Risultati per: Associazione FANS e Warfarin

Introduction
Atrial fibrillation is highly prevalent in patients on chronic dialysis. It is unclear whether anticoagulant therapy for stroke prevention is beneficial in these patients. Vitamin K-antagonists (VKA) remain the predominant anticoagulant choice. Importantly, anticoagulation remains inconsistently used and a possible benefit remains untested in randomised clinical trials comparing oral anticoagulation with no treatment in patients on chronic dialysis. The Danish Warfarin-Dialysis (DANWARD) trial aims to investigate the safety and efficacy of VKAs in patients with atrial fibrillation on chronic dialysis. The hypothesis is that VKA treatment compared with no treatment is associated with stroke risk reduction and overall benefit.

Methods and analysis
The DANWARD trial is an investigator-initiated trial at 13 Danish dialysis centres. In an open-label randomised clinical trial study design, a total of 718 patients with atrial fibrillation on chronic dialysis will be randomised in a 1:1 ratio to receive either standard dose VKA targeting an international normalised ratio of 2.0–3.0 or no oral anticoagulation. Principal analyses will compare the risk of a primary efficacy endpoint, stroke or transient ischaemic attack and a primary safety endpoint, major bleeding, in patients allocated to VKA treatment and no treatment, respectively. The first patient was randomised in October 2019. Patients will be followed until 1 year after the inclusion of the last patient.

Ethics and dissemination
The study protocol was approved by the Regional Research Ethics Committee (journal number H-18050839) and the Danish Medicines Agency (case number 2018101877). The trial is conducted in accordance with the Helsinki declaration and standards of Good Clinical Practice. Study results will be disseminated to participating sites, at research conferences and in peer-reviewed journals.

Trial registration numbers
NCT03862859, EUDRA-CT 2018-000484-86 and CTIS ID 2022-502500-75-00.

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Stroke, Volume 55, Issue Suppl_1, Page AWP19-AWP19, February 1, 2024. Objective:The presence of left atrial thrombus (LAT) in acute stroke patients with nonvalvular atrial fibrillation (NVAF) is the major embolic source for recurrent stroke. The aim of this study was to investigate whether direct oral anticoagulants (DOAC) is more effective than warfarin to reduce the size of LAT detected in acute stroke patients with NVAF.Methods:Among acute stroke patients admitted to five major comprehensive stroke centers from January 2017 to December 2022, acute stroke patients with both AF and LAT detected by transesophageal echocardiography (TEE) were selected, and patients with follow-up evaluation were enrolled. All patients were treated with anticoagulation such as DOAC or warfarin for LAT. Thus, patients were classified into two groups according to the type of anticoagulation; the DOAC group and the warfarin group. We compared the clinical characteristics, the dissolution of LAT, and recurrent stroke within three months after stroke onset evaluated between the two groups.Results:63 patients (median age 77, male 33 [52%]) were enrolled. DOAC and warfarin groups had 22 (35%) and 41(65%) patients, respectively. Age, gender, NIHSS scores on admission were not different between the two groups. Age was 77 years (IQR, 68-81) in the DOAC group and 76 years (IQR, 68-81) in the warfarin group (P=0.644). 10 men (46%) were in the DOAC group, and 23 (56%) were in the warfarin group (P=0.442). The NIHSS score at admission was 3 (IQR, 1-18) in the DOAC group and 4 (IQR, 2-14) in the warfarin group (P=0.393). Initial LAT size was 0.83 (IQR, 0.41-1.27) cm2 in DOAC and 0.88 (IQR, 0.40-1.56) cm2 in warfarin (p=0.48). On follow-up evaluation (10 [IQR, 7-15] days after initial TEE), the disappearance of LAT was more frequently seen in DOAC group than warfarin group (13/22 [59%] vs. 14/41 [34%], P=0.016). Recurrent stroke within three months after stroke was 1/22 (5%) in DOAC and 3/41 (7%) in warfarin (P=1.000), which was not different.Conclusion:In acute stroke patients with NVAF, DOAC should be more effective than warfarin to dissolve LAT detected by TEE.

Circulation, Ahead of Print. BACKGROUND:The efficacy and safety of non–vitamin-K antagonist oral anticoagulants (NOACs) across the spectrum of body mass index (BMI) and body weight (BW) remain uncertain.METHODS:We analyzed data from COMBINE AF (A Collaboration Between Multiple Institutions to Better Investigate Non-Vitamin K Antagonist Oral Anticoagulant Use in Atrial Fibrillation), which pooled patient-level data from the 4 pivotal randomized trials of NOAC versus warfarin in patients with atrial fibrillation. The primary efficacy and safety outcomes were stroke or systemic embolic events (stroke/SEE) and major bleeding, respectively; secondary outcomes were ischemic stroke/SEE, intracranial hemorrhage, death, and the net clinical outcome (stroke/SEE, major bleeding, or death). Each outcome was examined across BMI and BW. Because few patients had a BMI

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Circulation, Ahead of Print.

Circulation, Volume 148, Issue Suppl_1, Page A12514-A12514, November 6, 2023. Introduction:Atrial fibrillation (AF) and valvular heart disease (VHD) are common comorbidities, increasing the risk of thromboembolic events. While warfarin has been the standard for preventing stroke in AF patients, direct oral anticoagulants (DOACs) have emerged as an effective substitute. However, their safety and efficacy in VHD patients have yet to be established.Objective:To compare the effectiveness and safety of different DOAC agents versus warfarin in patients with AF and VHD in a network meta-analysis (NMA).Methods:We conducted an online search of databases for eligible studies from inception to April 2023. For dichotomous variables, we calculated the effect size using the risk ratio (RR) and its confidence interval (CI). We conducted frequentist and pairwise meta-analyses using the random-effects model in R-studio software.Results:Seven randomized controlled trials with 17533 patients were included in the review. Analysis of 6 studies showed that dabigatran 150 mg (RR 0.59, 95% CI [0.36, 0.98]) was associated with a lower risk of stroke compared to warfarin. Edoxaban 30 mg was associated with a significantly lower risk of major bleeding (RR 0.43, 95 CI [0.23, 0.81]). Compared to warfarin, dabigatran 110 mg (RR 0.29, 95% CI [0.13, 0.68]), edoxaban 30 mg (RR 0.30, 95% CI [0.11, 0.80]), dabigatran 150 mg (RR 0.36, 95% CI [0.17, 0.77]), edoxaban 60 mg (RR 0.37, 95% CI [0.15, 0.93]), and apixaban (RR 0.40, 95% CI [0.27, 0.61]), were associated with a significantly lower risk of intracranial hemorrhage (ICH). All DOACs did not show any difference in terms of all-cause or cardiovascular mortality, except for rivaroxabanConclusion:In patients with AF and VHD, Edoxaban 30 mg is the safest DOAC agent associated with a reduced risk of major bleeding, ICH, and GI trouble. Dabigatran 150 mg is associated with a reduced risk of stroke and ICH but with a higher risk of GI trouble. However, Rivaroxaban is associated with an increased risk of systemic embolism.

Circulation, Volume 148, Issue Suppl_1, Page A17671-A17671, November 6, 2023. Introduction:This study aims to evaluate the efficacy and safety of direct oral anticoagulants (DOACs) in the treatment of left ventricular thrombus (LVT). Warfarin has been shown to be an effective treatment in mitigating thrombotic events; however, numerous limitations exist, including the need for frequent monitoring and increased risk of side effects. Despite this, insight into DOAC use for the treatment of LVT remains limited. Thus, this study seeks to investigate the safety and efficacy of DOACs as a potential alternative to warfarin for the treatment of LVT.Hypothesis:DOACs decreases the risk of adverse events compared to Warfarin in patients with LVT.Methods:A retrospective cohort study was conducted using a federated realtime database called TriNetX which is comprised of over 100 million patient records. ICD-10 diagnostic codes and national drug codes were used to stratify adults by warfarin or DOAC treatment within 3 months of an initial LVT diagnosis. A 1:1 matched propensity score analysis was conducted, adjusting for comorbidities and demographics, to calculate adjusted Risk Ratios (aRR) with 95% CI. 90-day risk for mortality, stroke, need for blood transfusion, hemorrhage, and arterial embolism & thrombosis were examined.Results:In a matched sample of 11,206 patients in each cohort, patients with LVT who took warfarin within 3 months of initial diagnosis is at higher risk for stroke (aRR[95%CI]=1.44(1.34,1.55)], need for blood transfusion [1.29(1.11,1.51)], hemorrhage [1.56(1.35,1.8)], and arterial thromboembolism [1.28(1.13,1.45)] than LVT patients who took a DOAC. Risk for death was non-significant between cohorts.Conclusions:The findings from this large electronic medical record patient cohort establish higher rates of adverse events for patients with LVT treated with warfarin versus DOAC, with no statistically significant difference in therapeutic efficacy.

Circulation, Volume 148, Issue Suppl_1, Page A15632-A15632, November 6, 2023. Introduction:Warfarin is a commonly prescribed anticoagulant for treating atrial fibrillation, mechanical valves, and venous thromboembolism. Warfarin dose management remains challenging due to dosing variability between patients and warfarin’s narrow therapeutic window. Time in therapeutic range (TTR) is critical to warfarin’s safety and efficacy, but TTR typically remains low (40-50%) in community practices. Specialized anticoagulation clinics and protocolized approaches can increase TTR but have great administrative burdens and health care costs.Aim:To develop standardized optimal warfarin dose decision support using a machine learning model based on time series anticoagulation data and patient demographic characteristicsMethods:The dataset included 12,497 warfarin patients monitored in the anticoagulation tracker of electronic medical records across the Mayo Clinic Enterprise. The dataset contained time series anticoagulation data (warfarin dose, INR, INR target range) and patient demographic characteristics. We implemented an offline deep reinforcement learning model (DRL) to predict the cumulative warfarin dose for the days until the next INR test based on a patient’s historical anticoagulation data. Prior approaches utilized traditional supervised learning methods such as regression or Long Short Term Memory (LSTM) neural networks to approximate a function mimicking the behavior of the training data. On the other hand, DRL learned an optimal dosing policy through continuous interaction and feedback from the training data. The key advantage of DRL is the model can learn to behave differently (and potentially better) for suboptimal clinical states in the data such as overdosing or underdosing. To evaluate the DRL model we compared the predicted warfarin doses with the physician-prescribed dosesResults:DRL model’s prediction accuracy was 96.96%, outperforming our implementation of a baseline LSTM model with a prediction accuracy of 70.58%. Further evaluation of the DRL model indicated that the model correctly adjusted the warfarin dose at time steps when patients had out-of-range INRs.Conclusions:Offline deep reinforcement learning demonstrates potential in supporting warfarin dose management to maximize TTR.

Circulation, Volume 148, Issue Suppl_1, Page A14451-A14451, November 6, 2023. Introduction:Many patients are still using warfarin for thromboembolic prevention, even though Direct-Acting Oral Anticoagulants (DOACs) have replaced it in most indications to decrease the need for frequent dose adjustments and minimize drug interactions.Methods:This study is a clinic patient-based observational quality improvement project to review warfarin use in adult patients following at the anticoagulation clinic at Metropolitan Hospital. Electronic medical records were screened, and TTR was calculated over 3 months. STATA was used for statistical analysis, including Histograms, Skewness-Kurtosis tests for normality, student-T tests for continuous variables, and χ2 tests for categorical variables. The P-value of less than 0.05 was considered statically significant.Results:A total of 45 patients were included; the mean age was 61, of whom 23 (51.1%) were males. The comorbidities observed were hypertension (HTN), diabetes mellitus (DM), chronic obstructive pulmonary disease (COPD), and obesity. The time in therapeutic range (TTR) was less than 65% in 22 patients (48.9%). Warfarin was indicated in 28 patients (62.2%) and not indicated in 17 patients (37.8%), out of which 6 patients (36.3%) agreed to switch to direct oral anticoagulants (DOACs) (Figure 1).Conclusions:Our project revealed a significant number of patients are still using warfarin despite being suitable for DOACs. 60% prefer warfarin due to perceived safety with frequent clinic visits. Socioeconomic status affects the transition. The PINNACLE Study identified practice and provider variations, Practices with high-volume clinics, more electrophysiologists, and those located in the western region are more likely to switch to DOACs. Based on our findings, we recommend the following: – Physicians should engage in shared decision-making with patients on warfarin use. – Physicians may need to discuss the available DOACs options with insurance companies due to coverage limitations.

Circulation, Volume 148, Issue Suppl_1, Page A14628-A14628, November 6, 2023. Introduction:Despite oral anticoagulation treatment atrial fibrillation (AF) patients have residual risk of ischemic stroke and systemic embolism (SE) which could potentially be mitigated.Methods:Harmonized individual patient data from five landmark trials testing direct oral anticoagulants (DOAC) were pooled in the COMBINE-AF dataset, which we used to calculate annual rate of ischemic stroke/SE according to CHA2DS2-Vasc score, history of stroke, and AF type.Results:We included 71,794 subjects (median age 72 IQR 65-78 years 61.3% male) with CHA2DS2-Vasc scores≥2 randomized to either standard- or lower-dose DOAC or warfarin, and followed for a median of 2.1 (IQR 1.5-2.7) years. The median CHA2DS2-VASc score was 4 (IQR 3-5), and 18.8% had a history of stroke and 76.4% had non-paroxysmal AF. The overall annual stroke/SE rate was 1.33%/year (95%CI 1.27-1.39%). Subjects with non-paroxysmal AF had higher stroke/SE rates, 1.38%/year (95%CI 1.31-1.45%) compared to 1.15%/year (95%CI 1.05-1.27%) with paroxysmal AF. The rate increased by a RR 1.36 (95%CI 1.32-1.41%) per CHA2DS2-VASc point; in subjects with CHA2DS2-VASc≥4, the stroke/SE rate was 1.67%/year (95%CI 1.59-1.75%). Annual stroke/SE rates were higher in subjects with a prior stroke, 2.51%/year (95%CI 2.33-2.71%), and increased with higher CHA2DS2-VaSc score; RR 1.11 (95%CI 1.05-1.18),Figure 1. After premature permanent discontinuation of study drug, which occurred in 22% of individuals, stroke/SE rates were 3.6%/year (95%CI 3.4-3.9%) overall; 6.5%/year (95%CI 5.7-7.4%) in those with prior stroke. During follow-up 8.9% of subjects died.Conclusions:Despite treatment with oral anticoagulation in a clinical trial setting, there remains an 8.4% risk of stroke/SE over five years in subjects with CHA2DS2-Vasc≥4, and 12.5% over five years in subjects with a prior stroke. Permanent discontinuation is common, and associated with stroke/SE risks of almost 20% over five years.

Circulation, Volume 148, Issue Suppl_1, Page A17177-A17177, November 6, 2023. Introduction:Obesity affects nearly 650 million adults worldwide and the prevalence of obesity has been steadily increasing. Obesity has adverse effects on cardiovascular health, increasing the risk for developing hypertension, coronary artery disease, heart failure and atrial fibrillation (AF). It is well known that anticoagulation is warranted in patients with AF, however the safety and efficacy of direct oral anti-coagulant (DOAC) over vitamin K antagonist (VKA) are not well explored in the obese population. This meta-analysis aimed to compare DOAC to VKA in obese populations with AF.Methods:The PRISMA guidelines were followed for this meta-analysis, and it was registered in PROSPERO (CRD42023392711). PubMed, Medline, Embase, Cochrane Library and Scopus databases were searched for relevant articles from inception through January 2023. Two independent authors screened title and abstract, followed by full text review in Covidence. Data were extracted in Microsoft Excel and analyzed using RevMan v5.4 using odds ratio as effect measure.Results:2259 studies were identified from the database search and 19 studies were included in the analysis. There were significantly lesser odds of ischemic (OR 0.71, 95% CI 0.66-0.75) and hemorrhagic stroke (OR 0.47, 95% CI 0.35-0.62) in the DOAC group compared to VKA group. There were also lower odds for occurrence of systemic embolism (OR 0.67, 95% CI 0.54-0.83) and major bleeding (OR 0.62, 95% CI 0.54-0.72) in the DOAC group.Conclusions:Based on this meta-analysis it can be concluded that DOACs are safer and more efficacious than vitamin K antagonists in the obese population with AF.

Circulation, Volume 148, Issue Suppl_1, Page A13717-A13717, November 6, 2023. Introduction:Left ventricular assist devices (LVADs) are a therapy for the management of end stage heart failure. LVADs are typically managed with long-term therapeutic anticoagulation with warfarin to prevent thrombotic complications. Direct oral anticoagulants (DOACs) are easier to manage than warfarin for other medical conditions requiring therapeutic anticoagulation. There is limited data regarding DOAC safety in patients with LVADs.Hypothesis:There is no significant difference in outcomes for patients with LVAD when on DOAC compared to warfarin.Methods:In a single center retrospective analysis from February 2019 to May 2023, patients with LVAD who were switched to the DOAC apixaban (due to warfarin complications or compliance problems) were compared to patients who remained on warfarin. Overall survival, number of hospitalizations, bleeding and thrombotic complications were compared within/between groups.Results:72 patients were included. DOAC group vs warfarin group: n=12 vs 60, mean age = 52.5 vs 54.2 years; Male 75% vs 81.7%; black 66.7%; vs 58.3%. For DOAC group, 10 out of 12 were on warfarin prior to DOAC. Of these 10, incidence rates for bleeding related admissions were 4.2 per 1000 days on initial warfarin and 0.76 per 1000 days after switching to DOAC. Relative risk reduction of bleeding related admissions decreased by 81.9%. In the DOAC group, thrombosis related admissions on initial warfarin were 0, compared to 1 after switching to DOAC. When comparing DOAC and Warfarin groups, there were no statistically significant difference in bleeding or thrombotic complications (HR = 0.61; 95%CI= 0.21 to 1.46; HR= 0.74; 95%CI= 0.02 to 6.08, respectively) or mortality (HR = 0.44; 95%CI: 0.01 to 3.12). Incidence rates for bleeding related admissions were 0.98 per 1000 days and 1.59 per 1000 days, for DOAC and Warfarin, respectively. Incidence rates for thrombotic related admissions were 0.16 per 1000 days and 0.22 per 1000 days, for DOAC and Warfarin, respectively.Conclusions:There was no statistically significant difference in bleeding, thrombotic events, or mortality in LVAD patients receiving DOAC compared to Warfarin. Switching to DOAC improved bleeding rates in LVAD patients that suffered bleeding complications with Warfarin.

Objectives
We studied association of laboratory testing beyond the international normalised ratio (INR) with bleeding and stroke/transient ischaemic attack (TIA) outcomes in patients with atrial fibrillation treated with warfarin.

Design
This was a retrospective nested case–control study from the Finnish Warfarin in Atrial Fibrillation (FinWAF) registry (n=54 568), reporting the management and outcome in warfarin-anticoagulated patients. Associations of blood count test frequency and results were assessed together with risk of bleeding or stroke/TIA during 5-year follow-up.

Setting
National FinWAF registry, with data from all six hospital districts. Follow-up period for complications was 1 January 2007–31 December 2011.

Participants
A total of 54 568 warfarin-anticoagulated patients.

Results
The number of patients with bleeding was 4681 (9%) and stroke/TIA episodes, 4692 (9%). In patients with bleeds, lower haemoglobin (within 3 months) preceded the event compared with the controls (median 126 vs 135 g/L; IQR 111–141 g/L vs 123–147 g/L, p