Importance Renal denervation can reduce cardiac sympathetic activity that may result in an antiarrhythmic effect on atrial fibrillation. Objective To determine whether renal denervation when added to pulmonary vein isolation enhances long-term antiarrhythmic efficacy. Design, Setting, and Participants The Evaluate Renal Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation (ERADICATE-AF) trial was an investigator-initiated, multicenter, single-blind, randomized clinical trial conducted at 5 referral centers for catheter ablation of atrial fibrillation in the Russian Federation, Poland, and Germany. A total of 302 patients with hypertension despite taking at least 1 antihypertensive medication, paroxysmal atrial fibrillation, and plans for ablation were enrolled from April 2013 to March 2018. Follow-up concluded in March 2019. Interventions Patients were randomized to either pulmonary vein isolation alone (n = 148) or pulmonary vein isolation plus renal denervation (n = 154). Complete pulmonary vein isolation to v an end point of elimination of all pulmonary vein potentials; renal denervation using an irrigated-tip ablation catheter delivering radiofrequency energy to discrete sites in a spiral pattern from distal to proximal in both renal arteries. Main Outcomes and Measures The primary end point was freedom from atrial fibrillation, atrial flutter, or atrial tachycardia at 12 months. Secondary end points included procedural complications within 30 days and blood pressure control at 6 and 12 months. Results Of the 302 randomized patients (median age, 60 years [interquartile range, 55-65 years]; 182 men [60.3%]), 283 (93.7%) completed the trial. All successfully underwent their assigned procedures. Freedom from atrial fibrillation, flutter, or tachycardia at 12 months was observed in 84 of 148 (56.5%) of those undergoing pulmonary vein isolation alone and in 111 of 154 (72.1%) of those undergoing pulmonary vein isolation plus renal denervation (hazard ratio, 0.57; 95% CI, 0.38 to 0.85; P = .006). Of 5 prespecified secondary end points, 4 are reported and 3 differed between groups. Mean systolic blood pressure from baseline to 12 months decreased from 151 mm Hg to 147 mm Hg in the isolation-only group and from 150 mm Hg to 135 mm Hg in the renal denervation group (between-group difference, -13 mm Hg; 95% CI, -15 to -11 mm Hg; P < .001). Procedural complications occurred in 7 patients (4.7%) in the isolation-only group and 7 (4.5%) of the renal denervation group. Conclusions and Relevance Among patients with paroxysmal atrial fibrillation and hypertension, renal denervation added to catheter ablation, compared with catheter ablation alone, significantly increased the likelihood of freedom from atrial fibrillation at 12 months. The lack of a formal sham-control renal denervation procedure should be considered in interpreting the results of this trial. Trial Registration ClinicalTrials.gov Identifier: NCT01873352.

中文翻译：

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去肾神经和导管消融与单独导管消融对阵发性房颤合并高血压患者房颤复发的影响

重要性 肾去神经支配可以降低心脏交感神经活动，这可能导致对心房颤动的抗心律失常作用。目的 确定在肺静脉隔离中加入去肾神经支配是否能增强长期抗心律失常疗效。设计、设置和参与者 评估除导管消融外的肾脏去神经支配以消除心房颤动 (ERADICATE-AF) 试验是一项由研究者发起的、多中心、单盲、随机临床试验，在 5 个转诊中心进行，用于心房导管消融。俄罗斯联邦、波兰和德国的颤动。从 2013 年 4 月至 2018 年 3 月，共纳入 302 名尽管至少服用 1 种降压药、阵发性房颤和有消融计划的高血压患者。随访于 2019 年 3 月结束。 干预 患者随机接受单独肺静脉隔离（n = 148）或肺静脉隔离加肾去神经支配（n = 154）。完全肺静脉隔离以消除所有肺静脉电位的终点；使用灌注式尖端消融导管将射频能量以螺旋模式从远端到近端的两个肾动脉的离散位点进行肾去神经支配。主要结果和测量 主要终点是在 12 个月时没有房颤、房扑或房性心动过速。次要终点包括 30 天内的手术并发症和 6 个月和 12 个月的血压控制。结果 在 302 名随机患者中（中位年龄，60 岁 [四分位距，55-65 岁]；182 名男性 [60.3%]），283 (93. 7%) 完成了试验。所有人都成功地完成了指定的程序。在 12 个月时，148 名（56.5%）单独接受肺静脉隔离的患者中有 84 名观察到无房颤、扑动或心动过速，154 名（72.1%）接受肺静脉隔离加肾去神经支配的患者中有 111 名（风险比） , 0.57；95% CI，0.38 至 0.85；P = .006)。在 5 个预设的次要终点中，报告了 4 个，3 个在组间不同。从基线到 12 个月，仅隔离组的平均收缩压从 151 mmHg 降至 147 mmHg，肾去神经支配组从 150 mmHg 降至 135 mmHg（组间差异，-13 mmHg；95 % CI，-15 至 -11 毫米汞柱；P < .001）。仅隔离组 7 名患者 (4.7%) 和去肾神经支配组 7 名患者 (4.5%) 发生手术并发症。结论和相关性 在阵发性房颤合并高血压患者中，与单独导管消融相比，在导管消融中加入去肾神经支配可显着增加 12 个月时无心房颤动的可能性。在解释该试验的结果时，应考虑缺乏正式的假对照肾去神经支配程序。试验注册 ClinicalTrials.gov 标识符：NCT01873352。