The COFIDIS study aims to prove the superiority of the radial approach compared to the femoral approach for coronary interventions in patients with fistulas for dialysis in terms of vascular and bleeding complications. The study is a prospective, multicenter, randomized trial that will enroll 784 patients undergoing planned coronary interventions who will be randomized 1:1 to either radial or femoral access. The primary endpoint is the total in-hospital vascular and bleeding complications. Secondary endpoints include major and minor bleeding, vascular complications, radial occlusion rates, and outcomes at 6 months. The results of this study could demonstrate that the radial approach reduces complications in dialysis patients undergoing coronary procedures.

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