QUELLE ORDONNANCE APRS L'ANGIOPLASTIE ? AU-DEL DES STATINES - - PowerPoint PPT Presentation

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QUELLE ORDONNANCE APRS L'ANGIOPLASTIE ? AU-DEL DES STATINES - - PowerPoint PPT Presentation

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QUELLE ORDONNANCE APRS L'ANGIOPLASTIE ? AU-DEL DES STATINES Etienne PUYMIRAT Dpartement de Cardiologie Hpital Europen Georges Pompidou Universit Paris Descartes, Paris, France Fees for lectures and/or consulting: Amgen,

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QUELLE ORDONNANCE APRÈS L'ANGIOPLASTIE ? AU-DELÀ DES STATINES …

Etienne PUYMIRAT

Département de Cardiologie Hôpital Européen Georges Pompidou Université Paris Descartes, Paris, France

Fees for lectures and/or consulting: Amgen, Astra-Zeneca, Bayer, Biotronik, BMS, Boehringer Ingelheim, Daiichi-Sankyo, Lilly, MSD, The Medicine Company, Sanofi, Saint Jude Medical, Servier, Siemens

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Role du LDL-C dans l‘athérogénèse

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Recommandations ESC/EAS

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SLIDE 4

2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. EHJ 2016

Forte doses de statines Introduction des statines entre J1 et J4 Objectif LDL-C < 1.8mM (< 0.70 mg/dl) Réévaluation du bilan lipidique entre 4 à 6 mois

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Bénéfices CV et limites de statines

% reduction of events

CTT collaborators Lancet 2005

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Prescriptions de statines après un IdM

Données personnelles

STEMI NSTEMI AMI LDL, mg/dl 1.23 ± 0.42 1.15 ± 0.45 1.19 ± 0.43 Statines :

  • Before
  • < 48 h
  • At discharge

22% 91% 94% 35% 85% 89% 28% 88.5% 92% Atorvastatine 80mg Rosuvastatine 20mg 63% 43% 26% 9.5% 55.5% 30% 24% 7% 59.5% 38% 25% 8.5%

<50%

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SLIDE 7

Prise en charge de la dyslipidémie

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Association statine & ezetimibe

Gagne et al. AJC 2002

  • 25
  • 14
  • 4
  • 3

1 3

  • 30
  • 25
  • 20
  • 15
  • 10
  • 5

5

TG HDL-C LDL-C % Variation

Statine et EZE, N=375 Statine et PBO, N=388

  • 11 %

*p<0.001 vs statin + placebo; **p<0.05 vs statin + placebo; *** p< 0.01 vs statin + placebo ** ** * * *** ***

  • 21%
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Patients stabilized post ACS ≤ 10 days:

LDL-C 50–125*mg/dL (or 50–100**mg/dL if prior lipid-lowering Rx)

Standard Medical & Interventional Therapy

Ezetimibe / Simvastatin 10 / 40 mg Simvastatin 40 mg

Follow-up Visit Day 30, every 4 months Duration: Minimum 2 ½-year follow-up (at least 5250 events) Primary Endpoint: CV death, MI, hospital admission for UA, coronary revascularization (≥ 30 days after randomization), or stroke

N=18,144

Uptitrated to Simva 80 mg if LDL-C > 79

Study Design Study Design

*3.2mM **2.6mM

Cannon CP AHJ 2008;156:826-32; Califf RM NEJM 2009;361:712-7; Blazing MA AHJ 2014;168:205-12

90% power to detect ~9% difference

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LDL LDL-

  • C and Lipid Changes

C and Lipid Changes

1 Yr Mean LDL-C TC TG HDL hsCRP Simva 69.9 145.1 137.1 48.1 3.8 EZ/Simva 53.2 125.8 120.4 48.7 3.3 Δ in mg/dL

  • 16.7
  • 19.3
  • 16.7

+0.6

  • 0.5

Median Time avg 69.5 vs. 53.7 mg/dL

Baisse de 26% Baisse de 43%

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Primary Endpoint Primary Endpoint — — ITT ITT

Simva — 34.7% 2742 events EZ/Simva — 32.7% 2572 events HR 0.936 CI (0.887, 0.988) p=0.016

Cardiovascular death, MI, documented unstable angina requiring rehospitalization, coronary revascularization (≥30 days), or stroke

7-year event rates

NNT= 50

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Safety Safety — — ITT ITT

No statistically significant differences in cancer or No statistically significant differences in cancer or muscle muscle-

  • or gallbladder
  • r gallbladder-
  • related events

related events

Simva n=9077 % EZ/Simv a n=9067 % p ALT and/or AST≥3x ULN 2.3 2.5 0.43 Cholecystectomy 1.5 1.5 0.96 Gallbladder-related AEs 3.5 3.1 0.10 Rhabdomyolysis* 0.2 0.1 0.37 Myopathy* 0.1 0.2 0.32 Rhabdo, myopathy, myalgia with CK elevation* 0.6 0.6 0.64 Cancer* (7-yr KM %) 10.2 10.2 0.57

* Adjudicated by Clinical Events Committee % = n/N for the trial duration

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Total Primary Endpoint Events Total Primary Endpoint Events

# Events # Events

Ezetimibe Simvastatin Simvastatin Alone

4562 4562 4983 4983

Total Events RR 0.91 P=0.007

Additional Events RR 0.88 (0.79-0.98) 1st Event HR 0.936 P=0.016

  • 421
  • 251
  • 170
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SLIDE 14

Prise en charge de la dyslipidémie

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SLIDE 15

18,924 patients Placebo vs Alirocumab (75mg/15J ajusté sur LDL-C) Age moyen 58,5 ans (25% de femmes) Suivi moyen 2,8 ans

FOURIER ODYSSEY OUTCOMES

27,564 patients Placebo vs Evolocumab (140mg/15J ou 420 mg/mois) Age moyen 62,5 ans (25% de femmes) Suivi moyen 2,2 ans Sabatine MS et al. NEJM 2017 Schwartz GG et al. NEJM 2018

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18,924 patients Placebo vs Alirocumab (75mg/15J ajusté sur LDL-C) Age moyen 58,5 ans (25% de femmes) Suivi moyen 2,8 ans

FOURIER ODYSSEY OUTCOMES

27,564 patients Placebo vs Evolocumab (140mg/15J ou 420 mg/mois) Age moyen 62,5 ans (25% de femmes) Suivi moyen 2,2 ans Sabatine MS et al. NEJM 2017 Schwartz GG et al. NEJM 2018

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Sabatine MS et al. NEJM 2017 18,924 patients Placebo vs Alirocumab (75mg/15J ajusté sur LDL-C) Age moyen 58,5 ans (25% de femmes) Suivi moyen 2,8 ans

FOURIER ODYSSEY OUTCOMES

27,564 patients Placebo vs Evolocumab (140mg/15J ou 420 mg/mois) Age moyen 62,5 ans (25% de femmes) Suivi moyen 2,2 ans Schwartz GG et al. NEJM 2018

  • 40-85 ans
  • Athérosclérose documentée :

ATCD IDM ATCD AVC ischémique Artériopathie périphérique symptomatique

  • LDL-C≥70mg/L
  • ≥ 40 ans
  • Post Syndrome Coronarien Aigu (1-12

mois)

  • LDL-C≥70mg/L
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Recommandations ESC/EAS

Global high-risk markers on coronary CTA : Left main disease Prox LAD disease 3 Vessel disease Focal high-risk markers on coronary CTA : Sténosis severity >50% Lesion composition : mixed or non-calcified

2017 Update of ESC/EAS Task Force on practical clinical guidance for PCSK9 inhibitors. EHJ 2017

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CONCLUSION

  • Dyslipidémie : Quelle ordonnance après l’angioplastie

coronaire ? Risque CV Objectifs : LDL-C <0.7g/L