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As the body of evidence on COVID-19 and post-vaccination outcomes continues to expand, this analysis sought to evaluate the public health impact of the Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, during the first year of its rollout in the US. A combined Markov decision tree model compared clinical and economic outcomes of the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) versus no vaccination in individuals aged ≥12 years. Age-stratified epidemiological, clinical, economic, and humanistic parameters were derived from existing data and published literature. Scenario analysis explored the impact of using lower and upper bounds of parameters on the results. The health benefits were estimated as the number of COVID-19 symptomatic cases, hospitalizations and deaths averted, and Quality Adjusted Life Years (QALYs) saved. The economic benefits were estimated as the amount of healthcare and societal cost savings associated with the vaccine-preventable health outcomes. It was estimated that, in 2021, the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) contributed to averting almost 9 million symptomatic cases, close to 700,000 hospitalizations, and over 110,000 deaths, resulting in an estimated $30.4 billion direct healthcare cost savings, $43.7 billion indirect cost savings related to productivity loss, as well as discounted gains of 1.1 million QALYs. Scenario analyses showed that these results were robust; the use of alternative plausible ranges of parameters did not change the interpretation of the findings. The Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) contributed to generate substantial public health impact and vaccine-preventable cost savings in the first year of its rollout in the US. The vaccine was estimated to prevent millions of COVID-19 symptomatic cases and thousands of hospitalizations and deaths, and these averted outcomes translated into cost-savings in the billions of US dollars and thousands of QALYs saved. As only direct impacts of vaccination were considered, these estimates may be conservative. Why was this study done? Vaccination against COVID-19 is a crucial part of the public health response to the pandemic. The first vaccine against COVID-19 to be rolled out in the US was the Pfizer-BioNTech vaccine (also called Comirnaty or BNT162b2). In this study, we investigated how the BNT162b2 vaccine affected US public health and the economy in 2021, the first year of its use. Vaccination against COVID-19 is a crucial part of the public health response to the pandemic. The first vaccine against COVID-19 to be rolled out in the US was the Pfizer-BioNTech vaccine (also called Comirnaty or BNT162b2). In this study, we investigated how the BNT162b2 vaccine affected US public health and the economy in 2021, the first year of its use. What did the researchers do and find? We developed a mathematical model and populated it with published data on COVID-19 to estimate the benefits of receiving 2 BNT162b2 vaccine doses versus receiving no vaccination, in people 12 years and older.Vaccination against COVID-19 is a crucial part of the public health response to the pandemic. The first vaccine against COVID-19 to be rolled out in the US was the Pfizer-BioNTech vaccine (also called Comirnaty or BNT162b2). In this study, we investigated how the BNT162b2 vaccine affected US public health and the economy in 2021, the first year of its use.We estimated that the BNT162b2 vaccine helped prevent around 8.7 million symptomatic COVID-19 illnesses. We also estimated that the vaccine prevented almost 700,000 COVID-19–associated hospitalizations, and more than 110,000 deaths. We estimated that it saved around $30 billion on healthcare costs and $44 billion related to people being unable to work due to illness. Sensitivity and scenario analyses showed that, although changing the model parameters did affect the results, this did not alter the overall conclusion that the vaccine leads to favorable and substantial public health impact.This study did not include estimates for children under 12 years old, or research the benefits of a booster. We cannot assume the results would be the same for other COVID-19 vaccines. This study also did not account for the Omicron variant, which did not emerge until late in 2021. We developed a mathematical model and populated it with published data on COVID-19 to estimate the benefits of receiving 2 BNT162b2 vaccine doses versus receiving no vaccination, in people 12 years and older. Vaccination against COVID-19 is a crucial part of the public health response to the pandemic. The first vaccine against COVID-19 to be rolled out in the US was the Pfizer-BioNTech vaccine (also called Comirnaty or BNT162b2). In this study, we investigated how the BNT162b2 vaccine affected US public health and the economy in 2021, the first year of its use. We estimated that the BNT162b2 vaccine helped prevent around 8.7 million symptomatic COVID-19 illnesses. We also estimated that the vaccine prevented almost 700,000 COVID-19–associated hospitalizations, and more than 110,000 deaths. We estimated that it saved around $30 billion on healthcare costs and $44 billion related to people being unable to work due to illness. Sensitivity and scenario analyses showed that, although changing the model parameters did affect the results, this did not alter the overall conclusion that the vaccine leads to favorable and substantial public health impact. This study did not include estimates for children under 12 years old, or research the benefits of a booster. We cannot assume the results would be the same for other COVID-19 vaccines. This study also did not account for the Omicron variant, which did not emerge until late in 2021. What do researchers think the results mean? In the US, in 2021, the BNT162b2 COVID-19 vaccine contributed to preventing millions of people from getting symptomatic COVID-19 and saved billions of dollars. These results support recommendations for continued widespread vaccine use. In the US, in 2021, the BNT162b2 COVID-19 vaccine contributed to preventing millions of people from getting symptomatic COVID-19 and saved billions of dollars. These results support recommendations for continued widespread vaccine use.

Aim: To compare real-world effectiveness/safety of non-vitamin K antagonist oral anticoagulants and vitamin K antagonists among patients with non-valvular atrial fibrillation. Materials & methods: A systematic review of electronic databases yielded 7661 citations published from January 2013 to January 2020. Fifty-five studies were included in Bayesian network meta-analyses of hazard ratios. Results & conclusion: In comparison with vitamin K antagonists, apixaban, dabigatran and rivaroxaban were associated with a reduced risk of stroke or systemic embolism, ischemic stroke, intracranial hemorrhage and all-cause mortality. Apixaban, dabigatran and edoxaban, but not rivaroxaban, were associated with a reduced risk of major bleeding. This study confirmed the effectiveness and safety of non-vitamin K antagonist oral anticoagulants for the treatment of non-valvular atrial fibrillation in real-world settings, consistent with clinical trial evidence.

BackgroundThe impact of COVID-19 goes beyond the acute phase of infection. It is imperative to evaluate health related quality of life (HRQoL) pre-COVID-19, but there is currently no evidence of the retrospective application of the EQ-5D-5L for COVID-19 studies.MethodsSubjects with ≥1 self-reported symptom and positive RT-PCR for SARS-CoV-2 at CVS Health US test sites were recruited between 01/31/2022-04/30/2022. On the day of enrollment which was around day 3 after testing positive, consented participants completed the EuroQol 5D-5L (EQ-5D-5L) questionnaire twice : a modified version where all the questions were past tense to retrospectively assess pre-COVID-19 baseline QoL, and the standard version in present tense to assess current HRQoL. Duncan’s new multiple range test was adopted for post analysis of variance pairwise comparisons of EQ-VAS means between problem levels for each of 5 domains. A linear mixed model was applied to check whether the relationship between EQ visual analog scale (VAS) and utility index (UI) was consistent pre-COVID-19 and during COVID-19. Matching-adjusted indirect comparison was used to compare pre-COVID-19 UI and VAS scores with those of the US population. Cohen’s d was used to quantify the magnitude of difference in means between two groups.ResultsOf 676 participants, 10.2% were age 65 or more years old, 73.2% female and 71.9% white. Diabetes was reported by 4.7% participants and hypertension by 11.2%. The pre-COVID-19 baseline mean UI was 0.924 and the mean VAS was 87.4. The estimated coefficient for the interaction of UI-by-retrospective collection indicator (0=standard prospective collection for Day 3 after COVID-19 testing, 1=retrospective for pre-COVID-19), -4.2 (SE: 3.2), P=0.197, indicates that retrospective collection does not significantly alter the relationship between EQ-VAS and UI. After adjusting for age, gender, diabetes, hypertension, and percent of mobility problems, predicted means of pre-COVID-19 baseline VAS and UI were 84.6 and 0.866, respectively. Both of these means were close to published US population norms (80.4 and 0.851) than those observed (87.4 and 0.924). After adjusting for age, gender, diabetes, and hypertension, 19.0% patients with COVID-19 had mobility problems, which was significantly lower than US population norm 25.2%, PConclusionAt a group level the retrospectively collected pre-COVID-19 EQ-5D-5L is adequate and makes it possible to directly evaluate the impact of COVID-19 on HRQoL. Future studies are encouraged that are tailored to directly compare standard prospective assessment with retrospective assessment on the EQ-5D-5L during pre-COVID-19.

To assess the public health impact and economic value of booster vaccination with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent in the United States. A combined cohort Markov decision tree model estimated the cost-effectiveness and budget impact of booster vaccination compared to no booster vaccination in individuals aged ≥5 years. Analyses prospectively assessed three scenarios (base case, low, high) defined based upon the emergence (or not) of subvariants, using list prices. Age-stratified parameters were informed by literature. The cost-effectiveness analysis estimated cases, hospitalizations and deaths averted, Life Years (LYs) and Quality Adjusted Life Years (QALYs) gained, the incremental cost-effectiveness ratio (ICER), the net monetary benefit (NMB), and the Return on Investment (ROI). The budget impact analyses used the perspective of a hypothetical 1-million-member plan. Sensitivity analyses explored parameter uncertainty. Conservatively, indirect effects and broad societal benefits were not considered. The base case predicted that, compared to no booster vaccination, the Pfizer-BioNTech COVID-19 Vaccine, Bivalent could result in ∼3.7 million fewer symptomatic cases, 162 thousand fewer hospitalizations, 45 thousand fewer deaths, 373 thousand fewer discounted QALYs lost, and was cost-saving. Using a conservative value of $50,000 for 1 LY, every $1 invested yielded estimated $4.67 benefits. Unit costs, health outcomes and effectiveness had the greatest impact on results. At $50,000 per QALY gained, the booster generated a 34.2 billion NMB and probabilistic sensitivity analyses indicated a 92% chance of being cost-saving and 98% of being cost-effective. The bivalent was cost-saving or highly cost-effective in high and low scenarios. In a hypothetical 1-million-member health plan population, the vaccine was predicted to be a budget-efficient solution for payers. Booster vaccination with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for the US population aged ≥5 years could generate notable public health impact and be cost-saving based on the findings of our base case analyses.

We aimed to estimate the public health impact of booster vaccination against COVID-19 in the UK during an Omicron-predominant period. A dynamic transmission model was developed to compare public health outcomes for actual and alternative UK booster vaccination programs. Input sources were publicly available data and targeted literature reviews. Base case analyses estimated outcomes from the UK’s Autumn–Winter 2021–2022 booster program during January–March 2022, an Omicron-predominant period. Scenario analyses projected outcomes from Spring and in Autumn 2022 booster programs over an extended time horizon from April 2022–April 2023, assuming continued Omicron predominance, and explored hypothetical program alternatives with modified eligibility criteria and/or increased uptake. Estimates predicted that the Autumn–Winter 2021–2022 booster program averted approximately 12.8 million cases, 1.1 million hospitalizations, and 290,000 deaths. Scenario analyses suggested that Spring and Autumn 2022 programs would avert approximately 6.2 million cases, 716,000 hospitalizations, and 125,000 deaths; alternatives extending eligibility or targeting risk groups would improve these benefits, and increasing uptake would further strengthen impact. Boosters were estimated to provide substantial benefit to UK public health during Omicron predominance. Benefits of booster vaccination could be maximized by extending eligibility and increasing uptake.

Studies have shown that patients with non-valvular atrial fibrillation (NVAF) who discontinue oral anticoagulants (OACs) are at higher risk of complications such as stroke. This analysis compared the risk of non-persistence with OACs among patients with NVAF. Adult patients with NVAF who initiated apixaban, dabigatran, rivaroxaban, or warfarin were identified using 01JAN2013–30JUN2019 data from Centers for Medicare and Medicaid Services and four US commercial claims databases. Non-persistence was defined as discontinuation (no evidence of index OAC use for ≥ 60 days from the last days’ supply) or switch to another OAC. Kaplan–Meier curves were generated to illustrate time to non-persistence along with cumulative incidences of non-persistence. Baseline and time-varying covariates were evaluated, and adjusted Cox proportional hazards models were used to evaluate non-persistence risk. In total, 363,823 patients receiving apixaban, 57,121 receiving dabigatran, 282,831 receiving rivaroxaban, and 317,337 receiving warfarin were included. Of these, 47–72% discontinued/switched OAC therapy within an average 9-month follow-up. Apixaban was associated with a lower risk of non-persistence than were dabigatran (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.61–0.62), rivaroxaban (HR 0.76; 95% CI 0.75–0.76), and warfarin (HR 0.74; 95% CI 0.74–0.75). Dabigatran was associated with a higher risk of non-persistence than were warfarin (HR 1.21; 95% CI 1.19–1.22) and rivaroxaban (HR 1.23; 95% CI 1.22–1.25), and rivaroxaban was associated with a lower risk of non-persistence than was warfarin (HR 0.98; 95% CI 0.97–0.98). Clinical events (stroke/systemic embolism and major bleeding [MB]) during follow-up were predictors of non-persistence (stroke HR 1.57; 95% CI 1.53–1.61; MB HR 2.96; 95% CI 2.92–3.00). In over one million patients with NVAF, our results suggest differences in anticoagulation treatment persistence across OAC agents, even after accounting for clinical events after OAC initiation. It is important for clinicians and patients to take these differences into consideration, especially as non-persistence to OAC therapy is associated with thromboembolic complications.

Objective Global treatment guidelines recommend treatment with oral anticoagulants (OACs) for patients with non-valvular atrial fibrillation (NVAF) and an elevated stroke risk. However, not all patients with NVAF and an elevated stroke risk receive guideline-recommended therapy. A literature review and synthesis of observational studies were undertaken to identify the body of evidence on untreated and undertreated NVAF and the association with clinical and economic outcomes. Methods An extensive search (1/2010-4/2020) of MEDLINE, the Cochrane Library, conference proceedings, and health technology assessments (HTAs) was conducted. Studies must have evaluated rates of nontreatment or undertreatment in NVAF. Nontreatment was defined as absence of OACs (but with possible antiplatelet treatment), while undertreatment was defined as treatment with only antiplatelet agents. Results Sixteen studies met our inclusion criteria. Rates of nontreatment for patients with elevated stroke risk ranged from 2.0-51.1%, while rates of undertreatment ranged from 10.0-45.1%. The clinical benefits of anticoagulation were reported in the evaluated studies with reductions in stroke and mortality outcomes observed among patients treated with anticoagulants compared to untreated or undertreated patients. Adverse events associated with all bleeding types (i.e. hemorrhagic stroke, major bleeding or gastrointestinal hemorrhaging) were found to be higher for warfarin patients compared to untreated patients in real-world practice. Healthcare resource utilization was found to be lower among patients highly-adherent to warfarin compared to untreated patients. Conclusions Rates of nontreatment and undertreatment among NVAF patients remain high and are associated with preventable cardiovascular events and death. Strategies to increase rates of treatment may improve clinical outcomes.

BackgroundSARS-CoV-2 (COVID-19) virus is estimated to cost the United States (US) economy trillions of dollars over the next decade. Mass immunization has played a major role in reducing morbidity and mortality related to COVID-19 in the US, but the high-risk population remains vulnerable to developing severe COVID-19. A large clinical trial and several real-world evidence (RWE) studies have demonstrated the effectiveness of nirmatrelvir; ritonavir in reducing hospitalizations or death in high-risk patients. This study aimed to estimate the economic impact of using nirmatrelvir; ritonavir in a high-risk US population infected with COVID-19 as measured by reduction in hospitalizations and associated costs during a time of Omicron predominance.MethodsAn economic model was developed to estimatethe impact of nirmatrelvir; ritonavir in reducing hospitalizations and associated costs from a healthcare perspective. The model compared nirmatrelvir; ritonavir with no treatment in the outpatient setting among patients with mild-to-moderate COVID-19 at high-risk of progressing to severe disease as consistent with the EPIC-HR trial. Hospitalization rate reductions were derived from recent RWE studies conducted during the Omicron period while costs were gathered from the literature. A simulated population of 100,000 COVID-19 patients was modelled and was restricted to patients ≥12 years of age. Sensitivity analyses applied alternative model assumptions.ResultsResults from the model showed that treatment with nirmatrelvir; ritonavir was associated with fewer hospitalizations compared to no treatment, 3,269 vs 6,134 per 100,000 patients, respectively, with a reduction of 2,865 hospitalizations per 100,000 patients and an estimated cost savings of $133,754,359 per 100,000 patients ($152,634,256 for nirmatrelvir; ritonavir and $286,388,614 for no treatment). Varying the rate of hospitalization by 10% showed similar results.ConclusionTreatment with nirmatrelvir; ritonavir during the Omicron period could result in substantial cost savings due to reduction in hospitalizations. This is an important outcome measure that will help reduce the devastating economic burden that COVID-19 has imposed on the US health care system.

In the USA, there is a steady rise of atrial fibrillation due to the aging population with increased morbidity. This study evaluated the risk of stroke/systemic embolism (S/SE) and major bleeding (MB) among elderly patients with non-valvular atrial fibrillation (NVAF) and multimorbidity prescribed direct oral anticoagulants (DOACs).Using the CMS Medicare database, a retrospective observational study of adult patients with NVAF and multimorbidity who initiated apixaban, dabigatran, or rivaroxaban from January 1, 2012 to December 31, 2017 was conducted. High multimorbidity was classified as having ≥ 6 comorbidities. Cox proportional hazard models were used to evaluate the hazard ratios of S/SE and MB among three 1:1 propensity score matched DOAC cohorts. All-cause healthcare costs were estimated using generalized linear models.Overall 36% of the NVAF study population had high multimorbidity, forming three propensity score matched (PSM) cohorts: 12,511 apixaban-dabigatran, 60,287 apixaban-rivaroxaban, and 12,567 dabigatran-rivaroxaban patients. Apixaban was associated with a lower risk of stroke/SE and MB when compared with dabigatran and rivaroxaban. Dabigatran had a lower risk of stroke/SE and a similar risk of MB when compared with rivaroxaban. Compared to rivaroxaban, apixaban patients incurred lower all-cause healthcare costs, and dabigatran patients incurred similar all-cause healthcare costs. Compared to dabigatran, apixaban patients incurred similar all-cause healthcare costs.Patients with NVAF and ≥ 6 comorbid conditions had significantly different risks for stroke/SE and MB when comparing DOACs to DOACs, and different healthcare expenses. This study's results may be useful for evaluating the risk-benefit ratio of DOAC use in patients with NVAF and multimorbidity.

By August 1, 2022, the SARS-CoV-2 virus had caused over 90 million cases of COVID-19 and one million deaths in the United States. Since December 2020, SARS-CoV-2 vaccines have been a key component of US pandemic response; however, the impacts of vaccination are not easily quantified. Here, we use a dynamic county-scale metapopulation model to estimate the number of cases, hospitalizations, and deaths averted due to vaccination during the first six months of vaccine availability. We estimate that COVID-19 vaccination was associated with over 8 million fewer confirmed cases, over 120 thousand fewer deaths, and 700 thousand fewer hospitalizations during the first six months of the campaign.

BackgroundAlthough there is extensive literature on the clinical benefits of COVID-19 vaccination, data on humanistic effects are limited. This study evaluated the impact of SARS-CoV-2 infection on symptoms, Health Related Quality of Life (HRQoL) and Work Productivity and Impairment (WPAI) prior to and one month following infection, and compared results between individuals vaccinated with BNT162b2 and those unvaccinated.MethodsSubjects with ≥1 self-reported symptom and positive RT-PCR for SARS-CoV-2 at CVS Health US test sites were recruited between 01/31/2022-04/30/2022. Socio-demographics, clinical characteristics and vaccination status were evaluated. Self-reported symptoms, HRQoL, and WPAI outcomes were assessed using questionnaires and validated instruments (EQ-5D-5L, WPAI-GH) across acute COVID time points from pre-COVID to Week 4, and between vaccination groups. Mixed models for repeated measures were conducted for multivariable analyses, adjusting for several covariates. Effect size (ES) of Cohen’s d was calculated to quantify the magnitude of outcome changes within and between vaccination groups.ResultsThe study population included 430 subjects: 197 unvaccinated and 233 vaccinated with BNT162b2. Mean (SD) age was 42.4 years (14.3), 76.0% were female, 38.8% reported prior infection and 24.2% at least one comorbidity. Statistically significant differences in outcomes were observed compared with baseline and between groups. The EQ-Visual analogue scale scores and Utility Index dropped in both cohorts at Day 3 and increased by Week 4, but did not return to pre-COVID levels. The mean changes were statistically lower in the BNT162b2 cohort at Day 3 and Week 4. The BNT162b2 cohort reported lower prevalence and fewer symptoms at index date and Week 4. At Week 1, COVID-19 had a large impact on all WPAI-GH domains: the work productivity time loss among unvaccinated and vaccinated was 65.0% and 53.8%, and the mean activity impairment was 50.2% and 43.9%, respectively. With the exception of absenteeism at Week 4, the BNT162b2 cohort was associated with statistically significant less worsening in all WPAI-GH scores at both Week 1 and 4.ConclusionsCOVID-19 negatively impacted HRQoL and work productivity among mildly symptomatic outpatients. Compared with unvaccinated, those vaccinated with BNT162b2 were less impacted by COVID-19 infection and recovered faster.

To evaluate utilization of anticoagulants (ACs) and the predictors of treatment of patients with a diagnosis of atrial fibrillation (AF) during a hospital stay in the USA.Patients (≥18 years of age) who had a primary or secondary discharge diagnosis code of AF during a hospitalization (without a diagnosis of venous thromboembolism) were identified from the Premier Hospital database (1 January 2016-30 September 2017). AC treatments were examined during hospitalizations to assign AF patients into 3 study cohorts: those who received an oral AC (OAC), those who received parenteral AC only, and those who did not receive AC therapy. Multivariable logistic regression analyses were carried out to evaluate potential predictors of receiving parenteral AC only vs. OAC therapy, no AC therapy vs. OAC therapy, as well as the specific OAC drug choices.Of the patients hospitalized with an AF diagnosis (OAC utilization may have been underestimated since outpatient OAC utilization was not included in the analysis.A substantial portion of hospitalized AF patients did not receive any AC therapy, particularly those patients with an AF diagnosis in the second position on hospital records. The predictors of inpatient AC treatment that were identified may be helpful in the clinical decision-making process for patients who are hospitalized with AF.

Results There were 33,269 apixaban-warfarin, 9,345 dabigatran-warfarin, and 42,156 rivaroxaban-warfarin matched pairs, with a median follow-up of 4-5 months. Compared with warfarin, apixaban was associated with lower rates of stroke/systemic embolism (hazard ratio [HR] 0.52; 95% confidence interval [95% CI], 0.43-0.62), major bleeding (HR 0.60; 95% CI, 0.55-0.66) and stroke/myocardial infarction/all-cause mortality (HR 0.70; 95%CI, 0.66-0.74); dabigatran was associated with lower rates of major bleeding (HR: 0.73; 95% CI, 0.62-0.85); dabigatran and rivaroxaban were associated with lower rates of stroke/myocardial infarction/all-cause mortality (HR 0.77; 95% CI, 0.69-0.86 and HR 0.81; 95% CI, 0.77-0.85, respectively). Rivaroxaban was associated with a lower rate of stroke/systemic embolism (HR 0.61; 95% CI, 0.53-0.71) and a higher rate of major bleeding (HR 1.10; 95%CI, 1.03-1.18) versus warfarin.

BACKGROUND Atrial fibrillation is the most common cardiac arrhythmia, affecting 33.5 million patients globally. It is associated with increased morbidity, leading to significant clinical and economic burden. There exist only limited data in the Middle Eastern region from the existing registries. The goal of the FLOW-AF (atrial FibriLlatiOn real World management registry in the Middle East and Africa) registry is to evaluate the characteristics, treatment patterns, and clinical and economic outcomes associated with anticoagulation among patients newly diagnosed with nonvalvular atrial fibrillation in Egypt, Lebanon, the Kingdom of Saudi Arabia, and the United Arab Emirates. METHODS This study will be a multicountry, multicenter, prospective observational registry aiming to enroll 1446 newly diagnosed nonvalvular atrial fibrillation patients at more than 20 sites across the four countries. During the recruitment period, patients will be included if they were newly diagnosed with nonvalvular atrial fibrillation and had initiated treatment for the prevention of stroke/systemic embolism. Patient data will be assessed prospectively at 6 and 12 months from their enrollment date. Demographics, clinical characteristics, antithrombotic treatments received, clinical outcomes, adverse events, healthcare resource utilization, and direct costs associated with management of nonvalvular atrial fibrillation will be collected and analyzed overall, by country, and by groups created based on treatment, demographics, and clinical characteristics, medical history and risk factors. CONCLUSION The FLOW-AF registry will provide information on the uptake of oral anticoagulants, treatment patterns, clinical outcomes, and healthcare utilization and costs among newly diagnosed nonvalvular atrial fibrillation patients in the Middle Eastern region.

Background: The safety and effectiveness of warfarin depend on anticoagulation control quality. Observational studies associate poor control with increased morbidity, mortality and healthcare costs. Objectives: To develop a profile of non-valvular atrial fibrillation (NVAF) patients treated with warfarin in a Brazilian private ambulatory and hospital setting, evaluate the quality of anticoagulation control, and its association with clinical and economic outcomes. Methods: This retrospective study, through a private health insurance dataset in Brazil, identified NVAF patients treated with warfarin between 01 MAY 2014 to 30 APRIL 2016, described their anticoagulation management, and quantified disease-related costs. Data on demographics, clinical history, concomitant medication and time in therapeutic range (TTR) of international normalized ratio (INR) values were retrieved. Patients were grouped into TTR quartiles, with good control defined as TTR ≥ 65% (Rosendaal method). Major bleeds and all-cause direct medical costs were calculated and compared between good and poor control subgroups. P-values < 0.05 were considered statistically significant. Results: The analysis included 1220 patients (median follow-up: 1.5 years; IQR: 0.5-2.0). On average, each patient received 0.95 monthly INR measurements (mean INR: 2.60 ± 0.88, with 26.1% of values < 2 and 24.8% > 3), (median TTR: 58%; IQR: 47-68%), (mean TTR: 56.6% ± 18.9%). Only 31% of patients were well-controlled (mean TTR: 78% ± 10%), with 1.6% having major bleeds within median follow-up, and direct medical costs per member per year (PMPY) of R$25,352(± R$ 37,762). Poorly controlled patients (69%) were associated with 3.3 times more major bleeds (5.3% vs. 1.6%; p < 0.01) and 40% higher costs (R$35,384 vs. R$25,352; p < 0.01). Conclusions: More than 60% of the patients were below the desired target and the associated costs were higher. Resumo Fundamento: A segurança e a eficácia da varfarina dependem da qualidade do controle da anticoagulação. Estudos observacionais associam controle deficiente com aumento de morbidade, mortalidade e custos com saúde. Objetivos: Desenvolver um perfil de pacientes com fibrilação atrial não valvar (FANV) tratados com varfarina em ambiente ambulatorial e hospitalar privado brasileiro, avaliar a qualidade do controle da anticoagulação e sua associação com resultados clínicos e econômicos. Métodos: Este estudo retrospectivo, por meio de um conjunto de dados de seguros privados de saúde no Brasil, identificou pacientes com FANV tratados com varfarina entre 01 de maio de 2014 a 30 de abril de 2016, descreveu seu manejo da anticoagulação e quantificou os custos relacionados à doença. Foram recuperados dados demográficos, histórico clínico, medicação concomitante e tempo na faixa terapêutica (TTR) dos valores da razão normalizada internacional (RNI). Os pacientes foram agrupados em quartis de TTR, com um bom controle sendo definido como TTR ≥65% (método de Rosendaal). Sangramentos maiores e custos médicos diretos por todas as causas foram calculados e comparados entre subgrupos de controle bons e ruins. Valores de p < 0,05 foram considerados estatisticamente significantes. Resultados: A análise incluiu 1220 pacientes (mediana de seguimento: 1,5 anos; IIQ: 0,5-2,0). Em média, cada paciente recebeu 0,95 medidas mensais de RNI (RNI média: 2,60 ± 0,88, com 26,1% dos valores < 2 e 24,8% > 3), (mediana de TTR: 58%; IIQ: 47-68%), (TTR médio: 56,6% ± 18,9%). Apenas 31% dos pacientes estavam bem controlados (TTR médio: 78% ± 10%), com 1,6% apresentando grandes sangramentos na mediana do seguimento e custos médicos diretos por membro por ano (PMPY) de R$25.352 (± R$37.762). Pacientes com controle abaixo do ideal (69%) foram associados a 3,3 vezes mais sangramentos graves (5,3% vs. 1,6%; p

IntroductionFrom July through October of 2021, several countries issued recommendations for increased COVID-19 vaccine protection for individuals with one or more immunocompromised (IC) conditions. It is critically important to understand the vaccine effectiveness (VE) of COVID-19 vaccines among IC populations as recommendations are updated over time in response to the evolving COVID-19 pandemic.Areas coveredA targeted literature review was conducted to identify real-world studies that assessed COVID-19 VE in IC populations between December 2020 and September 2021. A total of 10 studies from four countries were identified and summarized in this review.Expert opinion/commentaryVE of the widely available COVID-19 vaccines, including BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna), Ad26.COV2.S (Janssen), and ChAdOx1 nCoV-19 (Oxford/AstraZeneca), ranged from 64%-90% against SARS-CoV-2 infection, 73%-84% against symptomatic illness, 70%-100% against severe illness, and 63%-100% against COVID-19-related hospitalization among the fully vaccinated IC populations included in the studies. COVID-19 VE for most outcomes in the IC populations included in these studies was lower than in the general populations. These findings provide preliminary evidence that the IC population requires greater protective measures to prevent COVID-19 infection and associated illness, hence should be prioritized while implementing recommendations of additional COVID-19 vaccine doses.

ObjectivesTo describe the characteristics, healthcare resource use and costs associated with initial hospitalization and readmissions among pediatric patients with COVID-19 in the US.MethodsHospitalized pediatric patients, 0-11 years of age, with a primary or secondary discharge diagnosis code for COVID-19 (ICD-10 code U07.1) were selected from 1 April 2020 through 30 September 2021 in the US Premier Healthcare Database Special Release (PHD SR). Patient characteristics, hospital length of stay (LOS), in-hospital mortality, hospital costs, hospital charges, and COVID-19-associated readmission outcomes were evaluated and stratified by age groups (0-4, 5-11), four COVID-19 disease progression states based on intensive care unit (ICU) and invasive mechanical ventilation (IMV) usage, and three sequential calendar periods. Sensitivity analyses were performed using the US HealthVerity claims database and restricting the analyses to primary discharge code.ResultsAmong 4,573 hospitalized pediatric patients aged 0-11 years, 68.0% were 0-4 years and 32.0% were 5-11 years, with a mean (median) age of 3.2 (1) years; 56.0% were male, and 67.2% were covered by Medicaid. Among the overall study population, 25.7% had immunocompromised condition(s), 23.1% were admitted to the ICU and 7.3% received IMV. The mean (median) hospital LOS was 4.3 (2) days, hospital costs and charges were $14,760 ($6,164) and $58,418 ($21,622), respectively; in-hospital mortality was 0.5%. LOS, costs, charges, and in-hospital mortality increased with ICU admission and/or IMV usage. In total, 2.1% had a COVID-19-associated readmission. Study outcomes appeared relatively more frequent and/or higher among those 5-11 than those 0-4. Results using the HealthVerity data source were generally consistent with main analyses.LimitationsThis retrospective administrative database analysis relied on coding accuracy and inpatient admissions with validated hospital costs.ConclusionsThese findings underscore that children aged 0-11 years can experience severe COVID-19 illness requiring hospitalization and substantial hospital resource use, further supporting recommendations for COVID-19 vaccination.

To evaluate the public health impact of the UK COVID-19 booster vaccination program in autumn 2021, during a period of SARS-CoV-2 Delta variant predominance. A compartmental Susceptible-Exposed-Infectious-Recovered model was used to compare age-stratified health outcomes for adult booster vaccination versus no booster vaccination in the UK over a time horizon of September–December 2021, when boosters were introduced in the UK and the SARS-CoV-2 Delta variant was predominant. Model input data were sourced from targeted literature reviews and publicly available data. Outcomes were predicted COVID-19 cases, hospitalizations, post-acute sequelae of COVID-19 (PASC) cases, deaths, and productivity losses averted, and predicted healthcare resources saved. Scenario analyses varied booster coverage, virus infectivity and severity, and time horizon parameters. Booster vaccination was estimated to have averted approximately 547,000 COVID-19 cases, 36,000 hospitalizations, 147,000 PASC cases, and 4,200 deaths in the UK between September and December 2021. It saved over 316,000 hospital bed-days and prevented the loss of approximately 16.5 million paid and unpaid patient work days. In a scenario of accelerated uptake, the booster rollout would have averted approximately 3,400 additional deaths and 25,500 additional hospitalizations versus the base case. A scenario analysis assuming four-fold greater virus infectivity and lower severity estimated that booster vaccination would have averted over 105,000 deaths and over 41,000 hospitalizations versus the base case. A scenario analysis assuming pediatric primary series vaccination prior to adult booster vaccination estimated that expanding vaccination to children aged ≥5 years would have averted approximately 51,000 additional hospitalizations and 5,400 additional deaths relative to adult booster vaccination only. The model did not include the wider economic burden of COVID-19, hospital capacity constraints, booster implementation costs, or non-pharmaceutical interventions. Booster vaccination during Delta variant predominance reduced the health burden of SARS-CoV-2 in the UK, releasing substantial NHS capacity.

Background Despite treatment guidelines recommending the use of oral anticoagulants (OACs) for patients with non-valvular atrial fibrillation (NVAF) and moderate to high risk of stroke (CHA2DS2-VASc score ≥1), many patients remain untreated. A study conducted among Medicare beneficiaries with AF and a CHA2DS2-VASc score of ≥2 found that 51% of patients were not prescribed an OAC despite being eligible for treatment. When left untreated, NVAF poses an enormous burden to society, as stroke events are estimated to cost the US healthcare system about $34 billion each year in both direct medical costs and indirect productivity losses. This research explored the short-term clinical implications and budget impact (BI) of increasing OAC use among Medicare beneficiaries with NVAF. Methods A decision-analytic model was developed from the payer and societal perspectives to estimate the impact of increasing treatment rates among Medicare-eligible NVAF patients with a moderate-to-high risk of stroke over 1 year. Results of the model compared (1) a base case scenario using literature-derived rates of OAC use, and (2) a hypothetical scenario assuming an absolute 5% increase in overall OAC use. Clinical outcomes included the incremental annual number of ischemic stroke, hemorrhagic stroke, and gastrointestinal bleeding events, and stroke-related deaths. Economic outcomes included incremental annual and per-member per-month (PMPM) direct medical costs for the payer perspective and the incremental sum of annual direct medical and indirect costs from productivity loss and caregiver burden for the societal perspective. Results In total, 1.95 million Medicare patients with NVAF were estimated to be treated with OACs in the base case (3.8% of beneficiaries). In the hypothetical scenario analysis, nearly 200,000 more patients were treated resulting in 3,705 fewer ischemic strokes, 14 fewer gastrointestinal bleeds, 141 more hemorrhagic strokes, and 175 fewer deaths. The total incremental BI was $399.16 million ($0.65 PMPM) from the payer perspective and $377.10 million from the societal perspective due to indirect cost savings ($22.06 million). Conclusion Our findings suggest that increased overall OAC use has a positive clinical benefit on the annual number of ischemic stroke events and deaths avoided in the Medicare population, while maintaining a modest increase in the overall BI to the Medicare system.

Real-world studies have evaluated the use of anticoagulants in obese patients with nonvalvular atrial fibrillation (NVAF), but they have been limited by sample size or the use of diagnosis codes on claims to define obesity. This retrospective study used body weight data of ≥100 kg or a body mass index of ≥30 kg/m

Aim: Economic consequences associated with the rise in nonvitamin K antagonist oral anticoagulant use on a societal level remain unclear. Materials & methods: Evidence from the past decade on the societal economic burden associated with stroke, bleeding and international normalized ratio monitoring in atrial fibrillation was collected and summarized through a systematic literature review. Results: There were 14 studies identified that reported indirect costs, which were highest among patients with hemorrhagic stroke and intracranial hemorrhage. The contribution of indirect costs to the total was marginal during acute treatment but substantially increased (30–50%) 2 years after stroke and bleeding events. Conclusion: Limited data were available on societal costs in atrial fibrillation and further research is warranted.

Background: There is a dearth of real-world evidence regarding patient characteristics, Oral Anti-Coagulant (OAC) treatment, and International Normalized Ratio (INR) patterns in Dubai, United Arab Emirates (UAE). Methods: This was a retrospective observational study among newly diagnosed adult Non-valvular Atrial Fibrillation (NVAF) patients in the Dubai Real World Claims Database. Selected patients had at least one activity claim during the 12 months pre-index date (baseline period), and a pharmacy claim for apixaban, dabigatran, rivaroxaban, or warfarin from 01 JAN 2015-31 JUL 2017. Patients with valvular heart disease, cardiac surgery, venous thromboembolism, transient atrial fibrillation, pregnancy, or OAC claims during baseline were excluded. Comorbidities and treatment patterns related to OAC use, index dosing, baseline medications, and INR patterns were described. Results: Among 5,072 NVAF patients, 468 met the study criteria. A minority of them (14.3%) were prescribed warfarin, and the most frequently prescribed non-vitamin K antagonist OACs (NOACs) were rivaroxaban (33.3%) and apixaban (31.4%), followed by dabigatran (20.9%). Patients’ mean age was 59 years and mean CHA2DS2-VASc score was 2.3, with most frequent comorbidities of diabetes mellitus, hypertension, coronary artery disease, and peripheral vascular disease. Additionally, 51% and 33% were on statins and aspirin, respectively, while 39% were on other anticoagulant agents. A large proportion of dabigatran patients were on a lower dose (57%). INR patterns revealed 13% of rivaroxaban, 12% of apixaban, and 7% of dabigatran patients had INR claims. Conclusion: This study provides relevant insights into the use of OACs in real-world clinical practice settings in Dubai, UAE.

OBJECTIVES Older adult patients are underrepresented in clinical trials comparing non–vitamin K antagonist oral anticoagulants (NOACs) and warfarin. This subgroup analysis of the ARISTOPHANES study used multiple data sources to compare the risk of stroke/systemic embolism (SE) and major bleeding (MB) among very old patients with nonvalvular atrial fibrillation (NVAF) prescribed NOACs or warfarin. DESIGN Retrospective observational study. SETTING The Centers for Medicare & Medicaid Services and three US commercial claims databases. PARTICIPANTS A total of 88 582 very old (aged ≥80 y) NVAF patients newly initiating apixaban, dabigatran, rivaroxaban, or warfarin from January 1, 2013, to September 30, 2015. MEASUREMENTS In each database, six 1:1 propensity score matched (PSM) cohorts were created for each drug comparison. Patient cohorts were pooled from all four databases after PSM. Cox proportional hazards models were used to estimate hazard ratios (HRs) of stroke/SE and MB. RESULTS The patients in the six matched cohorts had a mean follow‐up time of 7 to 9 months. Compared with warfarin, apixaban (HR = .58; 95% confidence interval [CI] = .49‐.69), dabigatran (HR = .77; 95% CI = .60‐.99), and rivaroxaban (HR = .74; 95% CI = .65‐.85) were associated with lower risks of stroke/SE. For MB, apixaban (HR = .60; 95% CI = .54‐.67) was associated with a lower risk; dabigatran (HR = .92; 95% CI = .78‐1.07) was associated with a similar risk, and rivaroxaban (HR = 1.16; 95% CI = 1.07‐1.24) was associated with a higher risk compared with warfarin. Apixaban was associated with a lower risk of stroke/SE and MB compared with dabigatran (stroke/SE: HR = .65; 95% CI = .47‐.89; MB: HR = .60; 95% CI = .49‐.73) and rivaroxaban (stroke/SE: HR = .72; 95% CI = .59‐.86; MB: HR = .50; 95% CI = .45‐.55). Dabigatran was associated with a lower risk of MB (HR = .77; 95% CI = .67‐.90) compared with rivaroxaban. CONCLUSION Among very old NVAF patients, NOACs were associated with lower rates of stroke/SE and varying rates of MB compared with warfarin. J Am Geriatr Soc 67:1662–1671, 2019

ObjectiveTo evaluate COVID-19 vaccine breakthrough infections among immunocompromised (IC) individuals.MethodsIndividuals vaccinated with BNT162b2 were selected from the US HealthVerity database (12/10/2020-7/8/2021). COVID-19 vaccine breakthrough infections were examined in fully vaccinated (≥14 days after 2nddose) IC individuals (IC cohort), 12 mutually exclusive IC condition groups, and a non-IC cohort. IC conditions were identified using an algorithm based on diagnosis codes and immunosuppressive (IS) medication usage.ResultsOf 1,277,747 individuals ≥16 years of age who received 2 BNT162b2 doses, 225,796 (17.7%) were identified as IC (median age: 58 years; 56.3% female). The most prevalent IC conditions were solid malignancy (32.0%), kidney disease (19.5%), and rheumatologic/inflammatory conditions (16.7%). Among the fully vaccinated IC and non-IC cohorts, a total of 978 breakthrough infections were observed during the study period; 124 (12.7%) resulted in hospitalization and 2 (0.2%) were inpatient deaths. IC individuals accounted for 38.2% (N=374) of all breakthrough infections, 59.7% (N=74) of all hospitalizations, and 100% (N=2) of inpatient deaths. The proportion with breakthrough infections was 3 times higher in the IC cohort compared to the non-IC cohort (N=374 [0.18%] vs. N=604 [0.06%]; unadjusted incidence rates were 0.89 and 0.34 per 100 person-years, respectively. Organ transplant recipients had the highest incidence rate; those with >1 IC condition, antimetabolite usage, primary immunodeficiencies, and hematologic malignancies also had higher incidence rates compared to the overall IC cohort. Incidence rates in older (≥65 years old) IC individuals were generally higher versus younger IC individuals (LimitationsThis retrospective analysis relied on coding accuracy and had limited capture of COVID-19 vaccine receipt.ConclusionsCOVID-19 vaccine breakthrough infections are rare but are more common and severe in IC individuals. The findings from this large study support FDA authorization and CDC recommendations to offer a 3rdvaccine dose to increase protection among IC individuals.

To conduct a systematic review and network meta-analysis of real-world evidence comparing adherence, persistence, cost, and utilization between oral anticoagulant (OAC) in non-valvular atrial fibrillation (NVAF) patients. A systematic search of MEDLINE and Embase (inception-July 2019) was conducted for published observational cohort studies comparing outcomes between ≥2 OACs. A network meta-analysis was performed to estimate odds ratios for non-persistence using a random-effects model. There were 80 studies evaluating the outcomes of interest. However, due to a paucity in adherence studies and heterogeneity in adherence, cost, and utilization definitions, persistence was the focus of this network meta-analysis. There were 36 studies evaluating non-persistence in 395,593 participants, 24 of which used 3 gap definitions (30-, 60-, and 90-days); 18 unique studies evaluating non-persistence at 12 months were included in the network meta-analysis. Using 30- and 90-day gaps, all NOACs, when compared with VKAs, had lower odds of non-persistence (30-day OR (95%CI): apixaban: 0.63 (0.58, 0.69); rivaroxaban: 0.69 (0.62, 0.76); dabigatran: 0.89 (0.82, 0.97); 90-day OR (95%CI): apixaban: 0.33 (0.22, 0.47); rivaroxaban: 0.47 (0.36, 0.61); dabigatran 0.61 (0.44, 0.85)). When using a 60-day gap, dabigatran had higher odds of non-persistence vs VKAs (OR: 1.35; 95%CI: 1.12, 1.61), but there were no significant differences for apixaban and rivaroxaban. Apixaban had the lowest probability of non-persistence across the 3-gap definitions (95.7% with 30-day gap, 76.9% with 60-day gap, 98.4% with 90-day gap). The current findings, despite multiple limitations, can raise awareness and understanding of real-world persistence associated with OAC therapy in NVAF patients.

The aims of this study were to evaluate health outcomes and the economic burden of hospitalized COVID-19 patients in the United States. Hospitalized patients with a primary or secondary discharge diagnosis code for COVID-19 (ICD-10 code U07.1) from 1 April to 31 October 2020 were identified in the Premier Healthcare COVID-19 Database. Patient demographics, hospitalization characteristics, and concomitant medical conditions were assessed. Hospital length of stay (LOS), in-hospital mortality, hospital charges, and hospital costs were evaluated overall and stratified by age groups, insurance types, and 4 COVID-19 disease progression states based on intensive care unit (ICU) and invasive mechanical ventilation (IMV) usage. Of the 173,942 hospitalized COVID-19 patients, the median age was 63 years, 51.0% were male, and 48.5% were covered by Medicare. The most prevalent concomitant medical conditions were cardiovascular disease (73.5%), hypertension (64.8%), diabetes (40.7%), obesity (27.0%), and chronic kidney disease (24.2%). Approximately one-fifth (21.9%) of the hospitalized COVID-19 patients were admitted to the ICU and 16.9% received IMV; most patients (73.6%) did not require ICU admission or IMV, and 12.4% required both. The median hospital LOS was 5 days, in-hospital mortality was 13.6%, median hospital charges were $43,986, and median hospital costs were $12,046. Hospital LOS and in-hospital mortality increased with ICU and/or IMV usage and age; hospital charges and costs increased with ICU and/or IMV usage. Patients with both ICU and IMV usage had the longest median hospital LOS (15 days), highest in-hospital mortality (53.8%), and highest hospital charges ($198,394) and hospital costs ($54,402). This retrospective administrative database analysis relied on coding accuracy and a subset of admissions with validated/reconciled hospital costs. This study summarizes the severe health outcomes and substantial hospital costs of hospitalized COVID-19 patients in the US. The findings support the urgent need for rapid implementation of effective interventions, including safe and efficacious vaccines.

Introduction: While a few studies have been conducted that evaluated anticoagulant (AC) treatment of patients with atrial fibrillation (AF) in the outpatient setting, little is known regarding inpatient AC treatment practices. Objective: To identify predictors of AC treatment among patients hospitalized with AF in the US Methods: Patients (≥18 years of age) who had a primary or secondary discharge diagnosis code of AF during a hospitalization (without a diagnosis of venous thromboembolism) were selected from the Premier Hospital database (1/1/2016-9/30/2017). Patients were grouped into 2 study cohorts: 1) Patients who received oral AC (OAC) therapy during hospitalization and 2) Patients who did not receive any AC therapy. Demographics, patient clinical characteristics, and hospital characteristics were examined. A multivariable logistic regression analysis was carried out to evaluate potential predictors of not receiving any AC therapy vs. receiving OACs. Results: Of the patients hospitalized with an AF diagnosis, 65.7% (n=205,438; mean age: 74.4 years; 47.1% female) received OAC therapy and 34.3% (n=107,076; mean age: 75.9 years; 46% female) did not receive any AC therapy. The most common OACs received were warfarin (39.4%) and apixaban (34.2%). Key predictors of a greater likelihood of not receiving any AC therapy vs. receiving OACs were greater comorbidity (Charlson Comorbidity Index [CCI] ≥5 vs. 0 odds ratio [OR]: 1.72; 3-4 vs. 0: 1.32; 1-2 vs. 0: 1.11, all p2 DS 2 -VASc=5 vs. 0 OR: 0.48; 3-4 vs. 0: 0.51; 1-2 vs. 0: 0.58, all p Conclusions: A substantial portion of hospitalized AF patients in the study did not receive any AC therapy, particularly those patients with an AF diagnosis in the second position on insurance claims. The predictors of AC treatment that were identified may be helpful in the clinical decision-making process for patients who are hospitalized with AF.

Introduction: Global treatment guidelines (e.g., AHA/ACC/HRS, ESC, JCS) recommend treatment with oral anticoagulants (OACs) for patients with non-valvular atrial fibrillation (NVAF) and an elevated stroke risk, defined by CHA 2 DS 2 -VASc score ≥2. However, not all patients with NVAF and an elevated stroke risk receive guideline-recommended therapy. A systematic literature review of observational studies was undertaken based on PRISMA guidelines to identify the body of evidence on untreated and undertreated NVAF among patients with elevated stroke risk, and assess its epidemiological and clinical burden. Methods: An extensive search of MEDLINE, GoogleScholar, the Cochrane Library, relevant conference proceedings, and health technology assessments (HTAs) was conducted for RWE studies. Studies published between 1/2010-4/2020 were included if they evaluated rates of nontreatment or undertreatment in NVAF. Nontreatment was defined as absence of OACs, while undertreatment was defined as treatment with only antiplatelet agents. Studies focusing on valvular AF were excluded. Results: Thirty-nine published studies (13 countries) met inclusion criteria. Rates of nontreatment for patients with elevated stroke risk ranged from 2.0%-51.1% (median: 23.3%), while rates of undertreatment ranged from 10.0%-45.1% (median: 34.6%). Few studies assessed the relationship between nontreatment or undertreatment and clinical outcomes in the evaluated population. Among US outpatients with NVAF and an elevated stroke risk, those undertreated had a higher likelihood of death (HR: 1.22; 95% CI: 1.05-1.41; p=.006) compared to patients treated with OACs. Also, in a separate US study of NVAF patients with varying levels of warfarin exposure, patients with no warfarin exposure had significantly higher rates of ischemic stroke than patients with low adherence (4.41 vs. 1.87 per 100 person-years, p Conclusion: Rates of nontreatment and undertreatment among NVAF patients with elevated stroke risk remain high and are associated with potentially preventable cardiovascular events and death. Strategies to increase rates of treatment may reduce adverse clinical outcomes.

Background: Studies have shown that nonvalvular atrial fibrillation (NVAF) patients who discontinue direct oral anticoagulants (DOAC) are at higher risk of complications, such as stroke. This analysis compared the risk of non-persistence of OACs among NVAF patients. Methods: Adult NVAF patients who initiated apixaban, dabigatran, rivaroxaban, or warfarin were identified using 01JAN2013-31MAR2019 data from the IQVIA commercial claims database. Non-persistence was defined as discontinuation (no evidence of index OAC use for 60 days from the last days’ of supply) or switch to another OAC. Kaplan-Meier (KM) curves were generated to illustrate time-to-non-persistence along with cumulative incidences of non-persistence. Adjusted cox proportional hazards models, including time-varying covariates (e.g., major bleeding, stroke), were used to evaluate non-persistence risk. Results: A total of 32,103 apixaban, 5,906 dabigatran, 29,385 rivaroxaban, and 21,420 warfarin patients were included; mean age: 63. Apixaban was associated with a lower risk of non-persistence compared to dabigatran (hazard ratio [HR]: 0.54; 95% confidence interval [CI]: 0.52-0.56), rivaroxaban (HR: 0.79; 95% CI: 0.78-0.81), and warfarin (HR: 0.66; 95% CI: 0.65-0.68). Dabigatran was associated with a higher risk of non-persistence compared to warfarin (HR: 1.23; 95% CI: 1.19-1.28) and rivaroxaban (HR: 1.47; 95% CI: 1.42-1.52), and rivaroxaban was associated with a lower risk compared to warfarin (HR: 0.84; 95% CI: 0.82-0.86). KM curves and cumulative incidences are presented below (Figure). Conclusions: In this group of NVAF patients, apixaban was associated with a significantly lower risk of non-persistence compared to dabigatran, rivaroxaban, and warfarin. Rivaroxaban was associated with a lower risk of non-persistence compared to warfarin and dabigatran. Such differences are critical as persistence with OACs is essential to prevent thromboembolic complications.

To address literature gaps on treatment with real-world evidence, this study compared effectiveness, safety, and cost outcomes in NVAF patients with coronary or peripheral artery disease (CAD, PAD) prescribed apixaban versus other oral anticoagulants. NVAF patients aged ≥65 years co-diagnosed with CAD/PAD initiating warfarin, apixaban, dabigatran, or rivaroxaban were selected from the US Medicare population (January 1, 2013 to September 30, 2015). Propensity score matching was used to match apixaban versus warfarin, dabigatran, and rivaroxaban cohorts. Cox models were used to evaluate the risk of stroke/systemic embolism (SE), major bleeding (MB), all-cause mortality, and a composite of stroke/myocardial infarction/all-cause mortality. Generalized linear and two-part models were used to compare stroke/SE, MB, and all-cause costs between cohorts. A total of 33,269 warfarin-apixaban, 9,335 dabigatran-apixaban, and 33,633 rivaroxaban-apixaban pairs were identified after matching. Compared with apixaban, stroke/SE risk was higher in warfarin (hazard ratio [HR]: 1.93; 95% confidence interval [CI]: 1.61 to 2.31), dabigatran (HR: 1.69; 95% CI: 1.18 to 2.43), and rivaroxaban (HR: 1.24; 95% CI: 1.01 to 1.51) patients. MB risk was higher in warfarin (HR: 1.67; 95% CI: 1.52 to 1.83), dabigatran (HR: 1.37; 95% CI: 1.13 to 1.68), and rivaroxaban (HR: 1.87; 95% CI: 1.71 to 2.05) patients vs apixaban. Stroke/SE- and MB-related medical costs per-patient per-month were higher in warfarin, dabigatran, and rivaroxaban patients versus apixaban. Total all-cause health care costs were higher in warfarin and rivaroxaban patients compared with apixaban patients. In conclusion, compared with apixaban, patients on dabigatran, rivaroxaban, or warfarin had a higher risk of stroke/SE, MB, and event-related costs.

This ARISTOPHANES analysis examined stroke/systemic embolism (SE) and major bleeding (MB) among a subgroup of nonvalvular atrial fibrillation (NVAF) patients with obesity prescribed warfarin or non-vitamin K antagonist oral anticoagulants (NOACs) in order to inform clinical decision making. A retrospective observational study was conducted among NVAF patients who were obese and initiated apixaban, dabigatran, rivaroxaban, or warfarin from 1 January 2013&ndash, 30 September 2015, with data pooled from CMS Medicare and four US commercial claims databases. Propensity score matching was completed between NOACs and against warfarin in each database, and the results were pooled. Cox models were used to evaluate the risks of stroke/SE and MB. A total of 88,461 patients with obesity were included in the study. Apixaban and rivaroxaban were associated with a lower risk of stroke/SE vs. warfarin (HR: 0.63, 95% CI: 0.49&ndash, 0.82 and HR: 0.84, 95% CI: 0.72&ndash, 0.98). Dabigatran was associated with a similar risk of stroke/SE compared to warfarin. Compared with warfarin, apixaban and dabigatran had a lower risk of MB (HR: 0.54, 95% CI: 0.49&ndash, 0.61 and HR: 0.75, 95% CI: 0.63&ndash, 0.91). Rivaroxaban was associated with a similar risk of MB compared to warfarin. In this high-risk population with obesity, NOACs had a varying risk of stroke/SE and MB vs. warfarin.

Fundamento: A segurança e a eficácia da varfarina dependem da qualidade do controle da anticoagulação. Estudos observacionais associam controle deficiente com aumento de morbidade, mortalidade e custos com saúde. Objetivos: Desenvolver um perfil de pacientes com fibrilação atrial não valvar (FANV) tratados com varfarina em ambiente hospitalar privado brasileiro, avaliar a qualidade do controle da anticoagulação e sua associação com resultados clínicos e econômicos. Métodos: Este estudo retrospectivo, por meio de um grande conjunto de dados de seguros privados de saúde no Brasil, identificou pacientes com FANV tratados com varfarina entre 01 de maio de 2014 a 30 de abril de 2016, descreveu seu manejo da anticoagulação e quantificou os custos relacionados à doença. Foram recuperados dados demográficos, histórico clínico, medicação concomitante e tempo na faixa terapêutica (TTR) dos valores da razão normalizada internacional (RNI). Os pacientes foram agrupados em quartis de TTR, com um bom controle sendo definido como TTR ≥65% (método de Rosendaal). Sangramentos maiores e custos médicos diretos por todas as causas foram calculados e comparados entre subgrupos de controle bons e ruins. Valores de p < 0,05 foram considerados estatisticamente significantes. Resultados: A análise incluiu 1220 pacientes (mediana de seguimento: 1,5 anos; IIQ: 0,5–2,0). Em média, cada paciente recebeu 0,95 medidas mensais de RNI (RNI média: 2,60 ± 0,88, com 26,1% dos valores < 2 e 24,8% > 3), (mediana de TTR: 58%; IIQ: 47-68%), (TTR médio: 56,6% ± 18,9%). Apenas 31% dos pacientes estavam bem controlados (TTR médio: 78% ± 10%), com 1,6% apresentando grandes sangramentos na mediana do seguimento e custos médicos diretos por membro por ano (PMPY) de R$25.352 (± R$37.762). Pacientes mal controlados (69%) foram associados a 3,3 vezes mais sangramentos graves (5,3% vs. 1,6%; p