Association Between Sex and Treatment Outcomes of Atrial Fibrillation Ablation vs Drug Therapy
abstract
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Access this abstract nowBackground
Among patients with atrial fibrillation (AF), women are less likely to receive catheter ablation, and may have more complications and less durable results. Most information regarding sex-specific differences after ablation comes from observational data. We pre-specified an examination of outcomes by sex in the 2204-patient Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial.
Methods
CABANA randomized patients with AF age ≥65 or <65 with ≥1 risk factor for stroke to a strategy of catheter ablation with pulmonary vein isolation versus drug therapy with rate/rhythm control agents. The primary composite outcome was death, disabling stroke, serious bleeding, or cardiac arrest, and key secondary outcomes included AF recurrence.
Results
CABANA randomized 819 (37%) women (ablation 413, drug 406) and 1385 men (ablation 695, drug 690). Compared with men, women were older (median age 69 years vs. 67 for men), more symptomatic (48% Canadian Cardiovascular Society AF Severity Class 3 or 4 vs. 39% for men), had more symptomatic heart failure (42% with NYHA Class ≥II vs. 32% for men), and more often had a paroxysmal AF pattern at enrollment (50% vs. 39% for men), (p <.0001 for all). Women were less likely to have ancillary (non-pulmonary vein) ablation procedures performed during the index procedure (55.7% vs. 62.2% in men, p = 0.043), and complications from treatment were infrequent in both sexes. For the primary outcome, the hazard ratio (HR) for those who underwent ablation vs. drug therapy was 1.01 (95% CI 0.62-1.65) in women and 0.73 (95% CI 0.51-1.05) in men (interaction p value=0.299). The risk of recurrent AF was significantly reduced in patients undergoing ablation compared with those receiving drug therapy regardless of sex, but the effect was greater in men (HR 0.64, 95% CI 0.51-0.82 for women vs. HR 0.48, 95% CI 0.40-0.58 for men, interaction p value=0.060).
Conclusions
Clinically relevant treatment-related strategy differences in the primary and secondary clinical outcomes of CABANA were not seen between men and women, and there were no sex differences in adverse events. The CABANA trial results support catheter ablation as an effective treatment strategy for both women and men.
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Additional Info
Association Between Sex and Treatment Outcomes of Atrial Fibrillation Ablation Versus Drug Therapy: Results From the CABANA Trial
Circulation 2021 Jan 27;[EPub Ahead of Print], AM Russo, EP Zeitler, A Giczewska, AP Silverstein, HR Al-Khalidi, YM Cha, KH Monahan, TD Bahnson, DB Mark, DL Packer, JE PooleFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.