Cited by 5,051Atrial Fibrillation Management and OutcomesVenous Thromboembolism Diagnosis and ManagementAcute Ischemic Stroke Management

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Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials

Ruff, Christian T, Giugliano, Robert P, Braunwald, Eugene, Hoffman, Elaine B, Deenadayalu, Naveen, Ezekowitz, Michael D, Camm, A John, Weitz, Jeffrey I, Lewis, Basil S, Parkhomenko, Alexander, Yamashita, Takeshi, Antman, Elliott M·2014·The Lancet

DOI 10.1016/s0140-6736(13)62343-0

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Abstract

Background Four new oral anticoagulants compare favourably with warfarin for stroke prevention in patients with atrial fibrillation; however, the balance between efficacy and safety in subgroups needs better definition. We aimed to assess the relative benefit of new oral anticoagulants in key subgroups, and the effects on important secondary outcomes.Methods We searched Medline from Jan 1, 2009, to Nov 19, 2013, limiting searches to phase 3, randomised trials of patients with atrial fibrillation who were randomised to receive new oral anticoagulants or warfarin, and trials in which both efficacy and safety outcomes were reported. We did a prespecified meta-analysis of all 71,683 participants included in the RE-LY, ROCKET AF, ARISTOTLE, and ENGAGE AF-TIMI 48 trials. The main outcomes were stroke and systemic embolic events, ischaemic stroke, haemorrhagic stroke, all-cause mortality, myocardial infarction, major bleeding, intracranial haemorrhage, and gastrointestinal bleeding. We calculated relative risks (RRs) and 95% CIs for each outcome. We did subgroup analyses to assess whether differences in patient and trial characteristics affected outcomes. We used a random-effects model to compare pooled outcomes and tested for heterogeneity.Findings 42,411 participants received a new oral anticoagulant and 29,272 participants received warfarin. New oral anticoagulants significantly reduced stroke or systemic embolic events by 19% compared with warfarin (RR 0·81, 95% CI 0·73-0·91; p<0·0001), mainly driven by a reduction in haemorrhagic stroke (0·49, 0·38-0·64; p<0·0001). New oral anticoagulants also significantly reduced all-cause mortality (0·90, 0·85-0·95; p=0·0003) and intracranial haemorrhage (0·48, 0·39-0·59; p<0·0001), but increased gastrointestinal bleeding (1·25, 1·01-1·55; p=0·04). We noted no heterogeneity for stroke or systemic embolic events in important subgroups, but there was a greater relative reduction in major bleeding with new oral anticoagulants when the centre-based time in therapeutic range was less than 66% than when it was 66% or more (0·69, 0·59-0·81 vs 0·93, 0·76-1·13; p for interaction 0·022). Low-dose new oral anticoagulant regimens showed similar overall reductions in stroke or systemic embolic events to warfarin (1·03, 0·84-1·27; p=0·74), and a more favourable bleeding profile (0·65, 0·43-1·00; p=0·05), but significantly more ischaemic strokes (1·28, 1·02-1·60; p=0·045).Interpretation This meta-analysis is the first to include data for all four new oral anticoagulants studied in the pivotal phase 3 clinical trials for stroke prevention or systemic embolic events in patients with atrial fibrillation. New oral anticoagulants had a favourable risk-benefit profile, with significant reductions in stroke, intracranial haemorrhage, and mortality, and with similar major bleeding as for warfarin, but increased gastrointestinal bleeding. The relative efficacy and safety of new oral anticoagulants was consistent across a wide range of patients. Our findings offer clinicians a more comprehensive picture of the new oral anticoagulants as a therapeutic option to reduce the risk of stroke in this patient population.Funding None.

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Authors: Ruff, C. T., Giugliano, R. P., Braunwald, E., Hoffman, E. B., Deenadayalu, N., Ezekowitz, M. D., Camm, A. J., Weitz, J. I., Lewis, B. S., Parkhomenko, A., Yamashita, T., & Antman, E. M.
Affiliations: Brigham and Women's Hospital (US)
Thomas Jefferson University (US)
St George's, University of London (GB)
Thrombosis and Atherosclerosis Research Institute (CA)
Carmel Medical Center (IL)
Cardiovascular Institute Hospital (JP)
Corresponding author: Ruff, Christian T
ORCID: Ruff, Christian T
Giugliano, Robert P
Ezekowitz, Michael D
Camm, A John
Weitz, Jeffrey I
Lewis, Basil S
Parkhomenko, Alexander
Yamashita, Takeshi
Antman, Elliott M
Venue: The Lancet
Publisher: Elsevier BV
Published: 2014-03
Volume: 383
Issue: 9921
Pages: 955-962
ISSN: 0099-5355 (ISSN-L)
0140-6736
DOI: 10.1016/s0140-6736(13)62343-0
OpenAlex: W2152623033
Cited by: 5,051
References: 45
Citations by year: 2026: 249 · 2025: 310 · 2024: 399 · 2023: 426 · 2022: 410 · 2021: 490 · 2020: 521 · 2019: 462 · 2018: 456 · 2017: 447 · 2016: 406 · 2015: 318 · 2014: 139
FWCI: 49.57
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: The Lancet (publishedVersion)
PubMed (publishedVersion)
HAL (submittedVersion)
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
Health Sciences › Medicine › Clinical Neurology › Acute Ischemic Stroke Management
Keywords: direct oral anticoagulants, warfarin, atrial fibrillation, stroke prevention, systemic embolism, hemorrhagic stroke, intracranial hemorrhage, gastrointestinal bleeding, major bleeding, all-cause mortality, subgroup analysis, factor Xa inhibitors, dabigatran, rivaroxaban, apixaban
MeSH terms: Administration, Oral, Anticoagulants, Atrial Fibrillation, Embolism, Humans, Warfarin, Randomized Controlled Trials as Topic, Treatment Outcome, Stroke

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Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials

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