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1.
Sci Rep ; 14(1): 14679, 2024 06 25.
Article in English | MEDLINE | ID: mdl-38918543

ABSTRACT

In Asian patients with atrial fibrillation (AF) and end-stage renal disease (ESRD) undergoing dialysis, the use of direct oral anticoagulants (DOACs) remains debatable. From the national health insurance claims data in South Korea, we included 425 new users of OAC among patients with non-valvular AF and ESRD undergoing dialysis between 2013 and 2020. Patients were categorized into DOAC (n = 106) and warfarin group (n = 319). Clinical outcomes, including ischemic stroke, myocardial infarction (MI), intracranial hemorrhage (ICH), and gastrointestinal (GI) bleeding, were compared between the two groups using inverse probability of treatment weighting (IPTW) analysis. During the median follow-up of 3.2 years, the incidence of ischemic stroke was significantly reduced in the DOAC compared to the warfarin group [Hazard ratio (HR) 0.07; P = 0.001]. However, the incidence of MI (HR 1.32; P = 0.41) and GI bleeding (HR 1.78; P = 0.06) were not significantly different between the two groups. No ICH events occurred in the DOAC group, although the incidence rate did not differ significantly between the two groups (P = 0.17). In Asian patients with AF and ESRD undergoing dialysis, DOACs may be associated with a reduced risk of ischemic stroke compared with warfarin. The MI, ICH, and GI bleeding rates may be comparable between DOACs and warfarin.


Subject(s)
Anticoagulants , Atrial Fibrillation , Kidney Failure, Chronic , Renal Dialysis , Warfarin , Humans , Atrial Fibrillation/drug therapy , Atrial Fibrillation/complications , Kidney Failure, Chronic/therapy , Kidney Failure, Chronic/complications , Male , Female , Renal Dialysis/adverse effects , Aged , Anticoagulants/therapeutic use , Anticoagulants/administration & dosage , Anticoagulants/adverse effects , Warfarin/therapeutic use , Warfarin/adverse effects , Warfarin/administration & dosage , Administration, Oral , Middle Aged , Republic of Korea/epidemiology , Incidence , Asian People , Gastrointestinal Hemorrhage/epidemiology , Gastrointestinal Hemorrhage/etiology , Myocardial Infarction/epidemiology , Myocardial Infarction/etiology , Ischemic Stroke/epidemiology , Ischemic Stroke/etiology , Ischemic Stroke/prevention & control , Aged, 80 and over
2.
JAMA Netw Open ; 7(6): e2418114, 2024 Jun 03.
Article in English | MEDLINE | ID: mdl-38913375

ABSTRACT

Importance: Racial and ethnic disparities exist in anticoagulation therapy for atrial fibrillation (AF). Whether medical center racial and ethnic composition is associated with these disparities is unclear. Objective: To determine whether medical center racial and ethnic composition is associated with overall anticoagulation and disparities in anticoagulation for AF. Design, Setting, and Participants: Retrospective cohort study of Black, White, and Hispanic patients with incident AF from 2018 to 2021 at 140 Veterans Health Administration medical centers (VAMCs). Data were analyzed from March to November 2023. Exposure: VAMC racial and ethnic composition, defined as the proportion of patients from minoritized racial and ethnic groups treated at a VAMC, categorized into quartiles. VAMCs in quartile 1 (Q1) had the lowest percentage of patients from minoritized groups (ie, the reference group). Main Outcomes and Measures: The odds of initiating any anticoagulant, direct-acting oral anticoagulant (DOAC), or warfarin therapy within 90 days of an index AF diagnosis, adjusting for sociodemographics, medical comorbidities, and facility factors. Results: The cohort comprised 89 791 patients with a mean (SD) age of 73.0 (10.1) years; 87 647 (97.6%) were male, 9063 (10.1%) were Black, 3355 (3.7%) were Hispanic, and 77 373 (86.2%) were White. Overall, 64 770 individuals (72.1%) initiated any anticoagulant, 60 362 (67.2%) initiated DOAC therapy, and 4408 (4.9%) initiated warfarin. Compared with White patients, Black and Hispanic patients had lower rates of any anticoagulant and DOAC therapy initiation but higher rates of warfarin initiation across all quartiles of VAMC racial and ethnic composition. Any anticoagulant therapy initiation was lower in Q4 than Q1 (69.8% vs 74.9%; adjusted odds ratio [aOR], 0.80; 95% CI, 0.69-0.92; P < .001). DOAC and warfarin initiation were also lower in Q4 than in Q1 (DOAC, 69.4% vs 65.3%; aOR, 0.85; 95% CI, 0.74-0.97; P < .001; warfarin, 5.4% vs 4.5%; aOR, 0.82; 95% CI, 0.67-1.00; P < .001). In adjusted models, patients in Q4 were significantly less likely to initiate any anticoagulant therapy than those in Q1 (aOR, 0.88; 95% CI, 0.78-0.99). Patients in Q3 (aOR, 0.75; 95% CI, 0.60-0.93) and Q4 (aOR, 0.69; 95% CI, 0.55-0.87) were significantly less likely to initiate warfarin therapy than those in Q1. There was no significant difference in the adjusted odds of initiating DOAC therapy across racial and ethnic composition quartiles. Although significant Black-White and Hispanic-White differences in initiation of any anticoagulant, DOAC, and warfarin therapy were observed, interactions between patient race and ethnicity and VAMC racial composition were not significant. Conclusions and Relevance: In a national cohort of VA patients with AF, initiation of any anticoagulant and warfarin, but not DOAC therapy, was lower in VAMCs serving more minoritized patients.


Subject(s)
Anticoagulants , Atrial Fibrillation , Humans , Atrial Fibrillation/drug therapy , Atrial Fibrillation/ethnology , Male , Female , Aged , Anticoagulants/therapeutic use , Retrospective Studies , United States/epidemiology , Healthcare Disparities/ethnology , Healthcare Disparities/statistics & numerical data , United States Department of Veterans Affairs , Middle Aged , Warfarin/therapeutic use , Hispanic or Latino/statistics & numerical data , Aged, 80 and over , Ethnicity/statistics & numerical data , White People/statistics & numerical data
3.
J Cardiovasc Pharmacol ; 84(1): 36-44, 2024 Jul 01.
Article in English | MEDLINE | ID: mdl-38922590

ABSTRACT

ABSTRACT: Current guidelines recommend that direct anticoagulants should not be used in prevention of recurrent thrombosis in patients with antiphospholipid syndrome (APS). However, except for triple-positive APS and rivaroxaban use, little evidence supports such recommendation. In a real-life cohort study, we evaluated the risk of thromboembolism and bleeding in patients with APS on apixaban versus vitamin K antagonists (VKA). We enrolled 152 patients with APS (aged 44 years [interquartile range 36-56], 83% women), including 66 patients treated with apixaban 5 mg bid and 86 with warfarin (target international normalized ratio [INR] 2-3). During a median follow-up of 53 months, we recorded venous thromboembolism, ischemic stroke, or myocardial infarction, along with major bleeding. We observed 4 thrombotic events (6.1%, 3 venous thromboembolism and 1 ischemic stroke) in patients on apixaban and 12 events (14%, 9 venous thromboembolism, 2 ischemic strokes and 1 myocardial infarction) in VKA patients. Patients with APS on apixaban had similar risk of recurrent thromboembolism compared with those on warfarin (hazard ratio [HR] = 0.327, 95% confidence interval [CI]: 0.104-1.035). Thromboembolic events occurred less commonly in statin users (8% vs. 50%, P = 0.01) and more frequently in triple-positive APS (50% vs. 22.1%, P = 0.028) and in patients with higher D-dimer at baseline ( P = 0.023); the latter difference was present in the apixaban group ( P = 0.02). Patients on apixaban had similar risk of major bleeding compared with warfarin (HR = 0.54, 95% CI: 0.201-1.448). In real-life patients with APS, apixaban appears to be similar to VKA for the prevention of thromboembolism and risk of bleeding, which might suggest that some patients with APS could be treated with apixaban.


Subject(s)
Anticoagulants , Antiphospholipid Syndrome , Factor Xa Inhibitors , Hemorrhage , Pyrazoles , Pyridones , Vitamin K , Warfarin , Humans , Female , Pyrazoles/adverse effects , Pyrazoles/therapeutic use , Pyridones/adverse effects , Pyridones/therapeutic use , Pyridones/administration & dosage , Male , Antiphospholipid Syndrome/drug therapy , Antiphospholipid Syndrome/complications , Antiphospholipid Syndrome/diagnosis , Antiphospholipid Syndrome/blood , Middle Aged , Factor Xa Inhibitors/adverse effects , Factor Xa Inhibitors/administration & dosage , Factor Xa Inhibitors/therapeutic use , Hemorrhage/chemically induced , Vitamin K/antagonists & inhibitors , Adult , Treatment Outcome , Risk Factors , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , Anticoagulants/administration & dosage , Warfarin/adverse effects , Warfarin/therapeutic use , Warfarin/administration & dosage , Time Factors , Risk Assessment , Recurrence , Venous Thromboembolism/prevention & control , Venous Thromboembolism/epidemiology , Myocardial Infarction/prevention & control , Myocardial Infarction/epidemiology , Ischemic Stroke/prevention & control , Ischemic Stroke/diagnosis , Ischemic Stroke/epidemiology
4.
Neurology ; 103(1): e209568, 2024 Jul 09.
Article in English | MEDLINE | ID: mdl-38857466

ABSTRACT

BACKGROUND AND OBJECTIVES: Incidence and prevalence of atrial fibrillation (AF), a risk factor of dementia, have been increasing over time. Oral anticoagulation reduces risk of stroke and other negative outcomes of AF and may reduce dementia health inequities. The objective of this study was to estimate dementia incidence in patients with newly-diagnosed AF and taking an anticoagulant as use of direct oral anticoagulants (DOACs) increased. METHODS: We used a retrospective cohort design with annual incident AF cohorts of community-dwelling Medicare Fee-for-Service beneficiaries, enrolled in Parts A, B, and D from 2007 to 2017. The sample was limited to beneficiaries aged 67 years and older with incident AF; no prior dementia; and use of anticoagulants warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban in year t. RESULTS: A total of 1,083,338 beneficiaries were included in the study, 58.5% female, with mean (SD) age 77.2 (6.75) years. Among anticoagulated, incident AF cohorts, use of DOACs increased from 10.6% in their first year of availability (2011) to 41.4% in 2017. Among incident AF cohorts taking any oral anticoagulant, 3-year dementia incidence did not change significantly over the cohorts after adjusting for confounders. For example, incidence was 9.1% (95% CI 8.9-9.4) among White persons diagnosed with AF in 2007 and 2008 and 8.9% (95% CI 8.7-9.1) in 2017. Across cohorts, dementia incidence was consistently highest for Black persons, followed by American Indian/Alaska Native and White persons, and lowest for Asian persons. In 2017, 10.9% (95% CI 10.4-11.3) of Black persons in the cohort developed dementia within 3 years, 9.4% (95% CI 8.0-10.9) of American Indian/Alaska Native, 8.9% (95% CI 8.7-9.1) of White, 8.7% (95% CI 8.2-9.1) of Hispanic, and 6.9% (95% CI 6.4-7.4) of Asian persons. Across race/ethnicity, 3-year stroke risk decreased consistently over time; however, the increasing availability of DOACs did not alter the trend. DISCUSSION: Increased use of DOACs among incident AF cohorts from 2007 to 2017 was not associated with significant declines in dementia or stroke risk. Consideration of similar stroke and dementia risk, as well as differences in cost, is warranted when weighing the risks and benefits of available oral anticoagulants.


Subject(s)
Anticoagulants , Atrial Fibrillation , Dementia , Medicare , Humans , Atrial Fibrillation/drug therapy , Atrial Fibrillation/epidemiology , Aged , Female , Male , Dementia/epidemiology , Incidence , Aged, 80 and over , Anticoagulants/therapeutic use , Anticoagulants/administration & dosage , Retrospective Studies , United States/epidemiology , Administration, Oral , Dabigatran/therapeutic use , Rivaroxaban/therapeutic use , Cohort Studies , Warfarin/therapeutic use
5.
Molecules ; 29(11)2024 Jun 04.
Article in English | MEDLINE | ID: mdl-38893525

ABSTRACT

Oral anticoagulant therapy (OAT) for managing atrial fibrillation (AF) encompasses vitamin K antagonists (VKAs, such as warfarin), which was the mainstay of anticoagulation therapy before 2010, and direct-acting oral anticoagulants (DOACs, namely dabigatran etexilate, rivaroxaban, apixaban, edoxaban), approved for the prevention of AF stroke over the last thirteen years. Due to the lower risk of major bleeding associated with DOACs, anticoagulant switching is a common practice in AF patients. Nevertheless, there are issues related to OAT switching that still need to be fully understood, especially for patients in whom AF and heart failure (HF) coexist. Herein, the effective impact of the therapeutic switching from warfarin to DOACs in HF patients with AF, in terms of cardiac remodeling, clinical status, endothelial function and inflammatory biomarkers, was assessed by a machine learning (ML) analysis of a clinical database, which ultimately shed light on the real positive and pleiotropic effects mediated by DOACs in addition to their anticoagulant activity.


Subject(s)
Anticoagulants , Atrial Fibrillation , Heart Failure , Machine Learning , Humans , Atrial Fibrillation/drug therapy , Heart Failure/drug therapy , Anticoagulants/therapeutic use , Anticoagulants/administration & dosage , Anticoagulants/pharmacology , Administration, Oral , Male , Female , Aged , Chronic Disease , Warfarin/therapeutic use
6.
Europace ; 26(6)2024 Jun 03.
Article in English | MEDLINE | ID: mdl-38829189

ABSTRACT

AIMS: Elective cardioversion (ECV) is routinely used in atrial fibrillation (AF) to restore sinus rhythm. However, it includes a risk of thromboembolism even during adequate oral anticoagulation treatment. The aim of this study was to evaluate the risk of thromboembolic and bleeding complications after ECV in a real-life setting utilizing data from a large AF population. METHODS AND RESULTS: This nationwide register-based study included all (n = 9625) Finnish AF patients undergoing their first-ever ECV between 2012 and 2018. The thromboembolic and bleeding complications within 30 days after ECV were analysed. The mean age of the patients was 67.7 ± 9.9 years, 61.2% were men, and the mean CHA2DS2-VASc score was 2.6 ± 1.6. Warfarin was used in 6245 (64.9%) and non-vitamin K oral anticoagulants (NOACs) in 3380 (35.1%) cardioversions. Fifty-two (0.5%) thromboembolic complications occurred, of which 62% were ischaemic strokes, 25% transient ischaemic attacks, and 13% other systemic embolisms. Thromboembolic events occurred in 14 (0.4%) NOAC-treated patients and in 38 (0.6%) warfarin-treated patients (odds ratio 0.77; confidence interval: 0.42-1.39). The median time from ECV to the thromboembolic event was 2 days, and 78% of the events occurred within 10 days. Age and alcohol abuse were significant predictors of thromboembolic events. Among warfarin users, thromboembolic complications were more common with international normalized ratio (INR) <2.5 than INR ≥2.5 (0.9% vs. 0.4%, P = 0.026). Overall, 27 (0.3%) bleeding events occurred. CONCLUSION: The rate of thromboembolic and bleeding complications related to ECV was low without significant difference between NOAC- and warfarin-treated patients. With warfarin, INR ≥2.5 at the time of cardioversion reduced the risk of thromboembolic complications.


Subject(s)
Anticoagulants , Atrial Fibrillation , Electric Countershock , Hemorrhage , Registries , Thromboembolism , Humans , Atrial Fibrillation/epidemiology , Atrial Fibrillation/drug therapy , Male , Electric Countershock/adverse effects , Female , Aged , Thromboembolism/etiology , Thromboembolism/prevention & control , Thromboembolism/epidemiology , Anticoagulants/therapeutic use , Anticoagulants/adverse effects , Hemorrhage/epidemiology , Hemorrhage/chemically induced , Hemorrhage/etiology , Middle Aged , Finland/epidemiology , Risk Factors , Warfarin/adverse effects , Warfarin/therapeutic use , Risk Assessment , Time Factors
7.
J Int Med Res ; 52(6): 3000605241258474, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38901839

ABSTRACT

The gold standard therapy for end-stage heart failure is cardiac transplantation. However, in the face of a donor shortage, a mechanical assist device such as the left ventricular assist device HeartMate 3 (Abbott Laboratories, Abbott Park, IL, USA) serves as bridging therapy to transplantation and/or destination therapy. Current guidelines recommend anticoagulation with a vitamin K antagonist in combination with low-dose aspirin. We herein report a challenging anticoagulation regimen in a patient with a HeartMate 3 in whom systemic anticoagulation with warfarin was not feasible for 4 years because of low compatibility and a rare X-factor deficiency. This is a rare hematological disorder, estimated to affect approximately 1 in every 500,000 to 1,000,000 people in the general population. The patient finally received a modified anticoagulation regimen involving the combination of rivaroxaban and clopidogrel without warfarin. Under this regimen, the patient remained free of thromboembolic complications for 4 years with in situ placement of the left ventricular assist device. This case illustrates that under specific circumstances, long-term absence of warfarin therapy is feasible in patients with a HeartMate 3.


Subject(s)
Anticoagulants , Heart-Assist Devices , Thromboembolism , Warfarin , Humans , Heart-Assist Devices/adverse effects , Warfarin/therapeutic use , Warfarin/administration & dosage , Thromboembolism/etiology , Thromboembolism/prevention & control , Anticoagulants/therapeutic use , Anticoagulants/administration & dosage , Male , Heart Failure/surgery , Middle Aged , Clopidogrel/administration & dosage , Clopidogrel/therapeutic use , Clopidogrel/adverse effects , Rivaroxaban/administration & dosage , Rivaroxaban/therapeutic use , Withholding Treatment
8.
Clin Appl Thromb Hemost ; 30: 10760296241260736, 2024.
Article in English | MEDLINE | ID: mdl-38863211

ABSTRACT

Anticoagulation management using warfarin is challenging in clinical practice. This study aimed to evaluate the knowledge, adherence, and satisfaction with warfarin therapy and associated factors among outpatients at the Tikur Anbessa Specialized Hospital (TASH) in Addis Ababa, Ethiopia. An interview-based cross-sectional study was conducted among 350 patients receiving warfarin therapy at cardiac and hematology clinics of TASH. Anticoagulation knowledge assessment (AKA) questionnaires assessed the patients' warfarin knowledge. Adherence to warfarin was evaluated using the Morisky Green Levine Scale (MGLS), and patient satisfaction with warfarin therapy was assessed using the 17-item anticlot treatment scale (ACTS). Binary logistic regression was used to determine factors associated with the outcome variables, and p < .05 was used as the cut-off point to declare a significant association. The mean AKA score was 59.35 ± 13.04% (10.68 ± 2.34 correct answers), and 82 (23.4%) of participants achieved a passing score. Based on the MGLS, 192 (54.9%) study participants adhered well to warfarin. The mean level of satisfaction was 53.67 ± 8.56, with mean scores of 41.93 ± 7.80 and 11.74 ± 2.43 in the ACTS burden and benefit subscales, respectively. One hundred eighty-four (52.6%) patients were satisfied with warfarin therapy. The absence of hyperthyroidism was significantly associated with poor knowledge of warfarin therapy (adjusted odds ratio [AOR] = 4.28, 95% confidence interval [CI]: 1.01-18.22). Those living with family had a 56% lower chance of poor warfarin adherence (AOR: 0.44; 95% CI: 0.21-0.93) than those living alone. This study shows room for improvement in patient knowledge, adherence, and satisfaction with warfarin therapy.


Subject(s)
Outpatients , Patient Satisfaction , Warfarin , Humans , Warfarin/therapeutic use , Ethiopia , Female , Male , Middle Aged , Cross-Sectional Studies , Adult , Anticoagulants/therapeutic use , Medication Adherence/statistics & numerical data , Health Knowledge, Attitudes, Practice , Aged , Hospitals, Teaching , Hospitals, University , Surveys and Questionnaires
9.
Clin Cardiol ; 47(6): e24311, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38923583

ABSTRACT

INTRODUCTION: This study evaluates the cost-effectiveness of Apixaban and Rivaroxaban, compared to Warfarin, for stroke prevention in patients with non-valvular atrial fibrillation in Iran. METHOD: A Markov model with a 30-year time horizon was employed to simulate and assess different treatment strategies' cost-effectiveness. The study population comprised Iranian adults with NVAF, identified through specialist consultations, hospital visits, and archival record reviews. Direct medical costs, direct nonmedical, and indirect costs were included. Quality-adjusted life years (QALY) were assessed using an EQ-5D questionnaire. This study utilized a cost-effectiveness threshold of $11 134 per QALY. RESULTS: Apixaban demonstrated superior cost-effectiveness compared to Rivaroxaban and Warfarin. Over 30 years, total costs were lower in the Apixaban and Rivaroxaban groups compared to the Warfarin group ($126.18 and $109.99 vs. $150.49). However, Apixaban showed higher total QALYs gained compared to others (0.134 vs. 0.133 and 0.116). The incremental cost-effectiveness ratio for comparing Apixaban to Warfarin was calculated at -1332.83 cost per QALY, below the threshold of $11 134, indicating Apixaban's cost-effectiveness. Sensitivity analyses confirmed the robustness of the findings, with ICER consistently remaining below the threshold. Over 5 years (2024-2028) of Apixaban usage, the incremental cost starts at USD 70 250 296 in the first year and gradually rises to USD 71 770 662 in the fifth year. DSA and PSA were assessed to prove the robustness of the results. CONCLUSION: This study shows that Apixaban is a cost-effective option for stroke prevention in non-valvular atrial fibrillation patients in Iran compared to Warfarin.


Subject(s)
Anticoagulants , Atrial Fibrillation , Cost-Benefit Analysis , Factor Xa Inhibitors , Pyrazoles , Pyridones , Quality-Adjusted Life Years , Rivaroxaban , Stroke , Warfarin , Humans , Atrial Fibrillation/complications , Atrial Fibrillation/drug therapy , Atrial Fibrillation/economics , Pyrazoles/therapeutic use , Pyrazoles/economics , Pyridones/economics , Pyridones/therapeutic use , Warfarin/economics , Warfarin/therapeutic use , Iran/epidemiology , Stroke/prevention & control , Stroke/economics , Stroke/epidemiology , Stroke/etiology , Rivaroxaban/economics , Rivaroxaban/therapeutic use , Anticoagulants/economics , Anticoagulants/therapeutic use , Male , Factor Xa Inhibitors/economics , Factor Xa Inhibitors/therapeutic use , Female , Markov Chains , Aged , Drug Costs , Treatment Outcome , Middle Aged , Budgets , Time Factors
10.
JAMA Netw Open ; 7(5): e249465, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38709533

ABSTRACT

Importance: The influence of race and ethnicity on initiation of direct oral anticoagulants (DOACs) is relatively understudied in Medicare data. Objective: To investigate disparities in the initiation of DOACs compared with warfarin by race, ethnicity, and social vulnerability. Design, Setting, and Participants: This retrospective cohort study used a 50% sample of Medicare fee-for-service data from January 1, 2010, to December 31, 2019 (mean patient enrollment duration, 7.7 years). Analysis took place between January 2023 and February 2024. A cohort of older adults (aged ≥65 years) with atrial fibrillation who newly initiated warfarin or DOACs (dabigatran, rivaroxaban, apixaban, and edoxaban) was identified. Exposure: Patients were classified as non-Hispanic White, non-Hispanic Black, and Hispanic. Main Outcomes and Measures: The likelihood of starting use of DOACs compared with warfarin was modeled, adjusting for race, ethnicity, age, sex, county-level social vulnerability, and other clinical factors. Results: Among 950 698 anticoagulation initiations, consisting of 680 974 DOAC users and 269 724 warfarin users (mean [SD] age, 78.5 [7.6] years; 52.6% female), 5.2% were Black, 4.3% were Hispanic, and 86.7% were White. During the 10-year study period, DOAC use increased for all demographic groups. After adjustment, compared with White patients, Black patients were 23% less likely (adjusted odds ratio [AOR, 0.77; 95% CI, 0.75-0.79) and Hispanic patients were 13% less likely (AOR, 0.87; 95% CI, 0.85-0.89) to initiate DOAC use. Disparities in DOAC initiation were greatest among Black patients in the earlier years but attenuated during the study period. For instance, in 2010, the OR of Black patients initiating DOACs was 0.54 (95% CI, 0.50-0.57), attenuating linearly over time to 0.69 by 2013 (95% CI, 0.65-0.74) and 0.83 (95% CI, 0.78-0.89) by 2017. By 2019, these differences became nonsignificant (OR, 1.08; 95% CI, 0.99-1.18). Conclusions and Relevance: In this cohort study of Medicare patients with atrial fibrillation, Black and Hispanic patients were less likely to initiate DOACs for atrial fibrillation, although these differences diminished over time. Identifying the factors behind these early disparities is crucial for ensuring equitable access to novel therapies as they emerge for Black and Hispanic populations.


Subject(s)
Anticoagulants , Atrial Fibrillation , Healthcare Disparities , Medicare , Warfarin , Aged , Aged, 80 and over , Female , Humans , Male , Administration, Oral , Anticoagulants/therapeutic use , Atrial Fibrillation/drug therapy , Atrial Fibrillation/ethnology , Cohort Studies , Dabigatran/therapeutic use , Ethnicity/statistics & numerical data , Healthcare Disparities/ethnology , Healthcare Disparities/statistics & numerical data , Hispanic or Latino/statistics & numerical data , Medicare/statistics & numerical data , Pyrazoles/therapeutic use , Pyridines/therapeutic use , Pyridones/therapeutic use , Retrospective Studies , Rivaroxaban/therapeutic use , Thiazoles/therapeutic use , United States , Warfarin/therapeutic use , White People/statistics & numerical data , White , Black or African American
11.
J Am Heart Assoc ; 13(11): e028951, 2024 Jun 04.
Article in English | MEDLINE | ID: mdl-38780169

ABSTRACT

BACKGROUND: Days alive out of hospital (DAOH) is an objective and patient-centered net benefit end point. There are no assessments of DAOH in clinical trials of interventions for atrial fibrillation (AF), and it is not known whether this end point is of clinical utility in these populations. METHODS AND RESULTS: ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) was an international double-blind, double-dummy randomized clinical trial that compared rivaroxaban with warfarin in patients with atrial fibrillation at increased risk for stroke. We assessed DAOH using investigator-reported event data for up to 12 months after randomization in ROCKET AF. We assessed DAOH overall, by treatment group, and by subgroup, including age, sex, and comorbidities, using Poisson regression. The mean±SD number of days dead was 7.3±41.2, days hospitalized was 1.2±7.2, and mean DAOH was 350.7±56.2, with notable left skew. Patients with comorbidities had fewer DAOH overall. There were no differences in DAOH by treatment arm, with mean DAOH of 350.6±56.5 for those randomized to rivaroxaban and 350.7±55.8 for those randomized to warfarin (P=0.86). A sensitivity analysis found no difference in DAOH not disabled with rivaroxaban versus warfarin (DAOH not disabled, 349.2±59.5 days and 349.1 days±59.3 days, respectively, P=0.88). CONCLUSIONS: DAOH did not identify a treatment difference between patients randomized to rivaroxaban versus warfarin. This may be driven in part by the low overall event rates in atrial fibrillation anticoagulation trials, which leads to substantial left skew in measures of DAOH.


Subject(s)
Anticoagulants , Atrial Fibrillation , Factor Xa Inhibitors , Rivaroxaban , Stroke , Warfarin , Humans , Atrial Fibrillation/drug therapy , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Rivaroxaban/therapeutic use , Rivaroxaban/administration & dosage , Female , Male , Stroke/prevention & control , Stroke/etiology , Stroke/epidemiology , Aged , Warfarin/therapeutic use , Factor Xa Inhibitors/therapeutic use , Factor Xa Inhibitors/administration & dosage , Anticoagulants/therapeutic use , Anticoagulants/administration & dosage , Double-Blind Method , Middle Aged , Time Factors , Treatment Outcome , Morpholines/therapeutic use , Thiophenes/therapeutic use , Aged, 80 and over
12.
Thromb Res ; 238: 88-96, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38696925

ABSTRACT

INTRODUCTION: Recommendations about proper anticoagulation in obese patients, body mass index (BMI) > 30 kg/m2, are not yet clearly defined. Obese patients were included in randomized controlled trials comparing new anticoagulants (NOACs) with warfarin in patients with atrial fibrillation or thromboembolism. METHODS: We performed a medline search entering proper criteria and finally 6 post-hoc analysis of RCTs, reporting outcome according to BMI, were included in this meta-analysis. Two major outcomes were considered end points in our meta-analysis; thrombosis, including ischemic cerebral events (transient or not) and venous thrombosis (DVD) /pulmonary embolism (PE) and bleeding, including major bleeding and clinically relevant non-major bleeding. RESULTS: In the NOACs treated group, thrombosis occurred less frequently in obese vs non-obese patients; RR and 95 % CI 0,75 (0,58-0,97), p = 0,03, while low heterogeneity was observed (I2= 40 %). In the warfarin treated subgroup there was statistically significant difference with less thrombotic events occurring in the obese vs non-obese patients; RR and (95 % CI) 0,80 (0,66-0,98), p = 0,03, and heterogeneity was low (I2 = 24 %). This protective effect called the obesity paradox is limited to obese patients anticoagulated for non-valvular atrial fibrillation (NVAF); RR (95 % CI) was 0,70 (0,58-0,85) p = 0,03 and I2 = 24 %. Bleeding events were similar under both NOACs and warfarin in obese vs non-obese analysis. CONCLUSIONS: Obese patients anticoagulated for NVAF with either standard dose of xabans or INR guided warfarin are more efficiently protected against thrombosis compared to non-obese patients.


Subject(s)
Anticoagulants , Atrial Fibrillation , Obesity , Randomized Controlled Trials as Topic , Thrombosis , Warfarin , Humans , Atrial Fibrillation/drug therapy , Atrial Fibrillation/complications , Warfarin/therapeutic use , Obesity/complications , Obesity/drug therapy , Anticoagulants/therapeutic use , Thrombosis/prevention & control , Thrombosis/etiology , Hemorrhage/chemically induced , Factor Xa Inhibitors/therapeutic use
13.
Tex Heart Inst J ; 51(1)2024 May 15.
Article in English | MEDLINE | ID: mdl-38748549

ABSTRACT

BACKGROUND: Current venous thromboembolism guidelines recommend using direct oral anticoagulants (DOACs) over warfarin regardless of obesity status; however, evidence remains limited for the safety and efficacy of DOAC use in patients with obesity. This retrospective analysis sought to demonstrate the safety and efficacy of DOACs compared with warfarin in a diverse population of patients with obesity in light of current prescribing practices. METHODS: A retrospective cohort study was conducted at a large academic health system between July 2014 and September 2019. Adults with an admission diagnosis of deep vein thrombosis (DVT) or pulmonary embolism, with weight greater than 120 kg or a body mass index greater than 40, and who were discharged on an oral anticoagulant were included. Outcomes included occurrence of a thromboembolic event (DVT, pulmonary embolism, or ischemic stroke), bleeding event requiring hospitalization, and all-cause mortality within 12 months following index admission. RESULTS: Out of 787 patients included, 520 were in the DOAC group and 267 were in the warfarin group. Within 12 months of index hospitalization, thromboembolic events occurred in 4.23% of patients in the DOAC group vs 7.12% of patients in the warfarin group (hazard ratio, 0.6 [95% CI, 0.32-1.1]; P = .082). Bleeding events requiring hospitalization occurred in 8.85% of DOAC patients vs 10.1% of warfarin patients (hazard ratio, 0.93 [95% CI, 0.57-1.5]; P = .82). A DVT occurred in 1.7% and 4.9% of patients in the DOAC and warfarin groups, respectively (hazard ratio, 0.35 [95% CI, 0.15-0.84]; P = .046). CONCLUSION: No significant differences could be determined between DOACs and warfarin for cumulative thromboembolic or bleeding events, pulmonary embolism, ischemic stroke, or all-cause mortality. The risk of DVT was lower with apixaban and rivaroxaban. Regardless of patient weight or body mass index, physicians prescribed DOACs more commonly than warfarin.


Subject(s)
Anticoagulants , Obesity , Venous Thromboembolism , Warfarin , Humans , Retrospective Studies , Female , Male , Warfarin/adverse effects , Warfarin/administration & dosage , Warfarin/therapeutic use , Obesity/complications , Anticoagulants/adverse effects , Anticoagulants/administration & dosage , Anticoagulants/therapeutic use , Middle Aged , Venous Thromboembolism/epidemiology , Venous Thromboembolism/drug therapy , Administration, Oral , Aged , Treatment Outcome , Factor Xa Inhibitors/adverse effects , Factor Xa Inhibitors/administration & dosage , Factor Xa Inhibitors/therapeutic use , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Follow-Up Studies
14.
Sci Rep ; 14(1): 10784, 2024 05 11.
Article in English | MEDLINE | ID: mdl-38734732

ABSTRACT

Portal vein thrombosis (PVT) worsens the long-term prognosis of patients with cirrhosis; however, the optimal treatment remains to be determined. Reports on the efficacy of direct oral anticoagulants are increasing, and further evidence is needed. Therefore, we investigated the effectiveness of treatment with edoxaban in patients with PVT. We retrospectively reviewed the outcomes of edoxaban and warfarin as antithrombotic therapies for PVT. The median overall survival time was 4.2 years in patients with PVT, with a 1-year survival rate of 70.7% and a 5-year survival rate of 47.9%. The leading cause of death was hepatocellular carcinoma. The overall response rate for thrombolysis in the edoxaban group was 76.7% compared to 29.4% in the warfarin group, and edoxaban significantly improved PVT compared to warfarin. In addition, edoxaban provided long-term improvement of PVT. Warfarin, on the other hand, was temporarily effective but did not provide long-term benefits. The Child-Pugh and albumin-bilirubin scores did not change after edoxaban or warfarin use. No deaths occurred due to adverse events associated with edoxaban or warfarin. Edoxaban as a single agent can achieve long-term recanalization without compromising the hepatic reserves. Edoxaban is easy to initiate, even in an outpatient setting, and could become a major therapeutic agent for the treatment of PVT.


Subject(s)
Liver Cirrhosis , Portal Vein , Pyridines , Thiazoles , Venous Thrombosis , Warfarin , Humans , Thiazoles/therapeutic use , Thiazoles/administration & dosage , Pyridines/therapeutic use , Pyridines/adverse effects , Liver Cirrhosis/drug therapy , Liver Cirrhosis/complications , Portal Vein/pathology , Female , Male , Venous Thrombosis/drug therapy , Venous Thrombosis/etiology , Middle Aged , Aged , Retrospective Studies , Warfarin/therapeutic use , Warfarin/adverse effects , Anticoagulants/therapeutic use , Treatment Outcome , Factor Xa Inhibitors/therapeutic use , Adult
15.
J Med Case Rep ; 18(1): 246, 2024 May 14.
Article in English | MEDLINE | ID: mdl-38741148

ABSTRACT

INTRODUCTION: Thrombotic events are more than twice as common in inflammatory bowel disease patients as in the general population. We report an interesting and rare case of portal vein thrombosis as a venous thromboembolic event in the context of extraintestinal manifestations of Crohn's disease. We also conducted a literature review on portal vein thrombosis associated with inflammatory bowel disease, with the following concepts: inflammatory bowel diseases, ulcerative colitis, Crohn's disease, portal vein, and thrombosis. CASE PRESENTATION: A 24-year-old Syrian female with active chronic Crohn's disease was diagnosed 11 years ago and classified as A1L3B1P according to the Montreal classification. She had no prior surgical history. Her previous medications included azathioprine and prednisolone. Her Crohn's disease activity index was 390 points. Gastroduodenoscopy revealed grade I esophageal varices, a complication of portal hypertension. Meanwhile, a colonoscopy revealed several deep ulcers in the sigmoid, rectum, and descending colon. An investigation of portal vein hypertension revealed portal vein thrombosis. We used corticosteroids to induce remission, followed by tapering; additionally she received ustekinumab to induce and maintain remission. She began on low-molecular-weight heparin for 1 week, warfarin for 3 months, and then apixaban, a novel oral anticoagulant, after excluding antiphospholipid syndrome. Primary prophylaxis for esophageal varices was not required. After 1 year, she achieved clinical, biochemical, and endoscopic remission. Despite 1 year of treatment, a computed tomography scan revealed no improvement in portal vein recanalization. CONCLUSION: Portal vein thrombosis is a rare and poorly defined complication of inflammatory bowel disease. It is usually exacerbated by inflammatory bowel disease. The symptoms are nonspecific and may mimic a flare-up of inflammatory bowel disease, making the diagnosis difficult. Portal vein Doppler ultrasound for hospital-admitted inflammatory bowel disease patients may contribute to the diagnosis and management of this complication.


Subject(s)
Anticoagulants , Crohn Disease , Portal Vein , Venous Thrombosis , Humans , Crohn Disease/complications , Female , Portal Vein/diagnostic imaging , Venous Thrombosis/etiology , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/drug therapy , Young Adult , Anticoagulants/therapeutic use , Warfarin/therapeutic use
16.
Sci Rep ; 14(1): 12009, 2024 05 25.
Article in English | MEDLINE | ID: mdl-38796624

ABSTRACT

Spontaneous intracerebral hemorrhage (SICH) remains a devastating form of stroke. Prior use of antiplatelets or warfarin before SICH is associated with poor outcomes, but the effects of direct oral anticoagulants (DOACs) remain unclear. This study aimed to clarify trends in prior antithrombotic use and to assess the associations between prior use of antithrombotics and in-hospital mortality using a multicenter prospective registry in Japan. In total, 1085 patients were analyzed. Prior antithrombotic medication included antiplatelets in 14.2%, oral anticoagulants in 8.1%, and both in 1.8%. Prior warfarin use was significantly associated with in-hospital mortality (odds ratio [OR] 5.50, 95% confidence interval [CI] 1.30-23.26, P < 0.05) compared to no prior antithrombotic use. No such association was evident between prior DOAC use and no prior antithrombotic use (OR 1.34, 95% CI 0.44-4.05, P = 0.606). Concomitant use of antiplatelets and warfarin further increased the in-hospital mortality rate (37.5%) compared to warfarin alone (17.2%), but no such association was found for antiplatelets plus DOACs (8.3%) compared to DOACs alone (11.9%). Prior use of warfarin remains an independent risk factor for in-hospital mortality after SICH in the era of DOACs. Further strategies are warranted to reduce SICH among patients receiving oral anticoagulants and to prevent serious outcomes.


Subject(s)
Anticoagulants , Cerebral Hemorrhage , Fibrinolytic Agents , Hospital Mortality , Registries , Warfarin , Humans , Hospital Mortality/trends , Aged , Female , Male , Cerebral Hemorrhage/mortality , Cerebral Hemorrhage/drug therapy , Warfarin/therapeutic use , Warfarin/adverse effects , Japan/epidemiology , Aged, 80 and over , Anticoagulants/therapeutic use , Anticoagulants/adverse effects , Fibrinolytic Agents/therapeutic use , Fibrinolytic Agents/adverse effects , Middle Aged , Risk Factors , Platelet Aggregation Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/adverse effects , Prospective Studies
17.
Medicine (Baltimore) ; 103(19): e38022, 2024 May 10.
Article in English | MEDLINE | ID: mdl-38728459

ABSTRACT

Warfarin, a widely utilized anticoagulant, is paramount for preventing thromboembolic events in patients with mechanical heart valve replacements. However, its narrow therapeutic index can lead to over-anticoagulation and overdose, resulting in serious health risks. This study examines the efficacy of human prothrombin complex concentrate (PCC) in managing warfarin overdose, in comparison with traditional treatments. A retrospective analysis was conducted on 162 adults who presented with warfarin overdose (INR > 5.0) at a tertiary care hospital between 2016 and 2020. Participants were divided into 2 groups-those treated with PCC (n = 57) and those treated with conventional methods (n = 105), including vitamin K and fresh frozen plasma. The primary outcome was the rate of reaching the target (International Normalized Ratio) INR within 24 hours. Secondary outcomes included transfusion requirements, thromboembolic events, adverse reactions, 30-day mortality, and length of hospital stay. PCC demonstrated significant efficacy, with 89.5% of patients achieving the target INR within 24 hours, compared to 64.8% in the control group (P < .05). The PCC group also had reduced transfusion requirements and a shorter average hospital stay. There was no significant difference in thromboembolic events or adverse reactions between the 2 groups, and the reduced 30-day mortality in the PCC group was not statistically significant. Human prothrombin complex concentrate is associated with rapid reaching the target INR, decreased transfusion needs, and shortened hospitalization, making it a promising option for warfarin overdose management. While the results are encouraging, larger, multicenter, randomized controlled trials are necessary to further validate these findings and optimize PCC administration protocols.


Subject(s)
Anticoagulants , Blood Coagulation Factors , Drug Overdose , International Normalized Ratio , Warfarin , Humans , Warfarin/adverse effects , Warfarin/therapeutic use , Blood Coagulation Factors/therapeutic use , Blood Coagulation Factors/administration & dosage , Female , Male , Retrospective Studies , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , Middle Aged , Drug Overdose/drug therapy , Drug Overdose/therapy , Aged , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Thromboembolism/prevention & control , Adult , Treatment Outcome , Blood Transfusion/statistics & numerical data , Length of Stay/statistics & numerical data , Vitamin K/therapeutic use
18.
J Int Med Res ; 52(5): 3000605241255507, 2024 May.
Article in English | MEDLINE | ID: mdl-38749907

ABSTRACT

Traumatic splenic rupture is rare in pregnant women; and multiple venous thromboses of the portal vein system, inferior vena cava and ovarian vein after caesarean section and splenectomy for splenic rupture has not been previously reported. This case report describes a case of multiple venous thromboses after caesarean section and splenectomy for traumatic splenic rupture in late pregnancy. A 34-year-old G3P1 female presented with abdominal trauma at 33+1 weeks of gestation. After diagnosis of splenic rupture, she underwent an emergency caesarean section and splenectomy. Multiple venous thromboses developed during the recovery period. The patient eventually recovered after anticoagulation therapy with low-molecular-weight heparin and warfarin. These findings suggest that in patients that have had a caesarean section and a splenectomy, which together might further increase the risk of venous thrombosis, any abdominal pain should be thoroughly investigated and thrombosis should be ruled out, including the possibility of multiple venous thromboses. Anticoagulant therapy could be extended after the surgery.


Subject(s)
Cesarean Section , Splenectomy , Splenic Rupture , Venous Thrombosis , Humans , Female , Venous Thrombosis/etiology , Venous Thrombosis/surgery , Venous Thrombosis/drug therapy , Adult , Splenic Rupture/etiology , Splenic Rupture/surgery , Splenic Rupture/diagnosis , Pregnancy , Cesarean Section/adverse effects , Postpartum Period , Anticoagulants/therapeutic use , Heparin, Low-Molecular-Weight/therapeutic use , Warfarin/therapeutic use
19.
Clin Appl Thromb Hemost ; 30: 10760296241256938, 2024.
Article in English | MEDLINE | ID: mdl-38778542

ABSTRACT

OBJECTIVES: To assess the efficacy and safety of rivaroxaban compared to warfarin after inferior vena cava (IVC) filter implantation. METHOD: This retrospective analysis includes data from 100 patients with deep vein thrombosis (DVT) who underwent IVC filter implantation due to a free-floating thrombus (n = 64), thrombus propagation (n = 8), or acute bleeding (n = 8) on therapeutic anticoagulation, catheter-directed thrombolysis (n = 8), or had previously implanted filter with DVT recurrence. Patients were treated with warfarin (n = 41) or rivaroxaban (n = 59) for 3-12 months. Symptomatic venous thromboembolism (VTE) recurrence and bleeding events were assessed at 12 months follow-up. RESULTS: Three (7.3%) cases of VTE recurrence without IVC filter occlusion occurred on warfarin and none on rivaroxaban. The only (2.4%) major bleeding occurred on warfarin. Three (5.1%) clinically relevant non-major bleedings were detected on rivaroxaban. No significant differences existed between groups when full and propensity scores matched datasets were compared. CONCLUSIONS: Rivaroxaban seems not less effective and safe than warfarin after IVC filter implantation.


Subject(s)
Rivaroxaban , Vena Cava Filters , Warfarin , Humans , Warfarin/therapeutic use , Rivaroxaban/therapeutic use , Retrospective Studies , Male , Female , Middle Aged , Aged , Venous Thrombosis , Anticoagulants/therapeutic use , Adult , Administration, Oral , Hemorrhage
20.
Sci Rep ; 14(1): 11647, 2024 05 22.
Article in English | MEDLINE | ID: mdl-38773162

ABSTRACT

Warfarin remains the most prescribed oral anticoagulant of choice in atrial fibrillation (AF) patient in resource-limited settings. Despite evidence linking Time in Therapeutic Range (TTR) to patient outcomes, its use in clinical practice is not widespread. This prospective study explores the impact of a TTR-INR guided Warfarin adjustment protocol on TTR in AF patients. Conducted at the Warfarin clinic of King Chulalongkorn Memorial Hospital. TTR was calculated using the Rosendaal linear interpolation method at baseline, and then at 6 and 12 months post-protocol implementation. The primary outcome was the improvement in TTR following the protocol's implementation. The study analyzed 57 patients, with a mean age of 72 years and an even gender distribution. At baseline, 53% of patients had a TTR of less than 65%. However, TTR significantly improved from 65% at baseline to 80% after 12 months of protocol implementation (p < 0.001). Furthermore, there was a significant increase in the proportion of patients with a TTR of 65% or more, from 47 to 88% (p < 0.001). During the follow-up period in the first 12 months, three patients died, but no ischemic or major bleeding events occurred. The significant improvement in TTR after 12 months of protocol implementation suggests that this strategy could provide additional value in improving TTR and outcomes in AF patients receiving Warfarin.


Subject(s)
Anticoagulants , Atrial Fibrillation , International Normalized Ratio , Warfarin , Humans , Warfarin/administration & dosage , Warfarin/therapeutic use , Atrial Fibrillation/drug therapy , Male , Female , Aged , Anticoagulants/administration & dosage , Anticoagulants/therapeutic use , Prospective Studies , Middle Aged , Aged, 80 and over , Treatment Outcome , Drug Monitoring/methods
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