Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Saarland University, Homburg (Saar), Germany.
Jichi Medical University School of Medicine, Tochigi, Japan.
Lancet. 2020 May 2;395(10234):1444-1451. doi: 10.1016/S0140-6736(20)30554-7. Epub 2020 Mar 29.
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.
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.
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.
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.
Medtronic.
基于导管的肾脏去神经支配在先前的研究中显著降低了血压。在一项阳性的初步试验之后，SPYRAL HTN-OFF MED（SPYRAL 关键）试验旨在评估在没有抗高血压药物的情况下肾脏去神经支配的疗效。
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，患有诊室收缩压 150mmHg 至小于 180mmHg 的高血压患者被随机分配 1:1 接受肾脏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 个月的诊室收缩压的基线调整变化。我们使用具有信息先验的贝叶斯设计，因此主要分析结合了初步试验和关键试验的证据。主要疗效和安全性分析在意向治疗人群中进行。这项试验在 ClinicalTrials.gov 注册，NCT02439749。
从 2015 年 6 月 25 日至 2019 年 10 月 15 日，331 名患者被随机分配至肾脏去神经支配组（n=166）或假手术组（n=165）。主要和次要疗效终点均达到，两者的优势后验概率均大于 0·999。两组 24 小时收缩压的治疗差异为-3·9mmHg（贝叶斯 95%可信区间-6·2 至-1·6），诊室收缩压的差异为-6·5mmHg（-9·6 至-3·5）。在 3 个月内，没有发生与设备相关或与手术相关的重大安全性事件。
SPYRAL 关键表明，与假手术相比，基于导管的肾脏去神经支配更能安全地降低血压，且无需抗高血压药物。
美敦力公司。
