Rationale and design of AXAFA-AFNET 5: An investigator-initiated, randomized, open, blinded outcome assessment,multi-centre trial to comparing continuous apixaban to Vitamin K antagonists in patients undergoing atrial fibrillation catheter ablation

Europace

Volumn 19, Issue 1, 2017, Pages 132-138

  Di Biase, Luigi ^a,b,c,d   Callans, David ^e   Husler, Karl Georg ^f   Hindricks, Gerhard ^g   Al Khalidi, Hussein ^h   Mont, Lluis ⁱ   Nielsen, Jens Cosedis ^j   Piccini, Jonathan P ^k   Schotten, Ulrich ^l,m   Kirchhof, Paulus ^m,n,o  

^a MONTEFIORE MEDICAL CENTER   (United States)

^b TEXAS CARDIAC ARRHYTHMIA INSTITUTE   (United States)

^c The University of Texas at Austin   (United States)

^d UNIVERSITY OF FOGGIA   (Italy)

^e HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

^f CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^g UNIVERSITY OF LEIPZIG HEART CENTER   (Germany)

^h DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ HOSPITAL CLÍNIC   (Spain)

^j AARHUS UNIVERSITY HOSPITAL   (Denmark)

^k DUKE UNIVERSITY MEDICAL CENTER   (United States)

^l MAASTRICHT UNIVERSITY   (Netherlands)

^m German Atrial Fibrillation Competence Network (AFNET)   (Germany)

ⁿ UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^o UNIVERSITY HOSPITAL MÜNSTER   (Germany)

more..

Author keywords

Ablation; Apixaban; Atrial fibrillation; Bleeding; Oral anticoagulation; Stroke; Un interrupted; Warfarin

Indexed keywords

ANTIVITAMIN K; APIXABAN; HEPARIN; ANTICOAGULANT AGENT; BLOOD CLOTTING FACTOR 10A INHIBITOR; PYRAZOLE DERIVATIVE; PYRIDONE DERIVATIVE; VITAMIN K GROUP;

ADULT; AGED; ANTICOAGULANT THERAPY; ARTICLE; ATRIAL FIBRILLATION; BLEEDING; BRAIN DAMAGE; CATHETER ABLATION; CEREBROVASCULAR ACCIDENT; CONTROLLED STUDY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MORNING DOSAGE; MULTICENTER STUDY; NUCLEAR MAGNETIC RESONANCE IMAGING; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; TRANSESOPHAGEAL ECHOCARDIOGRAPHY; ADVERSE EFFECTS; ANTAGONISTS AND INHIBITORS; CHEMICALLY INDUCED; CLINICAL TRIAL; COMPARATIVE STUDY; DIAGNOSTIC IMAGING; DRUG ADMINISTRATION; EUROPE; METHODOLOGY; MORTALITY; ORAL DRUG ADMINISTRATION; PATHOPHYSIOLOGY; RISK FACTOR; STROKE; TIME FACTOR; TREATMENT OUTCOME; UNITED STATES;

ADMINISTRATION, ORAL; ANTICOAGULANTS; ATRIAL FIBRILLATION; CATHETER ABLATION; DRUG ADMINISTRATION SCHEDULE; ECHOCARDIOGRAPHY, TRANSESOPHAGEAL; EUROPE; FACTOR XA INHIBITORS; HEMORRHAGE; HUMANS; MAGNETIC RESONANCE IMAGING; PROSPECTIVE STUDIES; PYRAZOLES; PYRIDONES; RESEARCH DESIGN; RISK FACTORS; STROKE; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES; VITAMIN K;

EID: 85016182463     PISSN: 10995129     EISSN: 15322092     Source Type: Journal    
DOI: 10.1093/europace/euw368     Document Type: Article

References (35)

1. Kirchhof P, Curtis AB, Skanes AC, Gillis AM, Samuel Wann L and John Camm A. Atrial fibrillation guidelines across the Atlantic: A comparison of the current recommendations of the European Society of Cardiology/European Heart Rhythm Association/European Association of Cardiothoracic Surgeons, the American College of Cardiology Foundation/American Heart Association/Heart Rhythm Society, and the Canadian Cardiovascular Society. Eur Heart J 2013;34:1471-4.
2. January CT, Wann LS, Alpert JS, Calkins H, Cleveland JC Jr, Cigarroa JE 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. Circulation 2014;130:e199-267.
3. Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA 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.
4. Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS: The Task Force for the management of atrial fibrillation of the European Society of Cardiology (ESC)Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESCEndorsed by the European Stroke Organisation (ESO). Europace. 2016.
5. Wazni OM, Beheiry S, Fahmy T, Barrett C, Hao S, Patel D et al. Atrial fibrillation ablation in patients with therapeutic international normalized ratio: comparison of strategies of anticoagulation management in the periprocedural period. Circulation 2007;116:2531-4.
6. Di Biase L, Burkhardt JD, Mohanty P, Sanchez J, Horton R, Gallinghouse GJ et al. Periprocedural stroke and management of major bleeding complications in patients undergoing catheter ablation of atrial fibrillation: The impact of periprocedural therapeutic international normalized ratio. Circulation 2010;121:2550-6.
7. Santangeli P, Di Biase L, Burkhardt DJ, Horton R, Sanchez J, Bai R et al. Catheter ablation of atrial fibrillation: state-of-the-art techniques and future perspectives. J Cardiovasc Med (Hagerstown) 2012;13:108-24.
8. Di Biase L, Burkhardt JD, Santangeli P, Mohanty P, Sanchez JE, Horton R 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;129:2638-44.
9. Bassiouny M, Saliba W, Rickard J, Shao M, Sey A, Diab M et al. Use of dabigatran for periprocedural anticoagulation in patients undergoing catheter ablation for atrial fibrillation. Circ Arrhythm Electrophysiol 2013;6:460-6.
10. Lakkireddy D, Reddy YM, Di Biase L, Vanga SR, Santangeli P, Swarup V et al. Feasibility and safety of dabigatran versus warfarin for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation: results from a multicenter prospective registry. J Am Coll Cardiol 2012;59:1168-74.
11. Kaseno K, Naito S, Nakamura K, Sakamoto T, Sasaki T, Tsukada N et al. Efficacy and safety of periprocedural dabigatran in patients undergoing catheter ablation of atrial fibrillation. Circ J 2012;76:2337-42.
12. Snipelisky D, Kauffman C, Prussak K, Johns G, Venkatachalam K and Kusumoto F. A comparison of bleeding complications post-ablation between warfarin and dabigatran. J Interv Card Electrophysiol 2012;35:29-33.
13. Nagao T, Inden Y, Shimano M, Fujita M, Yanagisawa S, Kato H et al. Feasibility and safety of uninterrupted dabigatran therapy in patients undergoing ablation for atrial fibrillation. Intern Med 2015;54:1167-73.
14. Kaess BM, Ammar S, Reents T, Dillier R, Lennerz C, Semmler V et al. Comparison of safety of left atrial catheter ablation procedures for atrial arrhythmias under continuous anticoagulation with apixaban versus phenprocoumon. Am J Cardiol 2015;115:47-51.
15. Steinberg BA, Hasselblad V, Atwater BD, Bahnson TD, Washam JB, Alexander JH et al. Dabigatran for periprocedural anticoagulation following radiofrequency ablation for atrial fibrillation: A meta-analysis of observational studies. J Interv Card Electrophysiol 2013;37:213-21.
16. Aryal MR, Ukaigwe A, Pandit A, Karmacharya P, Pradhan R, Mainali NR 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;114:577-82.
17. Hohnloser SH, Camm AJ. Safety and efficacy of dabigatran etexilate during catheter ablation of atrial fibrillation: A meta-analysis of the literature. Europace 2013;15:1407-11.
18. Vamos M, Cappato R, Marchlinski FE, Natale A, Hohnloser SH. Efficacy and safety of rivaroxaban compared with vitamin K antagonists for peri-procedural anticoagulation in catheter ablation of atrial fibrillation: A systematic review and meta-analysis. Europace 2016;20;pii:euv408
19. Cappato R, Marchlinski FE, Hohnloser SH, Naccarelli GV, Xiang J, Wilber DJ et al. Uninterrupted rivaroxaban vs. uninterrupted vitamin K antagonists for catheter ablation in non-valvular atrial fibrillation. Eur Heart J 2015;36:1805-11.
20. Lakkireddy D, Reddy YM, Di Biase L, Vallakati A, Mansour MC, Santangeli P et al. Feasibility and safety of uninterrupted rivaroxaban for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation: results from a multicenter prospective registry. J Am Coll Cardiol 2014;63:982-8.
21. Di Biase L, Lakkireddy D, Trivedi C, Deneke T, Martinek M, Mohanty S et al. Feasibility and safety of uninterrupted peri-procedural apixaban administration in patients undergoing radiofrequency catheter ablation for atrial fibrillation: results from a multicenter study. Heart Rhythm 2015;12:1162-8.
22. Briceno DF, Natale A and Di Biase L. Heparin kinetics: The "holy grail" of periprocedural anticoagulation for ablation of atrial fibrillation. Pacing Clin Electrophysiol 2015;38:1137-41.
23. Di Biase L and Natale A. Apixaban is dear to me, but dearer still is warfarin. Pacing Clin Electrophysiol 2015;38:153-4.
24. Douketis JD. Anticoagulation therapy: Perioperative anticoagulation-are we at 'a bridge too far' Nat Rev Cardiol. 2015;12:133-134.
25. Di Biase L. Safety and efficacy of novel oral anticoagulants in the setting of atrial fibrillation ablation: Is it time to celebrate the "funeral" of warfarin J Interv Card Electrophysiol 2014;41:103-5.
26. Di Biase L, Gaita F, Toso E, Santangeli P, Mohanty P, Rutledge N et al. Does periprocedural anticoagulation management of atrial fibrillation affect the prevalence of silent thromboembolic lesion detected by diffusion cerebral magnetic resonance imaging in patients undergoing radiofrequency atrial fibrillation ablation with open irrigated catheters Results from a prospective multicenter study. Heart Rhythm 2014;11:791-8.
27. Di Biase L, Briceno DF, Trivedi C, Mohanty S, Gianni C, Burkhardt JD, Mohanty P, Bai R, Gunda S, Horton R, Bailey S, Sanchez JE, Al-Ahmad A, Hranitzky P, Gallinghouse GJ, Reddy YM, Zagrodzky J, Hongo R, Beheiry S, Lakkireddy D, Natale A. Is transesophageal echocardiogram mandatory in patients undergoing ablation of atrial fibrillation with uninterrupted novel oral anticoagulants Results from a prospective multicenter registry. Heart Rhythm 2016;13:1197-202
28. Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J et al. Standardized bleeding definitions for cardiovascular clinical trials: A consensus report from the bleeding academic research consortium. Circulation 2011;123:2736-47.
29. Ndrepepa G, Schuster T, Hadamitzky M, Byrne RA, Mehilli J, Neumann FJ et al. Validation of the bleeding academic research consortium definition of bleeding in patients with coronary artery disease undergoing percutaneous coronary intervention. Circulation 2012;125:1424-31.
30. Herm J, Fiebach JB, Koch L, Kopp UA, Kunze C, Wollboldt C et al. Neuropsychological effects of MRI-detected brain lesions after left atrial catheter ablation for atrial fibrillation: long-term results of the MACPAF study. Circ Arrhythm Electrophysiol 2013;6:843-50.
31. Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I et al. The montreal cognitive assessment, MoCA: A brief screening tool for mild cognitive impairment. J Am Geriatr Soc 2005;53:695-9.
32. Kirchhof P, Andresen D, Bosch R, Borggrefe M, Meinertz T, Parade U et al. Short-term versus long-term antiarrhythmic drug treatment after cardioversion of atrial fibrillation (Flec-SL): A prospective, randomised, open-label, blinded endpoint assessment trial. Lancet 2012;380:238-46.
33. Farrington CP and Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or nonunity relative risk. Stat Med 1990;9:1447-54.
34. Ellis ER, Culler SD, Simon AW and Reynolds MR. Trends in utilization and complications of catheter ablation for atrial fibrillation in medicare beneficiaries. Heart Rhythm 2009;6:1267-73.
35. Piccini JP, Sinner MF, Greiner MA, Hammill BG, Fontes JD, Daubert JP et al. Outcomes of medicare beneficiaries undergoing catheter ablation for atrial fibrillation. Circulation 2012;126:2200-7.