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Martin R Miller,1 Shamil Haroon,1 Rachel E Jordan,1 Alice J Sitch,1 Andrew P Dickens,1 Alexandra Enocson,1 David A Fitzmaurice,2 Peymané Adab1 1Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, UK; 2Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK Background: Consensus on the definition of airflow obstruction to diagnose COPD remains unresolved.Methods: We undertook systematic case finding for COPD in primary care using the fixed ratio (FR) criterion (forced expiratory volume in 1 s/forced vital capacity [FEV1/FVC]

Alexandra Enocson, Kate Jolly, Rachel Elizabeth Jordan, David A Fitzmaurice, SM Greenfield, Peymane Adab On behalf of the BLISS research team Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, UK Background: COPD is a leading cause of morbidity and mortality, yet it remains largely underdiagnosed. Case-finding is encouraged by many professionals, but there is a lack of information on the patients’ views and perspectives. Patients and methods: Semistructured interviews were conducted with adults, aged 40 years or older with a history of smoking, who were eligible and invited for case-finding for COPD as a part of a large UK primary care trial. Patients, including those who consented or declined participation and those with and without COPD after screen­ing, were interviewed. Interviews were transcribed and analyzed using the framework method.Results: The 43 interviews revealed the following two main categories of themes: patients’ views on COPD case-finding and barriers to case-finding. Overall, case-finding was deemed important and beneficial. Partici­pants highlighted the need for screening activities to be convenient for patients but perceived that general practitioners (GPs) lacked the time and accessing appointments was difficult. Desire for a health check among symptomatic patients facilitated participation in case-finding. Psychological barriers to engagement included denial of ill health or failure to recognize symptoms, fear of the “test”, and lung symptoms being low on the hierarchy of patient health complaints. Mechanical barriers included providing care for another person (and therefore being too busy), being unable to access GP appointments, and lacking feedback of spirometry results or communication of the diagnosis.Conclusion: Patient engagement with case-finding may be limited by denial or lack of recognition of symptoms and physical barriers to attendance. Increasing public awareness of COPD risk factors and early symptoms may enhance case-finding. Keywords: COPD, screening, qualitative research, primary care

Maria-Christina Kosteli,1 Nicola R Heneghan,1 Carolyn Roskell,1 Sarah E Williams,1 Peymane Adab,2 Andrew P Dickens,2 Alexandra Enocson,2 David A Fitzmaurice,2 Kate Jolly,2 Rachel Jordan,2 Sheila Greenfield,2 Jennifer Cumming1 1School of Sport, Exercise and Rehabilitation Sciences, 2Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, UK Background: Given that physical activity (PA) has a positive impact on COPD symptoms and prognosis, this study examined the factors that both encourage and limit participation in PA for individuals with COPD in a primary care setting from the perspective of social cognitive theory.Methods: A purposive sample of 26 individuals with a range of COPD severity (age range: 50–89 years; males =15) were recruited from primary care to participate in one of four focus groups. Thematic analysis was undertaken to identify key concepts related to their self-efficacy beliefs.Results: Several barriers and enablers closely related to self-efficacy beliefs and symptom severity were identified. The main barriers were health related (fatigue, mobility problems, breathing issues caused by the weather), psychological (embarrassment, fear, frustration/disappointment), attitudinal (feeling in control of their condition, PA perception, older age perception), and motivational. The main enabling factors were related to motivation (autonomous or controlled), attitudes, self-regulation, and performance accomplishments.Clinical implications: When designing interventions for individuals with COPD, it is important to understand the patient-specific social cognitive influences on PA participation. This information can then inform individually tailored management planning. Keywords: COPD, social cognitive theory, self-efficacy, barriers, enablers, primary care

Kiran K Rai,1 Rachel E Jordan,1 W Stanley Siebert,2 Steven S Sadhra,3 David A Fitzmaurice,1 Alice J Sitch,1 Jon G Ayres,1,3 Peymané Adab1 1Institute of Applied Health Research, 2The Department of Business and Labour Economics, 3Institute of Clinical Sciences, University of Birmingham, Edgbaston, Birmingham, UK Background: Employment rates among those with chronic obstructive pulmonary disease (COPD) are lower than those without COPD, but little is known about the factors that affect COPD patients’ ability to work. Methods: Multivariable analysis of the Birmingham COPD Cohort Study baseline data was used to assess the associations between lifestyle, clinical, and occupational characteristics and likelihood of being in paid employment among working-age COPD patients. Results: In total, 608 of 1,889 COPD participants were of working age, of whom 248 (40.8%) were in work. Older age (60–64 years vs 30–49 years: odds ratio [OR] =0.28; 95% confidence interval [CI] =0.12–0.65), lower educational level (no formal qualification vs degree/higher level: OR =0.43; 95% CI =0.19–0.97), poorer prognostic score (highest vs lowest quartile of modified body mass index, airflow obstruction, dyspnea, and exercise (BODE) score: OR =0.10; 95% CI =0.03–0.33), and history of high occupational exposure to vapors, gases, dusts, or fumes (VGDF; high VGDF vs no VGDF exposure: OR =0.32; 95% CI =0.12–0.85) were associated with a lower probability of being employed. Only the degree of breathlessness of BODE was significantly associated with employment. Conclusion: This is the first study to comprehensively assess the characteristics associated with employment in a community sample of people with COPD. Future interventions should focus on managing breathlessness and reducing occupational exposures to VGDF to improve the work capability among those with COPD. Keywords: chronic obstructive pulmonary disease, work, employed, breathlessness, severity, VGDF, UK

Kate Jolly,1 Saimma Majothi,1 Alice J Sitch,1 Nicola R Heneghan,2 Richard D Riley,3 David J Moore,1 Elizabeth J Bates,1 Alice M Turner,4 Susan E Bayliss,1 Malcolm J Price,1 Sally J Singh,5 Peymane Adab,1 David A Fitzmaurice,1 Rachel E Jordan11Institute of Applied Health Research, 2School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Edgbaston, Birmingham, 3Research Institute of Primary Care and Health Sciences, Keele University, Keele, Staffordshire, 4Institute of Inflammation and Ageing, University of Birmingham, Birmingham, 5Centre for Exercise and Rehabilitation Science, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UKPurpose: This systematic review aimed to identify the most effective components of interventions to facilitate self-management of health care behaviors for patients with COPD. PROSPERO registration number CRD42011001588.Methods: We used standard review methods with a systematic search to May 2012 for randomized controlled trials of self-management interventions reporting hospital admissions or health-related quality of life (HRQoL). Mean differences (MD), hazard ratios, and 95% confidence intervals (CIs) were calculated and pooled using random-effects meta-analyses. Effects among different subgroups of interventions were explored including single/multiple components and multicomponent interventions with/without exercise.Results: One hundred and seventy-three randomized controlled trials were identified. Self-management interventions had a minimal effect on hospital admission rates. Multicomponent interventions improved HRQoL (studies with follow-up >6 months St George’s Respiratory Questionnaire (MD 2.40, 95% CI 0.75–4.04, I2 57.9). Exercise was an effective individual component (St George’s Respiratory Questionnaire at 3 months MD 4.87, 95% CI 3.96–5.79, I2 0%).Conclusion: While many self-management interventions increased HRQoL, little effect was seen on hospital admissions. More trials should report admissions and follow-up participants beyond the end of the intervention. Keywords: COPD, self-management, systematic review, meta-analysis

Shamil Haroon, Rachel E Jordan, David A Fitzmaurice, Peymane AdabSchool of Health and Population Sciences, University of Birmingham, Edgbaston, Birmingham, UKBackground: Chronic obstructive pulmonary disease (COPD) is common but largely underdiagnosed. Case-finding initiatives have been evaluated in primary care, but few studies have explored the views of service providers on implementing them in practice.Aim: To explore the views of primary health care providers on case finding for COPD.Methods: A total of 20 semi-structured interviews were conducted from March 2014 to September 2014 among general practitioners, nurses, and managers from practices participating in a large COPD case-finding trial based in primary care in the West Midlands, UK. Participants’ views were sought to explore perceived benefits, harms, barriers, and facilitators to implementing COPD case finding in practice. Interviews were transcribed and analyzed using the framework method.Results: Participants felt that case finding improves patient care but also acknowledged potential harms to providers (increase in workload) and to patients (overdiagnosis). Insufficient resources, poor knowledge of COPD, and limited access to diagnostic services were viewed as barriers to diagnosis, while provision of community respiratory services, including COPD specialist nurses, and support from secondary care were thought to be facilitators. Participants also expressed a need for more education on COPD for both patients and clinicians.Conclusion: Care providers believe that early detection of COPD improves patient care but also has accompanying harms. Barriers to diagnosing COPD, such as insufficient expertise in primary care and limited access to diagnostic services in the community, should be explored and addressed. The knowledge and attitudes of the public about COPD and its symptoms should also be investigated to inform future education and awareness-raising strategies.Keywords: chronic obstructive pulmonary disease, primary care, diagnosis, qualitative research

Saimma Majothi,1 Kate Jolly,1 Nicola R Heneghan,2 Malcolm J Price,1 Richard D Riley,3 Alice M Turner,4 Susan E Bayliss,1 David J Moore,1 Sally J Singh,5 Peymané Adab,1 David A Fitzmaurice,6 Rachel E Jordan1 1Public Health, Epidemiology and Biostatistics, School of Health and Population Sciences, University of Birmingham, Birmingham, UK; 2School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK; 3Research Institute of Primary Care and Health Sciences, Keele University, Staffordshire, UK; 4Queen Elizabeth Hospital Research Laboratories, Birmingham, UK; 5Centre for Exercise and Rehabilitation Science, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, UK; 6Primary Care Clinical Sciences, School of Health and Population Sciences, University of Birmingham, Birmingham, UK Purpose: Although many hospitals promote self-management to chronic obstructive pulmonary disease (COPD) patients post discharge from hospital, the clinical effectiveness of this is unknown. We undertook a systematic review of the evidence as part of a Health Technology Assessment review.Methods: A comprehensive search strategy with no language restrictions was conducted across relevant databases from inception to May 2012. Randomized controlled trials of patients with COPD, recently discharged from hospital after an acute exacerbation and comparing a self-management intervention with control, usual care or other intervention were included. Study selection, data extraction, and risk of bias assessment were undertaken by two reviewers independently. Results: Of 13,559 citations, 836 full texts were reviewed with nine randomized controlled trials finally included in quantitative syntheses. Interventions were heterogeneous. Five trials assessed highly supported multi-component interventions and four trials were less supported with fewer contacts with health care professionals and mainly home-based interventions. Total sample size was 1,466 (range 33–464 per trial) with length of follow-up 2–12 months. Trials varied in quality; poor patient follow-up and poor reporting was common. No evidence of effect in favor of self-management support was observed for all-cause mortality (pooled hazard ratio =1.07; 95% confidence interval [0.74 to 1.55]; I2=0.0%, [n=5 trials]). No clear evidence of effect on all-cause hospital admissions was observed (hazard ratio 0.88 [0.61, 1.27] I2=66.0%). Improvements in St George’s Respiratory Questionnaire score were seen in favor of self-management interventions (mean difference =3.84 [1.29 to 6.40]; I2=14.6%), although patient follow-up rates were low.Conclusion: There is insufficient evidence to support self-management interventions post-discharge. There is a need for good quality primary research to identify effective approaches. Keywords: chronic obstructive pulmonary disease, self-management support, post-discharge, systematic review

Aim: To establish and evaluate an external quality assessment scheme for warfarin dosing for users of a computerised decision support system, BAP-PC. Design: Analysis of 12 months of clinical data [...]

Background: Increasing indications for warfarin therapy has led to increased pressure on primary care to undertake therapeutic monitoring.Objective: This study evaluates a primary care model of oral anticoagulation monitoring which utilises computerized decision support (CDSS) and near patient testing (NPT) within a practice nurse-led clinic. Whilst this has been shown to be a successful model under trial conditions, this paper reports the first data from a long-standing clinic, outside a formal study.Method: A prospective evaluation of therapeutic and clinical control of all patients taking warfarin within one inner city general practice. Data were collected via CDSS.Results: 29 patients were seen in 208 appointments. The mean percentage of patients within therapeutic range was 72%. The costs to the practice were pound sterling 1751. The costs the practice would have incurred had these patients been seen at the hospital with the same frequency would have been pound sterling 2290.Conclusions: The use of CDSS and NPT for nurse-delivered oral anticoagulation monitoring could enable the safe transfer of the majority of patients from secondary to primary care. Funding mechanisms to support the transfer of costs will be essential for most practices, as will be the maintenance of adequate staff training and quality assurance. [ABSTRACT FROM AUTHOR]

Background: The GARFIELD-AF tool is a novel risk tool that simultaneously assesses the risk of all-cause mortality, stroke or systemic embolism, and major bleeding in patients with atrial fibrillation (AF)., Aim: To validate the GARFIELD-AF tool using UK primary care electronic records., Design and Setting: A retrospective cohort study using the Clinical Practice Research Datalink (CPRD) linked with Hospital Episode Statistics data and Office for National Statistics mortality data., Method: Discrimination was evaluated using the area under the curve (AUC) and calibration was evaluated using calibration-in-the-large regression and calibration plots., Results: A total of 486 818 patients aged ≥18 years with incident diagnosis of non-valvular AF between 2 January 1998 and 31 July 2020 were included; 50.6% ( n = 246 425/486 818) received anticoagulation at diagnosis The GARFIELD- AF models outperformed the CHA 2 DS 2 VASc and HAS-BLED scores in discrimination ability of death, stroke, and major bleeding at all the time points. The AUC for events at 1 year for the 2017 models were: death 0.747 (95% confidence interval [CI] = 0.744 to 0.751) versus 0.635 (95% CI = 0.631 to 0.639) for CHA 2 DS 2 VASc; stroke 0.666 (95% CI = 0.663 to 0.669) versus 0.625 (95% CI = 0.622 to 0.628) for CHA 2 DS 2 VASc; and major bleeding 0.602 (95% CI = 0.598 to 0.606) versus 0.558 (95% CI = 0.554 to 0.562) for HAS- BLED. Calibration between predicted and Kaplan- Meier observed events was inadequate with the GARFIELD-AF models., Conclusion: The GARFIELD-AF models were superior to the CHA 2 DS 2 VASc score for discriminating stroke and death and superior to the HAS-BLED score for discriminating major bleeding. The models consistently underpredicted the level of risk, suggesting that a recalibration is needed to optimise its use in the UK population., (© The Authors.)

This guideline has been written on behalf of the International Council for Standardisation in Haematology (ICSH) and focuses on two point of care haematology tests used within primary care, namely International Normalised Ratio (INR) and D-dimer. Primary care covers out of hospital settings and can include General Practice (GP), Pharmacy and other non-hospital settings (although these guidelines would also be applicable to hospital out-patient settings). The recommendations are based on published data in peer reviewed literature and expert opinion; they should supplement regional requirements, regulations or standards., (© 2023 John Wiley & Sons Ltd.)

Introduction: Atrial fibrillation (AF) is a common arrhythmia associated with 30% of strokes, as well as other cardiovascular disease, dementia and death. AF meets many criteria for screening, but there is limited evidence that AF screening reduces stroke. Consequently, no countries recommend national screening programmes for AF. The Screening for Atrial Fibrillation with ECG to Reduce stroke (SAFER) trial aims to determine whether screening for AF is effective at reducing risk of stroke. The aim of the pilot study is to assess feasibility of the main trial and inform implementation of screening and trial procedures., Methods and Analysis: SAFER is planned to be a pragmatic randomised controlled trial (RCT) of over 100 000 participants aged 70 years and over, not on long-term anticoagulation therapy at baseline, with an average follow-up of 5 years. Participants are asked to record four traces every day for 3 weeks on a hand-held single-lead ECG device. Cardiologists remotely confirm episodes of AF identified by the device algorithm, and general practitioners follow-up with anticoagulation as appropriate. The pilot study is a cluster RCT in 36 UK general practices, randomised 2:1 control to intervention, recruiting approximately 12 600 participants. Pilot study outcomes include AF detection rate, anticoagulation uptake and other parameters to incorporate into sample size calculations for the main trial. Questionnaires sent to a sample of participants will assess impact of screening on psychological health. Process evaluation and qualitative studies will underpin implementation of screening during the main trial. An economic evaluation using the pilot data will confirm whether it is plausible that screening might be cost-effective., Ethics and Dissemination: The London-Central Research Ethics Committee (19/LO/1597) and Confidentiality Advisory Group (19/CAG/0226) provided ethical approval. Dissemination will be via publications, patient-friendly summaries, reports and engagement with the UK National Screening Committee., Trial Registration Number: ISRCTN72104369., Competing Interests: Competing interests: JM has performed consultancy work for BMS/Pfizer and Omron. FDRH reports occasional consultancy for BMS/Pfizer, Bayer and BI over the past 5 years. NA is a member of the UK National Screening Committee’s Adult Reference Group. MS is a full-time employee of AstraZeneca. MRC reports consultancy for AstraZeneca, Abbott, Medtronic, Bayer, Novartis, Boehringer-Ingelheim-Lilly Alliance, Servier & Pfizer over the past 5 years. RMc’s employer the University of Oxford receives consultancy and licencing payments from Omron and Sensyne for BP telemonitoring interventions. GYHL: Consultant and speaker for BMS/Pfizer, Boehringer Ingelheim and Daiichi-Sankyo. No fees are received personally. SJG has received honoraria from Astra Zeneca for lectures at postgraduate educational meetings for primary care teams about type 2 diabetes. BF has received speaker fees, honoraria, and non-financial support from the BMS and Pfizer Alliance; grants to the Institution for investigator-initiated studies from the BMS and Pfizer Alliance; and loan devices for investigatorinitiated studies from Alivecor: all were unrelated to the present study but related to screening for AF., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Aims: To determine whether the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) integrated risk tool predicts mortality, non-haemorrhagic stroke/systemic embolism, and major bleeding for up to 2 years after new-onset AF and to assess how this risk tool performs compared with CHA2DS2-VASc and HAS-BLED., Methods and Results: Potential predictors of events included demographic and clinical characteristics, choice of treatment, and lifestyle factors. A Cox proportional hazards model was identified for each outcome by least absolute shrinkage and selection operator methods. Indices were evaluated in comparison with CHA2DS2-VASc and HAS-BLED risk predictors. Models were validated internally and externally in ORBIT-AF and Danish nationwide registries. Among the 52 080 patients enrolled in GARFIELD-AF, 52 032 had follow-up data. The GARFIELD-AF risk tool outperformed CHA2DS2-VASc for all-cause mortality in all cohorts. The GARFIELD-AF risk score was superior to CHA2DS2-VASc for non-haemorrhagic stroke, and it outperformed HAS-BLED for major bleeding in internal validation and in the Danish AF cohort. In very low- to low-risk patients [CHA2DS2-VASc 0 or 1 (men) and 1 or 2 (women)], the GARFIELD-AF risk score offered strong discriminatory value for all the endpoints when compared to CHA2DS2-VASc and HAS-BLED. The GARFIELD-AF tool also included the effect of oral anticoagulation (OAC) therapy, thus allowing clinicians to compare the expected outcome of different anticoagulant treatment decisions [i.e. no OAC, non-vitamin K antagonist (VKA) oral anticoagulants, or VKAs]., Conclusions: The GARFIELD-AF risk tool outperformed CHA2DS2-VASc at predicting death and non-haemorrhagic stroke, and it outperformed HAS-BLED for major bleeding in overall as well as in very low- to low-risk group patients with AF., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier for GARFIELD-AF: NCT01090362, ORBIT-AF I: NCT01165710; ORBIT-AF II: NCT01701817., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Objective: To investigate the clinical outcomes of patients who underwent cardioversion compared with those who did not have cardioverson in a large dataset of patients with recent onset non-valvular atrial fibrillation., Design: Observational study using prospectively collected registry data (Global Anticoagulant Registry in the FIELD-AF-GARFIELD-AF)., Setting: 1317 participating sites in 35 countries., Participants: 52 057 patients aged 18 years and older with newly diagnosed atrial fibrillation (up to six weeks' duration) and at least one investigator determined stroke risk factor., Main Outcome Measures: Comparisons were made between patients who received cardioversion and those who had no cardioversion at baseline, and between patients who received direct current cardioversion and those who had pharmacological cardioversion. Overlap propensity weighting with Cox proportional hazards models was used to evaluate the effect of cardioversion on clinical endpoints (all cause mortality, non-haemorrhagic stroke or systemic embolism, and major bleeding), adjusting for baseline risk and patient selection., Results: 44 201 patients were included in the analysis comparing cardioversion and no cardioversion, and of these, 6595 (14.9%) underwent cardioversion at baseline. The propensity score weighted hazard ratio for all cause mortality in the cardioversion group was 0.74 (95% confidence interval 0.63 to 0.86) from baseline to one year follow-up and 0.77 (0.64 to 0.93) from one year to two year follow-up. Of the 6595 patients who had cardioversion at baseline, 299 had a follow-up cardioversion more than 48 days after enrolment. 7175 patients were assessed in the analysis comparing type of cardioversion: 2427 (33.8%) received pharmacological cardioversion and 4748 (66.2%) had direct current cardioversion. During one year follow-up, event rates (per 100 patient years) for all cause mortality in patients who received direct current and pharmacological cardioversion were 1.36 (1.13 to 1.64) and 1.70 (1.35 to 2.14), respectively., Conclusion: In this large dataset of patients with recent onset non-valvular atrial fibrillation, a small proportion were treated with cardioversion. Direct current cardioversion was performed twice as often as pharmacological cardioversion, and there appeared to be no major difference in outcome events for these two cardioversion modalities. For the overall cardioversion group, after adjustments for confounders, a significantly lower risk of mortality was found in patients who received early cardioversion compared with those who did not receive early cardioversion., Study Registration: ClinicalTrials.gov NCT01090362., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from Kantor Charitable Foundation for the Kantor-Kakkar Global Centre for Thrombosis Science for the submitted work. TSH reports personal fees from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Imedic, Novartis, MSD, Sanofi, and Pfizer. JYLH reports personal fees from Bayer, BMS/Pfizer, Boehringer Ingelheim, and Daiichi-Sankyo. PJ has served as a consultant or on an advisory board for Bayer, Boehringer Ingelheim, and Novartis. RC reports research grants from Boston Scientific, Medtronic, Abbott, Pfizer, Daiichi Sankyo, Biosense Webster, Boehringer Ingelheim, Johnson and Johnson, and personal fees from Boston Scientific, Medtronic, Biosense Webster, Abbott. DA reports personal fees from Bayer, Boehringer-Ingelheim, Bristol Meier Squibb, MSD and Pfizer, and grants to the institution from Medtronic and BMS. AJC has received institutional grant funding and personal fees from Bayer, Boehringer Ingelheim, Bristol Meier Squibb, Daiichi Sankyo, and Pfizer. AKK has received grants from Bayer AG, and Sanofi, personal fees from Bayer AG, Janssen, Pfizer, Sanofi, Verseon, and Anthos Therapeutics. All other authors have reported that they have no relationships relevant to the content of this paper to disclose., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Oral anticoagulation (OAC) in atrial fibrillation (AF) reduces the risk of stroke/systemic embolism (SE). The impact of OAC discontinuation is less well documented., Objective: Investigate outcomes of patients prospectively enrolled in the Global Anticoagulant Registry in the Field-Atrial Fibrillation study who discontinued OAC., Methods: Oral anticoagulation discontinuation was defined as cessation of treatment for ≥7 consecutive days. Adjusted outcome risks were assessed in 23 882 patients with 511 days of median follow-up after discontinuation., Results: Patients who discontinued (n = 3114, 13.0%) had a higher risk (hazard ratio [95% CI]) of all-cause death (1.62 [1.25-2.09]), stroke/systemic embolism (SE) (2.21 [1.42-3.44]) and myocardial infarction (MI) (1.85 [1.09-3.13]) than patients who did not, whether OAC was restarted or not. This higher risk of outcomes after discontinuation was similar for patients treated with vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) (p for interactions range = 0.145-0.778). Bleeding history (1.43 [1.14-1.80]), paroxysmal vs. persistent AF (1.15 [1.02-1.29]), emergency room care setting vs. office (1.37 [1.18-1.59]), major, clinically relevant nonmajor, and minor bleeding (10.02 [7.19-13.98], 2.70 [2.24-3.25] and 1.90 [1.61-2.23]), stroke/SE (4.09 [2.55-6.56]), MI (2.74 [1.69-4.43]), and left atrial appendage procedures (4.99 [1.82-13.70]) were predictors of discontinuation. Age (0.84 [0.81-0.88], per 10-year increase), history of stroke/transient ischemic attack (0.81 [0.71-0.93]), diabetes (0.88 [0.80-0.97]), weeks from AF onset to treatment (0.96 [0.93-0.99] per week), and permanent vs. persistent AF (0.73 [0.63-0.86]) were predictors of lower discontinuation rates., Conclusions: In GARFIELD-AF, the rate of discontinuation was 13.0%. Discontinuation for ≥7 consecutive days was associated with significantly higher all-cause mortality, stroke/SE, and MI risk. Caution should be exerted when considering any OAC discontinuation beyond 7 days., (© 2021 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis.)

Objectives: This study evaluated the comparative effectiveness of vitamin K antagonists (VKAs), direct thrombin inhibitors (DTIs) and factor Xa inhibitors (FXaI) in patients with atrial fibrillation (AF) at risk of stroke in everyday practice., Methods: Data from patients with AF and Congestive heart failure, Hypertension, Age 75 years, Diabetes mellitus, prior Stroke, TIA, or thromboembolism, Vascular disease, Age 65-74 years, Sex category (CHA 2 DS 2 -VASc) score ≥2 (excluding gender) in the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation registry were analysed using an improved method of propensity weighting, overlap weights and Cox proportional hazards models., Results: All-cause mortality, non-haemorrhagic stroke/systemic embolism (SE) and major bleeding over 2 years were compared in 25 551 patients, 7162 (28.0%) not treated with oral anticoagulant (OAC) and 18 389 (72.0%) treated with OAC (FXaI (41.8%), DTI (11.4%) and VKA (46.8%)). OAC treatment compared with no OAC treatment was associated with decreased risk of all-cause mortality (HR 0.82 (95% CI 0.74 to 0.91)) and non-haemorrhagic stroke/SE (HR 0.71 (95% CI 0.57 to 0.88)) but increased risk of major bleeding (HR 1.46 (95% CI 1.15 to 1.86)). Non-vitamin K antagonist oral anticoagulant (NOAC) use compared with no OAC treatment was associated with lower risks of all-cause mortality and non-haemorrhagic stroke/SE (HR 0.67 (95% CI 0.59 to 0.77)) and 0.65 (95% CI 0.50 to 0.86)) respectively, with no increase in major bleeding (HR 1.10 (95% CI 0.82 to 1.47)). NOAC use compared with VKA use was associated with lower risk of all-cause mortality and major bleeding (rates/100 patient-years 3.6 (95% CI 3.3 to 3.9) vs 4.8 (95% CI 4.5 to 5.2) and 1.0 (95% CI 0.9 to 1.1) vs 1.4 (95% CI 1.2 to 1.6); HR 0.79 (95% CI 0.70 to 0.89) and 0.77 (95% CI 0.61 to 0.98) respectively), with similar risk of non-haemorrhagic stroke/SE (rates/100 patient-years 0.8 (95% CI 0.7 to 0.9) versus 1.0 (95% CI 0.8 to 1.1); HR 0.96 (95% CI 0.73 to 1.25)., Conclusion: Important benefits in terms of mortality and major bleeding were observed with NOAC versus VKA with no difference among NOAC subtypes., Trial Registration Number: NCT01090362., Competing Interests: Competing interests: AJC has received institutional grants and personal fees from Bayer, Boehringer Ingelheim, Pfizer/BMS and Daiichi Sankyo. KAAF has received grants and personal fees from Bayer/Janssen and AstraZeneca and personal fees from Sanofi/Regeneron and Verseon outside the submitted work. DF reports personal fees from Bayer outside the submitted work. BJG reports Data Safety Monitoring Board–Mount Sinai St Luke’s, Boston Scientific Corporation, St Jude Medical Inc, Janssen Research & Development LLC, Thrombosis Research Institute, Duke Clinical Research Institute, Duke University, Kowa Research Institute Inc, Cardiovascular Research Foundation, and Medtronic and general consulting for Janssen Scientific Affairs, Xenon Pharmaceuticals and Sirtex Medical Limited. SG has received research support from BiO2 Medical, Boehringer-Ingelheim, BMS, Boston Scientific, Daiichi, Janssen, NHLBI and the Thrombosis Research Institute; has served as a consultant for, Bayer, Boehringer-Ingelheim, BMS, Daiichi and Janssen. ShG has received personal fees from the Thrombosis Research Institute, Harvard University, the American Heart Association, and grants from the Vehicle Racing Commemorative Foundation, Nakatani Foundation for Advancement of Measuring Technologies in Biomedical Engineering, Bristol-Myers Squibb, Sanofi, Ono and Pfizer. SH has received personal fees from Aspen, Bayer Healthcare, BMS/Pfizer, Daiichi-Sankyo, Portola and Sanofi. FM is an employee of Bayer AG. AGGT has received personal fees from Bayer Healthcare, Janssen Pharmaceutical Research & Development LLC, Portola. FWAV has received grants from Bayer Healthcare; personal fees from Bayer Healthcare, BMS/Pfizer, Daiichi-Sankyo, and Boehringer-Ingelheim. RC reports reports a research grants from Boston Scientific, Medtronic, Abbott, Pfizer, Daiichi Sankyo, Biosense Webster, Boehringer Ingelheim, Jhonson and Jhonson and personale fee from Boston Scientific, Medtronic, Biosense Webster, Abbott. AKK has received grants from Bayer AG and Sanofi; personal fees from Bayer AG, Janssen, Pfizer, Sanofi, Verseon and Anthos Therapeutics. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)