Risultati per: Associazione FANS e Warfarin

Professore: ‘Ricerca si focalizzi su sostenibilità chirurgia’

Objectives
We aimed to understand the (1) perspectives of patients with atrial fibrilation (AF) regarding their experience and implementation of The SAMe-TT2R2 score-guided approach in anticoagulant-nave Thai patients with atrial fibrillation (TREATS-AF) educational intervention for warfarin therapy control, including views on cultural transferability to the Thai context, and (2) healthcare professionals’ (HCPs) experience of implementing the intervention.

Design
Qualitative research study.

Setting
Three university hospitals and four tertiary care hospitals in Thailand.

Participants
13 newly diagnosed patients with AF and 13 HCPs delivering the TREATS-AF intervention, an intensive structured educational programme.

Methods
Semistructured interviews. Patient participants were interviewed at two time points: 4 weeks and 6 months after intervention delivery. HCPs were interviewed when they had at least 6 months experience of intervention delivery. A thematic analysis of content was informed by the framework analytical approach.

Results
13 patients and 13 HCPs were interviewed; most were female (73.3% of patients and all HCPs). Mean age was 70 (68–76) and 40 (38–42.5) years for patients and HCPs, respectively. There were four categories related to the experience of the TREATS-AF intervention: (1) key experiences of the educational sessions, (2) core perceptions of the educational materials provided, (3) suggestions for improving the educational materials and session, and (4) behavioural change and self-management influenced by the TREATS-AF intervention.

Conclusions
The TREATS-AF intervention assisted interviewees who were newly diagnosed with AF in preparing themselves with the necessary knowledge and skills to manage their condition. They stated that it increased their confidence in self-management.
For implementation, regionalised Thai-related food and beverages, patients’ literacy and family support should be considered, and infrastructure support for widespread use in healthcare settings would be required.

Trial registeration number
TCTR20180711003.

L’organizzazione accoglie a Roma chi viene da fuori per le cure

Stroke, Volume 56, Issue Suppl_1, Page A145-A145, February 1, 2025. Background:Patients with atrial fibrillation (AF) and previous stroke or transient ischemic attack (TIA) are at high risk of recurrent stroke. Data regarding the efficacy and safety of new oral anticoagulant therapy (NOAC) compared to warfarin in patients with previous strokes are lacking.Method:PubMed, Scopus and Cochrane databases were searched for both randomized controlled trials (RCTs) and non-randomized controlled trials (non-RCTs) that compared NOAC to warfarin in patients with AF and previous stroke or TIA and that reported the outcomes of cardiovascular death, death from any cause, disabling or fatal stroke, gastrointestinal major bleeding, hemorrhagic stroke, intracranial bleeding, major bleeding, overall stroke etc. Heterogeneity was examined using I2statistics.Results:We included 7 RCTs and 2 non-RCTs comparing NOAC to warfarin in patients with atrial fibrillation and previous stroke or TIA. The pooled results showed that cardiovascular death (4.9% vs 5.2% respectively; OR = 0.92; 95% CI [0.78, 1.08]; I2= 34%; p = 0.298), death from any cause (6.7% vs 7.5% respectively; OR = 0.88; 95% CI [0.77, 1.01]; I2= 59%; p = 0.066), disabling or fatal stroke (2.4% vs 2.9% respectively; OR = 0.83; 95% CI [0.69, 1.01]; I2= 0%; p = 0.058), gastrointestinal major bleeding (2.4% vs 1.3% respectively; OR = 1.95; 95% CI [0.65, 5.83]; I2= 80%; p = 0.231), and ischemic or unknown type of stroke (RR = 0.86; 95% CI [0.69, 1.08]; I2= 48%; p = 0.200) are not statistically different between the NAOC group and warfarin group. However, hemorrhagic stroke (RR = 0.46; 95% CI [0.30, 0.69]; I2= 24%; p < 0.001), intracranial bleeding (0.82% vs 1.8% respectively; OR = 0.41; 95% CI [0.25, 0.66]; I2= 43%; p < 0.001), major bleeding (RR = 0.83; 95% CI [0.71, 0.98]; I2= 9%; p = 0.025), overall stroke (RR = 0.72; 95% CI [0.58, 0.89]; I2= 44%; p = 0.002) and stroke or systemic embolism (4.3% vs 5.0% respectively; OR = 0.84; 95% CI [0.73, 0.97]; I2= 0%; p = 0.015) are significantly reduced in the NAOC group compared to the warfarin group.Conclusion:In patients with atrial fibrillation and previous stroke or transient ischemic attack, treatment with NOAC did not show any significant difference compared with warfarin for outcomes of death from any cause, cardiovascular death, disabling or fatal stroke, and gastrointestinal major bleeding. NOAC reduces the risk of hemorrhagic stroke, intracranial bleeding, major bleeding, and overall stroke compared to warfarin.

Stroke, Volume 56, Issue Suppl_1, Page ATP13-ATP13, February 1, 2025. Background:Atrial fibrillation (AF) patients carry a high risk of stroke, and treatment related bleeding complications. Evidence for the safety and efficacy of anticoagulation remains sparse with conflicting results.Objective:We sought to investigate the effectiveness and safety of direct oral anticoagulant (DOAC) versus warfarin in atrial fibrillation patients.Methods:We performed a systematic literature search on PubMed, EMBASE, and ClinicalTrials.gov for relevant randomized controlled trials (RCTs) from inspection until July 30th, 2024, without any language restrictions. Odds ratios (OR) and 95% confidence intervals (CI) were pooled using a random-effect model, and a p-value of

This study assessed whether electric fans limit core temperature increases in adults aged 65 to 85 years exposed to conditions similar to those experienced in homes during heat waves in North America.

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 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 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

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»