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 Among OAC users, vitamin K antagonists (VKAs) have been replaced by non-VKA OACs (NOACs) as the more prevalent OAC option in all regions, with highest use in North America (66.5%) and lowest in Asia (50.2%).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

Evolution of antithrombotic therapy for patients with atrial fibrillation:The prospective global GLORIA-AF registry program

OBJECTIVE: To assess baseline characteristics and antithrombotic treatment (ATT) prescription patterns in patients enrolled in the third phase of the GLORIA-AF Registry Program, evaluate predictors of treatment prescription, and compare results with phase II. METHODS: GLORIA-AF is a large, global, prospective registry program, enrolling patients with newly diagnosed nonvalvular atrial fibrillation (AF) at risk of stroke. Patients receiving dabigatran were followed for two years in phase II, and all patients were followed for 3 years in phase III. Phase II started when dabigatran became available; phase III started when the characteristics of patients receiving dabigatran became roughly comparable with those receiving vitamin K antagonists (VKAs). RESULTS: Between 2014 and 2016, 21,241 patients were enrolled in phase III. In total, 82% of patients were prescribed oral anticoagulation ([OAC]; 59.5% novel/nonvitamin K oral anticoagulants [NOACs], 22.7% VKAs). A further 11% of patients were prescribed antiplatelets without OAC and 7% were prescribed no ATT. A high stroke risk was the main driver of OAC prescription. Factors associated with prescription of VKA over NOAC included type of site, region, physician specialty, and impaired kidney function. CONCLUSION: Over the past few years, data from phase III of GLORIA-AF show that OACs have become the standard treatment option, with most newly diagnosed AF patients prescribed a NOAC. However, in some regions a remarkable proportion of patients remain undertreated. In comparison with phase II, more patients received NOACs in phase III while the prescription of VKA decreased. VKAs were preferred over NOACs in patients with impaired kidney function

The Changing Landscape for Stroke\ua0Prevention in AF: Findings From the GLORIA-AF Registry Phase 2

Background GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic treatment patterns in patients with newly diagnosed nonvalvular atrial fibrillation at risk of stroke. Phase 2 began when dabigatran, the first non\u2013vitamin K antagonist oral anticoagulant (NOAC), became available. Objectives This study sought to describe phase 2 baseline data and compare these with the pre-NOAC era collected during phase&nbsp;1. Methods During phase 2, 15,641 consenting patients were enrolled (November 2011 to December 2014); 15,092 were eligible. This pre-specified cross-sectional analysis describes eligible patients\u2019 baseline characteristics. Atrial fibrillation&nbsp;disease characteristics, medical outcomes, and concomitant diseases and medications were collected. Data were analyzed using descriptive statistics. Results Of the total patients, 45.5% were female; median age was 71 (interquartile range: 64, 78) years. Patients were from Europe (47.1%), North America (22.5%), Asia (20.3%), Latin America (6.0%), and the Middle East/Africa (4.0%). Most had high stroke risk (CHA2DS2-VASc [Congestive heart failure, Hypertension, Age&nbsp; 6575 years, Diabetes mellitus, previous Stroke, Vascular disease, Age 65 to 74 years, Sex category] score&nbsp; 652; 86.1%); 13.9% had moderate risk (CHA2DS2-VASc&nbsp;= 1). Overall, 79.9% received oral anticoagulants, of whom 47.6% received NOAC and 32.3% vitamin K antagonists (VKA); 12.1% received antiplatelet agents; 7.8% received no antithrombotic treatment. For comparison, the proportion of phase 1 patients (of N&nbsp;= 1,063 all eligible) prescribed VKA was 32.8%, acetylsalicylic acid 41.7%, and no therapy 20.2%. In Europe in phase 2, treatment with NOAC was more common than VKA (52.3% and 37.8%, respectively); 6.0% of patients received antiplatelet treatment; and 3.8% received no antithrombotic treatment. In North America, 52.1%, 26.2%, and 14.0% of patients received NOAC, VKA, and antiplatelet drugs, respectively; 7.5% received no antithrombotic treatment. NOAC use was less common in Asia (27.7%), where 27.5% of patients received VKA, 25.0% antiplatelet drugs, and 19.8% no antithrombotic treatment. Conclusions The baseline data from GLORIA-AF phase 2 demonstrate that in newly diagnosed nonvalvular atrial fibrillation patients, NOAC have been highly adopted into practice, becoming more frequently prescribed than VKA in&nbsp;Europe and North America. Worldwide, however, a large proportion of patients remain undertreated, particularly in&nbsp;Asia&nbsp;and North America. (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation [GLORIA-AF]; NCT01468701

Ethical issues in competing clinical trials

The proliferation of clinical trials in the last decade and the relatively limited number of experienced clinical trial sites in comparison has created in some sites an environment of clinical trial abundance. As clinical trial protocols typically restrict patients from concurrent clinical trial participation, and patients may be eligible for more than one trial at any given time, selecting the best trial for an individual patient requires evaluation of not only the merits of the individual trials but also patient preferences. This article highlights some potential ethical issues which should be considered when clinical trials are raised as a treatment option and when patients are eligible for more than one trial at the time of evaluation. Keywords: Clinical trials, Ethic

Systematic review of treatment gaps in oral anticoagulant use in atrial fibrillation

Aims: Guidelines endorse long-term oral anticoagulation (OAC) for stroke prophylaxis in patients with atrial fibrillation (AF) and additional stroke risk factors. However, diverse estimates of guideline based OAC treatment are reported. The objective was to provide insight into the variability seen in estimates of OAC treatment uptake and treatment gaps in clinical practice. Methods and results: A systematic review was conducted following Cochrane methodology, using comprehensive search terms for AF and anticoagulation. MEDLINE and EMBASE databases (January 2006–2016) were searched, and prospective and retrospective observational studies reporting OAC use included. Study data and patient characteristics were extracted, OAC rates pooled by study factors, and meta-regression analysis conducted to identify factors associated with OAC uptake.Of 8861 records screened, 155 eligible datasets from 147 studies were identified [median (25th, 75th percentiles) 2259 (595, 10,240) patients, mean age 73.8 ± 7.1 years]. The majority of studies included AF patients with CHA2DS2-VASc >1 [median proportion (25th, 75th percentile) 0.92 (0.83, 1.00)]. OAC use varied across studies [median proportion (25th, 75th percentile) 51.2% (36.7%, 64.7%)] with high heterogeneity (I2 = 100.0%). In the meta-regression analysis [coefficient, p], prospective study design (0.093, p = 0.008), general practitioner treating physician (0.105, p = 0.001) and data collection after 2013 (0.072, p = 0.070) were associated with higher OAC use. Consecutive enrollment (−0.075, p = 0.008) and Asian region (−0.181, p < 0.001) were associated with lower OAC use. Conclusion: Study factors, geographical and treatment settings are associated with estimates of OAC use and are important considerations for researchers and policy makers to appropriately interpret reported anticoagulation treatment rates. Consideration of these factors may help to more effectively measure interventions, and design studies to improve anticoagulation uptake