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1.
medrxiv; 2024.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2024.02.12.24302698

ABSTRACT

Using longitudinal health records from 45.7 million adults in England followed for a year, our study compared the incidence of thrombotic and cardiovascular complications after first, second and booster doses of brands and combinations of COVID-19 vaccines used during the first two years of the UK vaccination program with the incidence before or without the corresponding vaccination. The incidence of common arterial thrombotic events (mainly acute myocardial infarction and ischaemic stroke) was generally lower after each vaccine dose, brand and combination. Similarly, the incidence of common venous thrombotic events, (mainly pulmonary embolism and lower limb deep venous thrombosis) was lower after vaccination. There was a higher incidence of previously reported rare harms after vaccination: vaccine-induced thrombotic thrombocytopenia after first ChAdOx1 vaccination, and myocarditis and pericarditis after first, second and transiently after booster mRNA vaccination (BNT-162b2 and mRNA- 1273) These findings support the wide uptake of future COVID-19 vaccination programs.


Subject(s)
Pulmonary Embolism , Myocardial Infarction , Venous Thromboembolism , Pericarditis , Cardiovascular Diseases , Cerebral Infarction , Thrombosis , Myocarditis , COVID-19 , Venous Thrombosis , Purpura, Thrombotic Thrombocytopenic
3.
medrxiv; 2023.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2023.12.06.23299602

ABSTRACT

Background: COVID-19 is associated with subsequent mental illness in both hospital- and population-based studies. Evidence regarding effects of COVID-19 vaccination on mental health consequences of COVID-19 is limited. Methods: With the approval of NHS England, we used linked electronic health records (OpenSAFELY-TPP) to conduct analyses in a 'pre-vaccination' cohort (17,619,987 people) followed during the wild-type/Alpha variant eras (January 2020-June 2021), and 'vaccinated' and 'unvaccinated' cohorts (13,716,225 and 3,130,581 people respectively) during the Delta variant era (June-December 2021). We estimated adjusted hazard ratios (aHRs) comparing the incidence of mental illness after diagnosis of COVID-19 with the incidence before or without COVID-19. Outcomes: We considered eight outcomes: depression, serious mental illness, general anxiety, post-traumatic stress disorder, eating disorders, addiction, self-harm, and suicide. Incidence of most outcomes was elevated during weeks 1-4 after COVID-19 diagnosis, compared with before or without COVID-19, in each cohort. Vaccination mitigated the adverse effects of COVID-19 on mental health: aHRs (95% CIs) for depression and for serious mental illness during weeks 1-4 after COVID-19 were 1.93 (1.88-1.98) and 1.42 (1.24-1.61) respectively in the pre-vaccination cohort and 1.79 (1.68-1.91) and 2.21 (1.99-2.45) respectively in the unvaccinated cohort, compared with 1.16 (1.12-1.20) and 0.91 (0.84-0.98) respectively in the vaccinated cohort. Elevation in incidence was higher, and persisted for longer, after hospitalised than non-hospitalised COVID-19. Interpretation: Incidence of mental illness is elevated for up to a year following severe COVID-19 in unvaccinated people. Vaccination mitigates the adverse effect of COVID-19 on mental health. Funding: Medical Research Council (MC_PC_20059) and NIHR (COV-LT-0009).


Subject(s)
Anxiety Disorders , Depressive Disorder , Intellectual Disability , COVID-19 , Stress Disorders, Traumatic , Feeding and Eating Disorders
4.
medrxiv; 2023.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2023.08.07.23293778

ABSTRACT

Background Type 2 diabetes (T2DM) incidence is increased after diagnosis of COVID-19. The impact of vaccination on this increase, for how long it persists, and the effect of COVID-19 on other types of diabetes remain unclear. Methods With NHS England approval, we studied diabetes incidence following COVID-19 diagnosis in pre-vaccination (N=15,211,471, January 2020-December 2021), vaccinated (N =11,822,640), and unvaccinated (N=2,851,183) cohorts (June-December 2021), using linked electronic health records. We estimated adjusted hazard ratios (aHRs) comparing diabetes incidence post-COVID-19 diagnosis with incidence before or without diagnosis up to 102 weeks post-diagnosis. Results were stratified by COVID-19 severity (hospitalised/non-hospitalised) and diabetes type. Findings In the pre-vaccination cohort, aHRS for T2DM incidence after COVID-19 (compared to before or without diagnosis) declined from 3.01 (95% CI: 2.76,3.28) in weeks 1-4 to 1.24 (1.12,1.38) in weeks 53-102. aHRS were higher in unvaccinated than vaccinated people (4.86 (3.69,6.41)) versus 1.42 (1.24,1.62) in weeks 1-4) and for hospitalised COVID-19 (pre-vaccination cohort 21.1 (18.8,23.7) in weeks 1-4 declining to 2.04 (1.65,2.51) in weeks 52-102), than non-hospitalised COVID-19 (1.45 (1.27,1.64) in weeks 1-4, 1.10 (0.98,1.23) in weeks 52-102). T2DM persisted for 4 months after COVID-19 for ~73% of those diagnosed. Patterns were similar for Type 1 diabetes, though excess incidence did not persist beyond a year post-COVID-19. Interpretation Elevated T2DM incidence after COVID-19 is greater, and persists longer, in hospitalised than non-hospitalised people. It is markedly less apparent post-vaccination. Testing for T2DM after severe COVID-19 and promotion of vaccination are important tools in addressing this public health problem.


Subject(s)
COVID-19 , Diabetes Mellitus, Type 2 , Diabetes Mellitus
5.
medrxiv; 2023.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2023.06.23.23291776

ABSTRACT

Despite reports of post-COVID-19 syndromes (long COVID) are rising, clinically coded long COVID cases are incomplete in electronic health records. It is unclear how patient characteristics may be associated with clinically coded long COVID. With the approval of NHS England, we undertook a cohort study using electronic health records within the OpenSAFELY-TPP platform in England, to study patient characteristics associated with clinically coded long COVID from 29 January 2020 to 31 March 2022. We estimated age-sex adjusted hazard ratios and fully adjusted hazard ratios for coded long COVID. Patient characteristics included demographic factors, and health behavioural and clinical factors. Among 17,986,419 adults, 36,886 (0.21%) were clinically coded with long COVID. Patient characteristics associated with coded long COVID included female sex, younger age (under 60 years), obesity, living in less deprived areas, ever smoking, greater consultation frequency, and history of diagnosed asthma, mental health conditions, pre-pandemic post-viral fatigue, or psoriasis. The strength of these associations was attenuated following two-dose vaccination compared to before vaccination. The incidence of coded long COVID was higher after hospitalised than non-hospitalised COVID-19. These results should be interpreted with caution given that long COVID was likely under-recorded in electronic health records.


Subject(s)
Asthma , Psoriasis , Obesity , COVID-19 , Fatigue
6.
medrxiv; 2023.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2023.03.01.23286624

ABSTRACT

Background COVID-19 is associated with a higher risk of cardiovascular outcomes in the general population. People with chronic respiratory disease have a higher risk of cardiovascular disease than the general population therefore, we investigated the association between pre-existing chronic respiratory disease and risk of cardiovascular events following COVID-19 using routinely collected data from 56 million people in England. Methods Primary and secondary care data from the English National Health Service and COVID-19-specific linked data were used to define a population of adults with COVID-19 between 01/01/2020-30/11/2021. Start of follow-up was from first COVID-19 diagnosis. Pre-existing chronic respiratory disease included asthma, chronic obstructive pulmonary disease, bronchiectasis, cystic fibrosis, or pulmonary fibrosis prior to COVID-19 diagnosis. Adjusted Cox Proportional Hazard regression was used to investigate the association between pre-existing chronic respiratory disease and risk of cardiovascular events. Secondary objectives investigated the impact of COVID-19 hospitalisation and vaccine dose on risk of cardiovascular outcomes. Findings A total of 3,670,455 people were included. People with pre-existing respiratory disease had a higher risk of cardiovascular events (adjusted HR 1.11, 95% confidence intervals 1.07-1.14), heart failure (1.15, 1.09-1.21), and pulmonary embolism (1.20, 1.11-1.30) compared with those without pre-existing respiratory disease. Regardless of pre-existing respiratory disease, the risk of cardiovascular events was lower with increasing COVID-19 vaccine dose. Interpretation People with chronic respiratory disease have a higher risk of some cardiovascular outcomes but the risk might be explained by the underlying respiratory condition. Risk of cardiovascular events was lower with increasing COVID-19 vaccine doses regardless of pre-existing chronic respiratory disease. Funding This work was funded by the British Heart Foundation Data Science Centre.


Subject(s)
Pulmonary Embolism , Heart Failure , Respiratory Tract Diseases , Bronchiectasis , Pulmonary Disease, Chronic Obstructive , Cardiovascular Diseases , Asthma , Cystic Fibrosis , COVID-19 , Pulmonary Fibrosis
7.
medrxiv; 2022.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2022.11.11.22282217

ABSTRACT

Background The link between ethnicity and healthcare inequity, and the urgency for better data is well-recognised. This study describes ethnicity data in nation-wide electronic health records in England, UK. Methods We conducted a retrospective cohort study using de-identified person-level records for the England population available in the National Health Service (NHS) Digital trusted research environment. Primary care records (GDPPR) were linked to hospital and national mortality records. We assessed completeness, consistency, and granularity of ethnicity records using all available SNOMED-CT concepts for ethnicity and NHS ethnicity categories. Findings From 61.8 million individuals registered with a primary care practice in England, 51.5 (83.3%) had at least one ethnicity record in GDPPR, increasing to 93·9% when linked with hospital records. Approximately 12·0% had at least two conflicting ethnicity codes in primary care records. Women were more likely to have ethnicity recorded than men. Ethnicity was missing most frequently in individuals from 18 to 39 years old and in the southern regions of England. Individuals with an ethnicity record had more comorbidities recorded than those without. Of 489 SNOMED-CT ethnicity concepts available, 255 were used in primary care records. Discrepancies between SNOMED-CT and NHS ethnicity categories were observed, specifically within “Other-” ethnicity groups. Interpretation More than 250 ethnicity sub-groups may be found in health records for the English population, although commonly categorised into “White”, “Black”, “Asian”, “Mixed”, and “Other”. One in ten individuals do not have ethnicity information recorded in primary care or hospital records. SNOMED-CT codes represent more diversity in ethnicity groups than the NHS ethnicity classification. Improved recording of self-reported ethnicity at first point-of-care and consistency in ethnicity classification across healthcare settings can potentially improve the accuracy of ethnicity in research and ultimately care for all ethnicities. Funding British Heart Foundation Data Science Centre led by Health Data Research UK. Research in context Evidence before this study Ethnicity has been highlighted as a significant factor in the disproportionate impact of SARS-CoV-2 infection and mortality. Better knowledge of ethnicity data recorded in real clinical practice is required to improve health research and ultimately healthcare. We searched PubMed from database inception to 14 th July 2022 for publications using the search terms “ethnicity” and “electronic health records” or “EHR,” without language restrictions. 228 publications in 2019, before the COVID-19 pandemic, and 304 publications between 2020 and 2022 were identified. However, none of these publications used or reported any of over 400 available SNOMED-CT concepts for ethnicity to account for more granularity and diversity than captured by traditional high-level classification limited to 5 to 9 ethnicity groups. Added value of this study We provide a comprehensive study of the largest collection of ethnicity records from a national-level electronic health records trusted research environment, exploring completeness, consistency, and granularity. This work can serve as a data resource profile of ethnicity from routinely-collected EHR in England. Implications of all the available evidence To achieve equity in healthcare, we need to understand the differences between individuals, as well as the influence of ethnicity both on health status and on health interventions, including variation in the behaviour of tests and therapies. Thus, there is a need for measurements, thresholds, and risk estimates to be tailored to different ethnic groups. This study presents the different medical concepts describing ethnicity in routinely collected data that are readily available to researchers and highlights key elements for improving their accuracy in research. We aim to encourage researchers to use more granular ethnicity than the than typical approaches which aggregate ethnicity into a limited number of categories, failing to reflect the diversity of underlying populations. Accurate ethnicity data will lead to a better understanding of individual diversity, which will help to address disparities and influence policy recommendations that can translate into better, fairer health for all.


Subject(s)
COVID-19
8.
researchsquare; 2022.
Preprint in English | PREPRINT-RESEARCHSQUARE | ID: ppzbmed-10.21203.rs.3.rs-2109276.v1

ABSTRACT

Background The CVD-COVID-UK consortium was formed to understand the relationship between COVID-19 and cardiovascular diseases through analyses of harmonised electronic health records (EHRs) across the four UK nations. Beyond COVID-19, data harmonisation and common approaches enables analysis within and across independent Trusted Research Environments. Here we describe the reproducible harmonisation method developed using large-scale EHRs in Wales to accommodate the fast and efficient implementation of cross-nation analysis in England and Wales as part of the CVD-COVID-UK programme. We characterise current challenges and share lessons learnt.Methods Serving the scope and scalability of multiple study protocols, we used linked, anonymised individual-level EHR, demographic and administrative data held within the SAIL Databank for the population of Wales. The harmonisation method was implemented as a four-layer reproducible process, starting from raw data in the first layer. Then each of the layers two to four is framed by, but not limited to, the characterised challenges and lessons learnt. We achieved curated data as part of our second layer, followed by extracting phenotyped data in the third layer. We captured any project-specific requirements in the fourth layer.Results Using the implemented four-layer harmonisation method, we retrieved approximately 100 health-related variables for the 3.2 million individuals in Wales, which are harmonised with corresponding variables for > 56 million individuals in England. We processed 13 data sources into the first layer of our harmonisation method: five of these are updated daily or weekly, and the rest at various frequencies providing sufficient data flow updates for frequent capturing of up-to-date demographic, administrative and clinical information.Conclusions We implemented an efficient, transparent, scalable, and reproducible harmonisation method that enables multi-nation collaborative research. With a current focus on COVID-19 and its relationship with cardiovascular outcomes, the harmonised data has supported a wide range of research activities across the UK.


Subject(s)
COVID-19
9.
medrxiv; 2022.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2022.03.06.21267462

ABSTRACT

We describe our analyses of data from over 52 million people in England and Wales, representing near-complete coverage of the relevant population, to assess the risk of myocarditis and pericarditis following COVID-19 vaccination. A self-controlled case series (SCCS) design has previously reported increased risk of myocarditis after first doses of ChAdOx1, BNT162b2, and mRNA-1273 vaccinations and after second doses of the mRNA COVID-19 vaccinations in England. Here, we use a cohort design to estimate hazard ratios for hospitalised or fatal myocarditis/pericarditis and excess events after first and second doses of BNT162b2 and ChAdOx1 vaccinations. SCCS and cohort designs are subject to different assumptions and biases and therefore provide the opportunity for triangulation of evidence. In contrast to the findings from the SCCS approach previously reported for England, we found evidence of lower incidence of hospitalised or fatal myocarditis/pericarditis after first dose ChAdOx1 and BNT162b2 vaccination.


Subject(s)
COVID-19 , Myocarditis , Pericarditis
10.
medrxiv; 2021.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2021.12.20.21268113

ABSTRACT

Deep learning (DL) and machine learning (ML) models trained on long-term patient trajectories held as medical codes in electronic health records (EHR) have the potential to improve disease prediction. Anticoagulant prescribing decisions in atrial fibrillation (AF) offer a use case where the benchmark stroke risk prediction tool (CHA2DS2-VASc) could be meaningfully improved by including more information from a patient's medical history. In this study, we design and build the first DL and ML pipeline that uses the routinely updated, linked EHR data for 56 million people in England accessed via NHS Digital to predict first ischaemic stroke in people with AF, and as a secondary outcome, COVID-19 death. Our pipeline improves first stroke prediction in AF by 17% compared to CHA2DS2-VASc (0.61 (0.57-0.65) vs 0.52 (0.52-0.52) area under the receiver operating characteristics curves, 95% confidence interval) and provides a generalisable, opensource framework that other researchers and developers can build on.


Subject(s)
Cerebral Infarction , Death , COVID-19 , Stroke , Atrial Fibrillation
11.
medrxiv; 2021.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2021.11.22.21266512

ABSTRACT

Importance: The long-term effects of COVID-19 on the incidence of vascular diseases are unclear. Objective: To quantify the association between time since diagnosis of COVID-19 and vascular disease, overall and by age, sex, ethnicity, and pre-existing disease. Design: Cohort study based on population-wide linked electronic health records, with follow up from January 1st to December 7th 2020. Setting and participants: Adults registered with an NHS general practice in England or Wales and alive on January 1st 2020. Exposures: Time since diagnosis of COVID-19 (categorised as 0-6 days, 1-2 weeks, 3-4, 5-8, 9-12, 13-26 and 27-49 weeks since diagnosis), with and without hospitalisation within 28 days of diagnosis. Main outcomes and measures: Primary outcomes were arterial thromboses (mainly acute myocardial infarction and ischaemic stroke) and venous thromboembolic events (VTE, mainly pulmonary embolism and lower limb deep vein thrombosis). We also studied other vascular events (transient ischaemic attack, haemorrhagic stroke, heart failure and angina). Hazard ratios were adjusted for demographic characteristics, previous disease diagnoses, comorbidities and medications. Results: Among 48 million adults, 130,930 were and 1,315,471 were not hospitalised within 28 days of COVID-19. In England, there were 259,742 first arterial thromboses and 60,066 first VTE during 41.6 million person-years follow-up. Adjusted hazard ratios (aHRs) for first arterial thrombosis compared with no COVID-19 declined rapidly from 21.7 (95% CI 21.0-22.4) to 3.87 (3.58-4.19) in weeks 1 and 2 after COVID-19, 2.80 (2.61-3.01) during weeks 3-4 then to 1.34 (1.21-1.48) during weeks 27-49. aHRs for first VTE declined from 33.2 (31.3-35.2) and 8.52 (7.59-9.58) in weeks 1 and 2 to 7.95 (7.28-8.68) and 4.26 (3.86-4.69) during weeks 3-4 and 5-8, then 2.20 (1.99-2.44) and 1.80 (1.50-2.17) during weeks 13-26 and 27-49 respectively. aHRs were higher, for longer after diagnosis, after hospitalised than non-hospitalised COVID-19. aHRs were also higher among people of Black and Asian than White ethnicity and among people without than with a previous event. Across the whole population estimated increases in risk of arterial thromboses and VTEs were 2.5% and 0.6% respectively 49 weeks after COVID-19, corresponding to 7,197 and 3,517 additional events respectively after 1.4 million COVID-19 diagnoses. Conclusions and Relevance: High rates of vascular disease early after COVID-19 diagnosis decline more rapidly for arterial thromboses than VTEs but rates remain elevated up to 49 weeks after COVID-19. These results support continued policies to avoid COVID-19 infection with effective COVID-19 vaccines and use of secondary preventive agents in high-risk patients.


Subject(s)
Pulmonary Embolism , Myocardial Infarction , Ischemic Attack, Transient , Heart Failure , Venous Thromboembolism , Angina Pectoris , Vascular Diseases , Cerebral Infarction , Thrombosis , COVID-19 , Stroke , Venous Thrombosis
12.
medrxiv; 2021.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2021.11.08.21265312

ABSTRACT

Background: Updatable understanding of the onset and progression of individuals COVID-19 trajectories underpins pandemic mitigation efforts. In order to identify and characterize individual trajectories, we defined and validated ten COVID-19 phenotypes from linked electronic health records (EHR) on a nationwide scale using an extensible framework. Methods: Cohort study of 56.6 million people in England alive on 23/01/2020, followed until 31/05/2021, using eight linked national datasets spanning COVID-19 testing, vaccination, primary & secondary care and death registrations data. We defined ten COVID-19 phenotypes reflecting clinically relevant stages of disease severity using a combination of international clinical terminologies (e.g. SNOMED-CT, ICD-10) and bespoke data fields; positive test, primary care diagnosis, hospitalisation, critical care (four phenotypes), and death (three phenotypes). Using these phenotypes, we constructed patient trajectories illustrating the transition frequency and duration between phenotypes. Analyses were stratified by pandemic waves and vaccination status. Findings: We identified 3,469,528 infected individuals (6.1%) with 8,825,738 recorded COVID-19 phenotypes. Of these, 364,260 (11%) were hospitalised and 140,908 (4%) died. Of those hospitalised, 38,072 (10%) were admitted to intensive care (ICU), 54,026 (15%) received non-invasive ventilation and 21,404 (6%) invasive ventilation. Amongst hospitalised patients, first wave mortality (30%) was higher than the second (23%) in non-ICU settings, but remained unchanged for ICU patients. The highest mortality was for patients receiving critical care outside of ICU in wave 1 (51%). 13,083 (9%) COVID-19 related deaths occurred without diagnoses on the death certificate, but within 30 days of a positive test while 10,403 (7%) of cases were identified from mortality data alone with no prior phenotypes recorded. We observed longer patient trajectories in the second pandemic wave compared to the first. Interpretation: Our analyses illustrate the wide spectrum of severity that COVID-19 displays and significant differences in incidence, survival and pathways across pandemic waves. We provide an adaptable framework to answer questions of clinical and policy relevance; new variant impact, booster dose efficacy and a way of maximising existing data to understand individuals progression through disease states.


Subject(s)
COVID-19 , Death
13.
medrxiv; 2021.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2021.09.03.21263023

ABSTRACT

ABSTRACT Objective Evaluate antithrombotic (AT) use in individuals with atrial fibrillation (AF) and high stroke risk (CHA 2 DS 2 -VASc score>=2) and investigate whether pre-existing AT use may improve COVID-19 outcomes. Methods Individuals with AF and a CHA 2 DS 2 -VASc score>=2 on January 1 st 2020 were identified using pseudonymised, linked electronic health records for 56 million people in England and followed-up until May 1 st 2021. Factors associated with pre-existing AT use were analysed using logistic regression. Differences in COVID-19 related hospitalisation and death were analysed using logistic and Cox regression for individuals exposed to pre-existing AT use vs no AT use, anticoagulants (AC) vs antiplatelets (AP) and direct oral anticoagulants (DOACs) vs warfarin. Results From 972,971 individuals with AF and a CHA 2 DS 2 -VASc score>=2, 88.0% (n=856,336) had pre-existing AT use, 3.8% (n=37,418) had a COVID-19 related hospitalisation and 2.2% (n=21,116) died. Factors associated with no AT use included comorbidities that may contraindicate AT use (liver disease and history of falls) and demographics (socioeconomic status and ethnicity). Pre-existing AT use was associated with lower odds of death (OR=0.92 [0 . 87-0 . 96 at 95% CI] ), but higher odds of hospitalisation OR=1.20 [1 . 15-1 . 26 at 95% CI] ). The same pattern was observed for AC vs AP (death (OR=0.93 [0.87-0.98]), hospitalisation (OR=1.17 [1.11-1.24])) but not for DOACs vs warfarin (death (OR=1.00 [0.95-1.05]), hospitalisation (OR=0.86 [0.82-0.89]). Conclusions Pre-existing AT use may offer marginal protection against COVID-19 death, with AC offering more protection than AP. Although this association may not be causal, it provides further incentive to improve AT coverage for eligible individuals with AF. KEY QUESTIONS What is already known about this subject? Anticoagulants (AC), a sub-class of antithrombotics (AT), reduce the risk of stroke and are recommended for individuals with atrial fibrillation (AF) and at high risk of stroke (CHA 2 DS 2 -VASc score>=2, National Institute for Health and Care Excellence threshold). However, previous evaluations suggest that up to one third of these individuals may not be taking AC. Over estimation of bleeding and fall risk in elderly patients have been identified as potential factors in this under medicating. In response to the COVID-19 pandemic, several observational studies have observed correlations between pre-existing AT use, particularly anticoagulants (AC), and lower risk of severe COVID-19 outcomes such as hospitalisation and death. However, these correlations are inconsistent across studies and have not compared all major sub-types of AT in one study. What does this study add? This study uses datasets covering primary care, secondary care, pharmacy dispensing, death registrations, multiple COVID-19 diagnoses routes and vaccination records for 56 million people in England and is the largest scale evaluation of AT use to date. This provides the statistical power to robustly analyse targeted sub-types of AT and control for a wide range of potential confounders. All code developed for the study is opensource and an updated nationwide evaluation can be rapidly created for future time points. In 972,971 individuals with AF and a CHA 2 DS 2 -VASc score>=2, we observed 88.0% (n=856,336) with pre-existing AT use which was associated with marginal protection against COVID-19 death (OR=0.92 [0 . 87-0 . 96 at 95% CI] ). How might this impact on clinical practice? These findings can help shape global AT medication policy and provide population-scale, observational analysis results alongside gold-standard randomised control trials to help assess whether a potential beneficial effect of pre-existing AT use on COVID-19 death alters risk to benefit assessments in AT prescribing decisions.


Subject(s)
COVID-19 , Atrial Fibrillation , Liver Diseases
14.
medrxiv; 2021.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2021.08.18.21262222

ABSTRACT

BackgroundThromboses in unusual locations after the COVID-19 vaccine ChAdOx1-S have been reported. Better understanding of population-level thrombotic risks after COVID-19 vaccination is needed. MethodsWe analysed linked electronic health records from adults living in England, from 8th December 2020 to 18th March 2021. We estimated incidence rates and hazard ratios (HRs) for major arterial, venous and thrombocytopenic outcomes 1-28 and >28 days after first vaccination dose for ChAdOx1-S and BNT162b2 vaccines. Analyses were performed separately for ages <70 and [≥]70 years, and adjusted for age, sex, comorbidities, and social and demographic factors. ResultsOf 46,162,942 adults, 21,193,814 (46%) had their first vaccination during follow-up. Adjusted HRs 1-28 days after ChAdOx1-S, compared with unvaccinated rates, at ages <70 and [≥]70 respectively, were 0.97 (95% CI: 0.90-1.05) and 0.58 (0.53-0.63) for venous thromboses, and 0.90 (0.86-0.95) and 0.76 (0.73-0.79) for arterial thromboses. Corresponding HRs for BNT162b2 were 0.81 (0.74-0.88) and 0.57 (0.53-0.62) for venous thromboses, and 0.94 (0.90-0.99) and 0.72 (0.70-0.75) for arterial thromboses. HRs for thrombotic events were higher at younger ages for venous thromboses after ChAdOx1-S, and for arterial thromboses after both vaccines. Rates of intracranial venous thrombosis (ICVT) and thrombocytopenia in adults aged <70 years were higher 1-28 days after ChAdOx1-S (adjusted HRs 2.27, 95% CI:1.33- 3.88 and 1.71, 1.35-2.16 respectively), but not after BNT162b2 (0.59, 0.24-1.45 and 1.00, 0.75-1.34) compared with unvaccinated. The corresponding absolute excess risks of ICVT 1-28 days after ChAdOx1-S were 0.9-3 per million, varying by age and sex. ConclusionsIncreases in ICVT and thrombocytopenia after ChAdOx1-S vaccination in adults aged <70 years were small compared with its effect in reducing COVID-19 morbidity and mortality, although more precise estimates for adults <40 years are needed. For people aged [≥]70 years, rates of arterial or venous thrombotic, events were generally lower after either vaccine.


Subject(s)
Venous Thromboembolism , Thrombocytopenia , Venous Thrombosis , Thrombosis , COVID-19 , Intracranial Thrombosis
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