Selecting an oral anticoagulant for patients with non-valvular atrial fibrillation
Carlos J. Gonzalez Quesada, MD,1 and Robert P. Giugliano, MD, SM, FACC, FAHA2
1, 2
Department of Medicine and 2the Cardiovascular Division, Brigham and Women’s Hospital,
Boston, MA
Corresponding author
Robert P. Giugliano, MD, SM, FACC, FAHA
Senior Investigator
TIMI Study Group
350 Longwood Ave., 1st Floor Offices
Boston, MA 02115
Email: rgiugliano@partners.org
TEL: 617-278-0145
FAX: 617-734-7329
First author
Carlos J. Gonzalez Quesada, M.D.
Internal Medicine and Global Health Equity Resident
Brigham and Women’s Hospital
75 Francis St
Boston, MA, 02115
Email: cgonzalezquesada@partners.org
TEL: 617-732-6041
FAX: 888-299-8621
Supplemental table 1. Evidence on the use of new oral anticoagulants in patients with valvular disease
and atrial fibrillation.
RE-LY
ROCKET-AF
ARISTOTLE
ENGAGE AF-TIMI
48
Subjects with
moderate or severe
MS or a mechanical
heart valve (subjects
with valve disease
other than MS,
bioprosthetic heart
valves and/or valve
repair were eligible).
Exclusion
criteria
History of heart
valve disorder
(e.g. prosthetic
valve or
hemodynamically
relevant valve
disease).
Hemodynamically
significant MS.
Prosthetic heart
valve (annuloplsty
with or without
prosthetic ring,
commissurotomy
and/or
valvuloplasty
were permitted).
Conditions other
than AF that
require chronic
anticoagulation
(e.g. prosthetic
mechanical heart
valve).
Moderate or
severe MS.
Enrolled patients
with VHD
3950 (21.8%) pts:
- MR, 3101 pts.
- MS, 193 pts.
- AR, 817 pts.
- AS, 471 pts.
- TR, 1179 pts.
1992 (14.1%) pts
with significant
VHD:
- 89.6% had MR
+/- AS or AR.
4808 (26.4%) pts:
- Moderate MR,
3526 pts.
- MS, 131 pts.
- AR, 887 pts.
- AS, 384 pts.
- TR, 2124 pts.
- Valve surgery,
251 pts.
Information has not
been published.
Outcomes
The benefits of
dabigatran
compared to
warfarin in terms
of stroke and SE,
major bleeding
and lifethreatening or
intracranial
bleeding were
similar in patients
with and without
VHD (p-values
for interaction not
significant).
The effect of
rivaroxaban and
warfarin on
thromboembolic
and ischemic
outcomes are not
modified by the
presence of
significant VHD
(p-values for
interaction not
significant).
Bleeding
outcomes were
more common on
rivaroxaban than
warfarin in
individuals with
significant VHDa.
The benefits of
apixaban
compared with
warfarin
regarding stroke
and SE; reduction
in major
bleeding; and
decreased
mortality, were
not modified by
the presence of
VHD (p-values
for interaction not
significant).
Information has not
been published.
U.S. FDA
prescribing
information
Contraindicated in
patients with
mechanical
prosthetic heart
valves.
Use not recommended in patients with
prosthetic heart valves.
Application
submittedb.
Use not
recommended in
patients with
bioprosthetic
heart valves.
EMA
prescribing
information
Contraindicated in
patients with
prosthetic heart
valves requiring
anticoagulation.
.
Use not recommended in patients with
prosthetic heart valves.
Application
submittedb.
AF, atrial fibrillation; AR, aortic regurgitation; ARISTOTLE, Apixaban for Reduction in Stroke and
Other Thromboembolic Events in Atrial Fibrillation; AS, aortic stenosis; ENGAGE AF-TIMI 48,
Effective aNticoaGulation with factor xA next Generation in Atrial Fibrillation-Thrombolysis in
Myocardial Infarction study 48; MR, mitral regurgitation; MS, mitral stenosis; EMA, European
Medicines Agency; RE-LY, Randomized Evaluation of Long-Term Anticoagulation Therapy;
ROCKET-AF, Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K
Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation; SE, systemic
embolism; TR, tricuspid regurgitation; U.S. FDA, United States Food and Drug Administration; VHD,
valvular heart disease
a
Major or nonmajor clinically relevant bleeding, p-value for interaction 0.034. Major bleeding, p-value
for interaction 0.010
b
At the time of submission of this manuscript, the ENGAGE AF-TIMI 48 trial was under review by
regulatory agencies worldwide. It is unknown if the use of edoxaban will be approved in individuals
with AF with bioprosthetic valves or other forms of valvular disease.
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