Effectiveness and safety of dabigatran in Latin American patients with atrial fibrillation:Two years follow up results from GLORIA-AF registry

Background: Real-world data from different regions are needed to support the external validity of con trolled trials and assess the impact of new oral anticoagulants (NOAC) in clinical practice. Methods: ‘‘GLORIA-AF” is a large, ongoing, multicenter, global, prospective registry program in patients with newly diagnosed non-valvular atrial fibrillation (NVAF) at risk of stroke. Newly diagnosed patients with NVAF (within 4.5 months) and a CHA2DS2-VASc score 1 were consecutively enrolled. The study objective was to estimate the incidence rate of stroke and major bleeding after a two year follow up of patients on dabigatran that participated in the ‘‘GLORIA-AF” study (Phase II) in Latin America. Results: Latin America included 378 eligible patients that received dabigatran in eight countries (Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, Perú, and Venezuela): 56.3% were male; mean age was 70.3 ± 10.8 years; 43.4% had paroxysmal AF; 36.0% persistent AF and 20.6% permanent AF. Mean CHA2DS2-VASc score was 3.2 ± 1.4; mean HAS-BLED score was 1.2 ± 0.8. Incidence rates for clinical events after 2-years of follow-up per 100 patient-years were as follows: stroke 0.33 (95% CI: 0.04–1.17), major bleeding 0.49 (95% CI: 0.10–1.42) and all-cause death 4.06 (95% CI: 2.63–6.00). Persistence with dabiga tran at 6, 12 and 24 months was 91%, 86%, and 80%, respectively. Conclusion: These regional data shows the sustained safety and effectiveness of dabigatran over two years of follow-up, consistent with already available evidence. An increase in accessibility and incorpo ration of NOAC to anticoagulant treatment strategies could potentially have a positive impact on AF stroke prevention in Latin America

Regional Differences in Antithrombotic Treatment for Atrial Fibrillation:Insights from the GLORIA-AF Phase II Registry

Introduction Although guideline-adherent antithrombotic therapy (ATT) for stroke prevention in atrial fibrillation (AF) is associated with lower mortality and thromboembolism, ATT uptake shows geographic variation worldwide. We aimed to assess thromboembolic risk and baseline ATT by geographic region and identify factors associated with prescription of ATT in a large, truly global registry of patients with recently diagnosed AF. Methods and Results Our analysis comprises 15,092 patients newly diagnosed with non-valvular AF at risk for stroke, enrolled in Phase II of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF). Global oral anticoagulation (OAC) use was 79.9%, being highest in Europe (90.1%), followed by Africa/Middle East (87.4%) and Latin America (85.3%), North America (78.3%) and Asia (55.2%). Among OAC users, vitamin K antagonists (VKAs) have been replaced by non-VKA OACs (NOACs) as the more prevalent OAC option in all regions, with highest use in North America (66.5%) and lowest in Asia (50.2%). In Asia, OAC was 80.4% in community hospitals but only 49.8% in university hospitals and 42.6% in specialist offices, and varied from 21.0% in China to 89.7% in Japan (NOACs at 5.8% in China and 83.3% in Japan). Globally, 76.5% of low-risk patients were prescribed ATT (46.1% OAC), whereas 17.7% high-risk patients were not anticoagulated (Europe 8.8%; North America 18.9%; Asia 42.4%). Conclusion Substantial inter- and intra-regional differences in ATT for stroke prevention in AF are evident in this global registry. While guideline-adherent ATT can be further improved, NOACs are the main contributor to high OAC use worldwide.</jats:p

Atrial fibrillation and comorbidities:Clinical characteristics and antithrombotic treatment in GLORIA-AF

BackgroundPatients with AF often have multimorbidity (the presence of ≥2 concomitant chronic conditions).ObjectiveTo describe baseline characteristics, patterns of antithrombotic therapy, and factors associated with oral anticoagulant (OAC) prescription in patients with AF and ≥2 concomitant, chronic, comorbid conditions.MethodsPhase III of the GLORIA-AF Registry enrolled consecutive patients from January 2014 through December 2016 with recently diagnosed AF and CHA2DS2-VASc score ≥1 to assess the safety and effectiveness of antithrombotic treatment.ResultsOf 21,241 eligible patients, 15,119 (71.2%) had ≥2 concomitant, chronic, comorbid conditions. The proportions of patients with multimorbidity receiving non-vitamin K antagonist oral anticoagulants (NOACs) and vitamin K antagonists (VKA) were 60.2% and 23.6%, respectively. The proportion with paroxysmal AF was 57.0% in the NOAC group and 45.4% in the VKA group. Multivariable log-binomial regression analysis found the following factors were associated with no OAC prescription: pattern of AF (paroxysmal, persistent, or permanent), coronary artery disease, myocardial infarction, prior bleeding, smoking status, and region (Asia, North America, or Europe). Factors associated with OAC prescriptions were age, body mass index, renal function, hypertension, history of cerebral ischemic symptoms, and AF ablation.ConclusionMultimorbid AF patients prescribed NOACs have fewer comorbidities than those prescribed VKAs. Age, AF pattern, comorbidities, and renal function are associated with OAC prescription

Changes in anticoagulant prescription patterns over time for patients with atrial fibrillation around the world.

BackgroundPrescribing patterns for stroke prevention in atrial fibrillation (AF) patients evolved with approval of non-Vitamin K antagonist oral anticoagulants (NOACs) over time.ObjectivesTo assess changes in anticoagulant prescription patterns in various geographical regions upon first approval of a NOAC and to analyze the evolution of oral anticoagulants (OACs) use over time in relation to CHA2DS2-VASc and HAS-BLED risk profiles.MethodsGlobal Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) Phases II and III reported data on antithrombotic therapy for patients with newly diagnosed AF and ≥1 stroke risk factor. We focused on sites enrolling patients in both phases and reported treatment patterns for the first 4 years after initial NOAC approval.ResultsFrom GLORIA-AF Phases II and III, 27 432 patients were eligible for this analysis. When contrasting the first year with the fourth year of enrolment, the proportion of NOAC prescriptions increased in Asia from 29.2% to 60.8%, in Europe from 53.4% to 75.8%, in North America from 49.0% to 73.9% and in Latin America from 55.7% to 71.1%. The proportion of Vitamin K antagonists (VKAs) use decreased across all regions over time, in Asia from 26.0% to 9.8%, in Europe from 35.5% to 16.8%, in North America from 28.9% to 12.1%, and in Latin America from 32.4% to 17.8%. In the multivariable analysis, factors associated with NOAC prescription were as follows: enrolment year, type of site, region, stroke and bleeding risk scores, and type and categorization of AF.ConclusionsDuring 4 years after the approval of the first NOAC, NOAC use increased, while VKA use decreased, across all regions

Dabigatran versus vitamin K antagonists for atrial fibrillation in clinical practice: final outcomes from Phase III of the GLORIA-AF registry.

BackgroundProspectively collected, routine clinical practice-based data on antithrombotic therapy in non-valvular atrial fibrillation (AF) patients are important for assessing real-world comparative outcomes. The objective was to compare the safety and effectiveness of dabigatran versus vitamin K antagonists (VKAs) in patients with newly diagnosed AF.Methods and resultsGLORIA-AF is a large, prospective, global registry program. Consecutive patients with newly diagnosed AF and CHA2DS2-VASc scores ≥ 1 were included and followed for 3 years. To control for differences in patient characteristics, the comparative analysis for dabigatran versus VKA was performed on a propensity score (PS)-matched patient set. Missing data were multiply imputed. Proportional-hazards regression was used to estimate hazard ratios (HRs) for outcomes of interest. Between 2014 and 2016, 21,300 eligible patients were included worldwide: 3839 patients were prescribed dabigatran and 4836 VKA with a median age of 71.0 and 72.0 years, respectively; > 85% in each group had a CHA2DS2-VASc-score ≥ 2. The PS-matched comparative analysis for dabigatran and VKA included on average 3326 pairs of matched initiators. For dabigatran versus VKAs, adjusted HRs (95% confidence intervals) were: stroke 0.89 (0.59-1.34), major bleeding 0.61 (0.42-0.88), all-cause death 0.78 (0.63-0.97), and myocardial infarction 0.89 (0.53-1.48). Further analyses stratified by PS and region provided similar results.ConclusionsDabigatran was associated with a 39% reduced risk of major bleeding and 22% reduced risk for all-cause death compared with VKA. Stroke and myocardial infarction risks were similar, confirming a more favorable benefit-risk profile for dabigatran compared with VKA in clinical practice. Clinical trial registration https://www.Clinicaltrialsgov . NCT01468701, NCT01671007

Synthetic Social Support: Theorizing Lay Health Worker Interventions

Levels of social support are strongly associated with health outcomes and inequalities. The use of lay health workers (LHWs) has been suggested by policy makers across the world as an intervention to identify risks to health and to promote health, particularly in disadvantaged communities. However, there have been few attempts to theorize the work undertaken by LHWs to understand how interventions work. In this article, the authors present the concept of 'synthetic socialsupport' and distinguish it from the work of health professionals or the spontaneous social support received from friends and family. The authors provide new empirical data to illustrate the concept based on qualitative, observational research, using a novel shadowing method involving clinical and non-clinical researchers, on the everyday work of 'pregnancy outreach workers' (POWs) in Birmingham, UK. The service was being evaluated as part of a randomized controlled trial. These LHWs provided instrumental, informational, emotional and appraisal support to the women they worked with, which are all key components of social support. The social support was 'synthetic' because it was distinct from the support embedded in spontaneous social networks: it was non-reciprocal; it was offered on a strictly time-limited basis; the LHWs were accountable for the relationship, and the social networks produced were targeted rather than spontaneous. The latter two qualities of this synthetic form of social support may have benefits over spontaneous networks by improving the opportunities for the cultivation of new relationships (both strong and weak ties) outside the women's existing spontaneous networks that can have a positive impact on them and by offering a reliable source of health information and support in a chaotic environment. The concept of SSS can help inform policy makers about how deploying lay workers may enable them to achieve desired outcomes, specify their programme theories and evaluate accordingly. [Abstract copyright: Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.