Ablation vs Pharmacotherapy: Quality of Life for Women With Atrial Fibrillation

Ablation for atrial fibrillation (AF) leads to more quality of life (QOL) improvement in both sexes compared with drug therapy, however, the AF-related QOL gap between men and women is not eliminated, and women with AF have worse AF-related QOL than men. These findings were published in the Journal of the American Heart Association.

CABANA (Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation; ClinicalTrials.gov Identifier: NCT00911508), a randomized controlled trial to determine if ablation-based therapy for AF is more effective than drug-based therapy in relation to cardiac arrest, serious bleeding, disabling stroke, or death, revealed these major clinical outcomes were similar by sex. CABANA included 2204 patients (819 women) at 126 international clinical sites with new-onset or undertreated symptomatic AF who were enrolled between 2009 and 2016. All patients were either at least 65 years of age and younger with at least 1 risk factor for stroke.

Investigators sought to describe the effects of ablation vs drug therapy on QOL outcomes stratified by sex in the CABANA trial. There were 413 women and 695 men in the ablation group and 406 women and 690 men in the drug therapy group. The investigators used the Mayo AF-Specific Symptom Inventory (MAFSI) frequency score to periodically evaluate symptoms over 60 months, and they used the Atrial Fibrillation Effect on Quality of Life (AFEQT) summary and component scores to evaluate QOL. Overall, women were older (mean age, 69 years vs 67 years) and more symptomatic at baseline (42% vs 32% in New York Heart Association class II or III; 48% vs 39% in Canadian Cardiovascular Society class 3 or 4) than men.

Baseline QOL scores were lower for women vs men (mean AFEQT, 55.9 vs 65.6). Patients with ablation improved more than patients with drug therapy with similar treatment effect by sex. Mean AFEQT summary score for women was 81.5 for ablation vs 75.3 for drug therapy. Mean AFEQT summary score for men was 89.3 for ablation vs 84.1 for drug therapy (12-month mean adjusted AFEQT treatment difference: women 6.1 points [95% CI, 3.5-8.6]; men 4.9 points [95% CI, 3.0-6.9]).

Roughly 75% of women and 51% of men had severe AF symptoms at enrollment, with baseline AFEQT summary scores of less than 70. Overall, the greatest QOL improvement was seen in patients with baseline AFEQT scores of less than 70 (12-month mean treatment difference: women 7.6 points; 95% CI, 4.3-10.9; men 6.4 points; 95% CI, 3.3-9.4). The MAFSI frequency score between patients randomly assigned to ablation vs drug therapy also showed a difference by sex (12-month mean adjusted difference: women -2.5 [95% CI, -3.4 to -1.6]; men -1.3 [95% CI, -2.0 to -0.6]).

Report limitations include potential patient response bias and clinician procedural bias. There are also a large number of potential outcome comparisons of QOL assessment and no standard for identifying QOL.

“On average, women with AF in CABANA consistently reported moderate-to severe AF-related baseline impairments in QOL with lower baseline scores than those reported on average by men,” the study authors wrote. “Despite clinically effective ablation, however, women averaged persistently lower QOL scores than men despite a similar relative benefit from ablation and a similar distribution of symptoms.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.