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

1. COronary
interven-on
in
pa-ents
with
FIstula
for
DIalysiS
:
Transradial
or
transfemoral
approach?
The
COFIDIS
study

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. Why
not
Radial
approach
in
dialysis
pa-ents
?
• To
preserve
controlateral
radial
in
case
of
problem
with
the
fistula

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. OBJECTIVE
• To
prove
the
superiority
of
radial
approach
versus
femoral
according
vascular
and
bleeding
complica-ons
without
compromising
the
arterial
radial
flow

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. 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. 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. 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. CONTACT
• Dr
Patrick
SCHIANO,
HIA
Val
de
Grâce,
PARIS,
patrick.schiano@gmail.com