STABLE-SR (Electrophysiological Substrate Ablation in the Left Atrium During Sinus Rhythm) for the Treatment of Nonparoxysmal Atrial Fibrillation: A Prospective, Multicenter Randomized Clinical Trial
Circumferential pulmonary vein isolation (CPVI) alone or combined with adjuvant substrate modifications is unsatisfactory for atrial fibrillation (AF) control in nonparoxysmal AF patients. Ablation targeting the fibrotic areas after CPVI (STABLE-SR [Electrophysiological Substrate Ablation in the Left Atrium During Sinus Rhythm]) is a newly evolved substrate modification strategy.Methods and Results:
In this multicenter, randomized clinical trial, 229 symptomatic nonparoxysmal AF patients were 1:1 randomized to STABLE-SR group (n=114) or conventional STEPWISE group (n=115). In the STABLE-SR group, after CPVI, cavotricuspid isthmus ablation and cardioversion to sinus rhythm, left atrial high-density mapping was performed. Areas with low-voltage and complex electrogram were further homogenized and eliminated, respectively. Dechanneling would be done if necessary. In the STEPWISE group, additional linear lesions and defragmentation were performed.The primary end point was freedom from documented atrial tachyarrhythmias for ≥30 s after a single ablation procedure without antiarrhythmic medications at 18 months. At 18 months, 74.0% of the patients in the STABLE-SR group and 71.5% in the STEPWISE group (hazard ratio, 0.78; 95% confidence interval, 0.47–1.29; P=0.325) achieved success according to intention-to-treat analysis. However, less procedure time (186.8±52.7 versus 210.5±48.0 minutes, P<0.001), reduced post-CPVI fluoroscopic time (11.0±7.8 versus 13.7±8.9 minutes, P=0.006), and shorter energy delivery time (60.1±25.1 versus 75.0±24.3 minutes, P<0.001) were observed in the STABLE-SR group compared with the STEPWISE group.Conclusions:
STABLE-SR is a simplified, personalized, and effective ablation strategy in nonparoxysmal AF patients. More importantly, over 50% nonparoxysmal AF patients do not need further ablation beyond CPVI and therefore can avoid excessive ablation.Clinical Trial Registration:
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01761188.