BACKGROUND Catheter-based renal denervation has significantly reduced blood pressure in previous studies. Following a positive pilot trial, the SPYRAL HTN-OFF MED (SPYRAL Pivotal) trial was designed to assess the efficacy of renal denervation in the absence of antihypertensive medications. METHODS In this international, prospective, single-blinded, sham-controlled trial, done at 44 study sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the UK, and the USA, hypertensive patients with office systolic blood pressure of 150 mm Hg to less than 180 mm Hg were randomly assigned 1:1 to either a renal denervation or sham procedure. The primary efficacy endpoint was baseline-adjusted change in 24-h systolic blood pressure and the secondary efficacy endpoint was baseline-adjusted change in office systolic blood pressure from baseline to 3 months after the procedure. We used a Bayesian design with an informative prior, so the primary analysis combines evidence from the pilot and Pivotal trials. The primary efficacy and safety analyses were done in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT02439749. FINDINGS From June 25, 2015, to Oct 15, 2019, 331 patients were randomly assigned to either renal denervation (n=166) or a sham procedure (n=165). The primary and secondary efficacy endpoints were met, with posterior probability of superiority more than 0·999 for both. The treatment difference between the two groups for 24-h systolic blood pressure was -3·9 mm Hg (Bayesian 95% credible interval -6·2 to -1·6) and for office systolic blood pressure the difference was -6·5 mm Hg (-9·6 to -3·5). No major device-related or procedural-related safety events occurred up to 3 months. INTERPRETATION SPYRAL Pivotal showed the superiority of catheter-based renal denervation compared with a sham procedure to safely lower blood pressure in the absence of antihypertensive medications. FUNDING Medtronic.

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在没有抗高血压药物（SPYRAL HTN-OFF MED Pivotal）的情况下，基于导管的肾去神经支配的疗效：一项多中心、随机、假对照试验。

背景在先前的研究中，基于导管的肾去神经支配显着降低了血压。在一项积极的试点试验之后，SPYRAL HTN-OFF MED (SPYRAL Pivotal) 试验旨在评估在没有抗高血压药物的情况下肾去神经支配的疗效。方法 在这项国际性、前瞻性、单盲、假对照试验中，在澳大利亚、奥地利、加拿大、德国、希腊、爱尔兰、日本、英国和美国的 44 个研究地点进行，患有办公室收缩压的高血压患者150 mm Hg 至低于 180 mm Hg 的患者以 1:1 的比例随机分配至肾去神经支配或假手术。主要疗效终点是 24 小时收缩压的基线调整变化，次要疗效终点是从基线到手术后 3 个月的办公室收缩压的基线调整变化。我们使用了具有信息先验的贝叶斯设计，因此主要分析结合了来自试点和关键试验的证据。在意向治疗人群中进行了主要疗效和安全性分析。该试验已在 ClinicalTrials.gov 注册，NCT02439749。结果 从 2015 年 6 月 25 日到 2019 年 10 月 15 日，331 名患者被随机分配接受去肾神经支配 (n=166) 或假手术 (n=165)。主要和次要疗效终点均达到，两者的后验优势概率均超过 0·999。24 h收缩压两组治疗差异为-3·9 mm Hg（贝叶斯95%可信区间-6·2至-1·6），诊室收缩压差异为-6·5毫米汞柱（-9·6 至 -3·5）。长达 3 个月没有发生重大的设备相关或程序相关的安全事件。解释 SPYRAL Pivotal 表明，与假手术相比，基于导管的肾去神经支配在没有抗高血压药物的情况下安全地降低血压的优势。资助美敦力。解释 SPYRAL Pivotal 表明，与假手术相比，基于导管的肾去神经支配在没有抗高血压药物的情况下安全地降低血压的优势。资助美敦力。解释 SPYRAL Pivotal 表明，与假手术相比，基于导管的肾去神经支配在没有抗高血压药物的情况下安全地降低血压的优势。资助美敦力。