Prasugrel Compared With Clopidogrel In Patients Stemi

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prasugrel bests clopidogrel in STEMI, 28-2-LANCET 2009

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Prasugrel Compared With Clopidogrel In Patients Stemi

  1. 1. Prof  Gilles Montalescot  MD  a  ,  Stephen D Wiviott  MD  b ,  Eugene Braunwald  MD  b ,  Sabina A Murphy  MPH  b ,  C Michael Gibson MD  b ,  Carolyn H McCabe  BS  b ,  Elliott M Antman  MD  b , for the TRITON-TIMI 38 investigators The Lancet,  Volume 373, Issue 9665 , Pages 723 - 731, 28 February 2009
  2. 2. <ul><li>Mechanical reperfusion with stenting for ST-elevation myocardial infarction (STEMI) is supported by dual antiplatelet treatment with aspirin and clopidogrel. </li></ul><ul><li>Prasugrel, a potent and rapid-acting thienopyridine, is a potential alternative to clopidogrel. </li></ul><ul><li>We aimed to assess prasugrel versus clopidogrel in patients undergoing percutaneous coronary intervention (PCI) for STEMI. </li></ul>
  3. 3. <ul><li>We undertook a double-blind, randomised controlled trial in 707 sites in 30 countries. </li></ul><ul><li>3534 participants presenting with STEMI were randomly assigned by interactive voice response system either prasugrel (60 mg loading, 10 mg maintenance [n=1769]) or clopidogrel (300 mg loading, 75 mg maintenance [n=1765]) and were unaware of the allocation. </li></ul><ul><li>was cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. Efficacy analyses were by intention to treat. Follow-up was to 15 months, with secondary analyses at 30 days.  </li></ul>
  4. 4. Montalescot et al. The lancet 2009 * 2 patients were missing data for primary or secondary All ACS /PCI patients N=13608 UA/NSTEMI patients N=10074 STEMI patients N=3534 Primary PCI N=2438 (69%) Secondary PCI N=1094 (31%)* Clopidogrel N=1235 Prasugrel N=1203 Clopidogrel N=530 Prasugrel N=564
  5. 5. TRITON-TIMI 38 <ul><ul><li>TRITON allowed recruitment of STEMI patients undergoing primary PCI when they presented < 12 hours of symptom onset or secondary PCI when they presented late </li></ul></ul>P=0.03 P=0.01 P=0.002 Wiviott et al. New Engl J Med 2007;357:2001-2015 0 5 10 15 0 30 60 90 180 270 360 450 HR 0.81 (0.73-0.90) Days CV Death, MI, Stroke (%) 12.1 9.9 NNT= 46 Prasugrel Clopidogrel P<0.001
  6. 6. Montalescot et al. Variable Primary PCI (%) Secondary PCI (%) p Age (years) 59 58 0.01 History of diabetes 16.8 24.1 0.001 Prior CABG 1.9 3.2 0.02 Multivessel PCI 6.5 11.0 0.001 GPIIb/IIIa inhibitor 64.5 59.8 0.01 Creatinine clear. < 60mL/min 11.4 8.8 0.02
  7. 7. <ul><li>was cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. </li></ul>
  8. 8. <ul><li>Efficacy analyses were by intention to treat. </li></ul><ul><li>Follow-up was to 15 months, with secondary analyses at 30 days. </li></ul>
  9. 9. End point  Clopidogrel(%)  Prasugrel(%)  Hazard ratio (95% CI)  Cardiovascular death, nonfatal MI, and nonfatal stroke   9.5 6.5 0.68 (0.54-0.87) Cardiovascular death, nonfatal MI, and TVR   8.8 6.7 0.75 (0.59-0.96) Cardiovascular death and MI   8.8 6.2 0.70 (0.55-0.90) Cardiovascular death   2.4 1.4 0.61 (0.37-1.00)
  10. 10. End point MI  (CLOPIDOGREL) 7.0 (PRASUGREL) 4.9 0.70 (0.53-0.92) TLR   1.9 1.3 0.66 (0.39-1.14) Stroke   0.9 0.4 0.43 (0.18-1.06) Stent thrombosis  2.4 1.2 0.49 (0.28-0.84) TIMI major bleeding unrelated to CABG surgery  1.3 1.0 0.74 (0.39-1.38)
  11. 11. End point  Clopidogrel(%)  Prasugrel(%)  Hazard ratio (95% CI)  Cardiovascular death, nonfatal MI, and nonfatal stroke   12.4 10.0 0.79 (0.65-0.97) Cardiovascular death, nonfatal MI, and TVR   12.0 9.6 0.79 (0.65-0.97)  Cardiovascular death and MI  11.5 8.8 0.75 (0.61-0.93) Cardiovascular death  3.4 2.4 0.74 (0.50-1.09)
  12. 12. Montalescot et al. p=0.02 NNT=42 Death / non-fatal MI / non-fatal stroke or major non-CABG bleeding Death / MI /stroke/ major bleeding (CABG and non-CABG) p=0.04 NNT=45 Clopidogrel Prasugrel Proportion of population (%)
  13. 13. <ul><li>Prasugrel was superior to standard dose clopidogrel to prevent ischaemic events </li></ul><ul><li>Prasugrel did not have more bleeding events compared to those who were treated with clopidogrel, and this was equally true for: </li></ul><ul><ul><li>Primary PCI </li></ul></ul><ul><ul><li>Secondary PCI </li></ul></ul><ul><ul><li>Major bleeding </li></ul></ul><ul><ul><li>Minor bleeding </li></ul></ul><ul><li>These data make prasugrel an especially attractive alternative to clopidogrel in PCI for STEMI </li></ul>Montalescot
  14. 14. <ul><li>In his editorial, Stone notes several limitations of the TRITON study, the first being the dose of the comparator drug. </li></ul><ul><li>In the study, prasugrel was compared with a 300-mg loading dose of clopidogrel rather than the more potent 600-mg dose, the current standard of care for primary PCI.  </li></ul>
  15. 15. <ul><li>He also notes that STEMI patients enrolled in the study between 12 hours and 14 days after symptom onset, designated secondary PCI, likely did not receive the full benefit of clopidogrel because of inadequate preloading. </li></ul><ul><li>Overall, 72% of patients in the clopidogrel arm received the study drug during PCI, whereas just 27% were preloaded within the allocated 24 hours prior to the procedure. </li></ul>
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