Urban P

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Bleeding: Is It a Real Problem ?

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Urban P

  1. 1. Rencontres Interventionnelles - Transradial Approach Prague, Czech Republic, Thursday 29th & Friday 30th September 2011BLEEDINGIS IT A REAL PROBLEM? Philip Urban La Tour Hospital Geneva, Switzerland
  2. 2. BLEEDING: IS IT A REAL PROBLEM?
  3. 3. PCI  &  Bleeding  •  The  problem   –  Nature  and  8ming   –  Prognos8c  impact  •  The  solu8ons   –  Assess  bleeding  risk  prior  to  PCI   –  Op8mize  vascular  access   –  An8platelet  treatment   •  Drugs   •  Dose   •  Dura8on      
  4. 4. Circula8on  2011;123:  2736  •  Type 1: not actionable•  Type 2: requiring medical intervention and/or admission and/or evaluation•  Type 3: –  3a) Hb drop 3-5 g/dl and/or any blood transfusion –  3b) Hb drop > 5 g/dl, tamponade, surgery or vasoactive treatment –  3c) Intracranial or intraocular bleeding with vision impairment•  Type 4: CABG related –  chest tubes > 2 liters/24h, transfusion > 5 units –  intracerebral bleed < 48h –  any reoperation for bleeding•  Type 5: fatal
  5. 5. Bleeding in patients admitted for AMI Spencer FA et al Circulation 2007; 116: 2793 MB = 2.8% 10% of all deaths Access = 29% of MB40087 patients, GRACE registry
  6. 6. Bleeding  and  DAPT  compliance     Wang  T  et  al,  Circula8on  2008;  118:21392498 patients from the PREMIER registry: patients with vs. without bleeding
  7. 7. Transfusion in ACSN=24,111 pts from PURSUIT, PARAGON B, GUSTO IIb Rao SV, et. al., JAMA 2004
  8. 8. Number of stent thrombosis major bleedings 15157 patients treated with SES Weeks after stent implantation Urban P et al. J Am Coll Cardiol 2011; 57: 1445
  9. 9. PCI  &  Bleeding  •  The  problem   –  Nature  and  8ming   –  Prognos8c  impact  •  The  solu8ons   –  Assess  bleeding  risk  prior  to  PCI   –  Op8mize  vascular  access   –  An8platelet  treatment   •  Drugs   •  Dose   •  Dura8on      
  10. 10. %15157 patients treated with SES – 1 year follow-up Urban P et al. J Am Coll Cardiol 2011; 57: 1445
  11. 11. PCI  &  Bleeding  •  The  problem   –  Nature  and  8ming   –  Prognos8c  impact  •  The  solu8ons   –  Assess  bleeding  risk  prior  to  PCI   –  Op8mize  vascular  access   –  An8platelet  treatment   •  Drugs   •  Dose   •  Dura8on      
  12. 12. Predictors  of  bleeding  in  ACS     Moscucci  et  al  (GRACE)  EHJ  2003;  24:  1815
  13. 13. 15157 patients treated with SES – 1 year follow-up CEC-adjudicated events N= 1238 3339 1234 427 801 675 291 1596 1062 1776 3179 2278 Urban P et al. J Am Coll Cardiol 2011; 57: 1445
  14. 14. CCI= Charlson Comorbidity IndexUrban P et al. J Am Coll Cardiol 2011; 57: 1445 Charlson et al., J Chronic Dis 1987; 40:373-83
  15. 15. Hb < 117 g/l Hb > 117/l (n=801) (n=10067) Major bleeding 3.8% 0.9% <0.001 Any death 6.0% 1.3% <0.001 15147 patients Myocardial infarction 5.1% 1.9% <0.001 Clinically driven TLR 4.3% 2.1% <0.001 Definite or probable ST 2.6% 0.8% <0.00115157 patients treated with SES – 1 year follow-up Urban P et al. J Am Coll Cardiol 2011; 57: 1445
  16. 16. PCI  &  Bleeding  •  The  problem   –  Nature  and  8ming   –  Prognos8c  impact  •  The  solu8ons   –  Assess  bleeding  risk  prior  to  PCI   –  Op8mize  vascular  access   –  An8platelet  treatment   •  Drugs   •  Dose   •  Dura8on      
  17. 17. REPLACE-­‐2     Lincoff  AM  et  al  JAMA  2003;  289:8536010 patients, 100% femoral accessRao SV et al, JACC 2010
  18. 18. NSTEMI  subsets  (PARAGON,  GUSTO,  PURSUIT,  SYNERGY)  100% femoral accessRao SV et al, JACC 2010
  19. 19.  Radial  vs.  Femoral  access  Pooled  analysis  of  23  RCT’s  (n=  7020)     Jolly  et  al  AHJ  2009;157:132
  20. 20. Lancet 2011;377:1409• 7021 ACS patients• Radial vs.femoral access• Primary EP @ 30 days: • Death • MI • Stroke • Non CABG bleed
  21. 21. Bleeding in the RIVAL trial Lancet 2011; 377:1409 Fatal TF of > 2 units Hb drop > 5 g/dl Hemodynamic impact Need for surgery Lasting sequellae Intracebral/ocular* p<0.0001 - Includes large hematomas and surgically treated pseudo-aneurysms
  22. 22. PCI  &  Bleeding  •  The  problem   –  Nature  and  8ming   –  Prognos8c  impact  •  The  solu8ons   –  Assess  bleeding  risk  prior  to  PCI   –  Op8mize  vascular  access   –  An8platelet  treatment   •  Drugs   •  Dose   •  Dura8on      
  23. 23. ACUITY    Stone  G  et  al,  NEJM  2008;358:21   P<0.0001 P=0.03
  24. 24. NEJM 2007;357:2001vendredi,  octobre  7,  2011   25  
  25. 25. HR for protocol-defined major bleeding = 1.04 (0.95-1.13)
  26. 26. PRODIGY - Valgimigli et al. ESC 2011
  27. 27. PRODIGY - Valgimigli et al. ESC 2011
  28. 28. Conclusions  (I)  •  Bleeding  during/ader  PCI  is  associated  with  a  significantly  increased   morbidity  and  mortality  •  This  is  par8ally  due  to  the  direct  consequences  of  bleeding  (including   medica8on  adjustments,  transfusions,  etc)  but  is  also  explained  by  the   fact  that  bleeding  is  a  powerful  marker  of  comorbidity  •  Early  ader  PCI,  major  bleeding  appears  less  dangerous  than  stent   thrombosis,  and  this  should  be  kept  in  mind  when  adjus8ng   an8thrombo8c  treatment  •   Some  types  of  an8thrombo8c  treatment  can  decrease  both  bleeding  and   mortality  without  loss  of  efficacy  (ACUITY)  •  Prolonged  dura8on  of  DAPT  beyond  6  months  may  increase  the  risk  of   bleeding  without  any  gain  in  efficacy  (PRODIGY)  
  29. 29. Conclusions  (II)  •  Access  site  bleeding  accounts  for  30-­‐70%  of  all  significant  bleeding   episodes  in  series  with  100%  femoral  access  •  Radial  access    is  associated  with  a  decreased  risk  of  local  vascular   complica8ons  and  bleeding  •  Using  a  common  defini8on  for  bleeding  events  (BARC)  will  allow  to   clarify  several  issues  and  compare  different  trials  
  30. 30. Thank you!
  31. 31. EHJ 2011;32:2256 Protocol definition TIMI MajorTIMI Major @ 30 days 32  
  32. 32. Title of your presentation…

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