Evidence map›Paper›PMID 30586727›Full record

Trial reportCirculation2019

Performance of the ABC Scores for Assessing the Risk of Stroke or Systemic Embolism and Bleeding in Patients With Atrial Fibrillation in ENGAGE AF-TIMI 48.

David D Berg, Christian T Ruff, Petr Jarolim, Robert P Giugliano, Francesco Nordio, Hans J Lanz, Michele F Mercuri, Elliott M Antman, Eugene Braunwald, David A Morrow

2 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 65 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 7 pooled it
15.1field-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.

NCT00781391 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)

TypeinterventionalSponsorDaiichi SankyoRan2008 to 2013Enrolled21,105ConditionsStroke, Atrial Fibrillation, EmbolismArmswarfarin tablets, Edoxaban tablets (high dose regimen-60mg), Edoxaban tablets (low dose regimen-30mg), placebo warfarin, placebo edoxaban
NCT05635864 completednot on this mapstarted 2021, after this paper: background citation

Impact of Catheter Ablation of Atrial Tachyarrhythmias on ABC Stroke and ABC Bleeding Risk Scores

TypeobservationalSponsorHannover Medical SchoolRan2021 to 2025Enrolled167ConditionsAtrial Fibrillation, Atrial Flutter, Stroke, BleedingArmsCatheter ablation
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 7 syntheses or guidelines pooled it, 138 citations in OpenAlex.

  1. Pooled it
  2. Comprehensive comparison of stroke risk score performance: a systematic review and meta-analysis among 6 267 728 patients with atrial fibrillation.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 · 2022
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5 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 2 countries.

David D BergTIMI Study Group, Cardiovascular Division, Department of Medicine (D.D.B., C.T.R., R.P.G., F.N., E.M.A., E.B., D.A.M.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Christian T RuffTIMI Study Group, Cardiovascular Division, Department of Medicine (D.D.B., C.T.R., R.P.G., F.N., E.M.A., E.B., D.A.M.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Petr JarolimDepartment of Pathology (P.J.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Robert P GiuglianoTIMI Study Group, Cardiovascular Division, Department of Medicine (D.D.B., C.T.R., R.P.G., F.N., E.M.A., E.B., D.A.M.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Francesco NordioTIMI Study Group, Cardiovascular Division, Department of Medicine (D.D.B., C.T.R., R.P.G., F.N., E.M.A., E.B., D.A.M.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Hans J LanzDaiichi Sankyo, Munich, Germany (H.J.L.).
Michele F MercuriDaiichi Sankyo, Basking Ridge, NJ (M.F.M.).
Elliott M AntmanTIMI Study Group, Cardiovascular Division, Department of Medicine (D.D.B., C.T.R., R.P.G., F.N., E.M.A., E.B., D.A.M.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Eugene BraunwaldTIMI Study Group, Cardiovascular Division, Department of Medicine (D.D.B., C.T.R., R.P.G., F.N., E.M.A., E.B., D.A.M.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
David A MorrowTIMI Study Group, Cardiovascular Division, Department of Medicine (D.D.B., C.T.R., R.P.G., F.N., E.M.A., E.B., D.A.M.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Thrombolysis in Myocardial Infarction Study Group · USBrigham and Women's Hospital · USDaiichi Sankyo (Germany) · DEDaiichi Sankyo (United States) · US

Funding

TRAINING PROGRAM IN CARDIOVASCULAR RESEARCHT32HL007604 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI MARK W FEINBERG · 1985 to 2026
$19.0M
NHLBI NIH HHS T32 HL007604
6 · The paper itself

Abstract

backgroundThe ABC (age, biomarker, clinical history)-stroke and ABC-bleeding risk scores incorporate clinical variables and cardiovascular biomarkers to estimate risk of stroke or systemic embolic events and bleeding, respectively, in patients with atrial fibrillation. These scores have been proposed for routine clinical use, but their performance in external cohorts remains uncertain.

methodsENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) was a multinational randomized trial of the oral factor Xa inhibitor edoxaban in patients with atrial fibrillation and a CHADS

resultsMedian baseline hsTnT, NT-proBNP, and GDF-15 levels were 13.7 ng/L (25th-75th percentiles, 9.6-20.4 ng/L), 811 pg/mL (386-1436 pg/mL), and 1661 pg/mL (1179-2427 pg/mL), respectively. Elevated hsTnT, NT-proBNP, and GDF-15 were independently associated with higher rates of stroke or systemic embolic events, and elevated hsTnT and GDF-15 were independently associated with higher rates of major bleeding ( P<0.001 for each). The ABC-stroke and ABC-bleeding scores were well calibrated and yielded higher c indexes than the CHA

conclusionsThe ABC-stroke and ABC-bleeding scores evaluated in this anticoagulated clinical trial cohort were well calibrated and outperformed the CHA CLINICAL

trial registrationURL: https://www.clinicaltrials.gov . Unique identifier: NCT00781391.

Indexed as

AgedAnticoagulantsAtrial FibrillationBiomarkers, PharmacologicalCohort StudiesDisease ProgressionEmbolismFactor Xa InhibitorsFemaleGermanyHemorrhageHumansMaleMiddle AgedPyridinesRiskAnticoagulantsBiomarkers, PharmacologicaledoxabanFactor Xa InhibitorsPyridinesThiazolesatrial fibrillationbiomarkershemorrhagerisk assessmentstroke

Identifiers

PMID30586727
PMCPMC6363338
OpenAlexW2900136549

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.