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房颤类型对消融与药物治疗结局的影响:CABANA 研究结果。

Influence of atrial fibrillation type on outcomes of ablation vs. drug therapy: results from CABANA.

机构信息

Mayo Clinic, 1216 2nd St. SW, Rochester, MN 55902, USA.

Intermountain Health Care, University of Utah, Salt Lake City, UT 84132, USA.

出版信息

Europace. 2022 Oct 13;24(9):1430-1440. doi: 10.1093/europace/euac055.

Abstract

AIMS

Influence of atrial fibrillation (AF) type on outcomes seen with catheter ablation vs. drug therapy is incompletely understood. This study assesses the impact of AF type on treatment outcomes in the Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA).

METHODS AND RESULTS

CABANA randomized 2204 patients ≥65 years old or <65 with at least one risk factor for stroke to catheter ablation or drug therapy. Of these, 946 (42.9%) had paroxysmal AF (PAF), 1042 (47.3%) had persistent AF (PersAF), and 215 (9.8%) had long-standing persistent AF (LSPAF) at baseline. The primary endpoint was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Symptoms were measured with the Mayo AF-Specific Symptom Inventory (MAFSI), and quality of life was measured with the Atrial Fibrillation Effect on Quality of Life (AFEQT). Comparisons are reported by intention to treat. Compared with drug therapy alone, catheter ablation produced a 19% relative risk reduction in the primary endpoint for PAF {adjusted hazard ratio [aHR]: 0.81 [95% confidence interval (CI): 0.50, 1.30]}, and a 17% relative reduction for PersAF (aHR: 0.83, 95% CI: 0.56, 1.22). For LSPAF, the ablation relative effect was a 7% reduction (aHR: 0.93, 95% CI: 0.36, 2.44). Ablation was more effective than drug therapy at reducing first AF recurrence in all AF types: by 51% for PAF (aHR: 0.49, 95% CI: 0.39, 0.62), by 47% for PersAF (aHR: 0.53, 95% CI: 0.43,0.65), and by 36% for LSPAF (aHR 0.64, 95% CI 0.41,1.00). Ablation was associated with greater improvement in symptoms, with the mean difference between groups in the MAFSI frequency score favouring ablation over 5 years of follow-up in all subgroups: PAF had a clinically significant -1.9-point difference (95% CI: -1.2 to -2.6); PersAF a -0.9 difference (95% CI: -0.2 to -1.6); LSPAF a clinically significant difference of -1.6 points (95% CI: -0.1 to -3.1). Ablation was also associated with greater improvement in quality of life in all subgroups, with the AFEQT overall score in PAF patients showing a clinically significant 5.3-point improvement (95% CI: 3.3 to 7.3) over drug therapy alone over 5 years of follow-up, PersAF a 1.7-point difference (95% CI: 0.0 to 3.7), and LSPAF a 3.1-point difference (95% CI: -1.6 to 7.8).

CONCLUSION

Prognostic treatment effects of catheter ablation compared with drug therapy on the primary and major secondary clinical endpoints did not differ consequentially by AF subtype. With regard to decreases in AF recurrence and improving quality of life, ablation was more effective than drug therapy in all three AF type subgroups.

CLINICALTRIALS.GOV IDENTIFIER: NCT00911508.

摘要

目的

心房颤动(AF)类型对导管消融与药物治疗相比的结果的影响尚不完全清楚。本研究评估了 AF 类型对 Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial(CABANA)中治疗结果的影响。

方法和结果

CABANA 将≥65 岁或<65 岁且至少有 1 个中风危险因素的 2204 名患者随机分为导管消融或药物治疗组。其中,946 名(42.9%)为阵发性 AF(PAF),1042 名(47.3%)为持续性 AF(PersAF),215 名(9.8%)为长期持续性 AF(LSPAF)。主要终点是死亡、致残性中风、严重出血或心脏骤停的复合终点。症状通过 Mayo AF 特异性症状量表(MAFSI)进行测量,生活质量通过房颤对生活质量的影响量表(AFEQT)进行测量。按意向治疗进行比较。与单独药物治疗相比,导管消融可使 PAF 的主要终点相对风险降低 19%(调整后的危险比 [aHR]:0.81 [95%置信区间(CI):0.50,1.30]),PersAF 的相对降低 17%(aHR:0.83,95%CI:0.56,1.22)。对于 LSPAF,消融的相对效果降低了 7%(aHR:0.93,95%CI:0.36,2.44)。在所有 AF 类型中,消融在降低首次 AF 复发方面比药物治疗更有效:PAF 降低了 51%(aHR:0.49,95%CI:0.39,0.62),PersAF 降低了 47%(aHR:0.53,95%CI:0.43,0.65),LSPAF 降低了 36%(aHR 0.64,95%CI 0.41,1.00)。消融与症状改善的相关性更大,在所有亚组中,5 年随访期间,MAFSI 频率评分组间平均差异有利于消融:PAF 有临床显著的-1.9 分差异(95%CI:-1.2 至-2.6);PersAF 为-0.9 分差异(95%CI:-0.2 至-1.6);LSPAF 为临床显著的-1.6 分差异(95%CI:-0.1 至-3.1)。消融也与所有亚组的生活质量改善相关,PAF 患者的 AFEQT 总评分在 5 年随访期间显示出与单独药物治疗相比具有临床显著的 5.3 分改善(95%CI:3.3 至 7.3),PersAF 为 1.7 分差异(95%CI:0.0 至 3.7),LSPAF 为 3.1 分差异(95%CI:-1.6 至 7.8)。

结论

与药物治疗相比,导管消融在主要和主要次要临床终点的预后治疗效果在 AF 亚型之间没有显著差异。就 AF 复发的减少和生活质量的改善而言,消融在所有三个 AF 类型亚组中比药物治疗更有效。

临床试验注册号

NCT00911508。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4a8c/11249917/48ecdc7b3de7/euac055ga1.jpg

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