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Nuevos antiagregantes plaquetarios

Nuevos antiagregantes plaquetarios. XII Curso de Formación Continuada. 26-28 marzo 2014 Hotel El Montanyà. Seva, Barcelona. ¿Sigue siendo importante el pretratamiento con los nuevos antiagregantes plaquetarios?. Concepto de pretratamiento en SCA. SCACEST. SCASEST. AAS

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Nuevos antiagregantes plaquetarios

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  1. Nuevos antiagregantes plaquetarios XII Curso de Formación Continuada 26-28 marzo 2014 Hotel El Montanyà. Seva, Barcelona

  2. ¿Sigue siendo importante el pretratamiento con los nuevos antiagregantes plaquetarios?

  3. Concepto de pretratamiento en SCA SCACEST SCASEST AAS P2Y12 antg. ? ICP ICP1ª Tto. médico Cirugía

  4. Clopidogrel pretreatment and early risk 30-day death, MI & urg. TVR (%) No pretreatment PCI-CURE CREDO Pretreatment p=0.01 p=0.05 300 mg + 75 mg for median of 10 days 300 mg <6 hrs 6–24 hrs

  5. Clopidogrel: ¿Cúal es la dosis óptima? Activación GPIIb/IIIa (ADP2M) 100 300 mg ( n=20) p<0.0001 600 mg ( n=20) 80 p=0.009 p=0.005 60 % Cel. positivas 40 p=0.001 (MANOVA) 20 0 Basal 4h 24h 48h PostACTP Angiolillo DJ, Fernandez-Ortiz A, Bernardo E et al. Eur Heart J 2004;25(21):1903-10

  6. ARMYDA-5 PRELOAD: Study design 30 days Clopidogrel 600 mg given 4-8 hrs before angio N= 267 Medical Rx N= 72 • 536 Patients with • Stable angina • or • NSTE-ACS • undergoingcoronaryangiography N= 409 PCI 600 mg Preload N= 204 Primaryend point:cardiac death, MI, TVR Angiography Randomization Clopidogrel 600 mg at the time of PCI N= 269 PCI 600 mg in-lab N= 205 CABG N= 55 1st blood sample 2nd, 3rd, 4th and 5th blood samples Baseline At the time of PCI 2 hrs after PCI 8 and 24 hrs after PCI • CKa-MB • Troponin-I • PRU • PRU • PRU • CK-MB • Troponin-I • PRU Di Sciascio G et al. J Am Coll Cardiol 2010;56:550-557

  7. ARMYDA-5 PRELOAD: Primary endpoint Adverse events at 30 days (Clopidogrel in-lab load vs preload) In-lab load Preload 20 16 p=0.72 12 Cumulative incidence of MACE (%) 8 4 0 10 15 20 25 30 5 Days after PCI Di Sciascio G et al. J Am Coll Cardiol 2010;56:550-557

  8. ARMYDA-5 PRELOAD: Safety secondary end point 20 16 p=0.42 12 % of patients In-lab load 7.8 Preload 8 5.4 4 0 0 0 Major bleeding Minor bleeding Di Sciascio G et al. J Am Coll Cardiol 2010;56:550-557

  9. * * * * p<0.001 vs. Clop 300 mgor 600 mg LD* * Pras 60 mg LD † † † ! †p<0.001 vs. Clop 300 mg * Clop 600 mg LD !p<0.05 vs. Clop 300 mg ! Clop 300 mg LD New P2Y12 AntagonistsEarly onset and high inhibition • Pre-treatment with aspirin and a P2Y12 antagonist is a class I recommendation and is common practice for the treatment of NSTE-ACS • In CURE, patients were managed conservatively • In TRITON, patients were not pretreated before cath • In PLATO, patients were pretreated before cath • No trial had ever randomized patients presenting with NSTE-ACS, invasively managed, to pre-treatment with clopidogrel, prasugrel or ticagrelor vs. no pre-treatment …… ACCOAST Loading dose 100 80 60 Inhibition of platelet aggregation (%) 40 20 mean ± SEM 20 μM ADP 0 0 0.25 0.5 1 2 4 6 24 Time after loading dose (hrs) 1. Wiviott SD et al. Am Heart J. 2006;152:627-635. 2. Payne CD et al. Am J Cardiol. 2006;98:S8. LD, Loading dose

  10. NSTEMI + Troponin ≥ 1.5 times ULN local lab value Clopidogrel naive or on long term clopidogrel 75 mg n~4100 (event driven) ACCOAST design Randomize 1:1 Double-blind Prasugrel 30 mg Placebo CABG or Medical Management (no more prasugrel) CABG or Medical Management (no prasugrel) Coronary Angiography Coronary Angiography Prasugrel 60 mg Prasugrel 30 mg PCI PCI Prasugrel 10 mg or 5 mg (based on weight and age) for 30 days 1° Endpoint: CV Death, MI, Stroke, Urg Revasc, GP IIb/IIIa inh. Bailout, at 7 days Montalescot G et al. Am Heart J 2011;161:650-656

  11. Pharmacodynamic Sub-Study Data presented as median ± SEM. * p<0.05 relative to the No pre-treatment group. LD = loading dose. Pretreatment=Prasugrel 30 mg/Prasugrel 30 mg; No Pre-treatment=Placebo/Prasugrel 60 mg

  12. 1° Efficacy End Point @ 7 + 30 days (All Patients) 15 CV Death, MI, Stroke, UR, GPIIb/IIIa Bailout Pre-treatment Pre-treatment 10.8 10.0 10 No Pre-treatment 10.8 No Pre-treatment Endpoint (%) 9.8 Hazard Ratio, 0.997 (95% 0.83, 1.20) 5 P=0.98 Hazard Ratio, 1.02 (95% 0.84, 1.25) P=0.81 0 0 5 10 15 20 25 30 Days From First Dose No. at Risk, Primary Efficacy End Point: 1996 1769 1762 No pre-treatment 1788 1775 1752 1621 2037 1802 1797 Pre-treatment 1821 1809 1791 1616

  13. All TIMI (CABG or non-CABG) Major Bleeding (All Treated patients) 5 Hazard Ratio, 1.90 Hazard Ratio, 1.97 (95% 1.19, 3.02) (95% 1.26, 3.08) 4 P=0.006 P=0.002 Pre-treatment 2.9 3 Pre-treatment 2.6 Endpoint (%) 2 All TIMI Major Bleeding 1 No Pre-treatment 1.5 0 No Pre-treatment 1.4 0 5 10 15 20 25 30 Days From First Dose No. at Risk, All TIMI Major Bleeding: No pre-treatment 1947 1328 1284 1263 1996 1297 1288 Pre-treatment 1972 1339 1297 1280 2037 1310 1299

  14. All TIMI Major Bleeding for Prespecified Subgroups Through 7 days (All Treated Patients) *Hazard ratio not evaluated for <10 events. †Interaction p-value is from a Cox proportional hazards model with treatment, subgroup, and the treatment-by-subgroup interaction as fixed effects; ‡CRUSADE score is a post-hoc analysis; PCI includes 11 patients with PCI + CABG.

  15. Pretratamiento en SCASCEST: preguntas • ¿Existe evidencia del beneficio del pretatamiento con clopidogrel? • ¿Necesitan todos los pacientes pretratamiento? • Con los nuevos antiagregantes, ¿es importante el pretratamiento? • ¿Es igual con prasugrel que con tricagrelor? • ¿Influye la precocidad en realizar la coronariografía? • ¿ Dónde iniciar el tratamiento de los nuevos antiagregantes?, ¿ambulancia?, ¿urgencias?, ¿lab. hemodinámica?

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