Je me débarrasse précocement de la Bi-thérapie ? Gilles ...
Transcript of Je me débarrasse précocement de la Bi-thérapie ? Gilles ...
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?