Non-vitamin K Antagonist Oral Anticoagulants Therapy Research Articles

Optimal antithrombotic strategy in patients with atrial fibrillation beyond 1 year after drug-eluting stent implantation: Design and rationale of the randomized ADAPT AF-DES trial

BackgroundBoth anticoagulation and antiplatelet therapies are recommended after percutaneous coronary intervention (PCI) in patients with atrial fibrillation (AF). Although contemporary guidelines recommend discontinuation of antiplatelet therapy 1 year after drug-eluting stent (DES) implantation due to excessive bleeding risk, supporting randomized trials are still lacking. MethodsThe ADAPT AF-DES trial is a multicenter, prospective, open-label, randomized, non-inferiority trial, enrolling 960 patients with AF with a CHA2DS2-VASc score > 1, who underwent PCI with DES implantation at least 12 months before enrollment. Eligible patients are randomly assigned to receive either non-vitamin K antagonist oral anticoagulant (NOAC) monotherapy or NOAC plus clopidogrel combination therapy. The primary outcome is net adverse clinical event (NACE) at 1 year after randomization, defined as a composite of all-cause death, myocardial infarction, stent thrombosis, stroke, systemic embolism, and major or clinically relevant non-major bleeding, as defined by the International Society on Thrombosis and Hemostasis criteria. We hypothesize that NOAC monotherapy would be non-inferior to NOAC plus clopidogrel combination therapy for NACE in patients with AF beyond 12 months after DES implantation. ConclusionsThe ADAPT AF-DES trial will evaluate the efficacy and safety of NOAC monotherapy versus NOAC plus clopidogrel combination therapy in patients with AF beyond 12 months after PCI with DES implantation. The ADAPT AF-DES trial will provide robust evidence for an optimal antithrombotic strategy in patients with AF after DES implantation. Clinical trial registrationhttps://www.clinicaltrials.gov. Unique identifier: NCT04250116.

A comparison of the effects of NOAC and VKA therapy on the incidence of dementia in patients with atrial fibrillation: A systematic review and meta-analysis.

Atrial fibrillation (AF) patients are more susceptible to dementia, but the results about the effect of oral anticoagulants (OACs) on the risk of dementia are not consistent. We hypothesize that OAC is associated with a reduced risk of dementia with AF and that nonvitamin K antagonist oral anticoagulants (NOAC) are superior to vitamin K antagonists (VKA). Four databases were systematically searched until July 1, 2022. Two reviewers independently selected literature, evaluated quality, and extracted data. Data were examined using pooled hazard ratios (HRs) and 95% confidence intervals (CIs). Fourteen research studies involving 910 patients were enrolled. The findings indicated that OACs were associated with a decreased risk of dementia (pooled HR: 0.68, 95% CI: 0.55-0.82, I2 = 87.7%), and NOACs had a stronger effect than VKAs (pooled HR: 0.87, 95% CI: 0.79-0.95, I2 = 72%), especially in participants with a CHA2DS2VASc score ≥ 2 (pooled HR: 0.85, 95% CI: 0.72-0.99). Subgroup analysis demonstrated no statistical significance among patients aged <65 years old (pooled HR: 0.83, 95% CI: 0.64-1.07), patients in "based on treatment" studies (pooled HR: 0.89, 95% CI: 0.75-1.06), or people with no stroke background (pooled HR: 0.90, 95% CI: 0.71-1.15). This analysis revealed that OACs were related to the reduction of dementia incidence in AF individuals, and NOACs were better than VKAs, remarkably in people with a CHA2DS2VASc score ≥ 2. The results should be confirmed by further prospective studies, particularly in patients in "based on treatment" studies aged <65 years old with a CHA2DS2VASc score < 2 or without a stroke background.

Characteristics of Novel Anticoagulants versus Vitamin K Antagonists in the Ventricular Mural Thrombus

Background: To describe the characteristics, treatment practices, and clinical outcomes of patients with ventricular mural thrombus (VMT), with emphasis on the comparison of non-vitamin K antagonist oral anticoagulants (NOACs) and vitamin K antagonists (VKAs). Methods: We performed a retrospective cohort study between 2010 and 2019 in Fuwai Hospital, China. Patients with VMT newly treated with either NOACs or VKAs were included. The primary outcome was the incidence rate of thrombus resolution at 3 months. Results: We included 196 patients in total—68.9% (n = 135) were treated with VKAs while 31.1% (n = 61) were on NOACs. Patients with a medical history of heart failure (HF) (odds ratio (OR) 2.10, 95% confidence interval (CI) 1.17 to 3.77, p = 0.013) and a lower left ventricular ejection fraction (OR 0.36, 95% CI 0.20 to 0.65, p = 0.001) had a higher thrombus resolution. At 3 months, a significant difference was observed in the thrombus resolution between the NOACs and VKAs group with or without adjustment (OR 2.61, 95% CI 1.39 to 4.89, p = 0.003; adjusted OR 2.93, 95% CI 1.51 to 5.66, p = 0.001). Further investigation revealed that in the majority of the subgroups, individuals receiving NOAC therapy had a superior thrombus resolution than those receiving VKA therapy. Conclusions: Patients with a medical history of HF or left ventricular ejection fraction &lt;30% experienced greater effectiveness in thrombus resolution. Additionally, the resolution of VMT with NOAC treatment was considerably higher than that with VKA therapy at 3 months, with or without adjusting for baseline variables. Clinical Trial Registration: This study was registered at ClinicalTrials.gov as NCT 05006677 on August 4th, 2021.

Gastrointestinal Bleeding on Anticoagulant Therapy: Comparison of Patients Receiving Vitamin K Antagonists and Non-Vitamin K Oral Antagonists

Objectives: Prior studies comparing Gastrointestinal (GI) bleeding in patients receiving Vitamin-K Antagonists (VKA) and Non-Vitamin K Antagonist Oral Anticoagulants (NOAC) focused on the crude rate of GI bleeding and less on severity of such events. The aim of our study was to assess characteristics of GI bleeding in patients on VKA therapy versus NOAC therapy. Methods: Retrospective data was collected from patients hospitalized with GI bleeding at Hadassah University Medical Center between January 2010 and July 2017. Retrieved data included demographics, laboratory results, clinical outcomes and details regarding the bleeding characteristics, evaluation, treatment and hospitalization. Patients were divided into two groups – those receiving VKA and those receiving NOAC. Results: 514 patients who presented with GI bleeding were included. 439 patients were on VKA treatment and 75 on NOAC treatment. Atrial fibrillation was the indication for anticoagulation in 64% of VKA patients and in 91% of NOAC patients. The mean HAS-BLED score was the same in VKA and NOAC patient groups. Major bleeding events were seen in 38.3% of VKA patients and 30.7% of NOAC patients and life-threatening bleeding was seen in 34.4% of VKA patients and 26.7% of NOAC (p&lt;0.05). Packed red blood cell and fresh-frozen plasma transfusions were administered less in the NOAC patients as compared to the VKA patients. No statistically significant differences in length of hospitalization, re-bleeding, or mortality were seen between groups. Conclusions: GI bleeding events on NOAC therapy are less severe and use fewer hospital resources as compared to those treated with VKA.

How to handle a delayed or missed dose of edoxaban in patients with non-valvular atrial fibrillation? A model-informed remedial strategy.

Edoxaban is a non-vitamin K antagonist oral anticoagulant (NOAC) widely used for the long-term prevention of stroke in patients with non-valvular atrial fibrillation (NVAF). Adherence to NOAC therapy has been unsatisfactory and decreases over time. Remedial strategies are currently used to address the non-adherence events. Current recommendations, however, are generic and not well supported by evidence. The aim of this study was to explore appropriate remedial dosing regimens for non-adherent edoxaban-treated NVAF patients through Monte Carlo simulation. Six regimens were compared with the current recommendations of the European Heart Rhythm Association (EHRA) guide based on total deviation time. Both edoxaban plasma concentration and intrinsic Factor Xa activity were considered. Monte Carlo simulations were performed using RxODE based on a published population pharmacokinetic/pharmacodynamic (PK/PD) model. The proposed remedial strategies were different than the EHRA recommendations and were related to the delay time. However, it was found that the missed dose can be administered immediately if the delay time is within 11 h. When the delay is between 12 and 19 h, a half dose followed by a regular dosing schedule is recommended. When the delay time exceeds 19 h, a full dose followed by a half dose is preferred. PK/PD modelling and simulation are effective in developing and evaluating the remedial strategies of edoxaban, which can help maximise its therapeutic effect.

Bleeding risk in patients with atrial fibrillation treated with combined anti-platelet and non-vitamin K antagonist oral anticoagulant therapy.

The use of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with non-valvular atrial fibrillation (AF) has been increasing. Accordingly, the combined use of antiplatelet agents (APT) and NOAC therapy is commonly encountered in clinical practice. The purpose of this study was to compare the clinical outcomes between combination therapy (NOAC and APT) vs. monotherapy (NOAC only) in patients with AF. We retrospectively analyzed patients who were prescribed NOACs between January 2012 and December 2016. The primary outcome was major bleeding and any bleeding events, and the secondary outcomes were stroke/systemic embolic (SE) events and major adverse cardiac events (MACE). Of the 1068 participants, there were 264 (24.7%) patients in the combination therapy group. The prevalence of diabetes (p = 0.017) and history of stroke and transient ischemic attacks (p < 0.001) was higher in the combination group than in the monotherapy group. During the mean 14.6 ± 9.8 months of follow-up, the incidence of any bleeding was significantly higher in the combination therapy group than in the monotherapy group (p < 0.001). The rate of major bleeding, stroke/SE, and MACE between the two groups was similar. The rate of under-dosage NOAC prescriptions was higher in the combination therapy group than in the monotherapy group (p = 0.024). The combination therapy group had higher incidences of any bleeding events compared to the monotherapy in patients with appropriate dosing. However, there was no difference in stroke/SE, and MACE. The bleeding risk in AF patients taking the combination of NOACs and APT should be carefully evaluated.

Outcomes of left atrial appendage occlusion vs. non-vitamin K antagonist oral anticoagulants in atrial fibrillation

BackgroundThe effects of left atrial appendage (LAA) occlusion compared to non-vitamin K antagonist oral anticoagulant (NOAC) therapy in patients with atrial fibrillation (AF) remain unknown.AimsWe aimed to evaluate the outcomes in patients with AF who received LAA occlusion vs. NOAC therapy.MethodsWe utilised data from TriNetX which is a global federated health research network currently containing data for 88.5 million patients. ICD-10 codes were employed to identify AF patients treated with either LAA occlusion or NOAC between 1st December 2010 and 17th January 2019. Clinical outcomes of interest were analysed up to 2 years.Results108,697 patients were included. Patients who underwent LAA occlusion were younger, more likely to be white Caucasian and male, had a greater incidence of comorbidities, and were less likely to be prescribed other cardiovascular medications. Using propensity score matching, the risk of all-cause mortality was significantly lower among patients who received LAA occlusion compared to NOAC therapy [1.51% vs. 5.60%, RR 0.27 (95% CI 0.14–0.54)], but there were no statistical differences in the composite thrombotic or thromboembolic events [8.17% vs. 7.72%, RR 1.06 (95% CI 0.73–1.53)], ischaemic stroke or TIA [4.69% vs. 5.45%, RR 0.86 (95% CI 0.54–1.38)], venous thromboembolism [1.66% vs. 1.51%, RR 1.10 (95% CI 0.47–2.57)] and intracranial haemorrhage [1.51% vs. 1.51%, RR 1.00 (95% CI 0.42–2.39)].ConclusionOverall, LAA occlusion might be a suitable alternative to NOAC therapy for stroke prevention in patients with AF.Graphical abstract

Assessment of Knowledge Regarding Risks and Benefits of the Use of Non-Vitamin K Antagonist Oral Anticoagulants.

Background:Non-vitamin K antagonist oral anticoagulants (NOAC) have replaced vitamin K antagonist (VKA) oral anticoagulants as the first-line treatment option for stroke prevention in high-risk patients with atrial fibrillation. With VKA therapy, disease and treatment-related knowledge is associated with improved adherence and outcomes. There is concern that due to the lack of need for ongoing visits for laboratory monitoring in patients on NOACs, there is less opportunity for education, leading to poor disease- and treatment-related knowledge in this patient group.Methods:One hundred ninety-nine (199) patients presenting to 2 primary care clinics on NOAC therapy were surveyed regarding atrial fibrillation and their knowledge regarding NOACs. Chart review was completed to determine patient characteristics and data obtained was compared with survey results to determine the accuracy of the survey responses.Results:Patients with a lower degree of NOAC knowledge tended to be older (P < .001), have higher Charlson Comorbidity Index scores (P = .001), use apixaban more often (P = .008), and have been on NOACs for a shorter time period (P = .007).Conclusions:There is an opportunity to improve NOAC-related knowledge in patients with atrial fibrillation. When developing educational interventions, patient characteristics associated with poor knowledge should be considered. Based on our results, these are patients who are older, more medically complex, are on apixaban, and have been on NOAC therapy for a shorter duration.

Bleeding risk in patients with atrial fibrillation treated with combined anti-platelet and NOAC therapy

Abstract Background The combined use of antiplatelet agents (APT) and non-vitamin K antagonist oral anticoagulants (NOACs) in patient with atrial fibrillation (AF) is commonly encountered in clinical practice. The purpose of this study was to compare the clinical outcomes between combination therapy (NOAC and APT) and monotherapy (NOAC only). Methods and results We analyzed patients who were prescribed NOACs between January 2012 and December 2016. The primary outcome was major or any bleeding events and the secondary outcomes were stroke/systemic embolism (SE) and major adverse cardiac events (MACE). Of 1,068 participants, there were 264 (24.7%) patients in the combination group. The prevalence of diabetes (p=0.017) and history of stroke and transient ischemic attacks (p&amp;lt;0.001) was higher in the combination group than in the monotherapy group. During the mean 14.6±9.8 months of follow-up, the incidence of any bleeding was significantly higher in the combination group than in the monotherapy group (p&amp;lt;0.001). Major bleeding, stroke/SE, and MACE between the two groups were similar. The rate of under-dosage NOACs prescriptions was higher in the combination group than in the monotherapy group (p=0.024). Conclusions The combination therapy had higher incidences of any bleeding events compared to the monotherapy. However, there was no difference in stroke/SE and MACE. The bleeding risk in patients taking the combination of NOACs and APT should be carefully evaluated. Funding Acknowledgement Type of funding sources: None. Figure 1. Primary and secondary outcomes

Comparative effectiveness of NOAC vs VKA in patients representing common clinical challenges: results from the GARFIELD-AF registry

Abstract Introduction Large phase III trials of non-valvular atrial fibrillation (AF) patients have shown a favourable risk-to-benefit ratio with Non-Vitamin K antagonist oral anticoagulants (NOAC) compared to Vitamin K antagonists (VKA). Although the results of these trials are directly applicable to many AF patients, important subsets of patients were under-represented. Thus, there remains uncertainty about the safety and effectiveness of NOAC therapy in common challenging scenarios. Purpose The main purpose of this study is to quantify and compare the impact of NOAC vs VKA in settings where clinical uncertainty still exists and represents a considerable proportion of AF patients in clinical practice. Methods The analysis was conducted in patients enrolled in the largest AF multinational prospective registry (the Global Anticoagulant Registry in the FIELD–Atrial Fibrillation, GARFIELD-AF). We evaluated the effectiveness and safety of NOAC compared to VKA in three groups of patients representing common clinical challenges (CCC): 1) elderly patients (i.e. age ≥75), 2) increased bleeding risk (i.e. HAS-BLED ≥3 or prior bleeding), and 3) renal impairment (i.e. CKD stages II to IV). We applied a propensity score using an overlap weighting scheme to obtain unbiased estimates of the treatment effect within each CCC group. Weights were applied to Cox proportional hazards models to estimate the effects of the NOAC vs VKA comparison on the occurrence of death, non-haemorrhagic stroke/SE and major bleeding within 2 years of enrolment. Results Comparative effectiveness of NOAC vs VKA was assessed in 8607 elderly patients, 1711 with increased bleeding risk, and 4460 with renal impairment. The proportion of anticoagulated patients was low in patients with increased bleeding risk (59%), while in the other two CCC groups the corresponding proportion was close to the one in the overall population (72%). Among anticoagulated patients, NOAC were prescribed to 50–55% of patients in the CCC groups. Patients with a high risk of bleeding and impaired kidney function were less likely to be prescribed NOAC instead of VKA compared with the overall anticoagulated population (−5.4% and −4.7%, respectively). Propensity-weighted hazard ratios for all-cause mortality favored NOAC (vs VKA) in all three CCC groups: 0.86 (95% CI: 0.74–0.99) for elderly patients, 0.73 (0.53–1.00) for patients with increased bleeding risk, and 0.80 (0.65–0.98) for patients with renal impairment (Figure). Conclusion In the selected common challenging scenarios of AF patients, there were significant mortality reductions in favor of NOACs compared to VKAs. These observations suggest that NOACs are safe and effective in patients who are elderly, at increased bleeding risk, or renally impaired. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): This study was supported by an unrestricted research grant from Bayer AG, Berlin, Germany, to TRI, London, UK, which sponsors the GARFIELD-AF registry. The work is supported by KANTOR CHARITABLE FOUNDATION for the Kantor-Kakkar Global Centre for Thrombosis Science.

Persistence and adherence to non-vitamin K antagonist oral anticoagulant treatment in patients with atrial fibrillation across five Western European countries

AimsTo assess persistence and adherence to non-vitamin K antagonist oral anticoagulant (NOAC) treatment in patients with atrial fibrillation (AF) in five Western European healthcare settings.Methods and resultsWe conducted a multi-country observational cohort study, including 559 445 AF patients initiating NOAC therapy from Stockholm (Sweden), Denmark, Scotland, Norway, and Germany between 2011 and 2018. Patients were followed from their first prescription until they switched to a vitamin K antagonist, emigrated, died, or the end of follow-up. We measured persistence and adherence over time and defined adequate adherence as medication possession rate ≥90% among persistent patients only.ResultsOverall, persistence declined to 82% after 1 year and to 63% after 5 years. When including restarters of NOAC treatment, 85% of the patients were treated with NOACs after 5 years. The proportion of patients with adequate adherence remained above 80% throughout follow-up. Persistence and adherence were similar between countries and was higher in patients starting treatment in later years. Both first year persistence and adherence were lower with dabigatran (persistence: 77%, adherence: 65%) compared with apixaban (86% and 75%) and rivaroxaban (83% and 75%) and were statistically lower after adjusting for patient characteristics. Adherence and persistence with dabigatran remained lower throughout follow-up.ConclusionPersistence and adherence were high among NOAC users in five Western European healthcare settings and increased in later years. Dabigatran use was associated with slightly lower persistence and adherence compared with apixaban and rivaroxaban.

Costs of minor bleeds in atrial fibrillation patients using a non-vitamin K antagonist oral anticoagulant

Background A very common side effect of non-vitamin K antagonist oral anticoagulant (NOAC) is (minor) bleeding. Data about impact and costs of minor bleeds in NOAC therapy is still limited or not present in current literature. In this patient orientated study, we aim to provide an estimate of the costs of minor bleeds in patients with atrial fibrillation (AF) treated with a NOAC. Methods A retrospective observational cohort study was conducted. Patients with AF and on NOAC therapy were included. Data was obtained by questionnaires and information from electronic patient records. Reference prices were used to calculate the costs per patient. Furthermore, cost of minor bleeds per patient is compared with literature-based costs of minor and major bleeding. Results 139 patients were included. A total of 94 minor bleed were reported by 71 patients. The sum of minor bleeding costs from societal perspective were €9,851.49, or on average €70,87 (95% CI €54,37– €85,68) per patient with AF. The biggest cost drivers were rectal and vaginal bleeds, epistaxis was most commonly reported. Conclusion Total costs of minor bleeds from a societal perspective, in AF patients using NOACs, are non-trivial and exceed the costs presented in existing literature.

Non Vitamin K Antagonist Oral Anticoagulants in Atrial Fibrillation Patients Scheduled for Electrical Cardioversion: A Real-Life Propensity Score Matched Study.

AimThe aim of the present study was to assess the safety and effectiveness of non-vitamin K antagonist oral anticoagulants (NOACs) versus vitamin K antagonists (VKAs) in atrial fibrillation (AF) patients undergoing electrical cardioversion (EC).MethodsA propensity score-matched analysis was performed in order to identify two homogeneous groups including AF patients on NOACs and VKAs treatment scheduled for EC. The primary safety endpoint was major bleeding. The composite of stroke, transient ischemic attack (TIA) and systemic embolism (SE) was the primary effectiveness endpoint. The discontinuation rate of anticoagulant therapy was assessed.ResultsA total of 495 AF patients on NOACs therapy and scheduled for EC were compared to 495 VKAs recipients. No statistically significant differences in the incidence of both major bleeding (1.01% versus 1.4%; P= 0.5) and thromboembolic events (0.6% versus 0.8%; P= 0.7) were observed during a mean follow-up of 15 ± 3 months. The discontinuation rate of NOACs was significantly lower compared to VKAs (1.6% versus 3.6%, P=0.04).ConclusionWe showed a safe and effective clinical profile of NOACs among AF patients scheduled for electrical cardioversion in real-life setting. Patients on NOACs therapy showed a lower discontinuation rate compared to those on VKAs.

Comparative effectiveness and safety of non-vitamin-K antagonist oral anticoagulants and warfarin in older adults with atrial fibrillation and diabetes

Objective To evaluate comparative effectiveness and safety of non-vitamin-K antagonist oral anticoagulants (NOACs) versus warfarin in Medicare beneficiaries with non-valvular atrial fibrillation (NVAF) and comorbid diabetes mellitus (DM). Methods A retrospective cohort study using 2014–2016 5% national Medicare data was undertaken. NVAF patients with DM aged ≥65 years having at least one prescription for NOACs or warfarin between July 2014 and December 2015 were included in the study. Propensity score matching was used to balance demographic and baseline clinical characteristics of patients in two treatment groups. Cardiovascular outcomes including stroke/systemic embolism (SE) and myocardial infarction (MI) were evaluated to measure effectiveness. Assessment of safety outcomes included intracranial hemorrhage (ICH), major gastrointestinal bleeding (MGB), bleeding from other sites (OB) and all-cause mortality. Stratified Cox proportional hazards models were used to estimate hazard ratios for the outcomes in the matched cohort. Results The matched sample consisted of 4582 patients (2291 pairs). Compared to warfarin, NOACs had a significantly lower risk of stroke/SE (hazard ratio (HR): 0.373, 95% confidence interval (CI): 0.247−0.564, p < .001) and all-cause mortality (HR: 0.783, CI: 0.656−0.873, p = .007). NOACs were found to significantly reduce the risk of ICH (HR: 0.500, CI: 0.300−0.834, p = .008) and OB (HR: 0.608, CI: 0.424−0.870, p = .007), but no difference was observed in the risk of MGB (HR: 0.862, CI: 0.640−1.160, p = .326) between NOACs and warfarin. The composite outcome demonstrated superior overall effectiveness and safety of NOAC therapy compared to warfarin therapy (HR: 0.685, CI: 0.587−0.801, p < .001). Conclusion Oral anticoagulation therapy with NOACs was found to be more effective than warfarin therapy among older adults with NVAF and comorbid DM.

Non–Vitamin K Antagonist Oral Anticoagulant vs Warfarin for Post Cardiac Surgery Atrial Fibrillation

BackgroundTreatment guidelines for nonvalvular atrial fibrillation (AF) recommend use of non–vitamin K antagonist oral anticoagulants (NOACs) over warfarin, yet clinical trials excluded individuals with post cardiac surgery AF. We sought to compare outcomes with NOACs vs warfarin for new onset post cardiac surgery AF. MethodsWe examined 26,522 patients from The Society of Thoracic Surgeons’ database with post cardiac surgery AF who were discharged on oral anticoagulation from July 2017–December 2018. Three primary outcomes were evaluated: 30-day mortality, major bleeding complications, and stroke/transient ischemic attack. Secondary outcomes included postoperative length of stay, 30-day myocardial infarction, venous thromboembolism, and pericardial effusion/tamponade. ResultsA total of 9769 (36.8%) participants were prescribed NOACs and 16,753 (63.2%) warfarin. In multivariable analysis, there was no association between type of anticoagulant and 30-day major bleeding complications (odds ratio [OR]NOAC/warfarin 0.76, 95% confidence interval [CI] 0.49-1.18), stroke/transient ischemic attack (ORNOAC/warfarin 0.94, 95% CI 0.53-1.67) or mortality (ORNOAC/warfarin 1.08, 95% CI 0.80-1.45). After stratification by renal function or isolated coronary bypass vs valve surgery, there remained no difference in the primary outcomes. Additionally, there was no difference in 30-day myocardial infarction (ORNOAC/warfarin 1.17, 95% CI 0.62-2.22), venous thromboembolism (ORNOAC/warfarin 0.91, 95% CI 0.47-1.78), or pericardial effusion/tamponade (ORNOAC/warfarin 1.09, 95% CI 0.80-1.47) between the 2 groups. NOAC therapy was associated with a half-day reduction in postoperative length of stay (βNOAC/warfarin –0.47, 95% CI –0.62 to –0.33). ConclusionsNOACs are associated with a reduction in postoperative length of stay, without excess bleeding or other short-term complications, compared with warfarin. These findings support the broader use of NOACs as a safe alternative to warfarin in patients with post cardiac surgery AF at elevated stroke risk and acceptable bleeding risk.

Clinical Performance of Nonvitamin K Antagonist Oral Anticoagulants in Real-World Obese Patients with Atrial Fibrillation.

The prevalence of both atrial fibrillation (AF) and obesity has steadily increased. Nonvitamin K antagonist oral anticoagulants (NOACs) have been shown to be more effective and safer than vitamin K antagonists (VKAs) for long-term stroke prevention in patients with nonvalvular AF. There are still limited data in the literature regarding performance of NOACs in obese patients with AF in the "real world." The aim of our study was to compare the safety and effectiveness of NOACs versus well-controlled VKA therapy in obese AF patients in a "real-world" setting. Here, we have considered patients with AF and obesity (body mass index [BMI] > 30 kg/m2) on NOAC or VKA therapy included in the multicenter Atrial Fibrillation Research Database (NCT03760874). The occurrence of major bleedings (MBs) and thromboembolic events (composite of ischemic stroke, transient ischemic attack, and systemic embolism) was respectively considered primary safety and effectiveness outcomes. We identified 1,047 AF patients with obesity who received NOAC (n = 272) or VKA (n = 775) treatment. After propensity score matching analysis, 248 NOAC and 496 VKA recipients with similar clinical characteristics, including BMI (34.8 ± 3.4 in NOAC vs. 35.1 ± 3.8 in the VKA group; p = 0.50), were evaluated. The mean follow-up was 39 ± 7 months. The incidence rate of thromboembolic events was 1.10 per 100 person-years (0.67 in NOAC vs. 1.28 in the VKA group; hazard ratio [HR]: 0.52; 95% confidence interval [CI]: 0.22-1.22; p = 0.19). The incidence rate of MB was 1.9 per 100 person-years (1.1 in NOAC vs. 2.28 in the VKA group; HR: 0.46; 95% CI: 0.24-0.88; p = 0.04). The incidence rate of intracranial hemorrhage was 0.4 per 100 person-years (0.27 in NOAC vs. 0.47 in the VKA group; HR: 0.57; 95% CI: 0.12-2.73; p = 0.48). A positive net clinical benefit (NCB) of NOACs over VKAs was found (+0.91). Presence of anemia (HR: 1.75; p = 0.003) and concomitant use of antiplatelet drugs (HR: 2.41; p = 0.001) were found to be independent predictors of MB; moreover, age (HR: 1.65; p = 0.003) was an independent predictor of thromboembolic events. Our data support the hypothesis of safe and effective use of NOACs in patients with AF and obesity, justified by a statistically significant lower incidence of MB and a favorable NCB over VKAs.

How cardiologists manage antithrombotic treatment of patients with atrial fibrillation undergoing percutaneous coronary stenting: the WOEST survey 2018

BackgroundAntithrombotic treatment choices are complicated when patients have both atrial fibrillation (AF) and acute coronary syndrome and/or undergo percutaneous coronary intervention (PCI). In this study, we aimed to gain insight into antithrombotic management strategies in daily clinical practice.MethodsWe invited interventional cardiologists to complete the WOEST (What is the Optimal antiplatElet & Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary StenTing) survey 2018. In this questionnaire, we presented a patient with a non-ST-elevation myocardial infarction (NSTEMI) and an elective PCI case.ResultsThe results were based on 118 completed questionnaires (response rate 69.4%). In the case of the AF patient with NSTEMI, most cardiologists indicated they would initiate dual antiplatelet therapy (acetylsalicylic acid and clopidogrel) and continue non-vitamin K antagonist oral anticoagulant (NOAC) therapy at admission and during coronary angiography/PCI. At discharge, 70.3% would prescribe triple antithrombotic therapy (oral anticoagulation, acetylsalicylic acid and clopidogrel), mostly for 1 month. One year after NSTEMI, 83.1% would cancel the antiplatelet therapy and prescribe NOAC monotherapy. For the AF patient undergoing elective PCI, 51.7% would start dual antiplatelet therapy prior to the procedure and 52.5% would discontinue NOAC therapy prior to the PCI. At discharge, 55.1% would start triple antithrombotic therapy. Furthermore, 25.4% responded they routinely prescribe a reduced dose of NOAC after discharge. One year after PCI, 89.0% would continue NOAC monotherapy.ConclusionThe WOEST survey demonstrated heterogeneity in antithrombotic management strategies among interventional cardiologists. This observed variety mirrors the heterogeneity of the many guidelines and consensus documents. Further research is needed to guide patient-tailored medicine for AF patients undergoing PCI.Electronic supplementary materialThe online version of this article (10.1007/s12471-020-01500-3) contains supplementary material, which is available to authorized users.

The Efficacy of Non-Vitamin K Antagonist Oral Anticoagulants in the Prevention of Left Atrial Thrombus in Patients With Atrial Fibrillation Compared With Vitamin K Antagonists: A Meta-Analysis.

There is still a paucity of data on the efficacy of non-vitamin K antagonist oral anticoagulants (NOACs) in the prevention of left atrial thrombus (LAT) formation before cardioversion or catheter ablation. To assess the efficacy of NOACs in the prevention of LAT in patients with non-valvular atrial fibrillation (NVAF) compared with vitamin K antagonists (VKAs), we conducted a meta-analysis. We searched PubMed, Embase, and the Cochrane Library databases. For meta-analysis, dichotomous variables were analyzed by using the odds ratios (OR) computed using the Mantel Haenszel method (random models). All results were reported with 95% confidence intervals (CI). A total of 13 studies (one randomized controlled investigation and 12 observational studies) were included in the meta-analysis. There was no statistically significant difference between the NOACs and VKAs groups with respect to the odds of LAT/LAAT formations (OR 0.79; 95% CI: 0.52-1.21; P = .29; (I2 = 14%). NOACs were as effective as VKAs in the prevention of LAT/LAAT formation in patients with NVAF. Though patients on NOACs therapy showed a lower incidence of LAT/LAAT formation compared with VKAs, it was not significant (P = .29).

Dual-Pathway Antithrombotic Therapy in Patients With Atrial Fibrillation After Percutaneous Coronary Intervention in Stable Coronary Artery Disease: A Single-Center, Single-Operator, Retrospective Cohort Study.

Background: There is limited data evaluating the prescription practices for antithrombotic therapy in patients with atrial fibrillation (AF) following elective percutaneous coronary intervention (PCI).Objective: This single-center, single-operator, retrospective cohort study aimed to evaluate trends of antithrombotic treatment strategies in patients with AF undergoing elective PCI.Methods: Patients with AF who electively underwent PCI performed by a single interventionalist between April 2013 and May 2018 were identified. The primary outcome was the antithrombotic therapy at discharge assessed by chart review: triple (TAT, triple antithrombotic therapy) or dual (DAT, dual antithrombotic therapy) antithrombotic therapy and vitamin K antagonist (VKA) or non-vitamin K antagonist oral anticoagulant (NOAC), respectively.Results: Of 6,135 screened patients, 259 met the inclusion criteria. Among these, 133 (51%) patients received NOAC- and 126 (49%) VKA-therapy. Compared with patients on NOAC therapy, patients treated with VKA had higher bleeding risk (mean HAS-BLED-Score; 2.3 vs. 2.0; p = 0.02) and more co-morbidities (estimated glomerular filtration rate <30 ml/min, 11 vs. 4%; p = 0.04; diabetes mellitus, 33 vs. 20%; p = 0.03; history of previous PCI, 37 vs. 21%; p < 0.01). TAT was prescribed more frequently if the prescription included VKA compared with NOAC (61 vs. 41%; p < 0.01). Prescription of TAT and VKA decreased throughout the observed period (2013: 100% vs. 2018: 6%; p < 0.01 and 2013: 91% vs. 2018: 28%; p < 0.01).Conclusion: These observational data from a single center registry show a decrease of TAT- and VKA- prescription in favor of DAT with NOAC. Whether these observations are consistent with national or global trends should to be evaluated in further studies.

Minor bleeding in patients with atrial fibrillation using a non-vitamin-K antagonist oral anticoagulant

Aims We sought to investigate the magnitude of minor bleeding and identify risk factors for minor bleeds during non-vitamin-K antagonist oral anticoagulant (NOAC) therapy. Methods This was an observational cohort study of patients with atrial fibrillation (AF) referred to a regional NOAC outpatient clinic between February 2013 and October 2017. The study population consisted of 875 consecutive patients with AF who visited the NOAC outpatient unit to initiate treatment with apixaban (N = 303), dabigatran (N = 267) or rivaroxaban (N = 305) for long-term ischemic stroke prophylaxis. Minor bleed was defined as every overt bleeding that does not fulfil the criteria of major or non-major clinically relevant bleeding according to the International Society on Thrombosis and Haemostasis. Results Overall rate of minor bleeds was 19.2 per 100 patient years of follow-up. Bleeding rates for apixaban, dabigatran and rivaroxaban were 26, 8.3 and 23 per 100 patient-years of follow-up. Next to the type of NOAC, the main risk indicators for minor bleedings during NOAC therapy were a HAS-BLED score of 3 or higher and novel anticoagulant use (no history of vitamin K antagonist use). Limitation This was a retrospective observational study evaluating NOAC treatment in a non-randomized setting. Conclusion Our data showed that minor bleeds are common in novel NOAC users, especially when using apixaban and rivaroxaban. In the latter two NOACs, hematoma (bruises) and nose bleeds were more frequently observed and accounted for the difference with dabigatran. Besides type of NOAC, a higher HAS-BLED score and novel anticoagulant drug use were associated with an increased risk of minor bleeding.