Antithrombotic Therapy for Atrial Fibrillation with Stable Coronary Disease.
Aged
Aspirin
/ therapeutic use
Atrial Fibrillation
/ complications
Coronary Artery Bypass
Coronary Disease
/ complications
Drug Therapy, Combination
/ adverse effects
Factor Xa Inhibitors
/ adverse effects
Female
Humans
Kaplan-Meier Estimate
Male
Percutaneous Coronary Intervention
Platelet Aggregation Inhibitors
/ adverse effects
Proportional Hazards Models
Purinergic P2Y Receptor Antagonists
/ therapeutic use
Rivaroxaban
/ adverse effects
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
19 09 2019
19 09 2019
Historique:
pubmed:
3
9
2019
medline:
27
9
2019
entrez:
3
9
2019
Statut:
ppublish
Résumé
There are limited data from randomized trials evaluating the use of antithrombotic therapy in patients with atrial fibrillation and stable coronary artery disease. In a multicenter, open-label trial conducted in Japan, we randomly assigned 2236 patients with atrial fibrillation who had undergone percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) more than 1 year earlier or who had angiographically confirmed coronary artery disease not requiring revascularization to receive monotherapy with rivaroxaban (a non-vitamin K antagonist oral anticoagulant) or combination therapy with rivaroxaban plus a single antiplatelet agent. The primary efficacy end point was a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death from any cause; this end point was analyzed for noninferiority with a noninferiority margin of 1.46. The primary safety end point was major bleeding, according to the criteria of the International Society on Thrombosis and Hemostasis; this end point was analyzed for superiority. The trial was stopped early because of increased mortality in the combination-therapy group. Rivaroxaban monotherapy was noninferior to combination therapy for the primary efficacy end point, with event rates of 4.14% and 5.75% per patient-year, respectively (hazard ratio, 0.72; 95% confidence interval [CI], 0.55 to 0.95; P<0.001 for noninferiority). Rivaroxaban monotherapy was superior to combination therapy for the primary safety end point, with event rates of 1.62% and 2.76% per patient-year, respectively (hazard ratio, 0.59; 95% CI, 0.39 to 0.89; P = 0.01 for superiority). As antithrombotic therapy, rivaroxaban monotherapy was noninferior to combination therapy for efficacy and superior for safety in patients with atrial fibrillation and stable coronary artery disease. (Funded by the Japan Cardiovascular Research Foundation; AFIRE UMIN Clinical Trials Registry number, UMIN000016612; and ClinicalTrials.gov number, NCT02642419.).
Sections du résumé
BACKGROUND
There are limited data from randomized trials evaluating the use of antithrombotic therapy in patients with atrial fibrillation and stable coronary artery disease.
METHODS
In a multicenter, open-label trial conducted in Japan, we randomly assigned 2236 patients with atrial fibrillation who had undergone percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) more than 1 year earlier or who had angiographically confirmed coronary artery disease not requiring revascularization to receive monotherapy with rivaroxaban (a non-vitamin K antagonist oral anticoagulant) or combination therapy with rivaroxaban plus a single antiplatelet agent. The primary efficacy end point was a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death from any cause; this end point was analyzed for noninferiority with a noninferiority margin of 1.46. The primary safety end point was major bleeding, according to the criteria of the International Society on Thrombosis and Hemostasis; this end point was analyzed for superiority.
RESULTS
The trial was stopped early because of increased mortality in the combination-therapy group. Rivaroxaban monotherapy was noninferior to combination therapy for the primary efficacy end point, with event rates of 4.14% and 5.75% per patient-year, respectively (hazard ratio, 0.72; 95% confidence interval [CI], 0.55 to 0.95; P<0.001 for noninferiority). Rivaroxaban monotherapy was superior to combination therapy for the primary safety end point, with event rates of 1.62% and 2.76% per patient-year, respectively (hazard ratio, 0.59; 95% CI, 0.39 to 0.89; P = 0.01 for superiority).
CONCLUSIONS
As antithrombotic therapy, rivaroxaban monotherapy was noninferior to combination therapy for efficacy and superior for safety in patients with atrial fibrillation and stable coronary artery disease. (Funded by the Japan Cardiovascular Research Foundation; AFIRE UMIN Clinical Trials Registry number, UMIN000016612; and ClinicalTrials.gov number, NCT02642419.).
Identifiants
pubmed: 31475793
doi: 10.1056/NEJMoa1904143
doi:
Substances chimiques
Factor Xa Inhibitors
0
Platelet Aggregation Inhibitors
0
Purinergic P2Y Receptor Antagonists
0
Rivaroxaban
9NDF7JZ4M3
Aspirin
R16CO5Y76E
Banques de données
ClinicalTrials.gov
['NCT02642419']
UMIN-CTR
['UMIN000016612']
Types de publication
Comparative Study
Equivalence Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1103-1113Investigateurs
S Yasuda
(S)
A Nakamura
(A)
E Tamiya
(E)
T Yamamoto
(T)
S Suetake
(S)
T Noguchi
(T)
S Nakamura
(S)
A Matsumura
(A)
J Kojima
(J)
S Suwa
(S)
H Yamaguchi
(H)
K Kaikita
(K)
T Yasu
(T)
A Nakajima
(A)
T Yamada
(T)
H Arai
(H)
Y Hata
(Y)
T Sakanashi
(T)
H Tateishi
(H)
T Nakayama
(T)
Y Nozaki
(Y)
M Akao
(M)
Y Okumura
(Y)
M Tokue
(M)
N Kuroki
(N)
Y Maruyama
(Y)
T Matoba
(T)
N Hagiwara
(N)
H Suzuki
(H)
Y Nishida
(Y)
M Ajioka
(M)
K Yumoto
(K)
S Shimizu
(S)
T Aoyama
(T)
H Shimomura
(H)
T Takeda
(T)
K Oshiro
(K)
N Sugishita
(N)
Y Shibata
(Y)
T Otonari
(T)
H Kihara
(H)
H Ogawa
(H)
A Ohno
(A)
M Hazama
(M)
M Shimizu
(M)
K Tsukahara
(K)
S Haruta
(S)
T Wakeyama
(T)
T Haruna
(T)
M Ito
(M)
K Fujii
(K)
N Atsuchi
(N)
M Sata
(M)
K Kimura
(K)
N Hasebe
(N)
Y Kobayasi
(Y)
K Ohsato
(K)
K Hironaga
(K)
Y Naganuma
(Y)
K Anzaki
(K)
K Oiwa
(K)
S Okazaki
(S)
Y Nakagawa
(Y)
K Tokuhiro
(K)
K Tanaka
(K)
T Momose
(T)
Y Fukushima
(Y)
R Kametani
(R)
K Kawamitsu
(K)
Y Saito
(Y)
S Akashi
(S)
K Kumagai
(K)
K Eshima
(K)
T Tobaru
(T)
T Seo
(T)
K Okuhara
(K)
K Kozuma
(K)
Y Ikari
(Y)
T Takahashi
(T)
I Michishita
(I)
H Fujikura
(H)
S Momomura
(S)
Y Yamamoto
(Y)
K Otomo
(K)
T Matsubara
(T)
H Tashiro
(H)
T Inoue
(T)
M Ishihara
(M)
I Shiojima
(I)
E Tachibana
(E)
J Ako
(J)
K Sumii
(K)
N Yamamoto
(N)
N Ohmura
(N)
T Nakamura
(T)
Y Morita
(Y)
N Takahashi
(N)
K Watanabe
(K)
H Fujinaga
(H)
M Maruyama
(M)
T Oka
(T)
T Shirayama
(T)
T Amano
(T)
K Fukui
(K)
K Ando
(K)
S Oshima
(S)
S Kagiyama
(S)
H Teragawa
(H)
M Yuge
(M)
S Ono
(S)
T Koga
(T)
K Fujiu
(K)
M Kuwabara
(M)
Y Ohya
(Y)
Y Yumoto
(Y)
N Kuji
(N)
M Ikemura
(M)
K Kario
(K)
K Chatani
(K)
K Sato
(K)
H Miyagi
(H)
M Murakami
(M)
K Saito
(K)
M Hoshiga
(M)
S Sato
(S)
N Kubo
(N)
Y Sakamoto
(Y)
K Ashida
(K)
H Sakamoto
(H)
S Murasaki
(S)
H Uehara
(H)
T Akasaka
(T)
Y Ooba
(Y)
S Nakahara
(S)
Y Hanaoka
(Y)
T Nishimiya
(T)
R Tsunoda
(R)
Y Onuma
(Y)
S Higuchi
(S)
A Tani
(A)
A Wada
(A)
M Kato
(M)
H Obata
(H)
Y Higuchi
(Y)
T Endo
(T)
R Katou
(R)
T Matsunaga
(T)
T Matsuoka
(T)
H Noguchi
(H)
M Usui
(M)
T Hayashi
(T)
Y Otsuji
(Y)
T Osaki
(T)
H Zaizen
(H)
H Yoshihara
(H)
K Kadota
(K)
T Hirose
(T)
T Miyazawa
(T)
A Mori
(A)
M Takano
(M)
W Shimizu
(W)
M Wake
(M)
S Oriso
(S)
M Yoshiyama
(M)
S Kakinoki
(S)
T Nishioka
(T)
T Ozaki
(T)
K Nomoto
(K)
K Seki
(K)
K Kawai
(K)
Y Ozaki
(Y)
S Miura
(S)
M Kawasaki
(M)
R Funada
(R)
K Dote
(K)
T Nagano
(T)
S Okamoto
(S)
T Kubo
(T)
Y Murozono
(Y)
T Owada
(T)
T Doke
(T)
T Matsumura
(T)
M Horiuchi
(M)
A Takaishi
(A)
M Yamamoto
(M)
H Nakashima
(H)
M Munemasa
(M)
Y Sakata
(Y)
N Inoue
(N)
T Ota
(T)
Y Hamano
(Y)
N Abe
(N)
T Tsubokura
(T)
M Goto
(M)
I Kubota
(I)
M Yano
(M)
K Umetani
(K)
T Date
(T)
H Morimoto
(H)
T Noda
(T)
S Goto
(S)
K Hibi
(K)
A Nakano
(A)
S Hiramitsu
(S)
Y Kihara
(Y)
M Sugi
(M)
N Shiba
(N)
D Izumi
(D)
T Sato
(T)
S Tayama
(S)
T Matsui
(T)
A Suzuki
(A)
K Ajiki
(K)
M Oishi
(M)
M Kiryu
(M)
T Ko
(T)
H Ando
(H)
S Miyazaki
(S)
T Kinugawa
(T)
H Otake
(H)
H Kitaoka
(H)
Y Hirata
(Y)
S Honda
(S)
M Manita
(M)
Y Ishii
(Y)
H Oka
(H)
Y Nanba
(Y)
M Nishino
(M)
T Sakamoto
(T)
T Saito
(T)
H Sakai
(H)
M Ichikawa
(M)
S Namiuchi
(S)
K Inoue
(K)
N Komiyama
(N)
Y Akashi
(Y)
Y Nakamura
(Y)
T Komaru
(T)
T Hosokawa
(T)
T Chikamori
(T)
H Tanaka
(H)
O Arasaki
(O)
K Aonuma
(K)
Y Wakasa
(Y)
T Yoshizawa
(T)
T Sugano
(T)
N Yokota
(N)
A Kakutani
(A)
T Suzuki
(T)
Y Abe
(Y)
T Kataoka
(T)
H Okayama
(H)
H Yokoi
(H)
K Chin
(K)
K Hasegawa
(K)
H Tomita
(H)
H Honzyo
(H)
H Kawai
(H)
K Yamamoto
(K)
Y Morino
(Y)
S Tsujiyama
(S)
S Hamasaki
(S)
Y Niijima
(Y)
Y Mizuno
(Y)
A Maki
(A)
K Tanabe
(K)
T Murohara
(T)
S Naomi
(S)
M Arikawa
(M)
T Kato
(T)
N Matsumoto
(N)
T Minamino
(T)
H Sairenji
(H)
N Miyamoto
(N)
H Ito
(H)
Y Matsuura
(Y)
S Hata
(S)
Y Nakatsu
(Y)
T Onodera
(T)
M Yoshimura
(M)
H Amano
(H)
E Tokutake
(E)
M Kasao
(M)
M Moriguchi
(M)
M Tsuji
(M)
H Yamamoto
(H)
Y Yanbe
(Y)
T Iwasawa
(T)
M Suzuki
(M)
H Mori
(H)
Commentaires et corrections
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Informations de copyright
Copyright © 2019 Massachusetts Medical Society.