Evidence map›Paper›PMID 35697255›Full record

Trial reportThrombosis and haemostasis2022

Rivaroxaban Underdose for Atrial Fibrillation with Stable Coronary Disease: The AFIRE Trial Findings.

Hiroyuki Arashi, Junichi Yamaguchi, Nobuhisa Hagiwara, Satoshi Yasuda, Koichi Kaikita, Masaharu Akao, Junya Ako, Tetsuya Matoba, Masato Nakamura, Katsumi Miyauchi and 5 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Thrombosis and haemostasis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02642419 (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study), which is not on this map. Cited by 6 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 3 pooled it
2.1field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02642419 phase4unknown statusnot on this map

Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study (AFIRE Study)

TypeinterventionalSponsorJapan Cardiovascular Research FoundationRan2015 to 2017Enrolled2,200ConditionsAtrial FibrillationArmsRivaroxaban and single antiplatelet drug (aspirin, clopidogrel or prasugrel), Rivaroxaban
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 3 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Comparisons of effectiveness and safety between on-label dosing, off-label underdosing, and off-label overdosing in Asian and non-Asian atrial fibrillation patients treated with rivaroxaban: a systematic review and meta-analysis of observational studies.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2023
    Pooled it
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 11 institutions in 1 country.

Hiroyuki ArashiDepartment of Cardiology, Tokyo Women's Medical University, Tokyo, Japan.
Junichi YamaguchiDepartment of Cardiology, Tokyo Women's Medical University, Tokyo, Japan.
Nobuhisa HagiwaraDepartment of Cardiology, Tokyo Women's Medical University, Tokyo, Japan.
Satoshi YasudaDepartment of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Miyagi, Japan.
Koichi KaikitaDepartment of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
Masaharu AkaoDepartment of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
Junya AkoDepartment of Cardiovascular Medicine, Kitasato University School of Medicine, Kanagawa, Japan.
Tetsuya MatobaDepartment of Cardiovascular Medicine, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan.
Masato NakamuraDivision of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan.
Katsumi MiyauchiDepartment of Cardiovascular Medicine, Juntendo Tokyo Koto Geriatric Medical Center, Tokyo, Japan.
Kazuo KimuraCardiovascular Center, Yokohama City University Medical Center, Kanagawa, Japan.
Atsushi HirayamaDepartment of Cardiology, Osaka Police Hospital, Osaka, Japan.
Kunihiko MatsuiDepartment of General Medicine and Primary Care, Kumamoto University Hospital, Kumamoto, Japan.
Hisao OgawaKumamoto University, Kumamoto, Japan.
AFIRE investigators
Tokyo Women's Medical University · JPKumamoto University · JPKitasato University · JPKumamoto University Hospital · JPKyoto Medical Center · JPKyushu University · JPNational Cerebral and Cardiovascular Center · JPOsaka Police Hospital · JPToho University · JPTokyo Metropolitan Geriatric Hospital · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRivaroxaban monotherapy was noninferior to combination therapy (rivaroxaban plus antiplatelet therapy) in efficacy but superior in safety in the Atrial Fibrillation and Ischemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease (AFIRE) trial. Among 2,215 patients with atrial fibrillation (AF) and stable coronary artery disease (CAD), 1,378 had baseline creatinine clearance (CrCl) ≥50 mL/min and received 10 (underdose) or 15 mg/d (standard-dose) rivaroxaban. We aimed to assess the effects of rivaroxaban underdose on clinical outcomes.

methodsWe assessed efficacy endpoint (a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, and death from any cause) and major bleeding in the subgroup of patients with preserved renal function in the AFIRE trial.

resultsAge ≥75 years, female sex, lower CrCl, heart failure, and percutaneous coronary intervention history were associated with the underdose prescription. The underdose group had a similar incidence of the efficacy endpoint (3.62 vs. 3.51% per patient-year;

conclusionIn patients with AF, stable CAD, and preserved renal function, rivaroxaban underdose was associated with similar rates of thrombotic events but a lower incidence of hemorrhagic events than the standard dose. CLINICAL

trial registrationAFIRE UMIN Clinical Trials Registry (https://www.umin.ac.jp/ctr/), number UMIN000016612, and ClinicalTrials.gov, number NCT02642419.

Indexed as

Atrial FibrillationCoronary Artery DiseaseStrokeAgedAnticoagulantsFactor Xa InhibitorsFemaleHemorrhageHumansMalePlatelet Aggregation InhibitorsRivaroxabanTreatment OutcomeAnticoagulantsFactor Xa InhibitorsPlatelet Aggregation InhibitorsRivaroxaban

Identifiers

PMID35697255
PMCPMC9420554
OpenAlexW4282829957

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.