Risultati per: Associazione FANS e Warfarin

Circulation, Volume 150, Issue Suppl_1, Page A4142147-A4142147, November 12, 2024. Introduction:The utilization of direct oral anticoagulant (DOAC) agents for atrial fibrillation (AF) in individuals with end-stage renal disease (ESRD) has increased despite a lack of robust supportive data from randomized controlled trials. We planned to assess the outcomes associated with rivaroxaban versus warfarin in the ESRD population with AF.Methods:We utilized the TriNetX Global Collaborative Network, which includes 114 Healthcare organizations to perform a propensity-score matched retrospective cohort study. We used ICD-10 codes to identify individuals with ESRD and AF, over 18 years of age, excluding those with prosthetic valves and apixaban or edoxaban use. Data were collected from 2011 to 2024. We evaluated the incidence of ischemic stroke (I63), intracranial hemorrhage (I62.9), cardiac arrest (I46), mortality, gastrointestinal (GI) hemorrhage (K92.2), systemic embolism and thrombosis (I74.3, I74.2), and other cardiac arrythmias (I49). We performed propensity-score matching (PSM) on age, sex, race, BMI,hypertension, diabetes mellitus, tobacco use, heart failure, stroke, or acute myocardial infarction.Results:We identified 25,092 individuals in the warfarin group and 2,391 individuals in the rivaroxaban group. After PSM, 2,381 individuals remained in each group. The average age was 72.9, predominantly male (59.8%), with 62.9% white, 14.7% African American, and 6.5% Hispanic individuals. Compared to those treated with warfarin, individuals treated with rivaroxaban demonstrated a lower risk of a composite outcome (Infarct, intracranial hemorrhage, mortality) (RR 0.823, 95% CI 0.765-0.885), mortality (RR 0.830, 95% CI 0.775-0.888), GI hemorrhage (RR 0.566, 95% CI 0.439-0.730), and cardiac arrest (RR 0.696, 95% CI 0.531-0.911). We found no significant difference in the risk of ischemic stroke (RR 1.024, 95% CI 0.744-1.408), intracranial hemorrhage (RR 0.587, 95% CI 0.270-1.280), systemic embolism (RR 0.828 (95% CI 0.512-1.339), or other cardiac arrythmias (RR 0.973, 95% CI 0.804-1.179).Conclusion:In individuals with AF and ESRD the use of rivaroxaban, in comparison to warfarin, was associated with a reduction in the risk of mortality, gastrointestinal hemorrhage, and cardiac arrest. We found no difference in other clinically relevant outcomes, including ischemic stroke. These findings suggest an extension of the safety benefits previously observed with DOACs to the ESRD population, however further research is needed to guide management.

Circulation, Volume 150, Issue Suppl_1, Page A4141755-A4141755, November 12, 2024. Background:Mechanical heart valve replacement (MHVR) is an effective method for the treatment of severe heart valve disease. However, it subjects patients to lifelong warfarin therapy after MHVR, with the attendant risk of bleeding and thrombosis. Whether internet-based warfarin management reduces complications and improves patient quality of life remains unknown.Objective:This study aimed to compare the effects of internet-based warfarin management and the conventional approach in patients who received MHVR in order to provide evidence regarding alternative strategies for long-term anticoagulation.Methods:This was a prospective, multicenter, randomized, open-label, controlled clinical trial with a 1-year follow-up. Patients who needed long-term warfarin anticoagulation after MHVR were enrolled and then randomly divided into conventional and internet-based management groups. The percentage of time in the therapeutic range (TTR) was used as the primary outcome while bleeding, thrombosis, and other events were the secondary outcomes.Results:A total of 721 patients were enrolled. The baseline characteristics did not reach statistical differences between the two groups, suggesting the random assignment was successful. As a result, the internet-based group showed a significantly higher TTR (mean 0.53, SD 0.24 vs. mean 0.46, SD 0.21; P < .001) and fraction of time in the therapeutic range (mean 0.48, SD 0.22 vs. mean 0.42, SD 0.19; P < .001) than did those in the conventional group. Furthermore, as expected, the anticoagulation complications, including bleeding and embolic events, had a lower frequency in the internet-based group than in the conventional group (6.94% vs. 12.74%; P = .01). Logistic regression showed that internet-based management increased the TTR by 7% (odds ratio [OR] 1.07, 95% CI 1.05-1.09; P < .001) and reduced the bleeding and embolic risk by 6% (OR 0.94, 95% CI 0.92-0.96; P = .01). Moreover, low TTR was found to be a risk factor for bleeding and embolic events (OR 0.87, 95% CI 0.83-0.91; P = .005).Conclusions:Internet-based warfarin management is superior to the conventional method, as it can reduce anticoagulation complications in patients who receive long-term warfarin anticoagulation after MHVR.

Circulation, Volume 150, Issue Suppl_1, Page A4141024-A4141024, November 12, 2024. Background:Atrial fibrillation (AF) is increasingly prevalent in patients with liver cirrhosis, which is associated with both bleeding and thromboembolism. Patients with cirrhosis have been excluded from randomized controlled trials on the efficacy and safety of anticoagulants in AF. We performed a systematic review to compare direct oral anticoagulants (DOACs) with warfarin in patients with AF and concomitant cirrhosis.Methods:We systematically searched Pubmed and Embase from inception to the present. The primary outcome of interest was the hazard ratio of major bleeding. Secondary outcomes included gastrointestinal bleeding, all-cause bleeding, and ischemic stroke/systemic embolism[AN1] . Random effects models were used to calculate the weighted pooled hazard ratios for the outcomes. A two-tailed p

Hockey FIT reduced weight in men with overweight or obesity. Hockey FIT is an innovative approach to engage men at increased risk of non-communicable disease in effective health behaviour change, through their passion as fans of their local hockey team.

Introduction
Several randomised controlled trials have demonstrated that novel oral anticoagulants are safer compared with vitamin K antagonists for the management of non-valvular atrial fibrillation (NVAF) to prevent thromboembolic events in the general population. There is a growing interest in the use of apixaban in patients with end-stage renal disease (ESRD) undergoing peritoneal dialysis (PD) but there is a lack of randomised data in this population.

Methods and analysis
APIDP2 is a prospective parallel, randomised, open-label, blinded endpoint trial involving patients with ESRD undergoing chronic PD who have NVAF. A total of 178 participants will be recruited from 20 French PD centres. Eligible patients will be randomly assigned to receive either apixaban at a reduced dose of 2.5 mg two times per day (dose determined with the previous pharmacokinetic study APIDP1) or dose-adjusted to international normalised ratio (INR) target (2–3) coumadin therapy. Anticoagulation to prevent thromboembolic events will be initiated or changed according to the randomisation for a duration of 1 year. The primary outcome is a major or clinically relevant non-major bleeding from randomisation up to month 12, assessed according to the International Society on Thrombosis and Haemostasis Score. Secondary outcomes encompass an efficacy composite criterion combining stroke or transient ischaemic attack (TIA), cardiovascular death and thrombosis including myocardial infarction cumulated at 12 months. Bleeding events will be also classified according to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) and Thrombolysis In Myocardial Infarction (TIMI) criteria and pharmacodynamics outcomes will evaluate the time within the INR target range of 2–3 in the warfarin arm over 1 year, and anti-Xa apixaban activity in case of bleeding events and at 1 month, 6 months and 12 months of follow-up in the apixaban arm. To demonstrate that apixaban is safer than warfarin at 1 year, assuming two interim analyses after 60 and 118 patients, a bilateral alpha risk of 5% and a power of 80%, 178 patients are needed in this randomised trial (effect size found from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Study among patients with creatinine clearance 25–30 ml/min), that is, 89 patients per group.

Ethics and dissemination
The study has been approved by the ethics committee Comité de Protection des Personnes Sud Est III – Lyon – FRANCE, CT number 2023-507544-37-00. Written informed consent is required for each participant. Findings will be presented at scientific meetings and published in peer-reviewed journals.

Trial registration
ClinicalTrials.gov, NCT06045858; European Clinical Trial System, CT number 2023-507544-37-00.

Objectives
We sought to extrapolate the long-term costs and clinical impacts attributed to the rugby fans in training–New Zealand (RUFIT-NZ) trial in Aotearoa, New Zealand.

Design
A modelled cost-effectiveness analysis using efficacy data from RUFIT-NZ was conducted from the Aotearoa New Zealand healthcare perspective.

Setting
A Markov cohort model was constructed with a lifetime time horizon. The model simulated events of myocardial infarction (MI), stroke and type 2 diabetes mellitus (T2DM) occurring among a hypothetical cohort of 10 000 individuals receiving either the RUFIT-NZ intervention or no intervention. Efficacy data were based on the RUFIT-NZ trial, and the latest Global Burden of Disease study was used to extrapolate the impact of body weight reduction on clinical outcomes of T2DM, MI or stroke. Cost and utility data were drawn from the RUFIT-NZ trial and published sources.

Primary outcome measures
The incremental cost-effectiveness ratio (ICER).

Results
Over a lifetime time horizon, participants in the RUFIT-NZ intervention gained 0.02 (discounted) quality-adjusted life years (QALYs) at an additional cost of NZ$863, relative to no intervention. The estimated ICER was NZ$49 515 per QALY gained (discounted), which is above the arbitrary willingness-to-pay threshold of NZ$45 000 per QALY. Sensitivity analyses supported the robustness of these findings.

Conclusions
RUFIT-NZ was associated with a reduction in cardiovascular and endocrine events for overweight and obese males. However, based on conservative assumptions, RUFIT-NZ was unlikely to be cost-effective from a healthcare system perspective.

Trial registration number
ACTRN12619000069156.

Annals of Internal Medicine, Ahead of Print.

La Commissione europea ha concesso l’autorizzazione per l’insulina settimanale, Awiqli di Novo Nordisk, la prima al mondo indicata per il trattamento del diabete negli adulti. «Il farmaco – spiega una nota – è progettato per coprire il fabbisogno di insulina basale per un’intera settimana con una singola iniezione sottocutanea ed è stato approvato per gli adulti con diabete mellito»

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.

’14mila nati l’anno dopo stop a suoi divieti incostituzionali’

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