Je me dJe me déébarrasse prbarrasse préécocement de la Bicocement de la Bi--ththéérapie ?rapie ?

03Gilles MontalescotGilles Montalescot

Dr. Montalescot reports research Grants to theInstitution or Consulting/Lecture Fees from Abbott, AIM group, Amgen, Actelion, ACC Foundation, Astrazeneca, Axis-Santé, Bayer, Boston-Scientific, BMS, Beth Israel Deaconess Medical, Brigham Women’s Hospital, Fréquence Médicale, ICOM, Idorsia, Elsevier, ICAN, Lead-Up, Menarini, MSD, Novo-Nordisk, Pfizer, Quantum Genomics, Sanofi-Aventis, SCOR global life, Servier, WebMD.

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www.action-groupe.orgParis, France

Que disent les Que disent les recommandations?recommandations?

Question #1

DAPT duration

Minimal DAPT duration

PeutPeut--on faire 1 mois si HBR?on faire 1 mois si HBR?

Question #2

The problem is NOT 1month DAPT in HBR patients!

Elderly age ≥75 years

OAC planned after PCI

Renal failure (CrCl <40 ml/min)

Planned surgery <1 year

Anemia (Hgb <11 g/dl)

Hospitalization for bleeding within 1 year

Thrombocytopenia (<100,000/mm3)

Cancer diagnosed or treated w/i 3 years

Stroke within 1 year or any prior ICH

Severe chronic liver disease

Long-term NSAID or steroid use

Expected DAPT non-compliance

P2Y12 stopped @ 1 month in HBR

ONYX-ONE study, n=2000

NON-RANDOMIZED For DAPT duration

NON-RANDOMIZED For DAPT duration

Et TWILIGHT alors?Et TWILIGHT alors?

Question #3

TWILIGHT : HIR more than HBR patients!

BARC 2, 3 or 5 BleedingDeath, MI or Stroke

Mehran R et al . NEJM 2019

Elderly age ≥75 years

OAC planned after PCI

Renal failure (CrCl <40 ml/min)

Planned surgery <1 year

Anemia (Hgb <11 g/dl)

Hospitalization for bleeding within 1 year

Thrombocytopenia (<100,000/mm3)

Cancer diagnosed or treated w/i 3 years

Stroke within 1 year or any prior ICH

Severe chronic liver disease

Long-term NSAID or steroid use

Expected DAPT non-compliance

8% assumed8% assumed2/3 are MI2/3 are MI

The problem is NOT stopping ASA @ 1-3 month!

JY Hahn – JAMA. 2019 Jun 25;321(24):2428-2437H. Watanabe, JAMA. 2019 Jun 25;321(24):2414-2427

STOP-DAPT-2 SMART-CHOICE

BK Kim et al. JAMA 2020;323:2407-2416

TICO-STEMI

0

2

4

6

8

10

0 3 6 9 12

Months since randomization

Ticagrelor + Aspirin

Ticagrelor + Placebo

Cu

mu

lative

inci

de

nce

(%) 7.1%

4.0%

Placebo vs Aspirin

HR (95%CI): 0.56 (0.45 to 0.68)

P <0.001

ARD = -3.08% (-4.15% to -2.01%)

NNT = 33

BARC 2, 3 or 5 Bleeding (primary outcome)

TWILIGHT

Mehran R et al . NEJM 2019

CLOPIDOGREL

TICAGRELOR

Mais quid de garder lMais quid de garder l’’aspirine aspirine @1mois?@1mois?

Question #4

The question IS about stopping P2Y12!

The largest study ever of ASA removal is negative! Global-leaders

Vranckx P et a. Lancet 2018

At last one RCT with P2Y12 removed @1 month!

1°EP of cardiac death, MI, TVR, stroke, or major bleeding (STEEPLE criteria)

ONE-MONTH DAPT RCT – MK Hong et al. AHA 2020

Mais la prMais la préévention secondaire du vention secondaire du coronarien, ccoronarien, c’’est aspirine seul?est aspirine seul?

Question #5

The question is about the long-term benefit of DAPT or DPI!

THEMISCV death, MI, Stroke

Steg et al NEJM 2019.

COMPASSCV death, MI, Stroke

Eikelboom et al. NEJM 2017

The problem is the net benefit at long term!

Months from Randomization

Ticagrelor 90 mgHR 0.85 (95% CI 0.75 – 0.96)

P=0.008

Ticagrelor 60 mgHR 0.84 (95% CI 0.74 – 0.95)

P=0.004CV

Dea

th,

MI,

or

Str

oke

(%)

3 6 9 12 15 18 210 24 27 30 33 36

Placebo (9.0%)

Ticagrelor 90 (7.8%)Ticagrelor 60 (7.8%)

7

6

5

4

3

10

9

8

2

1

0

N = 21,162Median follow-up 33 months

TIMI major bleedTica 60mg

HR=2.3

THEMIS

PEGASUS

Conclusions

www.action-groupe.org

Long DAPT duration onlyin LBR high IR patients!

DAPT avec anticoagulationDAPT avec anticoagulation

Question #bonus

A FibFib and PCIPCI

2019201820172016

.

PIONEER AF – PCI 1

Rivaroxaban

PIONEER AF – PCI 1

Rivaroxaban

AHA 16

ESC 17

ACC 19

ESC 19

2020

None of these trials were powered for efficacy

RE-DUAL PCI 2

Dabigatran

RE-DUAL PCI 2

Dabigatran

N 2,124 N 2,725

AUGUSTUS ACS/PCI 3Apixaban

AUGUSTUS ACS/PCI 3Apixaban

2 x 2 factorial

ENTRUST AF- PCI 4,5Edoxaban

ENTRUST AF- PCI 4,5Edoxaban

Parallel assignment

Lopes RD et al. Circulation. 2020;141(9):781-783

HR 0.58; 95% CI, 0.28 to 1.22

— Aspirin— Placebo

0 30 60 90 120 150 180

Days since randomization

Aspirin 1746 1709 1692 1677 1663 1647 946

Placebo 1752 1709 1688 1671 1664 1653 946

Cu

mu

lati

ve in

cid

ence

of

sten

t th

rom

bo

sis

2.0%

1.5%

1.0%

0.5%

0.0%

AUGUSTUS, definite/probable ST

70% had an MI40% diedAll on the same day of ST

« Major bleeding is more important because more frequent »

MyocardialInfarction

Stent Thrombosis

When shall we drop the antiplatelet agent?