogrel (randomized) • Femoral & Radial subgroups • Radial vs. Femoral (nonrandomized)* • Primary composite • Death, MI, IDR, and Stent Thrombosis • Bleeding • GUSTO, TIMI, and ACUITY; transfusion • GUSTO severe bleeding primary safety endpoint *Multivariable analysis

  9. Results • 11,145 patients randomized • 10,492 • Received study treatment and PCI (mITT) • 8,064 (74%) femoral artery access • 2,855 (26%) radial artery access *mITT = modified intention to treat

  10. Results: Cangrelor vs. Clopidogrel

  11. Results: Cangrelor vs. Clopidogrel

  12. Results: Cangrelor vs. Clopidogrel 10 1 0.1 Favors Cangrelor Favors Clopidogrel

  13. Results: Cangrelor vs. Clopidogrel • Primary safety endpoint • GUSTO severe bleeding • No significant increase • Transfusion • No significant increase

  14. Results: Cangrelor vs. Clopidogrel 10 0.1 1 Favors Clopidogrel Favors Cangrelor

  15. Results: Radial vs. Femoral

  16. Results: Radial vs. Femoral

  17. Results: Radial vs. Femoral

  18. Results: Radial vs. Femoral

  19. Limitations • Potential benefit of cangrelor might be attenuated with prolonged clopidogrel, prasugrel, or ticagrelor pretreatment • Bleeding endpoints were not adjudicated • Treatment by access site was not randomized • CHAMPION PHOENIX was not powered to test the interaction between treatment and PCI access site

  20. Conclusions • Intravenous ADP receptor blockade with cangrelor • Reduces composite of death, MI, IDR, or stent thrombosis at 48 hours • Regardless of PCI access site • Femoral: 21% odds reduction • Radial: 24% odds reduction

  21. Conclusions • Cangrelor compared with clopidogrel • No significant increase at 48 hours • GUSTO or TIMI defined bleeding • Blood transfusions • Regardless of access site • ACUITY bleeding (more sensitive) • Increased rates of bleeding • Regardless of access site

  22. Conclusions • Radial vs. Femoral • Radial approach for PCI • 30 to 66% reduction in bleeding • Depending on bleeding definition • Improved bleeding profile was not associated with reduction in primary efficacy endpoint at 48 hours

  23. Conclusions • CHAMPION PHOENIX • Cangrelor • Intravenous ADP receptor inhibition • Reduces ischemic events • No significant increase in GUSTO severe bleeding or blood transfusion • Radial artery access for PCI • Reduces bleeding complications

  24. Thank you • Manuscript in press - European Heart Journal The Effect of Cangrelor and Access Site on Ischemic and Bleeding Events – Insights from CHAMPION PHOENIX J. Antonio Gutierrez, MD, MHS, Robert A. Harrington, MD, James C. Blankenship, MD, Gregg W. Stone, MD, Ph. Gabriel Steg, MD, C. Michael Gibson, MS, MD, Christian W. Hamm, MD, Matthew J. Price, MD, Philippe Genereux, MD, Jayne Prats, PhD, Efthymios N. Deliargyris, MD, Kenneth W. Mahaffey, MD, Harvey D. White, DSc, Deepak L. Bhatt, MD, MPH, on Behalf of the CHAMPION PHOENIX Investigators

  25. Back up slides

  26. Results: Cangrelor vs. Clopidogrel(Femoral)

  27. Results: Cangrelor vs. Clopidogrel(Radial)

  28. Results: Cangrelor vs. Clopidogrel

  29. Results: Femoral vs. Radial

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