Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials
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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Oral anticoagulation with vitamin K antagonists or non-vitamin K antagonist oral anticoagulants markedly reduces stroke and mortality in AF patients.
“Oral anticoagulation (OAC) with vitamin K antagonists (VKAs) or non-VKA oral anticoagulants (NOACs) markedly reduces stroke and mortality in AF patients.38,39”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [39]
OAC therapy can prevent the majority of ischaemic strokes in AF patients and can prolong life.
“OAC therapy can prevent the majority of ischaemic strokes in AF patients and can prolong life.”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [39]
There is strong evidence that patients with a CHA2DS2-VASc risk score of 2 or more in men, and 3 or more in women, benefit from oral anticoagulation.
“and hence there is strong evidence that patients with a CHA 2 DS 2 -VASc risk score of 2 or more in men, and 3 or more in women benefit from OAC.”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [39]
Controlled trials studying oral anticoagulation in AF patients have been enriched for patients at high risk of stroke.
“Controlled trials studying OAC in AF patients have been enriched for patients at high risk of stroke, 38,39,42,194,201,329,351,352”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [39]
In the meta-analysis, mortality was 10% lower in patients randomized to NOAC therapy (RR 0.90; 95% CI 0.85-0.95; P = 0.0003) and intracranial haemorrhage was halved (RR 0.48; 95% CI 0.39-0.59; P < 0.0001), while gastrointestinal bleeding events were more frequent (RR 1.25; 95% CI 1.01-1.55; P = 0.04).
“Mortality was 10% lower in patients randomized to NOAC therapy (RR 0.90; 95% CI 0.85-0.95;P = 0.0003) and intracranial haemorrhage was halved (RR 0.48; 95% CI 0.39-0.59;P < 0.0001), while gastrointestinal bleeding events were more frequent (RR 1.25; 95% CI 1.01-1.55;P = 0.04).39”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [39]
NOACs in high-dose treatment groups 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 (RR 0.49; 95% CI 0.38-0.64; P < 0.0001).
“NOACs in these dosages 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 (RR 0.49; 95% CI 0.38-0.64;P < 0.0001).”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [39]
A meta-analysis based on the high-dose treatment groups of the pivotal studies of warfarin versus NOACs included 42,411 patients receiving a NOAC and 29,272 receiving warfarin.
“A meta-analysis 39 based on the highdose treatment groups of the pivotal studies of warfarin versus NOACs included 42,411 patients receiving a NOAC and 29,272 receiving warfarin.”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [39]
Good data are available to support the use of anticoagulants in older patients from BAFTA, the NOAC trials, and analyses in elderly Americans (Medicare).
“Good data are available to support the use of anticoagulants in older patients from BAFTA (Birmingham Atrial Fibrillation Treatment of the Aged Study), 362 the NOAC trials, 39 and from analyses in elderly Americans (Medicare).396”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [39]
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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
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2014-03
- Volume
- 383
- Issue
- 9921
- Pages
- 955-962
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- 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 · 2013: 7 · 2012: 1
- FWCI
- 49.57
- Type
- journal article
- Language
- en
- Open access
- closed
- 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 › Epidemiology › 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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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