Trial reportJournal of the American Heart Association2017
Impact of Spontaneous Extracranial Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF-TIMI 48 Trial.
Trial report in Journal of the American Heart Association, 2017. 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 16 papers, 2 of them syntheses that pooled 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.
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.
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)
Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism: Pilot Randomized Study (RADIANT Study)
Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Implantable cardiac monitors to detect atrial fibrillation after cryptogenic stroke: a systematic review and economic evaluation.Health technology assessment (Winchester, England) · 2020Pooled it
- Direct oral anticoagulants versus warfarin for preventing stroke and systemic embolic events among atrial fibrillation patients with chronic kidney disease.The Cochrane database of systematic reviews · 2017Pooled it
- Predicting Bleeding Events in Anticoagulated Patients With Atrial Fibrillation: A Comparison Between the HAS-BLED and GARFIELD-AF Bleeding Scores.Journal of the American Heart Association · 2018Trial
- Rapid Access Atrial Fibrillation Clinics in Australia - Modelling Outcomes and Cost-Effectiveness.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2026Article
- Economic evaluation of telemedicine-based integrated management of atrial fibrillation in rural China: a modeling analysis.NPJ digital medicine · 2026Article
- Antithrombotic Therapy Discontinuation, Bleeding, and Thromboembolic Events in Patients With Cancer During the Last Phase of Life: Insights From Primary Care Records.Annals of family medicine · 2026Article
- Optimizing care for patients after major anticoagulant-related bleeding: a narrative review and proposal for a clinical care pathway.Research and practice in thrombosis and haemostasis · 2025Review
- Novel Anticoagulants for Stroke Prevention in Atrial Fibrillation: A Comprehensive Review.Cureus · 2024Review
- Subclinical Atrial Fibrillation and Anticoagulation: Weighing the Absolute Risks and Benefits.Circulation · 2024Article
- Observational
- Article
- Decrements in health-related quality of life associated with adverse events in people with diabetes.Diabetes, obesity & metabolism · 2022Article
- Convenience and satisfaction in direct oral anticoagulant-treated patients with atrial fibrillation.Research and practice in thrombosis and haemostasis · 2021Article
- Screening for Atrial Fibrillation in Sub-Saharan Africa: A Health Economic Evaluation to Assess the Feasibility in Nigeria.Global heart · 2021Article
- Article
- Bleeding in cardiac patients prescribed antithrombotic drugs: electronic health record phenotyping algorithms, incidence, trends and prognosis.BMC medicine · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe impact of different types of extracranial bleeding events on health-related quality of life and health-state utility among patients with atrial fibrillation is not well understood. METHODS AND
resultsThe ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) Trial compared edoxaban with warfarin with respect to the prevention of stroke or systemic embolism in atrial fibrillation. Data from the EuroQol-5D (EQ-5D-3L) questionnaire, prospectively collected at 3-month intervals for up to 48 months, were used to estimate the impact of different categories of bleeding events on health-state utility over 12 months following the event. Longitudinal mixed-effect models revealed that major gastrointestinal bleeds and major nongastrointestinal bleeds were associated with significant immediate decreases in utility scores (-0.029 [-0.044 to -0.014;
conclusionsAll categories of bleeding events were associated with negative impacts on health-state utility in patients with atrial fibrillation. Major bleeds were associated with relatively large immediate decreases in utility scores that gradually diminished over 12 months; clinically relevant nonmajor and minor bleeds were associated with smaller immediate decreases in utility that persisted over 12 months. CLINICAL
trial registrationURL: https://www.clinicaltrials.gov/. Unique identifier: NCT00781391.
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Identifiers
What OpenQuestion holds
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.