Patient-Reported Outcomes Using Win Ratio Analysis: A Post Hoc Analysis from the Randomized ENVISAGE-TAVI AF Trial.

To examine the risk of arterial thromboembolism, bleeding, and all-cause mortality in atrial fibrillation (AF) patients treated with direct oral anticoagulants (DOACs) vs. vitamin K antagonists (VKAs) undergoing transcatheter aortic valve implantation (TAVI). In this nationwide observational cohort study, 735 patients undergoing TAVI from 1 January 2012 to 30 June 2017 with a history of AF and who were treated with oral anticoagulants were identified using data from Danish nationwide registries. Of these, 219 (29.8%) and 516 (70.2%) patients were treated with DOACs and VKAs, respectively. The DOAC group was characterized by a higher prevalence of previous arterial thromboembolism and a lower prevalence of chronic kidney disease compared with the VKA group. The distribution of age, sex, CHA2DS2-VASc and HAS-BLED scores, and concomitant antiplatelet therapy was similar between groups. Compared with VKA, treatment with DOACs was not associated with a significantly different 3-year absolute risk of arterial thromboembolism [9.6% (95% confidence interval, CI 4.7-16.5%) vs. 7.4% (95% CI 4.9-10.5%) in the DOAC and VKA group, respectively], bleeding [14.3% (95% CI 7.6-22.9%) vs. 13.3% (95% CI 9.9-17.1%)], or all-cause mortality [32.7% (95% CI 21.8-44.0%) vs. 32.0% (95% CI 26.8-37.3%)]. In adjusted analyses, treatment with DOACs, when compared with VKAs, was not associated with a significantly different rate of arterial thromboembolism [hazard ratio (HR) 1.23 (95% CI 0.58-2.59)], bleeding [HR 1.14 (95% CI 0.63-2.06)], or all-cause mortality [HR 0.93 (95% CI 0.61-1.40)]. In patients with AF undergoing TAVI, treatment with DOACs was not associated with a significantly different risk of arterial thromboembolism, bleeding, or all-cause mortality compared with VKA.

Clinical Benefit of Direct Oral Anticoagulants Versus Vitamin K Antagonists in Patients with Atrial Fibrillation and Bioprosthetic Heart Valves

Safety and efficacy of direct oral anticoagulants versus vitamin K antagonists in atrial fibrillation electrical cardioversion: An update systematic review and meta-analysis

Direct oral anticoagulants versus vitamin K antagonists in real-world patients with nonvalvular atrial fibrillation. The FANTASIIA study.

Findings of prior studies about the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) in patients (≥80 years of age) with atrial fibrillation (AF) are controversial. So we performed a meta-analysis to evaluate the efficacy and safety of NOACs versus vitamin K antagonists (VKAs) in patients (≥80 years of age) with AF. A systematic review of PubMed, Cochrane, Embase, Web of Science and Chinese BioMedical databases was conducted until 1 October 2022. Studies reporting the effects and safety of NOACs versus warfarin in patients (≥80 years of age) with AF were included. Two authors independently performed study selection and data extraction. Discrepancies were resolved by consensus or through an independent third reviewer. Data were synthesised according to the Preferred Reporting Items for Systematic Reviews guidelines. We identified 15 studies providing data of 70 446 participants (≥80 years of age) suffering from AF. According to the meta-analysis (odds ratio (OR) (95% confidence interval, CI)), NOACs conferred better efficacy profile than VKAs in stroke and systemic embolism (0.8 (0.73-0.88)) and all-cause mortality (0.61 (0.57-0.65)). Otherwise, NOACs conferred a better safety profile than VKAs in major bleeding (0.76 (0.70-0.83)) and intracranial haemorrhage (ICH; 0.57 (0.47-0.68)). In conclusion, for patients (≥80 years of age) with AF, the risks of stroke and systemic embolism, all-cause mortality, were lower in NOACs compared to warfarin. The risks of major bleeding and ICH were also lower in NOACs compared to warfarin. NOACs showed better efficacy and safety than warfarin.

Randomized controlled trials (RCTs) comparing the efficacy and safety of direct oral anticoagulants (DOACs) versus Vitamin K antagonists (VKAs) in patients with thrombotic antiphospholipid syndrome (APS) have yielded inconsistent results, partly due to the inherent challenges of conducting RCTs in populations with rare medical conditions. We conducted a systematic review and meta-analysis to evaluate the comparative effects of DOACs versus VKAs in thrombotic APS. RCTs and observational studies comparing DOACs versus VKAs in patients with thrombotic APS were included. The primary endpoint was a composite of arterial (ATE) and venous thrombotic events (VTE). Incidence rate ratios (IRRs) and associated 95 % confidence intervals (CI) were used to account for different follow-up durations. GRADE was used for rating the certainty of evidence. Twelve studies, four randomized and eight observational, encompassing a total of 1307 APS patients were included. The use of DOACs was associated with an increase in the primary endpoint (IRR 2.33; 95 % CI 1.18-4.58; GRADE=moderate) driven by increased ATE (IRR 2.70; 95 % CI 1.42-5.13; GRADE=low), compared with the use of VKA. VTE (IRR 0.98; 95 % CI 0.59-1.64; GRADE=low), major (IRR 0.83; 95 % CI 0.48-1.43; GRADE=low) and non-major (IRR 1.32; 95 % CI 0.81-2.14; GRADE=very low) bleeding did not differ significantly between groups. Compared with VKAs, DOACs were associated with an increase in myocardial infarction (IRR 4.71; 95 % CI 1.00-22.21; GRADE=very low) and stroke (IRR 7.48; 95 % CI 1.27-44.13; GRADE=very low). The increased risk of arterial thrombotic events with DOACs was consistently observed in a dedicated analysis of RCTs and was mitigated by the concomitant use of single antiplatelet therapy. In patients with thrombotic APS, the use of DOACs is associated with increased thrombotic events compared with VKAs, mainly driven by arterial thrombotic events. A single antiplatelet therapy combined with DOACs maight offer a promising alternative to VKAs, warranting further dedicated investigations. The study was not funded. This study is registered in PROSPERO (CRD42024582033).

PCV79 - REAL-WORLD COST-EFFECTIVENESS OF RIVAROXABAN COMPARED WITH VITAMIN K ANTAGONISTS IN THE CONTEXT OF STROKE PREVENTION IN ATRIAL FIBRILLATION IN FRANCE

Catheter ablation (CA) of atrial fibrillation (AF) is an important rhythm control strategy for patients with drug-refractory AF. We aimed to perform an updated meta-analysis of direct oral anticoagulants (DOACs) vs vitamin K antagonists (VKAs) as uninterrupted anticoagulation in patients undergoing AF ablation to assess safety and efficacy of DOAC, after the publication of recent data on edoxaban in CA of AF. We performed a meta-analysis of RCTs enrolling patients undergoing AF ablation. We assessed Mantel-Haenszel pooled estimates of risk ratios (RRs) and 95% CIs for thromboembolic events, major bleeding (MB), and non-major bleeding (NMB). A total of 2118 patients have been included in the analysis. Compared with patients receiving VKA, patients receiving DOACs had a lower, although non-significant, risk of thromboembolic events (RR, 0.40; 95% CI, 0.09-1.76; P = 0.23). MB rates in patients treated with DOACs were statistically significantly lower than VKA (RR, 0.61; 95% CI, 0.39-0.93, P = 0.02). The incidence of NMB was not significantly different (RR, 0.98; 95% CI, 0.83-1.57, p n.s.). In a meta-analysis of RCTs, an uninterrupted DOACs strategy for CA of AF appears to be superior to uninterrupted VKA in terms of safety; a non-significant trend favoring DOACs in terms of efficacy is also evident.

Patients with atrial fibrillation (AF) are at an approximately 0.5% to 3% increased risk of thromboembolism during and immediately after catheter ablation. Treatment guidelines recommend periprocedural oral anticoagulation plus unfractionated heparin during ablation. Rivaroxaban and dabigatran are the only non-vitamin K oral anticoagulants for which there are randomized controlled trials assessing uninterrupted anticoagulation in patients undergoing catheter ablation of AF. Edoxaban, a direct factor Xa inhibitor, is noninferior vs warfarin for the prevention of stroke or systemic embolism with less major bleeding in patients with nonvalvular AF. The ELIMINATE-AF (Evaluation of Edoxaban Compared With VKA in Subjects Undergoing Catheter Ablation of Nonvalvular Atrial Fibrillation) trial is a multinational, multicenter, prospective, randomized, open-label, parallel-group, blinded-endpoint evaluation (PROBE) study to assess the safety and efficacy of once-daily edoxaban 60 mg (30 mg in patients indicated for a dose reduction) vs vitamin K antagonists (VKA) in patients with nonvalvular AF undergoing catheter ablation (http://www.ClinicalTrials.gov: NCT02942576). A total of 560 patients are planned for randomization to edoxaban or VKA (2:1 ratio) to obtain 450 patients fully compliant with the protocol. Patients will complete 21 to 28 days of anticoagulation prior to the ablation and a 90-day post-ablation period. The primary efficacy endpoint is the composite of all-cause death, stroke, and major bleeding. The primary safety endpoint is major bleeding. A magnetic resonance imaging substudy will assess the incidence of silent cerebral lesions post-ablation. ELIMINATE-AF will define the efficacy and safety of edoxaban for uninterrupted oral anticoagulation during catheter ablation of AF.

The objective of the study is mentioned, but it could be further clarified by explicitly stating the aim to compare the effectiveness and safety of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) specifically in patients with atrial fibrillation (AF) and end-stage renal disease (ESRD).We conducted a thorough electronic search of the literature, encompassing databases such as PubMed, EMBASE, Cochrane Library, and Web of Science from their inception up to March 5, 2024. Furthermore, we meticulously examined the bibliographies of included studies to identify additional relevant literature. The reporting of this meta-analysis adhered to the guidelines outlined in the Preferred Reporting of Systematic Review and Meta-analysisguidelines. The endpoints evaluated in this meta-analysis included all-cause mortality, stroke or systemic embolism, and major bleeding. Data analysis was carried out utilizing RevMan Version 5.4 (Cochrane, London, United Kingdom). Dichotomous outcomes, including all-cause mortality, stroke or systemic embolism, and major bleeding, were presented as risk ratios (RRs) with corresponding 95% confidence intervals (CI). A total of 11 studies were incorporated in this meta-analysis, comprising a pooled sample size of 44,863 participants with AF. The pooled analysis revealed no significant disparity between DOACs and VKAs concerning stroke or systemic embolism (RR: 0.93, 95% CI: 0.77 to 1.14) and all-cause mortality (RR: 0.86, 95% CI: 0.74 to 1.00). However, there was a noteworthy reduction in the risk of major bleeding events associated with DOACs compared to VKAs (RR: 0.84, 95% CI: 0.73 to 0.96). Consequently, DOACs may be considered a viable alternative to warfarin in patients with ESRD. However, we need further larger clinical trials to validate these findings.

Objective To systematically evaluate the effect and safety of uninterrupted non-vitamin K antagonist oral anticoagulants (NOACs) versus vitamin K antagonist(VKA) for ablation of atrial fibrillation. Methods Databases including PubMed, EMbase, The Cochrane Library (Issue 12, 2016), WanFang Data, CBM, CNKI were searched to collect the studies about NOACs versus VKA for ablation of atrial fibrillation from inception to December 2016.The meta-analysis was conducted using RevMan 5.3 software. Results A total of 9 studies involving 4 189 patients were included. The results of meta-analysis showed that thrombo-embolism(OR=1.68, 95%CI 0.51-5.49, P=0.39), transient ischemic attack/stroke(OR=1.26, 95%CI 0.43-3.69, P=0.67), massive hemorrhage(OR=0.76, 95%CI 0.41-1.42, P=0.39), mild bleeding(OR=0.89, 95%CI 0.68-1.17, P=0.40) cardiac tamponade(OR=1.68, 95%CI 0.51-5.49, P=0.39), subcutaneous hematoma(OR=1.00, 95%CI 0.72-1.40, P=0.98), there was no significant difference in effect and safety between group oral anticoagulants and group VKA. Conclusion Current studies suggested that uninterrupted NOACs were beneficial in terms of treatment and safety.Due to the limited region of the included studies, the above conclusion, especially in China, still need more high quality research to be verified. Key words: Anticoagulants; Atrial fibrillation; Meta analysis

BackgroundFive-year data from the PARTNER 3 trial showed that among low-risk patients with severe, symptomatic aortic stenosis, outcomes were similar among patients who had undergone transcatheter aortic-valve replacement (TAVR) and those who had undergone surgical aortic-valve replacement. Longer-term assessments of clinical outcomes and valve durability are needed.MethodsPatients were randomly assigned in a 1:1 ratio to undergo transfemoral TAVR or surgery. The first primary end point was a nonhierarchical composite of death, stroke, or rehospitalization related to the procedure, the valve, or heart failure. The second primary end point was a hierarchical composite of death, disabling stroke, nondisabling stroke, and the number of rehospitalization days related to the procedure, the valve, or heart failure, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, valve-durability, and health-status end points were assessed through 7 years.ResultsA total of 1000 patients underwent randomization. In the analysis of the first primary end point, the Kaplan–Meier estimate of the incidence of an end-point event was 34.6% with TAVR and 37.2% with surgery (difference, −2.6 percentage points; 95% confidence interval [CI], −9.0 to 3.7). The win ratio for the second primary end point was 1.04 (95% CI, 0.84 to 1.30). In the TAVR and surgery groups, respectively, the Kaplan–Meier estimates for the incidence of components of the first primary end point were as follows: death, 19.5% and 16.8%; stroke, 8.5% and 8.1%; and rehospitalization, 20.6% and 23.5%. The mean (±SD) aortic-valve gradients assessed by echocardiography at 7 years were 13.1±8.5 mm Hg after TAVR and 12.1±6.3 mm Hg after surgery. The percentage of bioprosthetic valves that failed was 6.9% in the TAVR group and 7.5% in the surgery group. Patient-reported outcomes were similar in the two groups.ConclusionsAmong low-risk patients with severe, symptomatic aortic stenosis, no significant differences with respect to two primary composite end points involving death, stroke, and rehospitalization were observed at 7 years between those who had undergone TAVR and those who had undergone surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.)

BackgroundAtrial fibrillation (AF) and low body weight (BW, <60 kg) are common in patients with heart failure (HF). However, the safety and effectiveness of direct oral anticoagulants (DOACs) in this group remain unclear. This study compares the efficacy and safety of apixaban versus vitamin K antagonists (VKAs) in patients with nonvalvular AF, low BW and HF.MethodsWe analysed 155,152 patients with HF and AF, weighing ≤100 kg and treated with oral anticoagulants (apixaban 86,493; VKA 68,659), from the TriNetX Global Research Network. Outcomes included ischaemic stroke/systemic embolism (SEE), clinically relevant bleedings, intracranial haemorrhage (ICH), all‐cause death and net clinical benefit (composite of stroke/SEE, bleedings and all‐cause death) across three BW categories: 60–100 kg (reference), 50–60 kg (low BW) and ≤50 kg (very low BW). Propensity score matching was used to balance the treatment groups.ResultsPatients with low BW had a higher risk of adverse events compared to those with reference BW, regardless of treatment. Apixaban consistently reduced the risk of ischaemic stroke/SEE and bleeding (including ICH) across all BW ranges (all p‐interaction >.10), and improved net clinical benefit compared to VKA (reference BW: HR .82 [95% CI: .80–.84]; low BW: HR .79 [95% CI: .74–.85]; very low BW: HR .86 [95% CI: .78–.95], p‐interaction = .366). However, a significant BW‐treatment interaction was observed for all‐cause mortality, indicating reduced relative effectiveness of apixaban vs. VKA as BW decreases.ConclusionIn this large real‐world analysis, treatment with apixaban was associated with a superior effectiveness and safety profile compared to VKA in patients with AF, HF and low BW. These results remained consistent, albeit slightly attenuated, in patients with very low BW. These findings provide preliminary evidence supporting the use of apixaban in this high‐risk population.

This meta-analysis aimed to evaluate the efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) versus vitamin K antagonists (VKAs) in secondary stroke prevention in atrial fibrillation (AF) patients. PubMed and Embase electronic databases were systematically searched from January 2009 to July 2019 for relevant randomized clinical trials and observational studies. A random-effects model was applied in the pooled analysis. A total of 14 studies (4 randomized clinical trials and 10 observational studies) were included. Based on the randomized clinical trials, compared with VKA use, the use of NOACs was associated with decreased risk of stroke and systemic embolism, major bleeding, and intracranial bleeding. Based on the observational studies, compared with VKAs, the subgroup analysis showed that dabigatran and rivaroxaban were associated with a reduced risk of stroke or systemic embolism, whereas dabigatran and apixaban were associated with a decreased risk of major bleeding. Based on current data, the use of NOACs is at least non-inferior to the use of VKAs in AF patients for secondary stroke prevention irrespective of NOAC type.

ObjectiveThe aim of this study was to investigate the association between oral anticoagulant type (direct oral anticoagulants (DOACs) vs vitamin K antagonists (VKAs)) and incident dementia or mild cognitive impairment...