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Bleeding: Is It a Real Problem ?

Bleeding: Is It a Real Problem ?

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  • 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. BLEEDING: IS IT A REAL PROBLEM?
  • 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. 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. 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. Bleeding  and  DAPT  compliance     Wang  T  et  al,  Circula8on  2008;  118:21392498 patients from the PREMIER registry: patients with vs. without bleeding
  • 7. Transfusion in ACSN=24,111 pts from PURSUIT, PARAGON B, GUSTO IIb Rao SV, et. al., JAMA 2004
  • 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. 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. %15157 patients treated with SES – 1 year follow-up Urban P et al. J Am Coll Cardiol 2011; 57: 1445
  • 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. Predictors  of  bleeding  in  ACS     Moscucci  et  al  (GRACE)  EHJ  2003;  24:  1815
  • 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. 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. 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. 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. REPLACE-­‐2     Lincoff  AM  et  al  JAMA  2003;  289:8536010 patients, 100% femoral accessRao SV et al, JACC 2010
  • 18. NSTEMI  subsets  (PARAGON,  GUSTO,  PURSUIT,  SYNERGY)  100% femoral accessRao SV et al, JACC 2010
  • 19.  Radial  vs.  Femoral  access  Pooled  analysis  of  23  RCT’s  (n=  7020)     Jolly  et  al  AHJ  2009;157:132
  • 20. Lancet 2011;377:1409• 7021 ACS patients• Radial vs.femoral access• Primary EP @ 30 days: • Death • MI • Stroke • Non CABG bleed
  • 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. 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. ACUITY    Stone  G  et  al,  NEJM  2008;358:21   P<0.0001 P=0.03
  • 24. NEJM 2007;357:2001vendredi,  octobre  7,  2011   25  
  • 25. HR for protocol-defined major bleeding = 1.04 (0.95-1.13)
  • 26. PRODIGY - Valgimigli et al. ESC 2011
  • 27. PRODIGY - Valgimigli et al. ESC 2011
  • 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. 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. Thank you!
  • 31. EHJ 2011;32:2256 Protocol definition TIMI MajorTIMI Major @ 30 days 32  
  • 32. Title of your presentation…