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ARCTIC. www.action-coeur.org. ARCTIC investigators.

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www.action-coeur.org

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  1. ARCTIC www.action-coeur.org ARCTIC investigators ARCTIC:Assessment by a double Randomization of a Conventional antiplatelet strategy versus a monitoring-guided strategy for drug-eluting stent implantation and, of Treatment Interruption versus Continuation one year after stenting - NCT 00827411 - COI Disclosure for Dr. Montalescot: Research Grants to the Institution or Consulting/Lecture Fees from Abbott Vascular, Astra-Zeneca, Bayer, Biotronik, Boehringer-Ingelheim, Boston Scientific, Cleveland Clinic Foundation, Cardiovascular Research Foundation, Cordis, Daiichi-Sankyo, Duke institute, Eli-Lilly, Europa, Fédération Française de Cardiologie, Fondation de France, GSK, ICM, INSERM, Medtronic, Menarini, Nanospheres, Novartis, Pfizer, Sanofi-Aventis Group, Servier, Société Française de Cardiologie, The Medicines Company, TIMI group.

  2. Trial conduct ACTION Study Group (Academic Research Organization - Paris): - Academic Coordinating Center: Institute of Cardiology - Pitié-Salpêtrière, Paris - AcademicSponsor: AP-HP, Paris - Academic Global Trial Operations: URC- Lariboisière, Paris - Funding:Fondation de France, Fondation SGAM, Sanofi-Aventis, Cordis, Boston-Scientific, Medtronic - Steering Committee: G. Montalescot, JP Collet, G. Cayla, T. Cuisset, S. Elhadad, G. Rangé, E. Vicaut - Investigation sites : 38 French Intervention Centers

  3. ARCTIC trial design Coronary angiogram Rd • Primary endpoint at 12 months: • Death, MI, stroke, stent thrombosis, urgent revascularization VerifyNow P2Y12 + ASA Standard of care Drug (ASA, clopidogrel, prasugrel, GP2b3a I.) and Doseadjustments if high platelet reactivity • Statistical considerations: • Assuming an annual risk of 9% and a 33% relative risk reduction (α risk at 5% and error βof 20%, bilateral test), 2,466 patients were necessary to demonstrate the superiority of the strategy of monitoring and adjustment Stent-PCI Stent-PCI Standard of care DrugandDoseadjustments if high platelet reactivity at Day 14 12-month FU ARCTIC study protocol - Collet JP, et al. Am Heart J 2011;161:5-12

  4. Inclusion/Exclusion • Primary PCI for STEMI • Any PCI with planned use of GPIIbIIai • BMS or oral anticoagulation requirement • Short life expectancy • Bleeding diathesis • Patients scheduled for planned PCI • DES implantation • Consent and Rx before start of PCI

  5. Primary Endpoint to 1 year Death, MI, stroke, stent thrombosis, urgent revascularization Monitoring Conventional HR = 1.13 [0.98-1.29] p= 0. 096 34.6% 31.1% 200 0 100 300

  6. Other Ischemic Endpoints

  7. Key Safety Outcomes STEEPLE definitions - Montalescot G, et al. N Engl J Med 2006; 355:1006–17

  8. PFT with antiplatelet therapy adjustment before and after stenting does not improve clinical outcome as compared with conventional treatment without PFT Our results do not support the routine use of PFT in patients undergoing stenting ARCTIC-2 continues: a 2nd randomization occurred 1 yr after the 1st randomization to determine the effect of continuation vs. interruption of clopidogrel ANTARCTIC (NCT01538446) evaluates the value of PFT in the elderly population with a focus on bleeding events. PFT: Platelet Function Testing

  9. Embargo lift at 6:52 PM ET, Sunday, November 4.

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