Platelet reactivity outcomes Myocardial infarction Myocardial - - PowerPoint PPT Presentation
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
- 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
ANTARCTIC a study by the ACTION Group
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.
Platelet reactivity
- utcomes
PRU PRU >208 (n=3610) >208 (n=3610) PRU PRU ≤208 (n=4839 ≤208 (n=4839) )
10 10
6.7% 6.7% 5.6% 5.6%
Major bleeding Major bleeding
HR [95%CI] = HR [95%CI] = 0.83 [0.69, 0.99] P=0.04 P=0.04
Myocardial infarction Myocardial infarction
HR [95%CI] = HR [95%CI] = 1.47 [1.15, 1.87] P=0.002 P=0.002 PRU PRU >208 (n=3610) >208 (n=3610) PRU PRU ≤208 (n=4839) ≤208 (n=4839)
10 10
ANTARCTIC a study by the ACTION Group
5 5
Months Months
6 6 12 12 5 5
Months Months
6 6 12 12
3.9% 3.9% 2.7% 2.7%
Stone GW et al. Lancet 2013; 382(9892): 614-23
ARCTIC
Standard of care VerifyNow P2Y12 + ASA
Drug and Dose adjustments if high
Coronary angiogram Rd
ANTARCTIC a study by the ACTION Group
adjustments if high platelet reactivity
Stent-PCI Standard of care
Drug and Dose adjustments if high platelet reactivity at Day 14
12-month FU Stent-PCI
Collet JP et al. N Engl J Med. 2012 Nov 29;367:2100-9.
Criticism after ARCTIC
Elderly, ACS patients Urgent PCI
- Low risk, stable patients
- Elective PCI
- ANTARCTIC
ANTARCTIC a study by the ACTION Group
Predominant use of prasugrel
- New PRU thresholds
- Predominant use of clopidogrel
- Old PRU thresholds
Montalescot G et al. N Engl J Med 2013;368:871-2 Montalescot G et al. Circulation 2014;129:2136-43
Conventional Arm :Prasugrel 5 mg Group 1 No monitoring Monitoring Arm :Prasugrel 5 mg
1st assessment : Verifynow P2Y12 : 2 weeks ± 2 d
Group 2
ANTARCTIC design ANTARCTIC a study by the ACTION Group
PRU≥208
Prasugrel 10 mg/day Clopidogrel 75 mg/day
Prasugrel 5 mg
Primary end point (net clinical benefit) over 12 months:: Bleeding type 2,3,5 of the BARC definition andMACE (CV death, MI, urgent revascularisation, stent thrombosis, stroke)
PRU ≤85
2nd assessment and adjustment: Verifynow P2Y12 : 2 weeks ± 2 d
85<PRU<208
Platelet reactivity and antiplatelet therapy
Control (n=442) Monitoring (n=435)
P-value
Within platelet platelet inhibition target (85<PRU< 208) at day 14 – %
N.D. 41.8%
Within platelet inhibition target (85<PRU< 208) after the last test performed (at
N.D. 66.0%
ANTARCTIC a study by the ACTION Group
(85<PRU< 208) after the last test performed (at day 14 or 28) - % patients
N.D. 66.0%
Final P2Y12 antagonist treatment prasugrel 5 mg – %
92.8% 55.2%
<0.0001
prasugrel 10 mg – %
1.1% 3.7%
clopidogrel 75 mg – %
4.1% 39.3%
No P2Y12 antagonist – %
2.0% 1.8%
Primary Endpoint
ANTARCTIC a study by the ACTION Group
CV death, MI, stroke, stent thrombosis, urgent revascularization or BARC 2, 3 or 5
Ischemic Endpoint
CV death, MI, stroke, stent thrombosis, urgent revascularization BARC 2,3,5
Bleeding Endpoint
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 a study by the ACTION Group
- 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
- f P2Y12 antagonist