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

Luigi Di Biase, David Callans, Karl Georg Husler, Gerhard Hindricks, Hussein Al-Khalidi, Lluis Mont, Jens Cosedis Nielsen, Jonathan P. Piccini, Ulrich Schotten, Paulus Kirchhof

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

Aims Catheter ablation is the most efficacious rhythm control therapy in atrial fibrillation (AF) patients. There is growing evidence that catheter ablation procedures are best performed during continuous oral anticoagulation, but outcomes are variable depending on the anticoagulation strategy or agent chosen. Specifically, there is a need to evaluate the peri-procedural use of non-vitamin K antagonist oral anticoagulants (NOACs) in patients undergoing catheter ablation of AF. The AXAFA-AFNET 5 trial will test whether peri-procedural anticoagulation therapy using apixaban is a safe alternative to vitamin K antagonist (VKA) therapy for patients undergoing catheter ablation of AF. Methods and results AXAFA-AFNET 5 is a randomized, prospective multi-centre study conducted in Europe and the USA. A total of 650 patients scheduled for AF ablation will be randomized 1:1 to undergo AF ablation on continuous treatment with the NOAC apixaban or with a VKA. Patients can undergo AF ablation after at least 30 days of continuous effective anticoagulation or after exclusion of atrial thrombi by transoesophageal echocardiogram. The trial includes a post-ablation magnetic resonance imaging substudy that will quantify silent brain lesions that can occur in neurologically asymptomatic patients after AF ablation. Patients will be followed on continuous anticoagulation for 3 months after the ablation. The primary outcome parameter of AXAFA-AFNET 5 is a composite of all-cause death, stroke, and major bleeding events. Conclusion The results of AXAFA-AFNET 5 will provide evidence informing about the safety of apixaban in ablation patients and on its efficacy including effects on silent brain lesions. AXAFA - AFNET 5 is an investigator-initiated trial sponsored by AFNET. The trial is supported by the DZHK (German Centre for Cardiovascular Research) and by the BMBF (German Ministry of Education and Research) and by Bristol-Myers Squibb/Pfizer Alliance.

Original languageEnglish (US)
Pages (from-to)132-138
Number of pages7
JournalEuropace
Volume19
Issue number1
DOIs
StatePublished - 2017

Fingerprint

Catheter Ablation
Vitamin K
Atrial Fibrillation
Research Personnel
Outcome Assessment (Health Care)
Anticoagulants
apixaban
Brain
Therapeutics
Research
Cause of Death
Thrombosis
Stroke
Magnetic Resonance Imaging
Hemorrhage
Safety
Education

Keywords

  • Ablation
  • Apixaban
  • Atrial fibrillation
  • Bleeding
  • Oral anticoagulation
  • Stroke
  • Un-interrupted
  • Warfarin

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

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. / Di Biase, Luigi; Callans, David; Husler, Karl Georg; Hindricks, Gerhard; Al-Khalidi, Hussein; Mont, Lluis; Nielsen, Jens Cosedis; Piccini, Jonathan P.; Schotten, Ulrich; Kirchhof, Paulus.

In: Europace, Vol. 19, No. 1, 2017, p. 132-138.

Research output: Contribution to journalArticle

Di Biase, Luigi ; Callans, David ; Husler, Karl Georg ; Hindricks, Gerhard ; Al-Khalidi, Hussein ; Mont, Lluis ; Nielsen, Jens Cosedis ; Piccini, Jonathan P. ; Schotten, Ulrich ; Kirchhof, Paulus. / 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. In: Europace. 2017 ; Vol. 19, No. 1. pp. 132-138.
@article{5b49af7c331449758b732005d7e4c2f1,
title = "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",
abstract = "Aims Catheter ablation is the most efficacious rhythm control therapy in atrial fibrillation (AF) patients. There is growing evidence that catheter ablation procedures are best performed during continuous oral anticoagulation, but outcomes are variable depending on the anticoagulation strategy or agent chosen. Specifically, there is a need to evaluate the peri-procedural use of non-vitamin K antagonist oral anticoagulants (NOACs) in patients undergoing catheter ablation of AF. The AXAFA-AFNET 5 trial will test whether peri-procedural anticoagulation therapy using apixaban is a safe alternative to vitamin K antagonist (VKA) therapy for patients undergoing catheter ablation of AF. Methods and results AXAFA-AFNET 5 is a randomized, prospective multi-centre study conducted in Europe and the USA. A total of 650 patients scheduled for AF ablation will be randomized 1:1 to undergo AF ablation on continuous treatment with the NOAC apixaban or with a VKA. Patients can undergo AF ablation after at least 30 days of continuous effective anticoagulation or after exclusion of atrial thrombi by transoesophageal echocardiogram. The trial includes a post-ablation magnetic resonance imaging substudy that will quantify silent brain lesions that can occur in neurologically asymptomatic patients after AF ablation. Patients will be followed on continuous anticoagulation for 3 months after the ablation. The primary outcome parameter of AXAFA-AFNET 5 is a composite of all-cause death, stroke, and major bleeding events. Conclusion The results of AXAFA-AFNET 5 will provide evidence informing about the safety of apixaban in ablation patients and on its efficacy including effects on silent brain lesions. AXAFA - AFNET 5 is an investigator-initiated trial sponsored by AFNET. The trial is supported by the DZHK (German Centre for Cardiovascular Research) and by the BMBF (German Ministry of Education and Research) and by Bristol-Myers Squibb/Pfizer Alliance.",
keywords = "Ablation, Apixaban, Atrial fibrillation, Bleeding, Oral anticoagulation, Stroke, Un-interrupted, Warfarin",
author = "{Di Biase}, Luigi and David Callans and Husler, {Karl Georg} and Gerhard Hindricks and Hussein Al-Khalidi and Lluis Mont and Nielsen, {Jens Cosedis} and Piccini, {Jonathan P.} and Ulrich Schotten and Paulus Kirchhof",
year = "2017",
doi = "10.1093/europace/euw368",
language = "English (US)",
volume = "19",
pages = "132--138",
journal = "Europace",
issn = "1099-5129",
publisher = "Oxford University Press",
number = "1",

}

TY - JOUR

T1 - Rationale and design of AXAFA-AFNET 5

T2 - 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

AU - Di Biase, Luigi

AU - Callans, David

AU - Husler, Karl Georg

AU - Hindricks, Gerhard

AU - Al-Khalidi, Hussein

AU - Mont, Lluis

AU - Nielsen, Jens Cosedis

AU - Piccini, Jonathan P.

AU - Schotten, Ulrich

AU - Kirchhof, Paulus

PY - 2017

Y1 - 2017

N2 - Aims Catheter ablation is the most efficacious rhythm control therapy in atrial fibrillation (AF) patients. There is growing evidence that catheter ablation procedures are best performed during continuous oral anticoagulation, but outcomes are variable depending on the anticoagulation strategy or agent chosen. Specifically, there is a need to evaluate the peri-procedural use of non-vitamin K antagonist oral anticoagulants (NOACs) in patients undergoing catheter ablation of AF. The AXAFA-AFNET 5 trial will test whether peri-procedural anticoagulation therapy using apixaban is a safe alternative to vitamin K antagonist (VKA) therapy for patients undergoing catheter ablation of AF. Methods and results AXAFA-AFNET 5 is a randomized, prospective multi-centre study conducted in Europe and the USA. A total of 650 patients scheduled for AF ablation will be randomized 1:1 to undergo AF ablation on continuous treatment with the NOAC apixaban or with a VKA. Patients can undergo AF ablation after at least 30 days of continuous effective anticoagulation or after exclusion of atrial thrombi by transoesophageal echocardiogram. The trial includes a post-ablation magnetic resonance imaging substudy that will quantify silent brain lesions that can occur in neurologically asymptomatic patients after AF ablation. Patients will be followed on continuous anticoagulation for 3 months after the ablation. The primary outcome parameter of AXAFA-AFNET 5 is a composite of all-cause death, stroke, and major bleeding events. Conclusion The results of AXAFA-AFNET 5 will provide evidence informing about the safety of apixaban in ablation patients and on its efficacy including effects on silent brain lesions. AXAFA - AFNET 5 is an investigator-initiated trial sponsored by AFNET. The trial is supported by the DZHK (German Centre for Cardiovascular Research) and by the BMBF (German Ministry of Education and Research) and by Bristol-Myers Squibb/Pfizer Alliance.

AB - Aims Catheter ablation is the most efficacious rhythm control therapy in atrial fibrillation (AF) patients. There is growing evidence that catheter ablation procedures are best performed during continuous oral anticoagulation, but outcomes are variable depending on the anticoagulation strategy or agent chosen. Specifically, there is a need to evaluate the peri-procedural use of non-vitamin K antagonist oral anticoagulants (NOACs) in patients undergoing catheter ablation of AF. The AXAFA-AFNET 5 trial will test whether peri-procedural anticoagulation therapy using apixaban is a safe alternative to vitamin K antagonist (VKA) therapy for patients undergoing catheter ablation of AF. Methods and results AXAFA-AFNET 5 is a randomized, prospective multi-centre study conducted in Europe and the USA. A total of 650 patients scheduled for AF ablation will be randomized 1:1 to undergo AF ablation on continuous treatment with the NOAC apixaban or with a VKA. Patients can undergo AF ablation after at least 30 days of continuous effective anticoagulation or after exclusion of atrial thrombi by transoesophageal echocardiogram. The trial includes a post-ablation magnetic resonance imaging substudy that will quantify silent brain lesions that can occur in neurologically asymptomatic patients after AF ablation. Patients will be followed on continuous anticoagulation for 3 months after the ablation. The primary outcome parameter of AXAFA-AFNET 5 is a composite of all-cause death, stroke, and major bleeding events. Conclusion The results of AXAFA-AFNET 5 will provide evidence informing about the safety of apixaban in ablation patients and on its efficacy including effects on silent brain lesions. AXAFA - AFNET 5 is an investigator-initiated trial sponsored by AFNET. The trial is supported by the DZHK (German Centre for Cardiovascular Research) and by the BMBF (German Ministry of Education and Research) and by Bristol-Myers Squibb/Pfizer Alliance.

KW - Ablation

KW - Apixaban

KW - Atrial fibrillation

KW - Bleeding

KW - Oral anticoagulation

KW - Stroke

KW - Un-interrupted

KW - Warfarin

UR - http://www.scopus.com/inward/record.url?scp=85016182463&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85016182463&partnerID=8YFLogxK

U2 - 10.1093/europace/euw368

DO - 10.1093/europace/euw368

M3 - Article

C2 - 28130378

AN - SCOPUS:85016182463

VL - 19

SP - 132

EP - 138

JO - Europace

JF - Europace

SN - 1099-5129

IS - 1

ER -