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Si tengo que elegir, ¿quién se beneficiaría más de los nuevos antiagregantes?

Si tengo que elegir, ¿quién se beneficiaría más de los nuevos antiagregantes?. TRITON-TIMI 38: Primary end point (CV death, non-fatal MI or non-fatal stroke) and safety all ACS. 15. Clopidogrel. 12.1 (781). Prasugrel. CV Death, NF MI or NF Stroke. 9.9 (643). 10. p<0.001. ↓ 138 events.

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Si tengo que elegir, ¿quién se beneficiaría más de los nuevos antiagregantes?

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  1. Si tengo que elegir, ¿quién se beneficiaría más de los nuevos antiagregantes?

  2. TRITON-TIMI 38: Primary end point (CV death, non-fatal MI or non-fatal stroke) and safety all ACS 15 Clopidogrel 12.1(781) Prasugrel CV Death, NF MI or NF Stroke 9.9 (643) 10 p<0.001 ↓ 138 events End Point (%) ↑ 35 events 5 p=0.03 Non-CABG TIMI Major Bleeding 2.4 (146) 1.8 (111) 0 0 30 60 90 180 270 360 450 120 Days After Randomization Cumulative Kaplan-Meier estimates of the rates of key study end points during the follow-up periodWiviott SD et al. N Eng J Med 2007;357:2001–2015

  3. PLATO: Primary end point (CV death, MI or stroke) at 12 months 15 11.7 9.8 10 End Point (%) 5 CV Death, MI or Stroke p<0.001 0 Ticagrelor 0 2 4 6 8 10 12 Clopidogrel Months Wallentin et al. New Eng J Med 2009;361:1045–1057

  4. PLATO: Safety outcomes (bleeding) p=0.43 p=0.57 p=0.03 p=0.03 Patients (%) All Major Bleeding PLATO Definition All Major Bleeding TIMI Criteria Non-CABG-related Major Bleeding PLATO Definition Non-CABG-related Major Bleeding TIMI Criteria Wallentin et al. New Eng J Med 2009;361:1045–1057

  5. Survival Benefit in PLATO TRITON All death PLATO All death Hazard ratio (95 % - confidence limit) Cardiovascular death HR 0,78 (0,69-0,89) Cardiovascular death 0.5 1 1.5 Study drug better Clopidogrel better Wiviott SD et al., N Engl J Med 2007; Wallentin L et al., N Engl J Med 2009

  6. Power to detect reduction in mortality Relative risk reduction 20%, α= 0.05 TRITON PLATO Mortality of control group 2.4 % 5.1 % Number of patients per study group 6,800 9,333 Power 35% 91% Wiviott SD et al., N Engl J Med 2007; Wallentin L et al., N Engl J Med 2009

  7. Prasugrel Ticagrelor TRITON vs PLATO: Major Efficacy End Points Hazard Ratio Primary Endpoint CV Death Nonfatal MI Nonfatal stroke All Cause Death Stent Thrombosis 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1.1 1.2 1.3 1.4 1.5 HR Prasugrel/Ticagrelor Better Clopidogrel Better Wiviott SD et al., N Engl J Med 2007; Wallentin L et al., N Engl J Med 2009

  8. TRITON TIMI-38: Stent Thrombosis ARC Definite + Probable 3 Any Stent at Index PCI n=12,844 Clopidogrel 2.4(142) 2 End Point (%) 74 events 1.1 (68) 1 Prasugrel HR 0.48P<0.0001 NNT=77 0 0 30 60 90 180 270 360 450 Days ARC = Academic Research Consortium; PCI = percutaneous coronary intervention Wiviott SD et al. N Engl J Med. 2007;357:2001-2015.

  9. Benefitofprasugrel in STEMI 15 Clopidogrel CV death / MI / stroke 12.4% 9.5% 10.0% 10 Prasugrel Endpoint(%) 6.5% 5 TIMI major non-CABG bleeds Prasugrel 2.4% 2.1% Clopidogrel 0 0 30 60 90 180 270 360 450 Days Montalescot G et al., Lancet 2009

  10. Benefitofprasugrel in diabetics 18 17.0% Clopidogrel 16 CV death / MI / stroke 14 12.2% 12 HR 0.70P < 0.001 10 Prasugrel Endpoint (%) 8 NNT = 21 6 TIMI major non-CABG bleeds Clopidogrel 4 2.6% 2.5% 2 Prasugrel 0 0 30 60 90 180 270 360 450 Days Wiviott SD et al. Circulation 2008; 118: 1626-1636

  11. PLATO

  12. PLATO Diabetes N=4662Primary endpoint Diabetes CV death, MI or stroke (%) No diabetes Number at risk DiabetesTicagrelor 6999 6507 6407 6252 5143 3955 3191Clopidogrel 6952 6434 6318 6153 5044 3869 3097 No diabetes Ticagrelor 2326 2113 2045 1959 1593 1199 953Clopidogrel 2336 2084 2041 1968 1604 1225 975 Days after randomization

  13. TRITON-TIMI 38 PLATO prasugrel clopidogrel ticagrelor clopidogrel HR=0,81 (0,73-0,90) HR=0,86 (0,76-0,98) HR=0,70 (0,58-0,85) HR=0,84 (0,77-0,92) HR=0,83 (0,74-0,93) HR=0,88 (0,76-1,03) % eventos isquémicos (muerte CV, infarto, ictus) Todos (n=13.608) No diabetes (n=10.462) Diabetes (n=3.146) Todos (n=18.624) No diabetes (n=13.951) Diabetes (n=4.662) Fernandez-Ortiz A, Vivas D, García-Rubira JC. Rev Esp Cardiol Supl. 2010;10:42D-48D

  14. Ticagrelor vs clopidogrel in ACS in relation to renal function 22,0% 17,3% HR 0,77 (0,65-0,90) Ccr <60mL/min (n=3.237) 8,9% 7,9% HR 0,90 (0,79-1,02) Ccr ≥60mL/min (n=11.965) James S, et al. Circulation 2010;122(11):1056-67.

  15. Nuevos antiagregantes ¿a quién?: preguntas • ¿quién es el mejor candidato para prasugrel? • ¿quién es el mejor candidato para ticagrelor? • ¿quién es el mejor candidato para clopidogrel? • ¿puedo cambiar el tratamiento? ¿cómo? • ¿nuevos en la fase aguda mejor, luego clopi? • Si solo puedo disponer de uno, ¿cuál?

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