Edoxaban is effective in reducing the incidence ofasymptomatic p
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Please
cite
this
article
in
press
as:
Kobayashi
H,
et
al.
Edoxaban
is
effective
in
reducing
the
incidence
of
asymptomatic
phlebographic
events
following
closed-wedge
high
tibial
osteotomy.
Orthop
Traumatol
Surg
Res
(2017),
http://dx.doi.org/10.1016/j.otsr.2017.07.016
ARTICLE IN PRESS
G Model
OTSR-1839;
No.
of
Pages
4
Orthopaedics
&
Traumatology:
Surgery
&
Research
xxx
(2017)
xxx–xxx
Available
online
at
ScienceDirect
www.sciencedirect.com
Original
article
Edoxaban
is
effective
in
reducing
the
incidence
of
asymptomatic
phlebographic
events
following
closed-wedge
high
tibial
osteotomy
H.
Kobayashi
∗
,
Y.
Akamatsu
,
K.
Kumagai
,
Y.
Kusayama
,
H.
Okuyama
,
K.
Hirotomi
,
K.
Shinohara
,
T.
Saito
Department
of
orthopaedic
surgery,
school
of
medicine,
Yokohama
City
University,
3–9,
Fukuura,
Kanazawa,
Yokohama,
Kanagawa
236-0004,
Japan
a
r
t
i
c
l
e
i
n
f
o
Article
history:
Received
9
December
2016
Accepted
31
July
2017
Keywords:
Closed-wedge
high
tibial
osteotomy
(CWHTO)
Venous
thromboembolism
(VTE)
Deep
vein
thrombosis
(DVT)
Pulmonary
embolism
(PE)
Edoxaban
a
b
s
t
r
a
c
t
Introduction:
The
purpose
of
this
study
was
twofold:
to
investigate
whether
edoxaban
significantly
decreases
the
rate
of
venous
thromboembolism
(VTE)
following
closed-wedge
high
tibial
osteotomy
(CWHTO),
in
terms
of
phlebographic
event,
and
to
determine
whether
edoxaban
is
safe
or
increases
the
rate
of
hemorrhagic
complications.
We
hypothesized
that
edoxaban
would
decrease
the
incidence
of
VTE
and
would
not
increase
the
rate
of
hemorrhagic
complications.
Materials
and
methods:
We
randomly
enrolled
60
patients
undergoing
CWHTO.
The
patients
were
divided
into
two
groups:
one
group
receiving
edoxaban
(15
mg
in
5
patients,
30
mg
in
23
patients)
and
a
non-edoxaban
group.
All
patients
underwent
computed
tomography
venography
on
day
7to
diagnose
postoperative
VTE.
Blood
samples
were
obtained
on
the
day
before
CWHTO
and
on
postoperative
days
1,
3,
7
and
14.
The
incidence
of
VTE
and
hemorrhagic
events
in
both
groups
was
compared
using
unpaired
Student
t-test
or
chi-square
test.
Results:
The
incidence
of
VTE
was
significantly
greater
in
the
non-edoxaban
group
(31.3%
versus
7.1%;
P
=
0.02).
The
incidence
of
deep
vein
thrombosis
(DVT)
was
also
significantly
greater
in
the
non-edoxaban
group
(28.1%
versus
3.6%;
P
=
0.01).
A
single
patient
from
the
edoxaban
group
experienced
major
bleeding.
On
days
3
and
7,
D-dimer
levels
were
significantly
lower
in
the
edoxaban
group
(P
=
0.03
and
0.003,
respectively).
On
days
3,
7
and
14,
activated
partial
thromboplastin
time
was
significantly
greater
in
the
edoxaban
group
(P
=
0.02,
0.01
and
0.006,
respectively).
Conclusion:
Patients
undergoing
CWHTO
are
at
risk
of
postoperative
VTE.
Edoxaban
helps
prevent
asymp-
tomatic
phlebographic
VTE
and
DVT
following
CWHTO;
however,
the
risk
of
major
bleeding
must
be
considered.
Level
of
evidence:
II.
©
2017
Published
by
Elsevier
Masson
SAS.
1.
Introduction
The
clinical
results
of
closed-wedge
high
tibial
osteotomy
(CWHTO)
are
generally
good.
CWHTO
provides
durable
pain
reduc-
tion
and
stabilization
of
the
osteoarthritic
process
[1,2].
However,
a
variety
of
complications
of
CWHTO
have
been
reported,
such
as
infection,
venous
thromboembolism
(VTE),
neurovascular
compli-
cations,
fractures,
delayed
union,
and
non-union
[3].
VTE
includes
both
deep
vein
thrombosis
(DVT)
and
pulmonary
embolism
(PE).
Without
thromboprophylaxis,
DVT
occurs
in
40%–60%
of
total
knee
arthroplasties
(TKA)
and
42–57%
of
total
hip
arthroplasties
∗
Corresponding
author.
E-mail
address:
hi-deo@live.jp
(H.
Kobayashi).
(THA)
[4–6].
Reports
on
the
incidence
of
VTE
following
CWHTO
are
scarce
[7–9].
VTE
rates
as
low
as
0.7%
and
as
high
as
41%
have
been
reported
[7–11].
The
American
College
of
Chest
Physicians
Evidence-based
Clinical
Practice
Guidelines
for
the
prevention
of
VTE
stated
that
routine
use
of
thromboprophylaxis
is
not
advised
for
patients
with
isolated
lower-limb
surgery
below
the
knee
[6].
However,
the
Japanese
Orthopaedic
Association
Guidelines
for
the
prevention
of
VTE
recommends
mechanical
thromboprophylaxis
with
elastic
stocking
or
intermittent
pneumatic
compression
[12].
Although
the
incidence
of
VTE
has
decreased
over
time
due
to
improved
surgical
techniques,
early
rehabilitation
and
mechan-
ical
thromboprophylactic
treatment
[13],
VTE
remains
a
serious
concern.
Various
anticoagulants
have
been
developed.
Edoxaban
(Lixiana
®
,
Daiichi
Sankyo,
Tokyo,
Japan)
is
an
oral
direct
factor-
Xa
inhibitor
for
the
prevention
and
treatment
of
thromboembolic
events
[14,15].
The
efficacy
and
safety
of
edoxaban
for
the
http://dx.doi.org/10.1016/j.otsr.2017.07.016
1877-0568/©
2017
Published
by
Elsevier
Masson
SAS.
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