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Persistence with Dabigatran Therapy for Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation: The Gloria-AF Registry

2016· article· en· W2979734755 on OpenAlexaff
Christine Teutsch, Menno V. Huisman, Gregory Y.H. Lip, Hans‐Christoph Diener, Sérgio Dubner, Changsheng Ma, Kenneth J. Rothman, Kristina Zint, Amelie Elsaesser, Miney Paquette, Dorothee B. Bartels, Jonathan L. Halperin

Bibliographic record

VenueBlood · 2016
Typearticle
Languageen
FieldMedicine
TopicAtrial Fibrillation Management and Outcomes
Canadian institutionsBoehringer Ingelheim (Canada)
Fundersnot available
KeywordsMedicineDiscontinuationAtrial fibrillationDabigatranStroke (engine)Interim analysisInternal medicineRivaroxabanHazard ratioPediatricsWarfarinVitamin K antagonistClinical trialConfidence interval

Abstract

fetched live from OpenAlex

Abstract Purpose/Background : Oral anticoagulation is recommended for stroke prevention in patients with non-valvular atrial fibrillation (NVAF) and stroke risk factors, but discontinuation rates are high among those treated with vitamin K antagonists (VKA). After the first year of treatment, about half of patients permanently stop taking VKA therapy. We examined persistence to therapy with dabigatran etexilate (DE) in patients enrolled in the global, prospective GLORIA-AF Registry Program. Methods: GLORIA-AF collects data in three phases from routine clinical practice in 44 countries worldwide. Enrollment in Phase II was initiated following approval of DE, the first non-VKA oral anticoagulant (NOAC) available. During this phase, all patients with newly diagnosed NVAF at risk for stroke starting DE are followed for 2 years. This analysis is based on a pre-specified interim analysis once follow-up of the first 3000 DE patients was completed. Patients were recruited between November 2011 and December 2013 at nearly 1,000 sites worldwide, by cardiologists, neurologists and general practitioners. To reduce selection bias, patients were recruited consecutively, irrespective of antithrombotic therapy. Persistence was defined as time from initiation to discontinuation of therapy for >30 days or substitution of initial treatment by another oral anticoagulant. Persistence rates were analyzed on the basis of a time-to-event analysis using the Kaplan Meier method. Results: Among eligible patients, 2,937 were prescribed DE; 823 (27.4%) in North America, 1,503 (50.1%) in Europe, 194 (6.5%) in Latin America, 54 (1.8%) in Africa/Middle East and 363 (12.1%) in Asia. Overall, 55.3% were male, the median age was 71.0 (range 23-98) years; 36.7% were ≥75 years old. The CHA2DS2VASc score was ≥2 in 88.2%, 78.9% had hypertension, 22.7% diabetes mellitus, 10.1% prior stoke and 24.9% heart failure. All but 5 eligible patients took at least one dose of DE. The probability of remaining on DE treatment was 76.6% at 1 year and 69.2% at 2 years (based on Kaplan-Meier method). At the 2 years visit, half of the permanently discontinued patients (418 out of 828) had switched to another oral anticoagulant. Characteristics of patients discontinuing vs. sustaining therapy and relationships to stroke risk and geographical region will be presented. Conclusions: In this global, prospective, cohort of patients newly diagnosed with NVAF and treated with DE, persistence on therapy was high through 2 years of treatment, with an estimated probability of remaining on treatment of about 77% after 1 year and 70% after 2 years. The detailed results will provide a global perspective on the factors that influence treatment persistence in patients prescribed a NOAC for stroke prophylaxis. Disclosures Teutsch: Boehringer Ingelheim: Employment. Huisman:Boehringer Ingelheim Pharma GmbH & Co.KG: Other: Grant support; GlaxoSmithKline: Other: Grant support; Bayer HealthCare: Other: Grant support; Pfizer: Other: Grant support; Actelion: Other: Grant support. Lip:Bayer, BMS/Pfizer, Boehringer Ingelheim and Sanofi Aventis: Speakers Bureau; Bayer, Astellas, Merck, Sanofi, Bristol-Myers Squibb (BMS)/Pfizer, Daiichi-Sankyo, Biotronik, Portola and Boehringer Ingelheim: Consultancy. Diener:AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Janssen-Cilag, Lundbeck, Novartis, Sanofi Aventis, Syngis and Talecris: Research Funding; Abbott, Allergan, AstraZeneca, Bayer Vital, BMS, Boehringer Ingelheim, CoAxia, Corimmun, Covidien, Daiichi-Sankyo, D-Pharm, Fresenius, GlaxoSmithKline, Janssen-Cilag, Johnson & Johnson, Knoll, Lilly, Medtronic, MindFrame, MSD, Neurobiological Technologies: Honoraria; The Department of Neurology at the University Duisburg-Essen received research grants from the German Research Council (DFG), German Ministry of Education and Research (BMBF), European Union, National Institutes of Health, Bertelsmann Foundation and Heinz: Research Funding. Dubner:steering committee member for Boehringer Ingelheim: Consultancy; St Jude Medical: Research Funding. Changsheng:steering committee member for Boehringer Ingelheim: Consultancy. Rothman:RTI Health Solutions: Employment. Zint:Boehringer Ingelheim: Employment. Elsaesser:Boehringer Ingelheim: Employment. Paquette:Boehringer Ingelheim: Employment. Bartels:Boehringer Ingelheim: Employment. Halperin:Bayer HealthCare: Consultancy; Boehringer Ingelheim: Consultancy.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.003
metaresearch head score (Gemma)0.006
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.009
Threshold uncertainty score0.018

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0030.006
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.001
Bibliometrics0.0010.002
Science and technology studies0.0000.000
Scholarly communication0.0010.001
Open science0.0010.001
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0010.001

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.033
GPT teacher head0.276
Teacher spread0.243 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations11
Published2016
Admission routes1
Has abstractyes

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