Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) Trial: Study Rationale and Design

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.

Figure 1.

CABANA Trial Design. AF, Atrial fibrillation; CVA, Cerebral vascular accident; R, Randomized; PVI, Pulmonary vein isolation; WACA, Wide area circumferential ablation; CFAE, Complex fractionated atrial electrograms (CFAE); GP, Ganglionated plexuses; CT/MR, Computed tomography/magnetic resonance; EQOL, Economic and Quality of Life; AD:AC, Autodetect/autocapture; LA, Left atria.

Figure 2.

CABANA Trial Organization and Process Flow. PI, Principal investigator; NHLBI, National Heart, Lung, and Blood Institute; QoL, Quality of Life; ECG/EGM, Electrocardiogram/electrograms mapping; FDA/CMS/HRS/AHA/ACC, Food and Drug Administration/Centers for Medicare & Medicaid Services/Heart Rhythm Society/American Heart Association/American College of Cardiology.