Evidence map›Paper›PMID 37621213›Full record

ArticleCirculation2023

Development and Validation of the DOAC Score: A Novel Bleeding Risk Prediction Tool for Patients With Atrial Fibrillation on Direct-Acting Oral Anticoagulants.

Rahul Aggarwal, Christian T Ruff, Saverio Virdone, Sylvie Perreault, Ajay K Kakkar, Michael G Palazzolo, Marc Dorais, Gloria Kayani, Daniel E Singer, Eric Secemsky and 4 more

Open access · greenAbstract read
In one paragraph

Article in Circulation, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 2 pooled it
21.1field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 2 syntheses or guidelines pooled it, 96 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. VARC-HBR criteria validation in TAVI patients on oral anticoagulation.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025
    Trial
  4. Observational
  5. Article
  6. Managing bleeds on anticoagulant therapy: a practical guide for clinicians.European heart journal. Acute cardiovascular care · 2026
    Review
  7. Article
  8. Observational
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Review
  17. Review
  18. Apixaban in subclinical atrial fibrillation: stroke-driven value amid economic uncertainty.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 · 2025
    Article
  19. Performance of DOAC and HAS-BLED scores in predicting major bleeding in Asian patients with non-valvular atrial fibrillation receiving direct oral anticoagulants.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 · 2025
    Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 10 institutions in 3 countries.

Rahul AggarwalRichard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center (R.A., E.S., U.A.T., R.W.Y.), Harvard Medical School, Boston.ORCID 0000-0002-4746-8511
Christian T RuffTIMI Study Group, Division of Cardiovascular Medicine (C.T.R., M.G.P.), Harvard Medical School, Boston.ORCID 0000-0002-4712-3206
Saverio VirdoneThrombosis Research Institute, London, United Kingdom (G.K., S.V., A.K.K.).ORCID 0000-0003-1849-6422
Sylvie PerreaultFaculty of Pharmacy, University of Montreal, Canada (S.P.).ORCID 0000-0002-0066-0127
Ajay K KakkarThrombosis Research Institute, London, United Kingdom (G.K., S.V., A.K.K.).
Michael G PalazzoloTIMI Study Group, Division of Cardiovascular Medicine (C.T.R., M.G.P.), Harvard Medical School, Boston.ORCID 0000-0002-2128-6752
Marc DoraisStatSciences Inc, Notre-Dame-de-l'Île-Perrot, Quebec, Canada (M.D.).
Gloria KayaniThrombosis Research Institute, London, United Kingdom (G.K., S.V., A.K.K.).ORCID 0000-0001-9677-2993
Daniel E SingerDivision of General Internal Medicine, Massachusetts General Hospital (D.E.S.), Harvard Medical School, Boston.ORCID 0000-0001-6145-4848
Eric SecemskyRichard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center (R.A., E.S., U.A.T., R.W.Y.), Harvard Medical School, Boston.ORCID 0000-0003-3861-3163
Jonathan PicciniDuke Clinical Research Institute, Duke University, Durham, NC (J.P.).ORCID 0000-0003-0772-2404
Usman A TahirRichard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center (R.A., E.S., U.A.T., R.W.Y.), Harvard Medical School, Boston.
Changyu ShenAdvanced Analytics, Biogen Digital Health and Worldwide Medical, Cambridge, MA (C.S.).ORCID 0000-0002-4444-0943
Robert W YehRichard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center (R.A., E.S., U.A.T., R.W.Y.), Harvard Medical School, Boston.ORCID 0000-0002-0564-4468
Deaconess Hospital · USThrombolysis in Myocardial Infarction Study Group · USThrombosis Research Institute · GBBeth Israel Deaconess Medical Center · USBiogen (United States) · USClinical Research Institute · USHôpital Notre-Dame · CAKensington College of Business · GBMassachusetts General Hospital · USUniversité de Montréal · CA

Funding

Using Claims-Based Signatures of Frailty to Support Individualized Treatment of Aortic Valve Stenosis and Coronary Artery DiseaseK24HL150321 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI Robert Yeh · 2020 to 2026
$862k
Shared Decision-Making to Improve the Health Status of Patients with Claudication: Developing and Implementing Strategies to Individualize Treatment DecisionsK23HL150290 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI SECEMSKY, ERIC ALEXANDER · 2020 to 2024
$851k
The Role of SECTM1 in Monocyte Biology and AtherosclerosisK08HL161445 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI Usman A. Tahir · 2022 to 2026
$822k
NHLBI NIH HHS K08 HL161445NHLBI NIH HHS K23 HL150290NHLBI NIH HHS K24 HL150321
6 · The paper itself

Abstract

backgroundCurrent clinical decision tools for assessing bleeding risk in individuals with atrial fibrillation (AF) have limited performance and were developed for individuals treated with warfarin. This study develops and validates a clinical risk score to personalize estimates of bleeding risk for individuals with atrial fibrillation taking direct-acting oral anticoagulants (DOACs).

methodsAmong individuals taking dabigatran 150 mg twice per day from 44 countries and 951 centers in this secondary analysis of the RE-LY trial (Randomized Evaluation of Long-Term Anticoagulation Therapy), a risk score was developed to determine the comparative risk for bleeding on the basis of covariates derived in a Cox proportional hazards model. The risk prediction model was internally validated with bootstrapping. The model was then further developed in the GARFIELD-AF registry (Global Anticoagulant Registry in the Field-Atrial Fibrillation), with individuals taking dabigatran, edoxaban, rivaroxaban, and apixaban. To determine generalizability in external cohorts and among individuals on different DOACs, the risk prediction model was validated in the COMBINE-AF (A Collaboration Between Multiple Institutions to Better Investigate Non-Vitamin K Antagonist Oral Anticoagulant Use in Atrial Fibrillation) pooled clinical trial cohort and the Quebec Régie de l'Assurance Maladie du Québec and Med-Echo Administrative Databases (RAMQ) administrative database. The primary outcome was major bleeding. The risk score, termed the DOAC Score, was compared with the HAS-BLED score.

resultsOf the 5684 patients in RE-LY, 386 (6.8%) experienced a major bleeding event, within a median follow-up of 1.74 years. The prediction model had an optimism-corrected C statistic of 0.73 after internal validation with bootstrapping and was well-calibrated based on visual inspection of calibration plots (goodness-of-fit

conclusionsIn individuals with atrial fibrillation potentially eligible for DOAC therapy, the DOAC Score can help stratify patients on the basis of expected bleeding risk.

Indexed as

Atrial FibrillationAnticoagulantsDabigatranFactor Xa InhibitorsHumansRivaroxabanAnticoagulantsDabigatranFactor Xa InhibitorsRivaroxabanapixabanatrial fibrillationdabigatranDOAC Scoreedoxabanhemorrhageriskrivaroxaban

Identifiers

PMID37621213
PMCPMC10529708
OpenAlexW4386152598

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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 Socratic graph.