non-vitaminK Anticoagulants Research Articles

One-Day Interruption of NOAC Is Associated with Low Risk of Periprocedural Adverse Events during Pulmonary Vein Isolation If Combined with Left Atrial Thrombus Exclusion with Computed Tomography.

Safety, efficacy, and patient comfort are the expectations during pulmonary vein isolation (PVI). We aimed to validate the combined advantages of pre- and periprocedural anticoagulation with non-vitamin K anticoagulants (NOACs) and rigorous left atrial appendage thrombus (LAAT) exclusion with computed tomography (CT). This study included a population of consecutive patients, between March 2018 and June 2020, who underwent cardiac CT within 24 h before PVI to guide the ablation and rule out LAAT. NOAC was omitted 24 h before the ablation. A total of 187 patients (63% male) underwent CT before PVI. None of the patients experienced stroke during or after the procedure. The complication rate was low, with no thromboembolic events and 2.1% of patients experiencing a major bleeding event. Omitting NOAC 24 h before the ablation might be safe if combined with left atrial thrombus exclusion with computed tomography.

Nonprocedural bleeding after left atrial appendage closure versus direct oral anticoagulants: A subanalysis of the randomized PRAGUE-17 trial.

Observational studies have shown low bleeding rates in patients with atrial fibrillation (AF) treated by left atrial appendage closure (LAAC); however, data from randomized studies are lacking. This study compared bleeding events among patients with AF treated by LAAC and nonvitamin K anticoagulants (NOAC). The Prague-17 trial was a prospective, multicenter, randomized trial that compared LAAC to NOAC in high-risk AF patients. The primary endpoint was a composite of a cardioembolic event, cardiovascular death, and major and clinically relevant nonmajor bleeding (CRNMB) defined according to the International Society on Thrombosis and Hemostasis (ISTH). The trial enrolled 402 patients (201 per arm), and the median follow-up was 3.5 (IQR 2.6-4.2) years. Bleeding occurred in 24 patients (29 events) and 32 patients (40 events) in the LAAC and NOAC groups, respectively. Six of the LAAC bleeding events were procedure/device-related. In the primary intention-to-treat analysis, LAAC was associated with similar rates of ISTH major or CRNMB (sHR 0.75, 95% CI 0.44-1.27, p = 0.28), but with a reduction in nonprocedural major or CRNMB (sHR 0.55, 95% CI 0.31-0.97, p = 0.039). This reduction for nonprocedural bleeding with LAAC was mainly driven by a reduced rate of CRNMB (sHR for major bleeding 0.69, 95% CI 0.34-1.39, p = .30; sHR for CRNMB 0.43, 95% CI 0.18-1.03, p = 0.059). History of bleeding was a predictor of bleeding during follow-up. Gastrointestinal bleeding was the most common bleeding site in both groups. During the 4-year follow-up, LAAC was associated with less nonprocedural bleeding. The reduction is mainly driven by a decrease in CRNMB.

RWD1 Risk of Bleeding When Concomitantly Exposed to Non-Vitamin K Anticoagulants and Other Medications

Non-vitamin K anticoagulants (NVKA) are replacing vitamin K anticoagulants due to simplified dosing and monitoring. However, patients on NVKAs are not exempt from bleeding risk. Potential NVKA drug interactions have been scarcely studied. The purpose of this study was to estimate the risk of bleeding in patients on NVKA and potentially interacting drugs.

A comparison of postoperative complications following cardiac implantable electronic device procedures in patients treated with antithrombotic drugs.

The incidence of postoperative complications following cardiac implantable electronic device (CIED) procedures in patients treated with antithrombotic drugs has not been studied sufficiently. Here we present a comparison of complications after CIED implantations. Using an observational study design, the study included 1807 patients with a taking antiplatelet drugs (n: 1601), nonvitamin K anticoagulants (NOAC) (n: 136), and warfarin (n: 70) undergoing CIED surgery. Primary endpoint was accepted as cumulative events including composite of clinically significant hematoma (CSH), pericardial effusion or tamponade, pneumothorax, and infection related to device system. Secondary outcomes included each compenent of cumulative events. Multivariable analysis was performed to identify predictors of cumulative events. The overall cumulative event rate was 3.7% (67 of 1807). Cumulative events occured 3.1% (50 of 1601) in the antiplatelet, 5.1% (7 of 136) NOAC, and 14.3% (10 of 70) warfarin groups (p<0.001). CSH occurred in 2 of 70 patients (2.9%) in the warfarin group, as compared with 5 of 1601 (0.3%) in the antiplatelet group (p: 0.032). However, no significant differences were found between NOAC and warfarin groups in terms of CSH (0.7%vs. 2.9% respectively, p: 0.267). Warfarin treatment was an independent predictor of cumulative events and increased 2.9-fold the risk of cumulative events. Major surgical complications were rare and did not differ significantly between the study groups. The incidence and severity of complications may be lower in patients treated with periprocedurally antiplatelet or NOAC therapy when compared with warfarin therapy. Further randomized control studies are required to confirm our findings.

The effect of left atrial appendage closure on heart failure biomarkers: A PRAGUE-17 trial subanalysis.

The randomized PRAGUE-17 trial demonstrated noninferiority of left atrial appendage closure (LAAC) to non-vitamin K anticoagulants (NOACs) for the prevention of major cardiovascular or cerebrovascular events. However, the left atrial appendage is an important source of natriuretic peptides and plays a role in left atrial reservoir function. Changes of heart failure (HF) biomarkers after LAAC compared to NOAC has not been studied. The aim of the study was to compare the changes in concentrations of HF biomarkers between LAAC and NOAC patients. Of 402 patients randomized in the PRAGUE-17 trial, biomarkers were analyzed in 144 patients (73 in the NOAC and 71 in the LAAC group). Both groups had similar baseline characteristics. Serum concentration of NT-proBNP, NT-proANP, Galectin-3, and GDF-15 were measured at baseline (before the procedure in the LAAC group), at the 6-month (and at 24-month for NT-proBNP) follow-up timepoint. There were no significant differences in baseline, 6 month, and delta (δ = baseline - 6 month) concentrations of NT-proANP between the groups (NOAC: baseline 2.6 [0.5; 4.9], 6-month 3.1 [1.8; 4.8], p = .068; LAAC: baseline 3.3 [1.1; 4.6], 6-month 2.6 [0.9; 5.3], p = .51; p value for δ in concentrations between groups = 0.42). Similarly, there were no significant differences in baseline, 6, 24 months, and delta concentrations of NT-proBNP between the groups (NOAC: baseline 461.0 [113.5; 1342.0], 6 month 440.0 [120.5; 1291.5], 24 month 798 [274; 2236], p = .39; LAAC: baseline 421.0 [100.0; 1320.0], 6 month 601.0 [145.0; 1230.0], 24 month 855 [410; 1367], p = .28; p value for δ in concentrations between groups = 0.73 at 6 months, and 0.58 at 24 months). Finally, no significant differences were present in baseline, 6 month, and δ concentrations of Galectin-3 and GDF-15 between the two groups. LAAC did not significantly influence the levels of HF biomarkers 6 months after the procedure.

Comparison between the incidence of intracranial haemorrhage in patients with atrial fibrillation treated with different types of oral anticoagulants

Background and Aims: Although Warfarin is more effective than aspirin in ischemic stroke prevention in patients at risk for ischemic stroke, however, it is associated with a high risk of intracranial haemorrhage (ICH). With the appearance of non-vitamin K anticoagulants (NOACs), there was a significant decrease in the incidence of ICH compared to warfarin in Atrial fibrilation (AF) patients.

Risk and incidence of intracranial hemorrhage associated with oral anticoagulant therapy in patients with atrial fibrillation

Background and Aims: Although Vitamin K Antagonists (VKA) more effective than aspirin in preventing ischemic stroke in patients at risk for ischemic stroke, VKA associated with a higher risk of intracranial hemorrhage (ICH). With the appearance of non-vitamin K anticoagulants (NOACs), there was a significant decrease in the incidence of ICH in comparison to VKAs in patients with AF.

Abstract P415: Is Hemostatic Efficacy of Four Factor Prothrombin Complex Concentrate Similar in Intracerebral Hemorrhage Patients Receiving Warfarin vs Non-Vitamin K Anticoagulants?

Introduction: Four Factor Prothrombin Complex Concentrate (4F-PCC) is indicated for reversal of warfarin-induced coagulopathy. In small cohort studies, 4F-PCC has similar hemostatic efficacy rates reversing non-vitamin K anticoagulants (NOACs). There are no comparison studies evaluating 4F-PCC for the reversal of warfarin versus NOACs in the setting of intracerebral hemorrhage (ICH). Methods: A multicenter retrospective cohort study was conducted between 2013-2020 at a comprehensive stroke system in ICH patients who received 4F-PCC for the reversal of warfarin or a NOAC. Patients were included if they were adults with an acute ICH, anticoagulant regimen of warfarin (INR 1.3 or greater) or NOAC, and 2 head CT scans within 24 hours to determine hemostatic efficacy. Hemostatic efficacy was evaluated by the Sarode scale. The chi square and t-test were used as appropriate for demographic and clinical data, with multivariable regression analysis conducted in a forward stepwise manner, retaining variables with significance less than 0.05. Results: One hundred fifty-seven patients were included (baseline characteristics in Table 1). There was no statistically significant difference in effective hemostasis observed between warfarin and NOAC patients (83% vs 75%, p=0.33). Similarly, multivariable analysis did not demonstrate a significant difference in effective hemostasis (OR 0.55, 95% CI: 0.2-1.3, p=0.2). However, due to wide 95% confidence intervals, we cannot exclude a key treatment effect from PCC. After controlling for baseline characteristics, patients treated with NOACs had 53% lower odds of a good clinical outcome compared to those treated with warfarin (Figure 1; OR 0.47, 95% CI: 0.2-1.3, p=0.13). Conclusions: In conclusion, there was no statistically significant difference in hemostatic efficacy or clinical outcomes between warfarin and NOAC patients following reversal with 4F-PCC.

Satisfaction of Patients with Nonvitamin K Anticoagulants Compared to Vitamin K Antagonists: a Systematic Review and Meta-analysis.

To undertake a systematic review and meta-analysis to assess the satisfaction of patients receiving nonvitamin K anticoagulants (NOACs), compared with vitamin K antagonists (VKAs). We searched CENTRAL, MEDLINE, Embase, and Clinicaltrials.gov for randomized controlled trials (RCTs) and observational studies. Two reviewers screened, extracted, and appraised data independently. We pooled data using a random-effects model. Outcome included treatment satisfaction, which was assessed by scores of Duke Anticoagulation Satisfaction Scale (DASS), Anticlot Treatment Scale (ACTS), Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2), or Treatment Satisfaction Questionnaire for Medication version II (TSQM-VII) and their domains reported with 95% confidence intervals (95% CIs). We followed MOOSE and PRISMA guidelines. We included four RCTs and 16 observational studies, enrolling 18,684 participants overall. Compared with VKAs, treatment with NOACs improved the ACTS Burdens score by 4.21 points (95% CI: 2.99-5.43, I 2 = 95%, combined n = 6,180), and ACTS Benefits by 0.49 points (95% CI: 0.18-0.81, I 2 = 85%, combined n = 6,171). Switching from VKAs to NOACs improved the ACTS Burdens score by 5.33 points (95% CI: 3.53-7.14, combined n = 3,097). Compared with VKAs, treatment with NOACs improved the TSQM-VII Global Satisfaction score by 6.86 points (95% CI: 3.00-10.73, combined n = 5,535). In patients with nonvalvular atrial fibrillation or venous thromboembolism, NOAC treatment is associated with greater satisfaction compared with VKAs. The switch from VKAs to NOACs was associated with improved patients' satisfaction. These effects were largely due to a lower degree of treatment burden with NOAC treatment.

Drug Consumption of Antibiotics and Anticoagulant Agents from Ecological and Longitudinal Perspectives – Recent Possibilities and Role of drug Consumption Studies in the Czech Republic

Drug consumption studies are part of important signal detecting descriptive pharmacoepidemiological studies. The possible sources of data for this kind of studies in the Czech Republic are: 1/database of State institute of drug control (reports from wholesalers) (since 1980). These databases allowed running ecological studies until 1989 due to monopoly of only one wholesaler “Zdravotnicke zasobovani” with its district subdivisions. 2/ databases of health assurance companies are running since 1996. 3/ database of aggregated data from insurance companies at Institute of Health Informatics and Statistics (UZIS) –– is running since 2000. Focus on antibiotics can help to analyze prescription and consumption antibiotics in longitudinal and ecological studies and can be used in forming of antibiotic policy. We have no access to data relating to link between the antibiotic consumption and diagnosis. Focus on recently authorized drugs as non-vitamin K anticoagulants (NOAC) can give us information about their exposure rate to analyze prescription behavior. We also can calculate reporting rate of adverse drug reaction and asses the effectivity of pharmacovigilance system. Aim of our research is To provide national longitudinal studies of antibiotics and NOAC and to compare them with consumption of antibiotics in Austria and the Netherlands. Database of SUKL, consumption of medicines with ATC code B1AA, B1AB (except of B1AB11), B1AE, B1AF, B1AX. Databases of UZIS was used to consumption of antibiotics (ATC code J01) in ambulatory health care (DDD/1000 insured/day (DID)). The rate of NOAC consumption in was 2016 20% of all anticoagulant agents. Total antibiotic consumption in Czech Republic in 2015 was 19,2 DID and in Austria and The Netherlands 14,1; 10,7DID respectively.

Real world persistence, adherence and switch-over across anticoagulants in atrial fibrillation-a national population-based study.

ABSTRACTBackgroundThe choice of oral anticoagulant(OAC) for stroke prevention in patients with atrial fibrillation(AF) is now between warfarin and four non-vitamin K anticoagulants(NOACs):dabigatran, rivaroxaban, apixaban and edoxaban. Although discontinuation rates were reported in clinical trials of the NOACs, real-world persistence, adherence and cross-over between therapies are unknown.&#x0D; MethodsPrescription data for OACs in adults with AF between April 2011 and December 2015 were analysed from a representative national primary care database in England(The Health Improvement Network, THIN). Edoxaban was approved for use in the UK in September 2015 and therefore insufficient numbers of prescriptions were available for analysis. Persistence(estimated by gap between prescriptions) and adherence(proportion of days covered, PDC) for OACs were assessed in individuals with AF newly treated with dabigatran, rivaroxaban, apixaban or warfarin with at least 365 days follow-up after the prescription date. For each NOAC, the proportion of cross-over to another OAC was analysed.&#x0D; ResultsAmong 4,354,740 individuals, 118,056 with AF were identified, of which 82,795 had available prescription data for OACs. Of these patients, 78,447 had at least 12 months data: warfarin (n=67781), dabigatran (n=2540), rivaroxaban (n=5666) and apixaban (n=2460). At 1 year, the crude persistence rates were 88.7% (95% CI 88.4-88.9) for warfarin, 59.1% (57.2-61.0) for dabigatran, 64.7% (63.4-65.9) for rivaroxaban and 67.0% (65.1-68.9) for apixaban. Persistence was significantly lower than in the clinical trials and was lower for NOACs than warfarin.&#x0D; The adherence rates (PDC&gt;80%) were 87.5% (CI 87.3,87.6) for warfarin, 83.5% (CI 82.3,84.8) for dabigatran, 84.1% (CI 83.1,85.1) for rivaroxaban and 83.6% (CI 81.6,85.5) for apixaban. The proportion of NOAC users crossing over to another NOAC and to warfarin were 12.1% and 7.3% for dabigatran, 3.4% and 3.4% for rivaroxaban, and 1.9% and 1.5% for apixaban respectively.&#x0D; ConclusionsIn a large English population, NOACs exhibited lower persistence rates than in clinical trials, warranting further analyses of side effect profile and acceptability of OACs. Routinely collected data can be used to measure real-world persistence and adherence which are important in future studies of comparative effectiveness.