Uninterrupted administration of edoxaban vs vitamin K antagonists in patients undergoing atrial fibrillation catheter ablation: Rationale and design of the ELIMINATE-AF study
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie
PubMed
29663464
PubMed Central
PMC6489708
DOI
10.1002/clc.22918
Knihovny.cz E-zdroje
- Klíčová slova
- Atrial Fibrillation, Catheter Ablation, Direct Oral Anticoagulant, Direct Oral Anticoagulant Edoxaban, Non-Vitamin K Oral Anticoagulants, Periprocedural,
- MeSH
- antikoagulancia aplikace a dávkování škodlivé účinky MeSH
- časové faktory MeSH
- cévní mozková příhoda diagnostické zobrazování etiologie prevence a kontrola MeSH
- fibrilace síní komplikace mortalita patofyziologie chirurgie MeSH
- inhibitory faktoru Xa aplikace a dávkování škodlivé účinky MeSH
- ischemie mozku diagnostické zobrazování etiologie prevence a kontrola MeSH
- katetrizační ablace * škodlivé účinky mortalita MeSH
- klinické protokoly MeSH
- krvácení chemicky indukované MeSH
- lidé MeSH
- magnetická rezonanční tomografie MeSH
- prospektivní studie MeSH
- pyridiny aplikace a dávkování škodlivé účinky MeSH
- rizikové faktory MeSH
- rozvrh dávkování léků MeSH
- thiazoly aplikace a dávkování škodlivé účinky MeSH
- vitamin K antagonisté a inhibitory MeSH
- výsledek terapie MeSH
- výzkumný projekt MeSH
- warfarin aplikace a dávkování škodlivé účinky MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Názvy látek
- antikoagulancia MeSH
- edoxaban MeSH Prohlížeč
- inhibitory faktoru Xa MeSH
- pyridiny MeSH
- thiazoly MeSH
- vitamin K MeSH
- warfarin MeSH
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.
Department of Cardiology Antwerp University Hospital University of Antwerp Antwerp Belgium
Department of Cardiology Hospital Clinic University of Barcelona Barcelona Spain
Department of Cardiology Institute for Clinical and Experimental Medicine Prague Czech Republic
Department of Global Medical Affairs Daiichi Sankyo Europe GmbH Munich Germany
Pharma Development Modeling and Simulation Daiichi Sankyo Basking Ridge New Jersey
Zobrazit více v PubMed
Calkins H, Reynolds MR, Spector P, et al. Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systematic literature reviews and meta‐analyses. Circ Arrhythm Electrophysiol. 2009;2:349–361. PubMed
Cappato R, Calkins H, Chen SA, et al. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010;3:32–38. PubMed
January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society [published correction appears in J Am Coll Cardiol. 2014;64:2305–2307]. J Am Coll Cardiol. 2014;64:e1–e76. PubMed
Calkins H, Kuck KH, Cappato R, et al. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: recommendations for patient selection, procedural techniques, patient management and follow‐up, definitions, endpoints, and research trial design. Europace. 2012;14:528–606. PubMed
Kirchhof P, Benussi S, Kotecha D, et al. 2016 ESC Guidelines for the Management of Atrial Fibrillation Developed in Collaboration With EACTS [article in English, Spanish; published correction appears in Rev Esp Cardiol (Engl Ed). 2017;70:1031]. Rev Esp Cardiol (Engl Ed). 2017;70:50.e1–50.e84. PubMed
Oral H, Chugh A, Ozaydin M, et al. Risk of thromboembolic events after percutaneous left atrial radiofrequency ablation of atrial fibrillation. Circulation. 2006;114:759–765. PubMed
Vazquez SR, Johnson SA, Rondina MT. Peri‐procedural anticoagulation in patients undergoing ablation for atrial fibrillation. Thromb Res. 2010;126:e69–e77. PubMed PMC
Di Biase L, Burkhardt JD, Santangeli P, et al. Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagulation management: results from the Role of Coumadin in Preventing Thromboembolism in Atrial Fibrillation (AF) Patients Undergoing Catheter Ablation (COMPARE) randomized trial. Circulation. 2014;129:2638–2644. PubMed
Ruff CT, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta‐analysis of randomised trials. Lancet. 2014;383:955–962. PubMed
Calkins H, Hindricks G, Cappato R, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017;14:e275–e444. PubMed PMC
Calkins H, Willems S, Gerstenfeld EP, et al; RE‐CIRCUIT Investigators . Uninterrupted dabigatran versus warfarin for ablation in atrial fibrillation. N Engl J Med. 2017;376:1627–1636. PubMed
Cappato R, Marchlinski FE, Hohnloser SH, et al; VENTURE‐AF Investigators . Uninterrupted rivaroxaban vs. uninterrupted vitamin K antagonists for catheter ablation in non‐valvular atrial fibrillation. Eur Heart J. 2015;36:1805–1811. PubMed PMC
Parasrampuria DA, Truitt KE. Pharmacokinetics and pharmacodynamics of edoxaban, a non‐vitamin K antagonist oral anticoagulant that inhibits clotting factor Xa. Clin Pharmacokinet. 2016;55:641–655. PubMed PMC
Savaysa (edoxaban) tablets [full prescribing information] . Parsippany, NJ: Daiichi‐Sankyo Inc., 2015.
Giugliano RP, Ruff CT, Braunwald E, et al; ENGAGE‐AF TIMI 48 Investigators . Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369:2093–2104. PubMed
Steffel J, Ruff CT, Hamershock RA, et al. First experience with edoxaban and atrial fibrillation ablation: insights from the ENGAGE AF‐TIMI 48 trial. Int J Cardiol. 2017;244:192–195. PubMed
Lip GY, Agnelli G. Edoxaban: a focused review of its clinical pharmacology. Eur Heart J. 2014;35:1844–1855. PubMed
Weitz JI, Connolly SJ, Patel I, et al. Randomised, parallel‐group, multicentre, multinational phase 2 study comparing edoxaban, an oral factor Xa inhibitor, with warfarin for stroke prevention in patients with atrial fibrillation. Thromb Haemost. 2010;104:633–641. PubMed
Rodeghiero F, Tosetto A, Abshire T, et al; ISTH/SSC Joint VWF and Perinatal/Pediatric Hemostasis Subcommittee Working Group . ISTH/SSC bleeding assessment tool: a standardized questionnaire and a proposal for a new bleeding score for inherited bleeding disorders. J Thromb Haemost. 2010;8:2063–2065. PubMed
Mehran R, Rao SV, Bhatt DL, et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011;123:2736–2747. PubMed
Chesebro JH, Knatterud G, Roberts R, et al. Thrombolysis in Myocardial Infarction (TIMI) Trial, Phase I: a comparison between intravenous tissue plasminogen activator and intravenous streptokinase. Clinical findings through hospital discharge. Circulation. 1987;76:142–154. PubMed
Herrera Siklódy C, Deneke T, Hocini M, et al. Incidence of asymptomatic intracranial embolic events after pulmonary vein isolation: comparison of different atrial fibrillation ablation technologies in a multicenter study. J Am Coll Cardiol. 2011;58:681–688. PubMed
Deneke T, Shin DI, Balta O, et al. Postablation asymptomatic cerebral lesions: long‐term follow‐up using magnetic resonance imaging. Heart Rhythm. 2011;8:1705–1711. PubMed
Haeusler KG, Koch L, Herm J, et al. 3 Tesla MRI‐detected brain lesions after pulmonary vein isolation for atrial fibrillation: results of the MACPAF study. J Cardiovasc Electrophysiol. 2013;24:142017. PubMed
Zhao Y, Yang Y, Tang X, et al. New oral anticoagulants compared to warfarin for perioperative anticoagulation in patients undergoing atrial fibrillation catheter ablation: a meta‐analysis of continuous or interrupted new oral anticoagulants during ablation compared to interrupted or continuous warfarin. J Interv Card Electrophysiol. 2017;48:267–282. PubMed
Aryal MR, Ukaigwe A, Pandit A, et al. Meta‐analysis of efficacy and safety of rivaroxaban compared with warfarin or dabigatran in patients undergoing catheter ablation for atrial fibrillation. Am J Cardiol. 2014;114:577–582. PubMed
Phan K, Wang N, Pison L, et al. Rivaroxaban versus warfarin or dabigatran in patients undergoing catheter ablation for atrial fibrillation: a meta‐analysis. Int J Cardiol. 2015;185:209–213. PubMed
Hohnloser SH, Camm AJ. Safety and efficacy of dabigatran etexilate during catheter ablation of atrial fibrillation: a meta‐analysis of the literature. Europace. 2013;15:1407–1411. PubMed
Nogami A, Machino T, Harada T, et al; ABRIDGE‐J Study Group . Clinical benefit of minimally interrupted dabigatran versus uninterrupted warfarin for catheter ablation of atrial fibrillation: a prospective randomized multicenter trial. Circulation. 2017;136:e448–e467. PubMed
Di Biase L, Callans D, Haeusler KG, et al. Rationale and design of AXAFA‐AFNET 5: an investigator‐initiated, randomized, open, blinded outcome assessment, multi‐centre trial comparing continuous apixaban to vitamin K antagonists in patients undergoing atrial fibrillation catheter ablation. Europace. 2017;19:132–138. PubMed
ClinicalTrials.gov
NCT02942576