Platelet reactivity outcomes Myocardial infarction Myocardial - PowerPoint PPT Presentation

The ANTARCTIC investigators The ANTARCTIC investigators A ssessment of a N ormal versus T ailored dose of prasugrel after stenting in patients A ged > 75 years to R educe the C omposite of bleeding, stent T hrombosis and I schemic C omplications ANTARCTIC a study by the ACTION Group

Dr. G. Montalescot reports research Grants to the Institution or Consulting/Lecture Fees from ADIR, Amgen, AstraZeneca, Bayer, Berlin Chimie AG, Boehringer Ingelheim, Bristol-Myers Squibb, Beth Israel Deaconess Medical, Brigham Women’s Hospital, Cardiovascular Research Foundation, Celladon, CME Resources, Daiichi-Sankyo, Eli- Lilly, Europa, Elsevier, Fédération Française de Cardiologie, Fondazione Anna Maria Lilly, Europa, Elsevier, Fédération Française de Cardiologie, Fondazione Anna Maria Sechi per il Cuore, Gilead, ICAN, Janssen, Lead-Up, Menarini, Medtronic, MSD, Pfizer, Sanofi-Aventis, The Medicines Company, TIMI Study Group, WebMD. ANTARCTIC a study by the ACTION Group

Platelet reactivity � � � � outcomes Myocardial infarction Myocardial infarction Major bleeding Major bleeding HR [95%CI] = HR [95%CI] = 1.47 [1.15, 1.87] HR [95%CI] = 0.83 [0.69, 0.99] HR [95%CI] = P=0.002 P=0.002 P=0.04 P=0.04 10 10 10 10 PRU >208 (n=3610) PRU >208 (n=3610) PRU PRU >208 (n=3610) >208 (n=3610) PRU PRU ≤208 (n=4839) ≤208 (n=4839) PRU ≤208 (n=4839 PRU ≤208 (n=4839) ) 6.7% 6.7% 5.6% 5.6% 5 5 5 5 3.9% 3.9% 2.7% 2.7% Months Months Months Months 0 0 0 0 0 0 6 6 12 12 0 0 6 6 12 12 Stone GW et al. Lancet 2013; 382(9892): 614-23 ANTARCTIC a study by the ACTION Group

ARCTIC Coronary angiogram Rd VerifyNow P2Y12 + ASA Standard of care Drug and Dose adjustments if high adjustments if high platelet reactivity Stent-PCI Stent-PCI Drug and Dose adjustments if high Standard of care platelet reactivity at Day 14 12-month FU Collet JP et al. N Engl J Med. 2012 Nov 29;367:2100-9. ANTARCTIC a study by the ACTION Group

� � � � Criticism after ARCTIC ANTARCTIC � Elderly, ACS patients • Low risk, stable patients � Urgent PCI • Elective PCI � Predominant use of prasugrel • Predominant use of clopidogrel � � New PRU thresholds � � • Old PRU thresholds Montalescot G et al. N Engl J Med 2013;368:871-2 Montalescot G et al. Circulation 2014;129:2136-43 ANTARCTIC a study by the ACTION Group

ANTARCTIC design Group 1 Group 2 Monitoring Arm :Prasugrel 5 mg Conventional Arm :Prasugrel 5 mg 1 st assessment : Verifynow P2Y 12 : 2 weeks ± 2 d No monitoring PRU≥208 85<PRU<208 PRU ≤85 Clopidogrel 75 mg/day Prasugrel 5 mg Prasugrel 10 mg/day 2 nd assessment and adjustment : Verifynow P2Y 12 : 2 weeks ± 2 d Primary end point (net clinical benefit) over 12 months :: Bleeding type 2,3,5 of the BARC definition and MACE (CV death, MI, urgent revascularisation, stent thrombosis, stroke) ANTARCTIC a study by the ACTION Group

Platelet reactivity and antiplatelet therapy Control (n=442) Monitoring (n=435) P-value Within platelet platelet inhibition target N.D. 41.8% (85<PRU< 208) at day 14 – % Within platelet inhibition target N.D. N.D. 66.0% 66.0% (85<PRU< 208) after the last test performed (at (85<PRU< 208) after the last test performed (at day 14 or 28) - % patients Final P2Y 12 antagonist treatment < 0.0001 92.8% 55.2% prasugrel 5 mg – % 1.1% 3.7% prasugrel 10 mg – % 4.1% 39.3% clopidogrel 75 mg – % 2.0% 1.8% No P2Y 12 antagonist – % ANTARCTIC a study by the ACTION Group

Primary Endpoint CV death, MI, stroke, stent thrombosis, urgent revascularization or BARC 2, 3 or 5 ANTARCTIC a study by the ACTION Group

Ischemic Endpoint Bleeding Endpoint CV death, MI, stroke, stent thrombosis, urgent revascularization BARC 2,3,5 ANTARCTIC a study by the ACTION Group

Conclusions • Largest randomized PCI study in the elderly Platelet function monitoring to adjust antiplatelet therapy in elderly • patients stented for an ACS does not improve their clinical outcomes • ANTARCTIC after ARCTIC, confirms failure to improve the prognosis of patients by monitoring platelet function to individualize antiplatelet therapy. Failure is not related to the risk level of the population or type of P2Y 12 antagonist ANTARCTIC a study by the ACTION Group