March 8, 2018Open Access
Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) Trial: Study Rationale and Design
Key Result
Catheter ablation is being tested against pharmacologic therapy in 2200 patients to detect a 30% relative reduction in mortality, disabling stroke, serious bleeding, or cardiac arrest.
Study Design
Type
RCT (n=2,200)
Randomization
1:1
Multicenter
Yes
Structured PICO
Does percutaneous left atrial catheter ablation reduce the composite of total mortality, disabling stroke, serious bleeding, or cardiac arrest in patients with atrial fibrillation compared to state-of-the-art rate or rhythm control drug therapy?
P
Population
2200 patients with documented atrial fibrillation warranting treatment, age >65 or ≤65 with ≥1 risk factor for stroke, eligible for both catheter ablation and ≥2 anti-arrhythmic or ≥2 rate control drugs.
I
Intervention
Percutaneous left atrial catheter ablation
C
Comparator
State-of-the-art rate or rhythm control drug therapy
O
Outcome
Composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrestcomposite
The CABANA trial is designed to evaluate whether catheter ablation is superior to state-of-the-art pharmacologic therapy for reducing mortality and major cardiovascular events in patients with atrial fibrillation.
Abstract
The Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA,NCT00911508)(1) trial is testing the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) is superior to current state-of-the-art pharmacologic therapy. This international 140-center clinical trial was designed to randomize 2200 patients to a strategy of catheter ablation versus state-of-the-art rate or rhythm control drug therapy. Inclusion criteria include: 1) age> 65, or ≤65 with≥ 1 risk factor for stroke, 2) documented AF warranting treatment, and 3) eligibility for both catheter ablation and≥ 2 anti-arrhythmic or≥ 2 rate control drugs. Patients were followed every 3 to 6 months (median 4 years) and underwent repeat trans-telephonic monitoring, Holter monitoring, and CT/MR in a subgroup of patient studies to assess the impact of treatment on AF recurrence and atrial structure. With 1100 patients in each treatment arm, CABANA is projected to have 90% power for detecting a 30% relative reduction in the primary composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest. Secondary endpoints include total mortality; mortality or cardiovascular hospitalization; a combination of mortality, stroke, hospitalization for heart failure or acute coronary artery events; cardiovascular death alone; and heart failure death, as well as AF recurrence, quality of life, and cost effectiveness. At a time when AF incidence is rising rapidly, CABANA will provide critical evidence with which to guide therapy and shape health care policy related to AF for years to come.