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ATRIAL FIBRILLATION TRIALS. A HRS – CVCT joint session


Chairpersons : George Van Hare (Saint Louis, USA), Heather Ross (Tempe, USA)
2.00 pm – 7.30 pm
 Ablation trials
o Current guidelines recommend pulmonary-vein isolation by means of catheter
ablation as treatment for drug-refractory paroxysmal atrial fibrillation.
Radiofrequency ablation is the most common method, and cryoballoon ablation is
the second most frequently used technology.
o It was recently reported that cryoballoon ablation was noninferior to
radiofrequency ablation with respect to efficacy for the treatment of patients with
drug-refractory paroxysmal atrial fibrillation, and there was no significant
difference between the two methods with regard to overall safety. (FIRE AND
ICE).
o It is not known whether successful ablation of AF, regardless of technique, will
result in reduced mortality. This is under investigation in the Catheter Ablation
versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA) and
Catheter Ablation versus Standard Conventional Treatment in Patients With LV
Dysfunction and AF (CASTLE-AF)
o However, specifically in persistent atrial fibrillation in patients with heart failure
catheter ablation, whether ablation is superior to amiodarone was examined in a
randomized study which showed that catheter ablation of atrial fibrillation is
superior to amiodarone in achieving freedom from AF at long-term follow-up and
reducing unplanned hospitalization and mortality in patients with heart failure and
persistent AF.
 NOAC trials
o Trials reporting anticoagulant benefits in AF were done in people with either
symptomatic AF or paroxysmal AF long enough to be recorded on multiple ECGs.
o Diagnosis of short term AF is of uncertain significance. It seems that only longerlasting
AF associates with stroke.
o How valuable short-duration AF as a surrogate marker is questionable and needs
further substantiation.
o Guidelines recommendations regarding anticoagulant therapy after percutaneous
coronary intervention (PCI) among patients with atrial fibrillation (AF) rely on
retrospective, nonrandomized observational data. Currently, patients are treated
with triple-therapy (dual antiplatelet therapy [DAPT] + oral anticoagulation
therapy), but neither the duration of DAPT nor the level of anticoagulation has
been studied in a randomized fashion. Recent studies also suggest dual pathway
therapy with clopidogrel plus oral anticoagulation therapy may be superior, and
other studies suggest that novel oral anticoagulants such as rivaroxaban may
further improve patient outcomes.
The PIONEER AF-PCI study is the first randomized comparison of VKA vs. novel
oral anticoagulant therapy in patients with AF receiving antiplatelet therapy after
PCI to assess the relative risks of bleeding complications.

 Left atrial appendage closure trials
After the initial trials and within the context of controversial evidence of efficacy of
the FDA approved Watchman percutaneous left atrial appendage closure (LAAC),
further data are derived from registries. CMS covers FDA approved LAAC for
non-valvular atrial fibrillation through Coverage with Evidence Development
(CED) in patients enrolled in certain well designed registries and in FDA approved
trials. Patients unsuitable for oral anticoagulation are further evaluated with in the
ASAP-TOO trial
 Research on the causes and mechanisms of AF points to the role of fibrosis. Trials
of anti fibrotic agents?
Trials of anti-thrombotic therapy in AF Ablation (AXAFA - AFNET 5 trial)
Paulus Kirchhof (Birmingham, GBR)
NOACs in patients with atrial fibrillation who undergo percutaneous coronary
intervention.
Harry Crijns (Maastricht, NED)
Targeted anticoagulation for short-term device detected AF. Is it ripe for a
prospective NOAC trial?
Renato Lopes (Durham, USA)
The value of trial derived novel biomarker-based bleeding risk score for patients
with AF.
Ziad Hijazi (Uppsala, SWE)
Left Atrial Appendage Closure. Registry non-randomized evidence and how it
aligns with randomized trial evidence
Lucas Boersma (Nieuwegein, NED)
Targeting the right patient population. Are trials addressing personalized AFib
prevention/treatment strategies?
Nassir Marrouche (Salt Lake City, USA)
Vascular closure device to shorten time to ambulation after AF ablation; The
AMBULATE Trial
Mintu Turakhia (Stanford, USA)
Industry perspective
Martin Unverdorben (Daiichi Sankyo, USA), Peter Dibattiste (Janssen, USA), Kenneth
Stein (Boston Scientific, USA)
Regulatory Perspective:
Andrew Farb (FDA, USA), Pieter DeGraeff (EMA, NED)

Benefit/risk and cost effectiveness considerations of anti-thrombotic strategies in
AF. Payers perspective:
Joseph Chin (CMS, USA)
Patient viewpoint : Natascha Van der Post (Nijmegen Area, NED)
Media viewpoint : Ron Winslow (Wall Street Journal, USA)
The Forum. Moderated discussion with the audience
How to progress from evidence generation to change in practice.
Chairpersons: George Van Hare (Saint Louis, USA), Heather Ross (Tempe, USA)
Panelists: Lucas Boersma (Nieuwegein, NED), Joseph Chin (CMS, USA), Harry Crijns
(Maastricht, NED), Pieter DeGraeff (EMA, NED), Peter Dibattiste (Janssen, USA),
Andrew Farb (FDA, USA), Ziad Hijazi (Uppsala, SWE), Paulus Kirchhof (Birmingham,
GBR), Renato Lopes (Durham, USA), Nassir Marrouche (Salt Lake City, USA), Heather
Ross (Tempe, USA), Kenneth Stein (Boston Scientific, USA), Mintu Turakhia (Stanford,
USA), Martin Unverdorben (Daiichi Sankyo, USA), Natascha Van der Post (Nijmegen
Area, NED), George Van Hare (Saint Louis, USA), Ron Winslow (Wall Street Journal,
USA)