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ARCTIC investigators COI D ISCLOSURE FOR D R. M ONTALESCOT : Research Grants to the Institution or Consulting/Lecture Fees from Abbott Vascular, Astra-Zeneca,

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Presentation on theme: "ARCTIC investigators COI D ISCLOSURE FOR D R. M ONTALESCOT : Research Grants to the Institution or Consulting/Lecture Fees from Abbott Vascular, Astra-Zeneca,"— Presentation transcript:

1 ARCTIC investigators COI D ISCLOSURE FOR D R. M ONTALESCOT : 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. 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 -

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

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

4 Inclusion / Exclusion Patients scheduled for planned PCIPatients scheduled for planned PCI DES implantationDES implantation Consent and Rx before start of PCIConsent and Rx before start of PCI Primary PCI for STEMIPrimary PCI for STEMI Any PCI with planned use of GPIIbIIa Any PCI with planned use of GPIIbIIa  BMS or oral anticoagulation requirementBMS or oral anticoagulation requirement Short life expectancyShort life expectancy Bleeding diathesisBleeding diathesis

5 Primary Endpoint to 1 year Death, MI, stroke, stent thrombosis, urgent revascularization HR = 1.13 [0.98-1.29] p= 0. 096 Conventional Monitoring 100 200 3000 34.6% 31.1%

6 ConventionalMonitoring HR [95%CI]P Death or myocardial Infarction - % 28.831.7 1.11 [0.96; 1.29]0.15 Any death - % 1.62.3 1.41 [0.79; 2.50]0.24 Myocardial infarction - % 28.430.3 1.08 [0.93; 1.25]0.32 Stent thrombosis - % 0.71 1.34 [0.56; 3.18]0.51 Stroke or TIA- % 0.60.7 1.15 [0.42; 3.18]0.78 Urgent revascularization - % 4.24.5 1.06 [0.73; 1.55]0.76 Other Ischemic Endpoints

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

8 1.PFT with antiplatelet therapy adjustment before and after stenting does not improve clinical outcome as compared with conventional treatment without PFT 2.Our results do not support the routine use of PFT in patients undergoing stenting 3.ARCTIC-2 continues: a 2 nd randomization occurred 1 yr after the 1 st randomization to determine the effect of continuation vs. interruption of clopidogrel 4.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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