Effects of Ablation Versus Drug Therapy on Quality of Life by Sex in Atrial Fibrillation: Results From the CABANA Trial.
Emily P ZeitlerYanhong LiAdam P SilversteinAndrea M RussoJeanne E PooleMelanie R DanielsHussein R Al-KhalidiKerry L LeeTristram D BahnsonKevin J AnstromDouglas L PackerDaniel B Marknull nullPublished in: Journal of the American Heart Association (2023)
Background Women with atrial fibrillation (AF) demonstrate more AF-related symptoms and worse quality of life (QOL). Whether increased use of ablation in women reduces sex-related QOL differences is unknown. Sex-related outcomes for ablation versus drug therapy was a prespecified analysis in the CABANA (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) trial. Methods and Results Symptoms were assessed periodically over 60 months with the Mayo AF-Specific Symptom Inventory (MAFSI) frequency score, and QOL was assessed with the Atrial Fibrillation Effect on Quality of Life (AFEQT) summary and component scores. Women had lower baseline QOL scores than men (mean AFEQT scores 55.9 and 65.6, respectively). Ablation patients improved more than drug therapy patients with similar treatment effect by sex: AFEQT 12-month mean adjusted treatment difference in women 6.1 points (95% CI, 3.5-8.6) and men 4.9 points (95% CI, 3.0-6.9). Participants with baseline AFEQT summary scores <70 had greater QOL improvement, with a mean treatment difference at 12 months of 7.6 points for women (95% CI, 4.3-10.9) and 6.4 points for men (95% CI, 3.3-9.4). The mean adjusted difference in MAFSI frequency score between women randomized to ablation versus drug therapy at 12 months was -2.5 (95% CI, -3.4 to -1.6); for men, the difference was -1.3 (95% CI, -2.0 to -0.6). Conclusions Compared with drug therapy for AF, ablation resulted in more QOL improvement in both sexes, primarily driven by improvements in those with lower baseline QOL. Ablation did not eliminate the AF-related QOL gap between women and men. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00911508.
Keyphrases
- catheter ablation
- atrial fibrillation
- left atrial
- left atrial appendage
- polycystic ovary syndrome
- oral anticoagulants
- direct oral anticoagulants
- heart failure
- pregnancy outcomes
- cervical cancer screening
- drug induced
- percutaneous coronary intervention
- clinical trial
- adverse drug
- randomized controlled trial
- phase iii
- study protocol
- middle aged
- stem cells
- bone marrow
- insulin resistance
- cell therapy
- depressive symptoms
- coronary artery disease
- physical activity
- open label
- venous thromboembolism
- prognostic factors
- metabolic syndrome
- patient reported outcomes
- weight loss
- double blind