Platelet reactivity outcomes Myocardial infarction Myocardial - - PowerPoint PPT Presentation

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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


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SLIDE 1

The ANTARCTIC investigators

ANTARCTIC a study by the ACTION Group

Assessment of a Normal versus Tailored dose of prasugrel after stenting in patients Aged > 75 years to Reduce the Composite of bleeding, stent Thrombosis and Ischemic Complications The ANTARCTIC investigators

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SLIDE 2
  • 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.

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SLIDE 3

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

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SLIDE 4

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.

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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

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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

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SLIDE 7

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%

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SLIDE 8

Primary Endpoint

ANTARCTIC a study by the ACTION Group

CV death, MI, stroke, stent thrombosis, urgent revascularization or BARC 2, 3 or 5

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Ischemic Endpoint

CV death, MI, stroke, stent thrombosis, urgent revascularization BARC 2,3,5

Bleeding Endpoint

ANTARCTIC a study by the ACTION Group

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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