Aspirin
is the antithrombotic drug
of choice for preventing recurrences
after a first acute coronary syndrome.
The addition of
clopidogrel
, another
antiplatelet agent, is helpful in case
of angioplasty with stenting. Fol-
lowing the acute phase,
warfarin
, an
anti-coagulant, alone or in combina-
tion with
aspirin
, may be used only
in specific situations, particularly for
patients with a high thrombotic risk
(due to atrial fibrillation for example).
Rivaroxaban
, an oral factor Xa
inhibitor anticoagulant, has been
authorised for use following an acute
coronary syndrome, but at a new dose
strength of 2.5 mg, in combination with
aspirin
alone or
aspirin
plus
clopido-
grel
.
Rivaroxaban
has not been com-
pared with
warfarin
in patients with
a high thrombotic risk following an
acute coronary syndrome.
Inadouble-blind,randomised,placebo-
controlled trial in 15 526 patients,
who were not at particularly high risk
of thrombosis, the addition of
rivaroxa-
ban
to
aspirin
or to
aspirin
plus
clopi-
dogrel
appeared to reduce mortality
during the first year of treatment (2.6%
versus 3.8% with placebo). However,
there is a large amount of missing data,
exceeding the inter-group difference in
the number of deaths, seriously under-
mining the results.
In the subgroup of about
1000 patients in whom antiplatelet
therapy consisted of
aspirin
alone,
addition of
rivaroxaban
did not lead
to a statistically significant decrease
in the incidence of cardiovascular
events or death.
The addition of
rivaroxaban
in-
creased the incidence of “clinically
relevant” bleeding episodes, as defined
in the study protocol (11.2% of patients
per year in the
rivaroxaban
group ver-
sus 6.4% in the placebo group), as well
as the incidence of major bleeding
events (respectively 1.2% and 0.3%
of patients per year) and intracranial
haemorrhage (14 versus 5 cases). The
patients selected for this trial were
considered to have a low risk of bleed-
ing, so the risk is likely to be higher in
many patients who have had an acute
coronary syndrome.
In practice, it has not yet been
demonstrated that adding
rivaroxaban
to
aspirin
or to
aspirin
plus
clopido-
grel
is beneficial following an acute
coronary syndrome. In addition, the
bleeding risk is likely to be higher in
routine practice than in the conditions
under which the comparative trial was
conducted. It is therefore best not to
use
rivaroxaban
in this setting but to
stick with best-known antithrombotic
drugs.
Prescrire International Special Edition 2015/Volume 24 N°158
A
•
P
age
3
Translated from
Rev Prescrire
May 2014; 34 (367): 326-329
rivaroxaban
2.5 mg
(X
arelto
°)
New Indication
No justification for using this anticoagulant after an acute coronary syndrome
NOT ACCEPTABLE
It has not been
demonstrated
that adding
r i varoxaban
to
aspirin
alone or to
aspirin
plus
clopido-
grel
benefits patients who have
had an acute coronary syndrome.
The risk of serious and fatal bleeds
is probably underestimated.
Caution dictates that
rivaroxa-
ban
should not be added to estab-
lished antithrombotic therapy in this
setting.
Rev Prescrire
2014; 34 (367): 326-329.
rivaroxaban
tablets
X
arelto
°
•
2.5 mg
of
rivaroxaban
per tablet
anticoagulant;
factor Xa inhibitor
Indication:
“(…) co-administered with
acetylsalicylic acid (ASA) alone or with
ASA plus clopidogrel or ticlopidine, (…) for
the prevention of atherothrombotic events
in adult patients after an acute coronary
syndrome (ACS) with elevated cardiac
biomarkers”.
[EU marketing authorisation, centralised
procedure]
Abstract
Prescrire Int • October 2014
In response to our request for infor-
mation, Bayer Santé provided us with
no documentation on its product.
