scholarly journals Direct Current Cardioversion in Atrial Fibrillation Patients on Edoxaban Therapy Versus Vitamin K Antagonists: a Real-world Propensity Score–Matched Study

2020 ◽  
Author(s):  
Anna Rago ◽  
Andrea Antonio Papa ◽  
Emilio Attena ◽  
Valentina Parisi ◽  
Paolo Golino ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Propensity Score ◽  
Vitamin K ◽  
Cumulative Incidence ◽  
Vitamin K Antagonists ◽  
Electrical Current ◽  
Thromboembolic Events ◽  
Safety Outcome ◽  
Direct Current Cardioversion ◽  
Significant Difference

Abstract Purpose The purpose of the present study was to compare the long-term effectiveness and safety of newly initiated anticoagulation with edoxaban (EDO) versus uninterrupted vitamin K antagonist (VKA) therapy in patients with atrial fibrillation (AF) scheduled for transesophageal echocardiogram (TEE)-guided direct electrical current cardioversion (DCC). Methods A propensity score-matched cohort observational study was performed comparing the safety and effectiveness of edoxaban versus well-controlled VKA therapy among a cohort of consecutive non-valvular AF patients scheduled for DCC. The primary safety outcome was major bleeding. The primary efficacy outcome was the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). Findings A total of 130 AF patients receiving edoxaban 60-mg (EDO) treatment were compared with the same number of VKA recipients. The cumulative incidence of major bleedings was 1.54% in the EDO group and 3.08% in the VKA group (P = 0.4). The cumulative incidence of thromboembolic events was 1.54% in the EDO group and 2.31% in the VKA group (P = 0.9). A non-significant trend in improved adherence was observed between the EDO and VKA groups with a total anticoagulant therapy discontinuation rate of 4.62% (6/130) vs 6.15% (8/130), respectively (P = 0.06). Implications Our study provides the evidence of a safe and effective use of edoxaban in this clinical setting, justified by no significant difference in major bleedings and thromboembolic events between edoxaban and well-controlled VKA treatments.

scholarly journals Clinical Outcome of Edoxaban vs. Vitamin K Antagonists in Patients with Atrial Fibrillation and Diabetes Mellitus: Results from a Multicenter, Propensity-Matched, Real-World Cohort Study

2020 ◽  
Vol 9 (6) ◽  
pp. 1621 ◽  
Author(s):  
Vincenzo Russo ◽  
Emilio Attena ◽  
Anna Rago ◽  
Enrico Melillo ◽  
Pierpaolo Di Micco ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Atrial Fibrillation ◽  
Cohort Study ◽  
Propensity Score ◽  
Incidence Rate ◽  
Vitamin K ◽  
Real World ◽  
Vitamin K Antagonists ◽  
Research Database ◽  
Thromboembolic Events

Diabetes mellitus (DM) is a chronic metabolic disease which is independently associated with unfavorable clinical outcomes in patients with atrial fibrillation (AF). Few real-world data are available about the clinical performance of non-vitamin K oral anticoagulants (NOACs) among patients with atrial fibrillation and diabetes. The aim of our propensity score-matched cohort study was to compare the safety and effectiveness of Edoxaban versus well-controlled vitamin K antagonists (VKAs) therapy among this population. In this study, we considered patients with AF and diabetes on Edoxaban or VKAs therapy included in the multicenter Atrial Fibrillation Research Database (NCT03760874). The occurrence of major bleedings (MB) and thromboembolic events (a composite of ischemic stroke, transient ischemic attack, systemic embolism) was respectively considered primary safety and effectiveness outcome. We identified 557 AF patients with diabetes who received Edoxaban (n: 230) or VKAs (n: 327) treatment. After propensity score matching analysis, 135 Edoxaban and 135 VKA recipients with similar clinical characteristics were evaluated. The mean follow-up was 27 ± 3 months. The incidence rate of thromboembolic events (TE) was 3.0 per 100 person-years (1.11 in Edoxaban vs. 1.9 in the VKA group, hazard ratio (HR): 0.59; 95% confidence interval (CI), 0.14 to 2.52; p = 0.48). The incidence rate of major bleedings (MB) was 3.7 per 100 person-years (1.2 in Edoxaban vs. 2.7 in the VKA group, HR: 0.43; 95% CI: 0.10 to 1.40; p = 0.14). The incidence rate of intracranial hemorrhage was 0.35 per 100 person-years in Edoxaban vs. 0.74 in the VKA group (HR: 0.49; 95% CI: 0.05 to 5.54; p = 0.56). A positive net clinical benefit (NCB) of Edoxaban over VKAs was found (+1.39). Insulin therapy (HR: 1.76, p = 0.004) and glycated hemoglobin (HR: 1.17, p = 0.002) were found to be independent predictors of TE; moreover, the concomitant use of antiplatelet drugs (HR: 2.41, p = 0.001) was an independent predictor of MB. Conclusions: Our data support the hypothesis of the safety and efficacy of Edoxaban for use in patients with AF and diabetes, justified by a favorable NCB over VKAs.

scholarly journals Anticoagulation in Atrial Fibrillation Cardioversion: What Is Crucial to Take into Account

2021 ◽  
Vol 10 (15) ◽  
pp. 3212
Author(s):  
Fabiana Lucà ◽  
Simona Giubilato ◽  
Stefania Angela Di Fusco ◽  
Laura Piccioni ◽  
Carmelo Massimiliano Rao ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Thrombus Formation ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Anticoagulation Therapy ◽  
Significant Advance ◽  
Thromboembolic Events ◽  
Thromboembolic Risk ◽  
Pharmacological Cardioversion

The therapeutic dilemma between rhythm and rate control in the management of atrial fibrillation (AF) is still unresolved and electrical or pharmacological cardioversion (CV) frequently represents a useful strategy. The most recent guidelines recommend anticoagulation according to individual thromboembolic risk. Vitamin K antagonists (VKAs) have been routinely used to prevent thromboembolic events. Non-vitamin K antagonist oral anticoagulants (NOACs) represent a significant advance due to their more predictable therapeutic effect and more favorable hemorrhagic risk profile. In hemodynamically unstable patients, an emergency electrical cardioversion (ECV) must be performed. In this situation, intravenous heparin or low molecular weight heparin (LMWH) should be administered before CV. In patients with AF occurring within less than 48 h, synchronized direct ECV should be the elective procedure, as it restores sinus rhythm quicker and more successfully than pharmacological cardioversion (PCV) and is associated with shorter length of hospitalization. Patients with acute onset AF were traditionally considered at lower risk of thromboembolic events due to the shorter time for atrial thrombus formation. In patients with hemodynamic stability and AF for more than 48 h, an ECV should be planned after at least 3 weeks of anticoagulation therapy. Alternatively, transesophageal echocardiography (TEE) to rule out left atrial appendage thrombus (LAAT) should be performed, followed by ECV and anticoagulation for at least 4 weeks. Theoretically, the standardized use of TEE before CV allows a better stratification of thromboembolic risk, although data available to date are not univocal.

Bleeding risk with rivaroxaban compared with vitamin K antagonists in patients aged 80 years or older with atrial fibrillation

Heart ◽  
2020 ◽  
pp. heartjnl-2020-317923 ◽  
Author(s):  
Olivier Hanon ◽  
Jean-Sébastien Vidal ◽  
George Pisica-Donose ◽  
Galdric Orvoën ◽  
Jean-Philippe David ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Propensity Score ◽  
Vitamin K ◽  
Lower Risk ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Risk ◽  
Matched Sample ◽  
Intracerebral Bleeding

ObjectiveDirect oral anticoagulants have been evaluated in the general population, but proper evidence for their safe use in the geriatric population is still missing. We compared the bleeding risk of a direct oral anticoagulant (rivaroxaban) and vitamin K antagonists (VKAs) among French geriatric patients with non-valvular atrial fibrillation (AF) aged ≥80 years.MethodsWe performed a sequential observational prospective cohort study, using data from 33 geriatric centres. The sample comprised 908 patients newly initiated on VKAs between September 2011 and September 2014 and 995 patients newly initiated on rivaroxaban between September 2014 and September 2017. Patients were followed up for up to 12 months. One-year risks of major, intracerebral, gastrointestinal bleedings, ischaemic stroke and all-cause mortality were compared between rivaroxaban-treated and VKA-treated patients with propensity score matching and Cox models.ResultsMajor bleeding risk was significantly lower in rivaroxaban-treated patients (7.4/100 patient-years) compared with VKA-treated patients (14.6/100 patient-years) after multivariate adjustment (HR 0.66; 95% CI 0.43 to 0.99) and in the propensity score–matched sample (HR 0.53; 95% CI 0.33 to 0.85). Intracerebral bleeding occurred less frequently in rivaroxaban-treated patients (1.3/100 patient-years) than in VKA-treated patients (4.0/100 patient-years), adjusted HR 0.59 (95% CI 0.24 to 1.44) and in the propensity score–matched sample HR 0.26 (95% CI 0.09 to 0.80). Major lower bleeding risk was largely driven by lower risk of intracerebral bleeding.ConclusionsOur study findings indicate that bleeding risk, largely driven by lower risk of intracerebral bleeding, is lower with rivaroxaban than with VKA in stroke prevention in patients ≥80 years old with non-valvular AF.

scholarly journals Vitamin K Antagonists, Non–Vitamin K Antagonist Oral Anticoagulants, and Vascular Calcification in Patients with Atrial Fibrillation

TH Open ◽  
2018 ◽  
Vol 02 (04) ◽  
pp. e391-e398 ◽  
Author(s):  
Frederique Peeters ◽  
Elton Dudink ◽  
Dorien Kimenai ◽  
Bob Weijs ◽  
Sibel Altintas ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Logistic Regression ◽  
Aortic Valve ◽  
Propensity Score ◽  
Vascular Calcification ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Adjusted Logistic Regression

Background Vitamin K antagonists (VKAs) are associated with coronary artery calcification in low-risk populations, but their effect on calcification of large arteries remains uncertain. The effect of non–vitamin K antagonist oral anticoagulants (NOACs) on vascular calcification is unknown. We investigated the influence of use of VKA and NOAC on calcification of the aorta and aortic valve. Methods In patients with atrial fibrillation without a history of major adverse cardiac or cerebrovascular events who underwent computed tomographic angiography, the presence of ascending aorta calcification (AsAC), descending aorta calcification (DAC), and aortic valve calcification (AVC) was determined. Confounders for VKA/NOAC treatment were identified and propensity score adjusted logistic regression explored the association between treatment and calcification (Agatston score > 0). AsAC, DAC, and AVC differences were assessed in propensity score–matched groups. Results Of 236 patients (33% female, age: 58 ± 9 years), 71 (30%) used VKA (median duration: 122 weeks) and 79 (34%) used NOAC (median duration: 16 weeks). Propensity score–adjusted logistic regression revealed that use of VKA was significantly associated with AsAC (odds ratio [OR]: 2.31; 95% confidence interval [CI]: 1.16–4.59; p = 0.017) and DAC (OR: 2.38; 95% CI: 1.22–4.67; p = 0.012) and a trend in AVC (OR: 1.92; 95% CI: 0.98–3.80; p = 0.059) compared with non-anticoagulation. This association was absent in NOAC versus non-anticoagulant (AsAC OR: 0.51; 95% CI: 0.21–1.21; p = 0.127; DAC OR: 0.80; 95% CI: 0.36–1.76; p = 0.577; AVC OR: 0.62; 95% CI: 0.27–1.40; p = 0.248). A total of 178 patients were propensity score matched in three pairwise comparisons. Again, use of VKA was associated with DAC (p = 0.043) and a trend toward more AsAC (p = 0.059), while use of NOAC was not (AsAC p = 0.264; DAC p = 0.154; AVC p = 0.280). Conclusion This cross-sectional study shows that use of VKA seems to contribute to vascular calcification. The calcification effect was not observed in NOAC users.

scholarly journals Az edoxabán véralvadásgátló hatásossága és biztonságossága nonvalvuláris pitvarfibrillációban

2018 ◽  
Vol 159 (12) ◽  
pp. 466-469
Author(s):  
Andrea Szegedi ◽  
Zoltán Csanádi
Keyword(s):  
Atrial Fibrillation ◽  
Anticoagulant Therapy ◽  
Vitamin K ◽  
Oral Anticoagulant ◽  
Randomized Trials ◽  
Vitamin K Antagonists ◽  
Thromboembolic Events ◽  
Direct Oral Anticoagulant ◽  
Anticoagulant Drugs

Abstract: The significantly increased incidence of stroke and systemic embolisation caused by atrial fibrillation can be prevented by adequately adjusted anticoagulant therapy. Vitamin K antagonists effectively decrease the risk of thromboembolic events but this effect is influenced by many factors. The development of the new direct oral anticoagulant drugs (DOAC) in the last few years provided new opportunities for us to choose the suitable anticoagulant therapy. According to the results of the ENGAGE AF–TIMI 48 and ENSURE-AF multicenter, randomized trials, edoxaban, the recently introduced DOAC is equally effective as the traditional coumarin therapy, nevertheless, it ensures more tolerable anticoagulation for patients suffering from non-valvular atrial fibrillation. Orv Hetil. 2018; 159(12): 466–469.

scholarly journals Non-valvular Atrial Fibrillation in CKD: Role of Vitamin K Antagonists and Direct Oral Anticoagulants. A Narrative Review

2021 ◽  
Vol 8 ◽  
Author(s):  
Aleix Cases ◽  
Pablo Gomez ◽  
Jose Jesus Broseta ◽  
Elisa Perez Bernat ◽  
Juan de Dios Arjona Barrionuevo ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Randomized Controlled Trials ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Controlled Trials ◽  
Thromboembolic Events ◽  
Randomized Controlled ◽  
Valvular Calcification

Atrial fibrillation (AF) is the most common arrhythmia in chronic kidney disease (CKD), with a close bidirectional relationship between the two entities. The presence of CKD in AF increases the risk of thromboembolic events, mortality and bleeding. Vitamin K antagonists (VKA) have been the mainstay of treatment for the prevention of thromboembolic events in AF until recently, with confirmed benefits in AF patients with stage 3 CKD. However, the risk-benefit profile of VKA in patients with AF and stages 4–5 CKD is controversial due to the lack of evidence from randomized controlled trials. Treatment with VKA in CKD patients has been associated with conditions such as poorer anticoagulation quality, increased risk of bleeding, faster progression of vascular/valvular calcification and higher risk of calciphylaxis. Direct oral anticoagulants (DOACs) have shown equal or greater efficacy in stroke/systemic embolism prevention, and a better safety profile than VKA in post-hoc analysis of the pivotal randomized controlled trials in patients with non-valvular AF and stage 3 CKD, yet evidence of its risk-benefit profile in more advanced stages of CKD is scarce. Observational studies associate DOACs with a good safety/effectiveness profile compared to VKA in non-dialysis CKD patients. Further, DOACs have been associated with a lower risk of acute kidney injury and CKD development/progression than VKA. This narrative review summarizes the evidence of the efficacy and safety of warfarin and DOACs in patients with AF at different CKD stages, as well as their effects on renal function, vascular/valvular calcification and bone health.

Abstract 13927: Advanced Age and Preferential Use of Vitamin K Antagonists in Severe Renal Impairment: First Results of the XARENO Registry in Patients With Non-valvular Atrial Fibrillation and Non-dialysis Dependent Advanced Chronic Kidney Disease

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Reinhold Kreutz ◽  
Gilbert Deray ◽  
Juergen Floege ◽  
Marianne Gwechenberger ◽  
Andreas Luft ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Chronic Kidney Disease ◽  
Renal Function ◽  
Kidney Disease ◽  
Vitamin K ◽  
Severe Renal Impairment ◽  
Vitamin K Antagonists ◽  
Thromboembolic Events ◽  
Increased Risk ◽  
First Results

Introduction: Patients with chronic kidney disease (CKD) and non-valvular atrial fibrillation (NVAF) are at increased risk for both ischemic stroke and hemorrhage. In addition, treatment with vitamin K antagonists (VKA) has been associated with worsening of renal function compared to direct oral anticoagulants (DOACs). XARENO (Factor XA -inhibition in RENal patients with non-valvular atrial fibrillation Observational registry) is an ongoing prospective, non-interventional, observational study conducted in Europe. XARENO evaluates the effectiveness of rivaroxaban in preserving renal function and preventing thromboembolic events as compared to VKA in NVAF patients with CKD in clinical practice. Methods: XARENO included male and female NVAF patients ≥18 years old with an estimated glomerular filtration rate (eGFR) between 15 and 49 mL/min per 1.73 m 2 and an indication for anticoagulation. Enrolment took place from April 2016 until January 2020. Patients treated with either rivaroxaban or VKA were included, while patients in whom physicians were withholding any anticoagulation could be also enrolled. Minimal planned follow-up is one year. Primary observational outcomes include efficacy and safety outcomes (progression of CKD, stroke, other thromboembolic events, major cardiovascular events, major bleeding, and all-cause mortality). First results on outcomes in the full cohort are expected in 2021. Results: In this analysis of a first set of 1485 patients (56.1% males), 731 and 666 patients received rivaroxaban and VKA, while 88 patients did not receive any anticoagulation. Mean age at baseline was 77.3 years (67.5% older than 75 years) with a mean eGFR of 38.9 mL/min per 1.73 m 2 . Overall 74.7% of patients had eGFR values below 45 mL/min per 1.73 m 2 and 28.0% below 30 mL/min per 1.73 m 2 . In the latter group, use of a VKA was about twofold more frequent compared to rivaroxaban. Conclusions: This first analysis of XARENO patients reveals the very high age of NVAF patients with concomitant non-dialysis dependent advanced CKD and a preferential use of VKA in stage 4 CKD. XARENO aims to provide important information on the real-world effectiveness and safety of rivaroxaban compared with VKA for this vulnerable patient group.

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