scholarly journals Uninterrupted edoxaban vs. vitamin K antagonists for ablation of atrial fibrillation: the ELIMINATE-AF trial

2019 ◽  
Vol 40 (36) ◽  
pp. 3013-3021 ◽  
Author(s):  
Stefan H Hohnloser ◽  
John Camm ◽  
Riccardo Cappato ◽  
Hans-Christoph Diener ◽  
Hein Heidbüchel ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Primary Endpoint ◽  
Vitamin K Antagonists ◽  
Brain Magnetic Resonance Imaging ◽  
Study Drug ◽  
Haemorrhagic Stroke ◽  
Open Label ◽  
Af Ablation ◽  
End Of Treatment

Abstract Aims Edoxaban is a direct factor Xa inhibitor approved for stroke prevention in atrial fibrillation (AF). Uninterrupted edoxaban therapy in patients undergoing AF ablation has not been tested. Methods and results The ELIMINATE-AF trial, a multinational, multicentre, randomized, open-label, parallel-group study, was conducted to assess the safety and efficacy of once-daily edoxaban 60 mg (30 mg in patients indicated for dose reduction) vs. vitamin K antagonists (VKAs) in AF patients undergoing catheter ablation. Patients were randomized 2:1 to edoxaban vs. VKA. The primary endpoint (per-protocol population) was time to first occurrence of all-cause death, stroke, or International Society of Thrombosis and Haemostasis-defined major bleeding during the period from the end of the ablation procedure to end of treatment (90 days). Overall, 632 patients were enrolled, 614 randomized, and 553 received study drug and underwent ablation; 177 subjects underwent brain magnetic resonance imaging to assess silent cerebral infarcts. The primary endpoint (only major bleeds occurred) was observed in 0.3% (1 patient) on edoxaban and 2.0% (2 patients) on VKA [hazard ratio (95% confidence interval): 0.16 (0.02–1.73)]. In the ablation population (modified intent-to-treat population including patients with ablation), the primary endpoint was observed in 2.7% of edoxaban (N = 10) and 1.7% of VKA patients (N = 3) between start of ablation and end of treatment. There were one ischaemic and one haemorrhagic stroke, both in patients on edoxaban. Cerebral microemboli were detected in 13.8% (16) patients who received edoxaban and 9.6% (5) patients in the VKA group (nominal P = 0.62). Conclusion Uninterrupted edoxaban therapy represents an alternative to uninterrupted VKA treatment in patients undergoing AF ablation.

Safety and efficacy of non-vitamin K antagonist oral anticoagulants in elderly patients with atrial fibrillation: systematic review and meta-analysis of 22 studies and 440 281 patients

2019 ◽  
Author(s):  
Angelo Silverio ◽  
Marco Di Maio ◽  
Costantina Prota ◽  
Elena De Angelis ◽  
Ilaria Radano ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Elderly Patients ◽  
Vitamin K ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Indirect Comparison ◽  
Haemorrhagic Stroke ◽  
Intracranial Bleeding ◽  
Efficacy And Safety ◽  
Fatal Bleeding

Abstract Aims The aim of the present meta-analysis was to evaluate the efficacy and safety of non-vitamin K oral antagonists (NOACs) vs. vitamin K antagonists (VKAs) in elderly patients with atrial fibrillation (AF) and indirectly compare NOACs in this population. Methods and results MEDLINE, Cochrane, ISI Web of Sciences, and SCOPUS were searched for randomized or adjusted observational studies comparing NOACs vs. VKAs for stroke prevention in AF patients ≥75 years. The primary efficacy and safety outcomes of this meta-analysis were the composite of stroke and systemic embolism (SSE) and major bleedings, respectively. Other secondary outcomes were also analysed. The analysis included 22 studies enrolling 440 281 AF patients ≥ 75 years. The risk of SSE was significantly lower with NOACs vs. VKAs [hazard ratio (HR) 0.79; 95% confidence interval (CI) 0.70–0.89], whereas no differences were found for major bleedings (HR 0.94; 95% CI 0.85–1.05). NOACs reduced the risk of intracranial bleeding (HR 0.46; 95% CI 0.38–0.58), haemorrhagic stroke (HR 0.61; 95% CI 0.48–0.79) and fatal bleeding (HR 0.46; 95% CI 0.30–0.72) but increased gastrointestinal (GI) bleedings (HR 1.46; 95% CI 1.30–1.65), compared to VKAs. The adjusted indirect comparison showed no significant differences in term of SSE between NOAC agents. Conversely, the risk of major bleeding was higher for rivaroxaban vs. apixaban (HR 1.69; 95% CI 1.39–2.08) and edoxaban (HR 1.37; 95% CI 1.14–1.67), and for dabigatran vs. apixaban (HR 1.47; 95% CI 1.18–1.85). Conclusion In elderly patients with AF, NOACs are associated to a lower risk of SSE, intracranial bleeding, haemorrhagic stroke and fatal bleeding than VKAs, but increase GI bleedings. In this analysis, the safety profile of individual NOAC agents was significantly different.

scholarly journals Periprocedural anticoagulation in the uninterrupted edoxaban vs. vitamin K antagonists for ablation of atrial fibrillation (ELIMINATE-AF) trial

EP Europace ◽  
2020 ◽  
Author(s):  
Stefan H Hohnloser ◽  
A John Camm ◽  
Riccardo Cappato ◽  
Hans-Christoph Diener ◽  
Hein Heidbüchel ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Study Drug ◽  
International Normalized Ratio ◽  
P Value ◽  
Group 14 ◽  
Group 13 ◽  
Post Hoc ◽  
Higher Doses

Abstract Aims  This post hoc analysis of ELIMINATE-AF evaluated requirements of unfractionated heparin (UFH) and procedure-related bleeding in atrial fibrillation (AF) patients undergoing ablation with uninterrupted edoxaban or vitamin K antagonist (VKA) therapy. Methods and results  Patients were randomized 2:1 to once-daily edoxaban 60 mg (or dose-reduced 30 mg) or dose-adjusted VKA (target international normalized ratio: 2.0–3.0). Uninterrupted anticoagulation was mandated for 21–28 days’ pre-ablation and 90 days’ post-ablation. During ablation, UFH administration targeted an activated clotting time (ACT) of 300–400 s. Periprocedural bleeding was differentiated between procedure-related (bleeding at puncture side, cardiac tamponade) and unrelated events. Of 614 randomized patients, 553 received study drug and underwent catheter ablation (edoxaban n = 375; VKA n = 178). The median (Q1–Q3) time from last dose to ablation procedure was 14.8 (13.3–16.5) vs. 16.5 (14.8–19.5) h (edoxaban vs. VKA group, respectively). Mean ACT (SD) ≥300 s was observed in 52% edoxaban- vs. 76% VKA-treated patients, despite a higher mean (SD) UFH dose in the edoxaban vs. VKA group [14 261 (6397) IU vs. 11 473 (4300) IU; exploratory P-value < 0.0001]. In the edoxaban group, 13 patients (3.5%) had procedure-related bleeds of whom 9 had received an UFH dose above the median (13 000 IU). In the VKA arm, 7 patients (3.9%) had procedure-related bleeds of whom 3 had received an UFH dose above the median (10 225 IU). Conclusion  The rate of procedure-related major/clinically relevant non-major bleeding did not differ between the treatment arms despite higher doses of UFH used with edoxaban vs. VKA to achieve a target ACT during AF ablation.

P472Cerebral thromboembolic risk in atrial fibrillation ablation: a direct comparison of vitamin K antagonists versus non-vitamin K-dependent oral anticoagulants

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
A M Petzl ◽  
M Derndorfer ◽  
G Kollias ◽  
K Moroka ◽  
J Aichinger ◽  
...  
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Cerebral Lesions ◽  
Cerebral Magnetic Resonance Imaging ◽  
Af Ablation ◽  
Significant Difference ◽  
Independent Risk Factors

Abstract Aims Cerebral thromboembolic events are well-known complications of pulmonary vein isolation (PVI) and can manifest as stroke or silent cerebral embolic lesions. Over the last years, the preferred oral anticoagulation in atrial fibrillation (AF) shifted from vitamin K antagonists (VKA) to non-vitamin K-dependent oral anticoagulants (NOAC). The aim of this study was to compare the incidence of cerebral embolic lesions after AF ablation in patients on VKA versus patients on NOAC, and to identify corresponding clinical and procedural risk factors. Methods A total of 421 patients undergoing PVI (by radiofrequency catheter or cryoballoon) were prospectively included into the study. Of these, 43.7% were on VKA and 56.3% on NOAC treatment. In the NOAC group 38% of patients had an interruption of anticoagulation for 24-36 hours. All patients underwent pre- and postprocedural cerebral magnetic resonance imaging. Results Periprocedural cerebral lesions occurred in 13.1% overall. Of these, three (0.7%) resulted in symptomatic cerebrovascular accidents. Incidence of cerebral lesions was significantly higher in patients on NOAC compared to VKA (16% vs. 9.2% respectively, p = 0.04), as well as in patients that had intraprocedural cardioversions compared to no cardivoersions (19.5% vs. 10.4% respectively, p = 0.03). In multivariate analysis both parameters were found to be independent risk factors for cerebral embolism. No significant difference between interrupted and uninterrupted NOAC administration could be detected. Conclusions In patients undergoing AF ablation, we identified the use of NOAC and intraprocedural cardioversion as independent risk factors for the occurrence of periprocedural cerebral embolic lesions. Abstract Figure. Incidence of cerebral embolic lesions

scholarly journals Prevalence of LAA thrombus in patients undergoing percutaneous ablation of atrial fibrillation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
C Silva ◽  
P.N Freitas ◽  
A.M Ferreira ◽  
F Albuquerque ◽  
S Guerreiro ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Left Atrial ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Pulmonary Veins ◽  
Percutaneous Ablation ◽  
Effective Radiation Dose ◽  
Af Ablation ◽  
Iodinated Contrast

Abstract Introduction Computed tomography (CT) is often performed before atrial fibrillation (AF) ablation to assess the anatomy of the pulmonary veins and exclude left atrial (LA) and left atrial appendage (LAA) thrombus. With the growing use of new oral anticoagulants (NOACs), a reassessment of the need for systematic thrombus exclusion in this context seems warranted. Objective To evaluate the prevalence of thrombus in LA/LAA in pre-ablation CT in a contemporary cohort of patients predominantly anticoagulated with NOACs. Methods We evaluated 789 consecutive patients (mean age 61±12 years; 38% female; 84% with paroxysmal AF) who underwent pre-ablation CT between Oct/2015 and Oct/2019. ECG-gated CT-angiography was performed using a dual-source 64-slice CT after iodinated contrast injection. Whenever necessary, a second dedicated acquisition was made 60 seconds after the first set of images. Presence of thrombus was defined as a persistent opacification defect. For each patient, thromboembolic risk was assessed with the CHA2DS2-VASc score. Results The median interval between CT and AF ablation was 1 day (IQR 1 – 2 days). The median CHA2DS2-VASc was 2 points (IQR 0 – 3 points), with 590 patients (75%) having CHA2DS2-VASc ≥1. Among the 199 patients (25%) with CHA2DS2-VASc = 0, 118 (59,3%) were anticoagulated with a NOAC and 14 (7%) with a vitamin K antagonist; 67 (34%) were not anticoagulated. Conversely, amongst the 590 patients with CHA2DS2-VASc ≥1, 84% were anticoagulated with a NOAC (n=494), 11% used vitamin K antagonists (n=62), and 34 patients were not anticoagulated (23 with CHA2DS2-VASc = 1). On cardiac CT, 521 (66%) patients were in sinus rhythm. Overall, only one LAA thrombus was found (0.12% [1/789]; 95% CI: 0.0–0.7%) – in a patient with CHA2DS2-VASc = 0, anticoagulated with a NOAC. The median effective radiation dose was 3.2 mSv (IQR 2.1–4.8 mSv). There were 5 minor allergic reactions to iodinated contrast. No strokes were documented within the first 24 hours after ablation. Conclusion In this contemporary cohort of patients with predominantly paroxysmal AF and anticoagulated with NOAC, the prevalence of intracavitary thrombus was extremely low (0.12%). While these findings do not compromise the multipurpose role of pre-ablation CT, they should nevertheless inform future discussions on the risk/benefit and cost/benefit of performing systematic exclusion of LA/LAA thrombi prior to AF ablation. Funding Acknowledgement Type of funding source: None

scholarly journals When is it appropriate to stop non-vitamin K antagonist oral anticoagulants before catheter ablation of atrial fibrillation? A multicentre prospective randomized study

2018 ◽  
Vol 40 (19) ◽  
pp. 1531-1537 ◽  
Author(s):  
Hee Tae Yu ◽  
Jaemin Shim ◽  
Junbeom Park ◽  
Tae-Hoon Kim ◽  
Jae-Sun Uhm ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Vitamin K ◽  
Oral Anticoagulants ◽  
Randomized Study ◽  
Vitamin K Antagonist ◽  
Comparable Efficacy ◽  
Bleeding Events ◽  
Open Label ◽  
Af Ablation

Abstract Aims Although a recent expert consensus statement has recommended periprocedural uninterrupted (UI) non-vitamin K antagonist oral anticoagulants (NOACs) during catheter ablation of atrial fibrillation (AF) as a Class I indication, there have been no clear randomized trials. We investigated the safety and efficacy of UI, procedure day single-dose skipped (SDS), and 24-hour skipped (24S) NOACs in patients undergoing AF ablation. Methods and results In this prospective, open-label, randomized multicentre trial, 326 patients (75% male, 58 ± 11 years old) scheduled for AF catheter ablation were randomly assigned in a 1:1:1 ratio to UI, SDS, and 24S at three tertiary hospitals. Bridging with low molecular weight heparin was carried out in the patients with persistent AF who were assigned to the 24S group. Dabigatran, rivaroxaban, and apixaban were assigned in order after randomization. The primary endpoint was the incidence of bleeding events within 1 month after ablation. The secondary endpoints included thrombo-embolic and other procedure-related complications. The intra-procedural heparin requirement was higher in the 24S group than others (P < 0.001), and the mean activated clotting time was comparable among the groups (P = 0.139). The incidence of major bleeding up to 1 month after ablation and a post-procedural reduction in the haemoglobin levels did not significantly differ among the treatment groups and different NOACs (P > 0.05). There were no fatal events or thrombo-embolic complications in all the three groups. Conclusion In patients undergoing AF ablation, UI NOACs and SDS or double dose skipped NOACs had a comparable efficacy and safety, regardless of the type of NOAC.

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