Schiano P

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Coronary Intervention in Patients with Fistula for Dialysis: Transradial or Transfemoral Approach ?

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Schiano P

  1. 1. COronary  interven-on  in  pa-ents   with  FIstula  for  DIalysiS  :   Transradial  or  transfemoral   approach?     The  COFIDIS  study  
  2. 2. Background  •  Radial   approach   is   safe   and   effec-ve   with   s i g n i fi c a n t   d e c r e a s e   f o r   b l e e d i n g   complica-ons   compare   to   femoral   approach   and   is   well-­‐recognized   to   improve   health’s   pa-ent    •  Dialysis   pa-ents   are   a   growing   popula-on   with  aging  and  lack  of  graI  
  3. 3. Why  not  Radial  approach  in  dialysis   pa-ents  ?  •  To  preserve  controlateral  radial  in  case  of   problem  with  the  fistula  
  4. 4. And  why  radial  approach?  •  Peripheral   artery   disease   is   frequent   in   this   p o p u l a - o n   w i t h   v a s c u l a r   f r a g i l i t y   (calcifica-ons,  s-ffness…)  •  Renal  failure  is  a  major  risk  factor  of  bleeding  •  AND  radial  occlusion  is  very  rare  with  radial   approach  (experienced  operator,   an-thrombo-c  cocktail,  improve  material…)  
  5. 5. OBJECTIVE  •  To   prove   the   superiority   of   radial   approach   versus   femoral   according   vascular   and   bleeding  complica-ons  without  compromising   the  arterial  radial  flow  
  6. 6. METHODS  (1)  •  Design:   a   prospec-ve,   mul-centric   and   randomized  1:1  interna-onal  study  •  Primary   endpoint:   Total   in-­‐hospital   vascular   and   bleeding   complica-ons   including   cholesterol   embolism   (bleeding   are   defined   according   TIMI   defini-ons)  •  Secondary   endpoints:   in-­‐hospital   major   and   minor   bleeding,   vascular   complica-ons,   radial   occlusion   rate,   MACE   and   mortality   in-­‐hospital   and   at   6   months,   total   bleeding   and   vascular   complica-ons  at  6  months  
  7. 7. METHODS  (2)  •  Inclusion   criteria:   all   pa-ents   with   fistula   for   end-­‐stage   renal   failure   who   need   scheduled   coronary  interven-on    •  Exclusion   criteria:   STEMI   and   NSTEMI,   previous   CABG,   previous   peripheral   artery   surgery,   pa-ents   not   eligible   for   radial   approach  (plethysmography)  
  8. 8. METHODS  (3)  •  Technical’s   considera-ons:   according   to   the   habits   of   the   operators.   Femoral   closure   system  and  Radial  compression  with  system  to   allow  persistent  radial  flow  are  encouraged.    •  Radial   flow   evalua-on   with   doppler   before   hospital  discharge  and  at  6  months  
  9. 9. Number  of  pa-ents  needed  to  be   randomized  •  Assuming  a  frequency  of  the  event  by  5%  with   femoral   approach   and   2%   with   the   radial   approach,   it   is   necessary   to   include   784   pa-ents  (with  a  90%  power  and  a  alpha  risk  of   5%)  
  10. 10. CONTACT  •  Dr  Patrick  SCHIANO,  HIA  Val  de  Grâce,  PARIS,   patrick.schiano@gmail.com  

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