Ablation led to greater quality of life improvements than drugs in patients with atrial fibrillation (AFib), according to results presented Aug. 29 at the European Society of Cardiology Congress.
Reduction of time in AFib did not differ significantly between the treatments.
The study is the first to use quality of life as the primary endpoint when assessing AFib ablation.
The multicenter, prospective, randomized trial enrolled 155 patients with symptomatic AFib who had failed one drug for either rate or rhythm control. Patients received an implantable cardiac monitor for a two-month phase-in period, then were randomized to ablation with pulmonary vein isolation or antiarrhythmic drug therapy.
Researchers assessed changes from baseline to 12 months in general health—measured by a 36-question survey—quality of life, symptoms, European Heart Rhythm Association (EHRA) Symptom Classification, AFib burden and safety.
After the one-year follow-up, the general health score had improved by 7.9 more points in the ablation group than the drug group. Also, the EHRA score improved significantly more in the ablation group (from 3.0 to 1.6) than the drug group (2.9 to 2.1).
"Using quality of life as the primary endpoint of a trial for the first time, we demonstrated that pulmonary vein isolation is significantly more effective than antiarrhythmic drugs in a mixed population of paroxysmal and persistent AFib patients, even at an early stage of their disease,” principal investigator Carina Blomström-Lundqvist, an adjunct professor in the department of medical science at Uppsala University in Sweden, said in a statement. “Quality of life should be the primary endpoint in future trials since the main indication for rhythm control is its improvement. The lack of a statistically significant difference between treatment groups in the reduction in AFib burden suggests that other mechanisms may explain the better improvement of quality of life and symptoms achieved with pulmonary vein isolation compared to antiarrhythmic drugs.”