Division of Cardiovascular Disease, Cooper Medical School of Rowan University, Camden, NJ (A.M.R.).
The Geisel School of Medicine at Dartmouth, Hanover, NH, Division of Cardiology, Dartmouth-Hitchcock Medical Center, and The Dartmouth Institute, Lebanon, NH (E.P.Z.).
Circulation. 2021 Feb 16;143(7):661-672. doi: 10.1161/CIRCULATIONAHA.120.051558. Epub 2021 Jan 27.
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 about sex-specific differences after ablation comes from observational data. We prespecified an examination of outcomes by sex in the 2204-patient CABANA trial (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation).
CABANA randomized patients with AF age ≥65 years or <65 years 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.
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 versus 67 years for men), were more symptomatic (48% Canadian Cardiovascular Society AF Severity Class 3 or 4 versus 39% for men), had more symptomatic heart failure (42% with New York Heart Association Class ≥II versus 32% for men), and more often had a paroxysmal AF pattern at enrollment (50% versus 39% for men) (<0.0001 for all). Women were less likely to have ancillary (nonpulmonary vein) ablation procedures performed during the index procedure (55.7% versus 62.2% in men, =0.043), and complications from treatment were infrequent in both sexes. For the primary outcome, the hazard ratio for those who underwent ablation versus 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 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 (hazard ratio, 0.64 [95% CI, 0.51-0.82] for women versus hazard ratio, 0.48 [95% CI, 0.40-0.58] for men; interaction value=0.060).
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. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00911508.
在心房颤动（AF）患者中，女性接受导管消融术的可能性较小，并且可能会出现更多的并发症，且治疗效果的持久性较差。大多数关于消融术后性别特异性差异的信息都来自观察性数据。我们在 2204 名患者的 CABANA 试验（导管消融术与抗心律失常药物治疗心房颤动）中预先设定了按性别检查结局的方案。
CABANA 将年龄≥65 岁或<65 岁且有≥1 个中风风险因素的 AF 患者随机分配至导管消融术联合肺静脉隔离与药物治疗（包括控制心率/节律的药物）策略。主要复合结局为死亡、致残性中风、严重出血或心脏骤停，关键次要结局包括 AF 复发。
CABANA 随机分配 819 名（37%）女性（消融术 413 例，药物治疗 406 例）和 1385 名男性（消融术 695 例，药物治疗 690 例）。与男性相比，女性年龄更大（中位数年龄为 69 岁，而男性为 67 岁），症状更严重（48%为加拿大心血管学会 AF 严重程度分级 3 或 4 级，而男性为 39%），有更多症状性心力衰竭（42%为纽约心脏协会心功能分级≥Ⅱ级，而男性为 32%），且在登记时更常出现阵发性 AF 模式（50%比男性的 39%）（所有比较均<0.0001）。女性在指数手术期间进行辅助（非肺静脉）消融术的可能性较低（女性为 55.7%，男性为 62.2%，=0.043），并且两种性别均很少发生与治疗相关的并发症。对于主要结局，与药物治疗相比，接受消融术治疗的患者发生的风险比为 1.01（95%CI，0.62-1.65），男性为 0.73（95%CI，0.51-1.05）（交互检验值=0.299）。无论性别如何，与接受药物治疗的患者相比，接受消融术治疗的患者发生 AF 复发的风险显著降低，但男性的效果更大（女性的风险比为 0.64[95%CI，0.51-0.82]，男性的风险比为 0.48[95%CI，0.40-0.58]；交互检验值=0.060）。
CABANA 主要和次要临床结局的治疗相关策略在男性和女性之间没有明显的临床相关差异，且不良事件也没有性别差异。CABANA 试验结果支持导管消融术作为一种有效治疗策略，适用于女性和男性。
