Use Of DOACs Research Articles

Evaluation of the biomarker-based ABC-AF-bleeding risk score and clinically based bleeding scores in 31,605 patients with atrial fibrillation treated with oral anticoagulation

Abstract Background International guidelines recommend a systematic evaluation of bleeding risk in patients with atrial fibrillation (AF) to guide oral anticoagulation. However, it remains challenging to accurately predict bleeding risk. The biomarker-based ABC-AF-bleeding risk score to predict bleeding in anticoagulated patients with AF has shown promise. Purpose To evaluate the performance of the biomarker-based ABC-AF-bleeding risk score and compare its performance with other bleeding risk scores in 31,605 patients randomized to direct oral anticoagulant or warfarin using individual patient data from three randomized clinical trials. Methods The COMBINE AF biomarker data set contains individual patient data from three pivotal randomized trials (ARISTOTLE, ENGAGE AF-TIMI 48, and RE-LY) comparing apixaban, edoxaban or dabigatran with warfarin, in patients with AF at increased risk of stroke. The ABC-AF-bleeding biomarkers were analyzed in plasma samples collected at baseline (hemoglobin, troponin T high-sensitivity, and GDF-15) using Roche Diagnostics Elecsys assays. The biomarker-based ABC-AF-bleeding risk score (Age, Biomarkers, Clinical history of prior bleeding) was calculated as previously published. The discrimination was assessed by Harrell’s c index and compared with three clinically based bleeding risk scores; HASBLED, ORBIT, and DOAC. Results During a median follow-up time of 2.0 years, a total of 1,572 ISTH major bleeding events occurred (incidence rate per 100 person-years of 2.79) including 593 gastrointestinal (1.04) and 270 intracranial (0.47) bleeding events. The biomarker-based ABC-AF-bleeding score was well calibrated for major bleeding in the total material (Figure). The c indices for major bleeding were 0.68 (95% confidence interval 0.67-0.70), for gastrointestinal bleeding 0.70 (0.68-0.72), and for intracranial bleeding 0.66 (0.63-0.69). The biomarker-based ABC-AF-bleeding risk score provided superior discrimination compared with the clinically based risk scores in the full cohort (Table). The ABC-AF-bleeding risk score also provided superior discrimination for major bleeding in clinically relevant subgroups based on age, sex, body mass index, coronary artery disease, diabetes, heart failure, kidney function, and irrespective of DOAC or VKA use. Conclusions In patients with AF treated with different types of OAC the biomarker-based ABC-AF-bleeding score provide better discrimination of the risk för major bleeding than risk scores based only on clinical factors. The results were consistent for different types of bleeding and across multiple subgroups. There was good calibration when comparing predicted vs observed rate of major bleeding. These findings support the utility of the biomarker-based ABC-AF-bleeding risk score for advancing precision medicine in patients with AF.Calibration of ABC-AF-bleeding scoreTable

Epidemiology of Deep Venous Thrombosis Among United States Emergency Departments Over an Eight-Year Period.

Deep vein thrombosis (DVT) is a significant cause of morbidity and mortality worldwide, accounting for substantial healthcare utilization. However, as management strategies have evolved, there is a critical need for current data on incidence, admission rates, and medical management of DVT in the ED setting. This cross-sectional study analyzed ED presentations for DVT from 2016-2023 using the Cosmos database. Inclusion criteria comprised patients aged ≥18 years with an ICD-10 code for acute extremity DVT. Outcomes included incidence rates, admission rates, and anticoagulant prescriptions. Data were analyzed using descriptive statistics, and subgroup analyses were performed for upper and lower extremity DVTs. Out of 190,144,463 total ED encounters, DVT represented 368,044 cases (0.2%). Among these cases, 119,986 (32.6%) were admitted, with admission rates stable over the study period. Apixaban was the most prescribed anticoagulant (40.3%), followed by rivaroxaban (28.3%), enoxaparin (7.9%), warfarin (3.6%), and dabigatran (0.3%). Use of apixaban increased from 12.4% in 2016 to 56.2% in 2023. Lower extremity DVTs comprised 88.5% of cases, with a 32.1% admission rate, while upper extremity DVTs accounted for 11.7% of cases, with a 37.0% admission rate. This study provides a summary of DVT presentations and management in United States EDs over an eight52 year period. The findings highlight stable incidence rates, reduced admission rates compared to historical data, and a significant shift towards the use of DOACs, particularly apixaban, for outpatient management. These trends underscore the importance of evidence-based practices 54 and ongoing research to optimize DVT management and improve patient outcomes.

Dual direct oral anticoagulant therapy in challenging thrombosis: a case series

BackgroundWhile anticoagulation therapy is highly effective at treating venous thromboembolism, some patients can develop rapidly progressive thrombosis in multiple organs or sites despite therapeutic anticoagulation. Effective strategies to manage life-threatening thrombosis in these patients are elusive. ObjectivesWe describe our experience using dual direct oral anticoagulant (DOAC) therapy with a factor (F)Xa inhibitor (such as rivaroxaban or apixaban) and a FIIa inhibitor (dabigatran) for refractory cases of thrombosis. MethodsA retrospective chart review of all patients treated with simultaneous dabigatran and an oral FXa inhibitor at our institution was conducted. We included all patients over the age of 18. The study was approved by the University of British Columbia Research Ethics Board (REB number: H23-02575). ResultsEight patients were included. All patients initiated standard therapeutic anticoagulation upon diagnosis of acute venous thromboembolism with a median of 3 breakthrough thrombotic events prior to dual DOAC use. Five patients had a positive heparin-induced thrombocytopenia screen, but only 2 had heparin-induced thrombocytopenia confirmed on serotonin release assay testing. There were no recurrent deep vein thrombosis, pulmonary embolism, or bleeding events during dual DOAC use. Most patients ultimately transitioned to a single oral FXa inhibitor. ConclusionDual DOAC therapy may be a useful strategy for managing challenging thrombosis cases resistant to conventional anticoagulation. Further research is warranted to validate these findings and explore the broader applicability of dual DOAC therapy in challenging thrombotic scenarios.

Impact of anticoagulation therapy on outcomes in patients with cirrhosis and portal vein thrombosis: A large-scale retrospective cohort study

IntroductionPortal vein thrombosis in cirrhotic patients presents a significant clinical challenge. This study aims to (1) explore the impact of anticoagulation therapy on patient outcomes; (2) comparative outcomes in portal vein thrombosis treated between direct oral anticoagulant and Vitamin K Antagonist (VKA). Materials and methodsWe leveraged the TriNetX database to analyze a cohort comprising 4224 patients with liver cirrhosis and PVT who were treated with anticoagulation, alongside a comparison group of 15,300 patients with the same conditions but not receiving anticoagulation therapy. ResultsThe anticoagulated group showed a significant reduction in mortality (27.9 % vs. 34.2 %, HR = 0.723, 95 % CI: 0.678–0.770, P < 0.001). When comparing direct oral anticoagulant versus. VKA, in compensated liver cirrhosis, the direct oral anticoagulant group exhibited significantly lower mortality rates compared to VKA (17.7 % vs. 26.5 %, HR = 0.655, 95 % CI: 0.452–0.951, P = 0.025), with no significant difference in liver transplantation rates (4.0 % vs. 4.7 %, P = 0.080). In decompensated liver cirrhosis, the direct oral anticoagulant group exhibited lower mortality compared to the VKA group (23.6 % vs. 30.6 %, HR = 0.732, 95 % CI: 0.629–0.851, P < 0.001), and a higher frequency of liver transplantation was observed in the VKA group (10.6 % vs. 16.0 %, HR = 0.622, 95 % CI: 0.494–0.784, P < 0.001). Hospitalization rates were significantly lower in the direct oral anticoagulant group compared to the VKA group in decompensated cirrhosis (33.4 % vs. 38.3 %, HR = 0.830, 95 % CI: 0.695–0.992, P = 1.937). ConclusionsOur study offers compelling evidence supporting the use of anticoagulation therapy in liver cirrhosis with portal vein thrombosis. The use of DOACs in patients with both compensated and decompensated liver cirrhosis showed a marked mortality benefit.

Potential interactions between medications for rate control and direct oral anticoagulants: Population-based cohort and case-crossover study

BackgroundDirect oral anticoagulants (DOACs) are commonly co-prescribed with amiodarone/diltiazem/verapamil, but whether there is a drug interaction between these drugs is unclear. ObjectiveThe purpose of this study was to investigate the risk of clinical outcomes associated with concomitant use of DOACs and amiodarone/diltiazem/verapamil. MethodsWe identified DOAC users in the Clinical Practice Research Datalink Aurum from January 1, 2011, to December 31, 2019. We used a cohort design to estimate hazard ratios for ischemic stroke, myocardial infarction, venous thromboembolism, intracranial bleeding, gastrointestinal bleeding, other bleeding, cardiovascular mortality, and all-cause mortality, comparing DOACs + amiodarone/diltiazem/verapamil users and DOACs + beta-blocker users. A case-crossover design comparing odds of exposure to different drug initiation patterns for all outcomes in hazard window vs referent window within an individual also was conducted. ResultsOf 397,459 DOAC users, we included 9075 co-prescribed amiodarone, 9612 co-prescribed diltiazem, and 2907 co-prescribed verapamil. There was no difference in risk of any outcomes between DOACs + amiodarone/diltiazem/verapamil users vs DOACs + beta-blocker users in the cohort design. However, in the case-crossover design, we observed an odds ratio (OR) of 2.09 (99% confidence interval [CI] 1.37–3.18) for all-cause mortality associated with initiation of a DOAC while taking amiodarone, which was greater than that observed for DOAC monotherapy (OR 1.30; 99% CI 1.25–1.35). Similar findings were observed for cardiovascular mortality and all-cause mortality respectively with diltiazem. ConclusionOur study showed no evidence of higher bleeding or cardiovascular risk associated with co-prescribed DOACs and amiodarone, diltiazem, or verapamil. Elevated risks of cardiovascular and all-cause mortality were only observed during DOAC initiation when diltiazem/amiodarone were being taken.

Meta-Analysis of the Safety and Efficacy of Direct Oral Anticoagulants for the Treatment of Left Ventricular Thrombus.

Literature on the preferred anticoagulant for treating left ventricular thrombus (LVT) is lacking. Thus, our objective was to compare the efficacy of DOACs versus warfarin in treating LVT. Databases were searched for RCTs and adjusted observational studies that compared DOAC versus warfarin through March 2024. The primary efficacy outcomes of interest were LVT resolution, systemic embolism, composite of stroke, and TIA. The primary safety outcomes encompassed all-cause mortality and bleeding events. Our meta-analysis including 31 studies demonstrated that DOAC use was associated with higher odds of thrombus resolution (OR: 1.08, 95% CI: 0.86-1.31, p: 0.46). A statistically significant reduction in the risk of stroke/TIA was observed in the DOAC group versus the warfarin group (OR: 0.65, 95% CI: 0.48-0.89, p: 0.007). Furthermore, statistically significant reduced risks of all-cause mortality (OR: 0.68, 95% CI: 0.47-0.98, p: 0.04) and bleeding events (OR: 0.70, 95% CI: 0.55-0.89, p: 0.004) were observed with DOAC use as compared to warfarin use. Compared to VKAs, DOACs are noninferior as the anticoagulant of choice for LVT treatment. However, further studies are warranted to confirm these findings.

Characteristics, management and prognosis of patients with coronary artery disease undergoing coronary intervention and atrial fibrillation

Abstract Funding Acknowledgements None. Introduction The selection of antithrombotic treatment in patients with ischaemic heart disease (IHD) and atrial fibrillation (AF) represents a challenge when trying to balance ischaemic and haemorrhagic risk. However, there is little "real-life" data on the selected antithrombotic treatment and its short and long-term prognosis. Methods A Prospective multicentre study that includes patients with IHD [acute coronary syndrome (ACS) or chronic coronary syndrome (CCS)] and AF admitted to 13 Spanish centres. The objective is to describe the characteristics, antithrombotic treatment and prognosis of patients undergoing PCI and AF. Results 373 patients were included. The average age was 77.6 ± 9.8 years (28% women). Patients had a high ischaemic and haemorrhagic risk [CHA2DS2VASc 4 (2-5) and HASBLED 3 (2-4)], with 25.5% being frail according to the Clinical Frailty Scale. The main reason for admission was ACS (44.8% NSTEMI, 22.2% STEMI and 33% CCS ), and 49.8% of patients had multivessel disease. 70.3% of patients underwent revascularisation, mainly percutaneously (92.2%). Among those percutaneously revascularised, the most used antithrombotic treatment was triple therapy with double antiplatelet therapy (DAPT) + oral anticoagulant (OAC) (62.5%), followed by double therapy with monoantiplatelet therapy + OAC (29.2%). In revascularised patients over 80, the most selected antithrombotic therapy was similar: 60.5% and 28.9%, respectively. The most used OAC was apixaban (42.3%), followed by vitamin K antagonists (17.3%). One-year survival was 88.5%. 2.6% of patients presented an ischemic stroke, and 4.8% suffered a new ACS. At the same time, haemorrhagic events (BARC ≥2) were 8.9%. Conclusions A high ischaemic and haemorrhagic risk co-exists in patients with IHD and AF. In our setting, triple therapy, mainly with the use of DOACs over VKA, is the preferred therapy. The long-term mortality of this subgroup of patients with IHD is high (&amp;gt;10%), with a rate of haemorrhagic events (8.9%) higher than ischaemic events (4.8%).Characteristics of patients

Detection and management of clinically relevant drug-drug interactions with direct oral anticoagulants: an intervention study in community pharmacies

IntroductionDirect oral anticoagulants (DOACs) are increasingly used and can be involved in clinically relevant drug-drug interactions (DDIs) that increase the risk of major bleeding or thromboembolism. Skilled drug interaction management is essential to ensure safe and effective use of DOACs. In this study, we aimed to investigate the impact of the detection and management of DDIs with DOACs in a real-life community pharmacy setting on the pharmacotherapy of DOAC users. MethodsWe conducted an intervention study in 201 community pharmacies in Belgium. On random days, patients purchasing DOACs or drugs known to interact with them were screened. When a DDI with the DOAC was detected, the pharmacist contacted the prescribing physician to discuss the management of the interaction. A previously developed practice-oriented DDI list accompanied by management plans for ambulatory care was used for both screening and management of the DDIs. ResultsIn total, 751 patients were included, among whom 875 DDIs were identified, primarily pharmacodynamic DDIs (95.7 %). Predominant interacting drug classes included selective serotonin or serotonin and norepinephrine reuptake inhibitors (32.9 %), antiplatelets (30.9 %), and non-steroidal anti-inflammatory drugs (28.9 %). In 43.0 % of DDIs, an intervention was decided upon. At three-month follow-up, proposed pharmacotherapy changes had been implemented in 79.1 % of these DDIs. ConclusionsThis study demonstrates that active screening and management of DDIs with DOACs in community pharmacies, in close collaboration with prescribing physicians, resulted in changes in pharmacotherapy in a substantial number of patients. This may contribute significantly to the safer utilisation of DOACs in high-risk populations.

Anticoagulant prophylaxis in patients with liver disease and atrial fibrillation

Atrial fibrillation (AF) is the most common cardiac arrhythmia in adults worldwide. The use of oral anticoagulants (DOACs) is an effective way to prevent ischemic stroke in patients with AF, reducing the risk of stroke by approximately 64 %. In patients with liver cirrhosis (LC), the presence of AF is associated with higher rates of in-hospital mortality, stroke and acute kidney injury compared with patients without arrhythmia. Liver disease and especially cirrhosis are associated with an increased risk of not only thrombosis but also bleeding, making the decision about anticoagulant therapy in these patients very difficult. The article reviews the current literature regarding the use of modern DOACs and traditional antithrombotic agents, such as vitamin K antagonists and heparins, in patients with cirrhosis and AF.

Top 5 Research Studies of the month for Italian Primary Care Physicians: March 2024.

This monthly article provides a collection of summaries of the most relevant studies identified as POEMs (patient-oriented evidence that matters) for Italian primary care physicians. 1) A simple, well-validated risk score can help clinicians counsel patients with atrial fibrillation regarding the use of DOACs to prevent stroke. The score shares its name with the drug class (the "DOAC" score). 2) Presumably by perturbing the intestinal microbiome, antibiotic treatment is associated with an increase in the likelihood of the development of irritable bowel disease; this is especially true with multiple courses of antibiotics. 3) Patients with uncomplicated gallstones can be managed over time with analgesia and monitoring, though approximately 25% will eventually undergo cholecystectomy over the next 18 months. Still, there appears to be no need to rush to surgery without evidence of common bile duct blockage or acute pancreatitis. 4) Delivering bad news (e.g. a cancer diagnosis) by telephone does not affect levels of anxiety, depression, or satisfaction with care as compared with delivering the news in person. 5) An updated high quality systematic review found that, in conjunction with psychosocial interventions, oral naltrexone (50 mg/day) and oral acamprosate have the strongest evidence for being effective in the treatment of alcohol use disorder.

Prevalence and Time Trends of Oral Anticoagulant Utilization in Adults with Sickle Cell Disease

Background: Sickle cell disease (SCD) is an inherited red blood cell disorder, caused by a genetic mutation in the β-hemoglobin chain. SCD is associated with chronic activation of coagulation and an increased risk of venous thromboembolism (VTE). Although the American Society of Hematology guidelines recommend indefinite anticoagulation for unprovoked or recurrent provoked VTE, no guidance is given regarding choice of anticoagulant due to a paucity of data. Existing evidence on the use of anticoagulants in patients with SCD has been mostly focused on oral anticoagulants, was limited by small sample sizes, and did not clearly demonstrate the temporal utilization patterns. Real-world evidence on oral anticoagulant use in SCD from large population-based studies is largely lacking. This study examined the prevalence and time trends of oral anticoagulant utilization in patients with SCD in the United States (US). Methods: This retrospective, repeated cross-sectional study analyzed the Cerner Health Facts® database from January 1, 2011, to December 31, 2016, which captures longitudinal electronic medical records (EMR) of patient data from participating facilities in the US. To be included, patients were required to (1) have ≥ 1 inpatient or emergency department encounters with SCD, or 2 outpatient encounters that were 30 days apart in a calendar year from 2012 to 2016, (2) have ≥ 1 prescription records on the encounters with SCD, (3) aged ≥ 18 years at index, and (4) have ≥ 1 encounter with SCD in a year prior to the index. For patients with multiple encounters with SCD in the calendar year, we randomly selected one encounter with SCD and defined it as the index. In this design, a patient contributed only one observation per year but may contribute to multiple years of observations if meeting the selection criterion. The outcome was the use of anticoagulants, defined as any prescription drug encounter for an oral anticoagulant (Vitamin K antagonist [VKA]: warfarin; direct oral anticoagulants [DOACs]: apixaban, rivaroxaban, dabigatran, edoxaban) within a grace period of 7 days discharged from the index. The independent variable was each calendar year measured as dummy variables. Covariates were measured during the 12-month baseline period prior to the index, which included patient demographics, comorbidities and complications of SCD, and facility characteristics. Time trends on the proportions of eligible patients with anticoagulant use against the calendar years of the SCD diagnosis were plotted, and the significance on the crude trend was examined using Cochran-Armitage trend test. In the main analysis, a modified Poisson regression by using generalized estimating equations (GEEs) estimated the adjusted prevalence ratios (APRs) for the trends and covariates associated with any anticoagulant utilization. In subgroup analysis, we estimated the APRs of covariates for the use of DOACs versus VKA. Results: The cohort included 8,824 adult patients with SCD in 182 facilities using automated Cerner EMR system for the years 2012 to 2016. Prescription rates of all oral anticoagulants gradually increased from 2012 to 2014; the rates of VKA prescriptions substantially dropped from 11.1/1000 to 4.1/1000 persons between 2014 and 2016, whereas prescription rates of DOACs increased significantly from 12.0/1000 to 29.1/1000. Prevalence of VTE was stable at approximately 6.2/1000 to 7.5/1000 between 2012 and 2016. Prescription rates of DOACs were lower in patients with (versus without) VTE (6.1/1000 vs 7.3/1000), while a reversed prescription pattern was observed for VKA (VTE [yes vs no]: 4.4/1000 vs 1.8/1000). Controlling for covariates, our main analysis demonstrated that patients with a diagnosis of acute chest syndrome, pulmonary hypertension, and depression were 1.51, 2.30, and 1.57 times more likely to have oral anticoagulant prescription, respectively (all p &amp;lt;0.05). Subgroup analysis showed that having a diagnosis of VTE was associated with a decreased likelihood of DOACs prescription relative to VKA (APR= 0.75, 95%CI: 0.62-0.91). Conclusion: Prescription of oral anticoagulants in adults with SCD has significantly increased from 2012 to 2016 and the increase was dominated by DOACs. The treatment paradox of a lower relative rate of DOACs utilization versus VKA in adults with SCD requires more study to understand the reasons and additional clinical outcomes associated with the utilization patterns.

Heavy Menstrual Bleeding in Adolescents on Direct Oral Anticoagulants

Background Direct oral anticoagulants (DOACs) - Dabigatran, Rivaroxaban, and Apixaban - are increasingly being used in the pediatric and adolescent population. DOACs have been shown to increase the likelihood of heavy menstrual bleeding (HMB) in adult women of childbearing age, when compared to vitamin K antagonists or low molecular weight heparins (LMWH). There are limited data regarding the prevalence of HMB in the adolescent population on DOACs. Pivotal trials leading up to the approval of DOACs in the adolescent and pediatric populations also failed to prespecify prospective analyses on the impact of DOACs on HMB. The effect of HMB and its treatment burden can contribute to the compliance rates of DOACs in this population, adding to the recurrence rates of venous thromboembolism. Our study aims to assess the rate of HMB with DOAC use in adolescents by comparing the rate of HMB and its associated healthcare burden to patients on other anticoagulants. Methods This is a retrospective cohort study conducted with deidentified data obtained from the Pediatric Health Information System (PHIS) database after IRB approval. The PHIS is a comparative database with clinical and resource utilization data for inpatient, ambulatory surgery, ED, and observation unit encounters from more than 49 children's hospitals. ICD-10 codes were used to query the data for pediatric patients between the ages of 9-18 years on anticoagulant therapy from January 2020-December 2022. DOAC group was defined as patients on Rivaroxaban, Dabigatran, or Apixaban at any point in their care. The control group was defined as patients on anticoagulants other than DOACs, such as LMWH, unfractionated heparin, coumadin, and bivalirudin. Data extracted included any episode of HMB (diagnosis codes for abnormal uterine bleeding, dysfunctional uterine bleeding, menorrhagia, or heavy menstrual bleeding), risk factors for HMB other than anticoagulants, and healthcare utilization data for HMB such as number of ED visits, hospital admission and length of stay, and ICU admission. For the Descriptive statistics, demographics and clinical characteristics of the patients were described using median and interquartile range (25th percentile, 75th percentile) for continuous variables, and frequency and percentages for categorical variables, as appropriate. Control group was matched to the DOAC group by propensity score matching using nearest method with the ratio 1:5 to generate the similar pairwise comparison. Categorical variables were analyzed with the chi-square test; continuous variables were assessed by Mann Whitney U test or Kruskal-Wallis rank sum test. P-value of less than 0.05 was considered as statistically significant for the analysis. All the analysis were performed using SAS software, version 9.4 (SAS Institute, Cary, NC) and R software, version 4.2.2 Results Of the total sample size of 87,119 patients on any anticoagulant, 84,411 (96.8%) patients were in the control group and 2,708 (3.1%) in the DOAC group before propensity matching. Of the three DOACs studied, 2013 were in Rivaroxaban group (74%), followed by Apixaban (671 or 25%) and Dabigatran (24 or 1%). Rates of HMB in patients on the largest DOAC group, Rivaroxaban vs the control group, and Rivaroxaban vs Apixaban are as shown in table 1.There was no significant difference in healthcare burden between the DOAC and control groups (p-value 0.954) with no difference in length of stay between the two groups (5 days for both groups). The rate of HMB with the use of DOACs or with known risk factors of HMB on any anticoagulant is as shown in table 2. Conclusion In contrast to adult patients, our study suggests similar rates of HMB in adolescents on DOACs when compared to the control group. Rivaroxaban was the most commonly used DOAC in our data set. Though the number of patients on Apixaban was small, there was no difference in the rate of HMB between Rivaroxaban and Apixaban groups. Patients with known risk factors of HMB had an increased rate of HMB with all anticoagulants. Prospective studies are needed to further elucidate the impact of DOACs and other anticoagulants on HMB in adolescents.

Impact of preoperative antiplatelet / anticoagulant therapy on postoperative bleeding rate in anorectal surgery. Analysis of a high-volume proctologic and pelvic floor clinical center

IntroductionThe aim of the present study is to analyze the impact of preoperative antiplatelet and/or anticoagulant therapy on postoperative bleeding in proctologic surgery. Material and MethodsA retrospective study was conducted on a consecutive series of patients who underwent to proctologic surgery between January 2016-December 2018. The patients were divided in two groups: non-therapy group without any cardiovascular problem and therapy group that received antiplatelet and/or anticoagulant therapy. A sub analysis was carried out stratifying the patients according to the type of preoperative therapy and the type of surgery. ResultsA total of 1832 operated patients were collected; 8.7 % of them received antiplatelet or anticoagulant therapy preoperatively. The postoperative bleeding rate was 2.8 % (2.1 % in the non-therapy group, and 10.1 % in the therapy group). The re-operation rate after bleeding was 1.2 % (1.1 % of non-therapy group, and 3.1 % therapy group). The re-operation rate in patients with postoperative bleeding was 51.4 % and 31.3 % for therapy and non-therapy group, respectively. The interval time between surgery and bleeding, was 7.8 days (non-therapy) and 8.5 days (therapy). Hemorrhoid's surgery showed to have the higher postoperative bleeding rate. The use of DOACs and OAC showed the highest rates of bleeding (20 % vs 36.4 %). ConclusionThe constant increase of patients with antiplatelet/anticoagulant treatment requiring surgery for benign diseases reveals a significant increase the post-operative risk of bleeding. The management of these complex patients needs to be discussed in a multidisciplinary team with the aim to follow shared guidelines but also to customize the approach.

Comparing U.S. and Canadian treatment patterns on venous thromboembolism outcomes in the GARFIELD-VTE registry

BackgroundEconomically developed countries continue to find that venous thromboembolism (VTE) is a major cause of morbidity and mortality. ObjectiveTo compare baseline risk profiles and patient workflow patterns between the United States (U.S.) and Canadian management of VTE patients from 2014 to 2017. MethodsThe Global Anticoagulant Registry in the FIELD (GARFIELD-VTE) is a prospective, observational study of 10,679 patients with objectively confirmed VTE, followed for 3 years. In total 1101 patients enrolled in the U.S. and Canada were included in this analysis. ResultsMedian age and body mass index were comparable between the U.S. (60.5; 30.2) and Canadian (59.7; 29) patients. A higher percentage of U.S. patients were black (n = 128, 24.1 %; n = 22, 3.9 %) and had a higher VTE-associated risk profile, including immobilization, hospitalization, and recent surgery. U.S. patients had a higher combined DVT and PE primary diagnoses (20.3 %) and were more likely to be treated in hospitals (77.2 %) than Canadians (13.3 %; 48.1 %). Direct oral anticoagulant therapy (DOAC) was nearly two-fold more frequent in Canadian patients (n = 218, 39.2 %) at the end of 3 years in comparison to the U.S. (n = 118, 23.0 %). Adjusted for sex, recent bleed event, heart failure, chronic immobilization, family history of VTE, history of cancer and prior VTE, and renal insufficiency, the risk of all-cause mortality was 51.9 % higher in patients from the U.S. compared to those in Canada after 3 years. Patients from the U.S. also had a higher likelihood of hospitalization, major bleeding, and recurrent VTE after controlling for prior history and comorbid conditions. ConclusionHigher rates of adverse VTE-associated outcomes in the U.S. may be attributed to different baseline risk profiles, facility care, and distribution of specialists and their subsequent treatment strategies. Type of researchGlobal, multicentre, non-interventional, prospective registry titled Global Anticoagulant Registry in the FIELD – Venous Thromboembolism (GARFIELD-VTE). Key findings531 U.S. and 557 Canadians patients included in study. DOAC use more frequent in Canadian patients after 3 years than U.S. (39.2 % vs. 23.0 %, respectively). Adjusted for sex, recent bleed event, heart failure, chronic immobilization, family history of VTE, history of cancer and prior VTE, and renal insufficiency, all-cause mortality risk remained higher in U.S. patients vs. Canadian patients after 3 years. U.S. patients had higher likelihood of hospitalization, major bleeding, and recurrent VTE. Take-home messageHigher rates of adverse VTE-associated outcomes in the U.S. may be attributed to different baseline risk profiles, facility care, and composition of specialists and their subsequent treatment strategies. Table of contents summaryGlobal, multicentre, non-interventional, prospective registry titled Global Anticoagulant Registry in the FIELD – Venous Thromboembolism (GARFIELD-VTE). Higher rates of adverse VTE-associated outcomes were observed in U.S. patients vs Canadian patients, which may be attributed to different baseline risk profiles, facility care, and distribution of specialists and their subsequent treatment strategies.

Abstract 12488: Oral Anticoagulation for New Onset Post-Operative Atrial Fibrillation After Combined Coronary Artery Bypass Grafting and Valve Surgery is Not Associated With Improved Outcomes

Introduction: Post-operative atrial fibrillation (POAF) after cardiac surgery is common and is associated with increased risk of stroke and death. The incidence of POAF is highest among patients who undergo combined CABG and valve surgery, at 40-60%. The risks and benefits of oral anticoagulation (OAC) in this high-risk population are not well established. Research Question: Among patients with POAF after combined CABG and valve surgery, what is the association between OAC use and clinical outcomes? Methods: From a population-based registry in Ontario, Canada, we identified consecutive patients &gt;65 years of age who developed POAF after combined CABG and left-sided, non-mechanical valve surgery from Oct/08-Mar/18. The exposure of interest was OAC prescription within 90 days after hospital discharge. Outcomes included death, cardiovascular death, stroke, MI, thromboembolism, and bleeding. Follow-up began at 90 days after discharge and continued for 24 months. Outcomes were analyzed using inverse probability of treatment weighting using the propensity score. Statistical measures of association were reported as hazard ratios with 95% confidence intervals. Results: Among 4,836 patients who had combined CABG/valve surgery, 1,939 (40.1%) developed POAF and these patients had a higher rate of death (HR 1.31, 95% CI 1.01-1.68 P=0.04). OAC was prescribed in 1,153 (59.5%) patients (86% warfarin and 14% DOAC). The use of OAC was not associated with a lower rate of death, stroke/MI/thromboembolism, or cardiovascular death but was associated with an increased rate of bleeding (HR 1.62, 95% CI 1.00-2.61, P=0.048). Conclusion: Among patients with POAF after combined CABG/valve surgery, use of warfarin or DOAC did not improve ischemic cardiovascular outcomes or survival and was associated with higher rates of bleeding. Randomized control trials are needed to define the risk and benefit of OAC use in this high-risk population. Until then, routine use of OAC is not recommended.

Role of Individual Clinician Authority in the Implementation of Informatics Tools for Population-Based Medication Management: Qualitative Semistructured Interview Study.

Direct oral anticoagulant (DOAC) medications are frequently associated with inappropriate prescribing and adverse events. To improve the safe use of DOACs, health systems are implementing population health tools within their electronic health record (EHR). While EHR informatics tools can help increase awareness of inappropriate prescribing of medications, a lack of empowerment (or insufficient empowerment) of nonphysicians to implement change is a key barrier. This study examined how the individual authority of clinical pharmacists and anticoagulation nurses is impacted by and changes the implementation success of an EHR DOAC Dashboard for safe DOAC medication prescribing. We conducted semistructured interviews with pharmacists and nurses following the implementation of the EHR DOAC Dashboard at 3 clinical sites. Interview transcripts were coded according to the key determinants of implementation success. The intersections between individual clinician authority and other determinants were examined to identify themes. A high level of individual clinician authority was associated with high levels of key facilitators for effective use of the DOAC Dashboard (communication, staffing and work schedule, job satisfaction, and EHR integration). Conversely, a lack of individual authority was often associated with key barriers to effective DOAC Dashboard use. Positive individual authority was sometimes present with a negative example of another determinant, but no evidence was found of individual authority co-occurring with a positive instance of another determinant. Increased individual clinician authority is a necessary antecedent to the effective implementation of an EHR DOAC Population Management Dashboard and positively affects other aspects of implementation. RR2-10.1186/s13012-020-01044-5.

FRI240 Aspirin Induced Adrenal Hemorrhage: Rare Side Effect Of A Common Medication!

Abstract Disclosure: H.A. Qadeer: None. R. Samkutty: None. V. Singh: None. Introduction: Adrenal hemorrhage is a heterogeneous disorder with various clinical presentations. Bilateral adrenal hemorrhage can result in acute adrenal insufficiency that can be fatal. With the increasing use of DOAC, cases of anticoagulation therapy induced adrenal hemorrhage have been reported. We present a rare case of unilateral adrenal hemorrhage in a patient with pre-existing adrenal myelolipoma after using Aspirin. Based on our literature search, previously only two cases of Aspirin Induced adrenal hemorrhage in a stable adrenal mass have been reported. Case Presentation: 55-year-old male with history of stable 6.2 cm right adrenal gland myelolipoma, fatty liver disease and hypertension, recent use of 2 doses 81 mg Aspirin after receiving right shoulder replacement surgery presented to emergency department with acute onset right sided flank pain, constant, radiating to the back and right upper quadrant associated with an episode of vomiting. He was hemodynamically stable. Blood work showed normal electrolytes, liver function and renal function at baseline. Hemoglobin was stable around 10g/dL. CT scan abdomen/pelvis with contrast showed increase in the size of a previously stable adrenal myelolipoma to 12.9 x 15.6 cm with mass effect upon the liver. Acute hemorrhage was suspected with the blood extending beyond the margins of the mass into the right retroperitoneal space, displacing the right kidney. On admission, aspirin was discontinued. With absence of hemodynamic instability, normal electrolytes, and normal AM cortisol level of 11.9 mcg/dL, adrenal insufficiency was ruled out. Hormonal work up for hyperfunctioning adrenal tumor was performed that ruled out pheochromocytoma, Cushing syndrome and Primary Aldosteronism. With symptomatic improvement, absence of progression of adrenal hemorrhage on repeat CT scan of the abdomen/pelvis, patient was discharged home. He received IR guided embolization of the right superior adrenal artery and middle adrenal artery in the outpatient setting. Discussion: Spontaneous adrenal gland hemorrhage is a rare event. Bilateral adrenal hemorrhage is associated with acute adrenal insufficiency that can be fatal. Major risk factors for adrenal hemorrhage include anticoagulant therapy, heparin Induced thrombocytopenia, hypercoagulable state, trauma and sever sepsis. Here we have reported a rare case of adrenal gland hemorrhage with therapeutic dose of aspirin used after orthopedic surgery. Aspirin is a very commonly used medication and high index of suspicion is required to avoid this side effect as Immediate discontinuation of the medication is necessary to prevent progression of the disease. Conclusion: Aspirin use can be associated with progression of stable benign adrenal tumors by causing spontaneous hemorrhage. A high index of clinical suspicion is required for timely recognition of this side effect. Presentation: Friday, June 16, 2023

Dementia Risk of Direct Oral Anticoagulants Versus Warfarin for Atrial Fibrillation: Systematic Review and Meta-Analysis

BackgroundDirect-acting oral anticoagulants (DOACs) have demonstrated superior efficacy in preventing stroke and death compared with warfarin in patients with atrial fibrillation (AF), but their influence on dementia risk remains unclear. ObjectivesThe purpose of this study was to evaluate the relative risks of dementia in DOAC vs warfarin in patients with AF. MethodsAn electronic literature search was conducted to retrieve studies reporting comparisons of dementia incidence between patients treated with DOACs and warfarin for AF. HRs and 95% CI were pooled in a random-effects meta-analysis. Meta-regression was performed to identify prognostic baseline variables. Network meta-analysis was performed to determine dementia risk between individual DOACs and warfarin. ResultsTen studies (n = 342,624) were retrieved. DOAC was associated with a significantly lower risk of developing dementia compared with warfarin (HR: 0.88; 95% CI: 0.80-0.98; P = 0.017; I2 = 75%); significance was also seen in Asian patients (HR: 0.81; 95% CI: 0.68-0.86) but not non-Asian patients. Subgroup analyses of propensity score–matched studies and patients aged 65-75 years showed similar significance, but not for patients aged ≥75 years. Meta-regression found that a lower mean age corresponded to significantly greater favoring of DOAC over warfarin. Network meta-analysis found significant reductions in dementia risk over warfarin for rivaroxaban (HR: 0.854; 95% CI: 0.763-0.955), apixaban (HR: 0.881; 95% CI: 0.778-0.997), and dabigatran (HR: 0.871; 95% CI: 0.770-0.987); the highest-ranked treatment based on P scores was edoxaban. ConclusionsThe use of DOAC in AF significantly reduces dementia risk compared with warfarin, particularly in Asian patients. The possible reversal of this effect with increasing age merits further randomized trials with long-term follow-up. (Dementia Risk of Direct Oral Anticoagulants Versus Warfarin for Atrial Fibrillation: A Systematic Review and Meta-Analysis; CRD42022365634)

DOACs in the Anticoagulation of Mechanical Valves: A Systematic Review and Future Perspectives.

A literature search of Pubmed, Embase, Web of Science (Core Collection), and Cochrane Library (from inception to May 2023) was performed using a search string that was well defined and not modified during the study. An extensive overview of the search terms used in each database can be found in the Appendix. Only prospective clinical trials were included in this review. A total of 10 publications were included in this review. This systematic review summarizes the different types of DOACs and their possible use in the anticoagulation of mechanical valves. We aim to propose future directions in anticoagulation research for mechanical valves. DOAC use in MHVs has been halted due to the failure of both dabigatran and apixaban in two major clinical trials. However, rivaroxaban was successful in two small clinical trials. Ample research is still needed to explore new valve designs as well as new anticoagulation targets.

The risk of intracranial hemorrhage in glioma patients receiving anticoagulant treatment for venous thromboembolism: a bayesian network meta-analysis.

We aimed to perform a Bayesian network meta-analysis to assess the risk of intracranial hemorrhage (ICH) in patients with glioma receiving anticoagulant treatment for venous thromboembolism. The PubMed, Embase and Web of Science databases were searched for relevant publications until September 2022. All studies evaluating the risk of ICH in patients with glioma receiving anticoagulant treatment were included. Bayesian network meta-analysis and pairwise meta-analysis were performed to compare the ICH risk between the anticoagulant treatments. The Cochrane's Risk of Bias Tool and the Newcastle-Ottawa Scale (NOS) were used to evaluate the quality of studies. A total of 11 studies with 1301 patients were included. Pairwise comparisons showed no significant differences excepted with LMWH vs. DOACs (OR: 7.28, 95% CI: 2.11-25.17) and LMWH vs. Placebo (OR: 3.66, 95% CI: 2.15-6.24). For network meta-analysis, significant difference was found between patients treated with LMWH vs. Placebo (OR: 4.16, 95% CI: 2.00-10.14) and LMWH vs. DOACs (OR: 10.13, 95% CI: 2.70-70.19). It seems that LMWH has the highest risk of ICH in glioma patients, while no evidence indicates that DOACs increase the risk of ICH. The use of DOACs may perhaps be a better choice. Further larger studies focusing on the benefit-to-risk ratio are warranted.