Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, 200 1st St SW, Rochester, MN, USA.
Department of Cardiovascular Medicine, Mayo Clinic, 200 1st St SW, Rochester, MN, USA.
Eur Heart J. 2019 Apr 21;40(16):1257-1264. doi: 10.1093/eurheartj/ehz085.
The Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial aimed to assess the impact of ablation on morbidity and mortality. This observational study was conducted in parallel to CABANA to assess trial generalizability.
Using a large US administrative database, we identified 183 760 patients with atrial fibrillation (AF) treated with ablation or medical therapy (antiarrhythmic or rate control drugs) between 1 August 2009 and 30 April 2016 (CABANA enrolment period). Propensity score weighting was used to balance patients treated with ablation (N = 12 032) or medical therapy alone (N = 171 728) on 90 dimensions. Ablation was associated with a reduction in the composite endpoint of all-cause mortality, stroke, major bleeding, and cardiac arrest [hazard ratio (HR) 0.75, 95% confidence interval (CI) 0.70-0.81; P < 0.001]. The majority of patients (73.8%) were potentially trial eligible; among whom the risk reduction associated with ablation was greatest (HR 0.70, 95% CI 0.63-0.77; P < 0.001). Among the 3.8% of patients who failed to meet the inclusion criterion, i.e. patients under 65 years without stroke risk factors, the event rates were low and there was no significant relationship with ablation (HR 0.67, 95% CI 0.29-1.56; P = 0.35). Among the 22.4% patients who met at least one of the trial exclusion criteria, there was a lesser but statistically significant reduction associated with ablation (HR 0.85, 95% CI 0.75-0.95; P = 0.01).
In routine clinical care, ablation was associated with a reduction in the primary CABANA composite endpoint of all-cause mortality, stroke, major bleeding, and cardiac arrest, particularly in patients who were eligible for the trial.
导管消融与抗心律失常药物治疗心房颤动(CABANA)试验旨在评估消融对发病率和死亡率的影响。这项观察性研究与 CABANA 同时进行,以评估试验的普遍性。
使用美国大型行政数据库,我们确定了 183760 例 2009 年 8 月 1 日至 2016 年 4 月 30 日期间接受消融或药物治疗(抗心律失常或心率控制药物)的心房颤动(AF)患者(CABANA 入组期间)。采用倾向评分加权法,对接受消融治疗的患者(N=12032)和单独接受药物治疗的患者(N=171728)进行 90 个维度的平衡。消融与全因死亡率、卒中、大出血和心脏骤停的复合终点降低相关[风险比(HR)0.75,95%置信区间(CI)0.70-0.81;P<0.001]。大多数患者(73.8%)具有潜在的试验入选资格;其中,消融相关风险降低最大(HR 0.70,95%CI 0.63-0.77;P<0.001)。在 3.8%不符合纳入标准的患者中,即年龄<65 岁且无卒中危险因素的患者,事件发生率较低,且与消融无显著关系(HR 0.67,95%CI 0.29-1.56;P=0.35)。在符合至少一项试验排除标准的 22.4%患者中,消融相关的风险降低虽较小,但具有统计学意义(HR 0.85,95%CI 0.75-0.95;P=0.01)。
在常规临床治疗中,消融与全因死亡率、卒中、大出血和心脏骤停的主要 CABANA 复合终点降低相关,特别是在符合试验入选标准的患者中。