University Hospital Erlangen, Department of Nephrology and Hypertension, Erlangen.
Department of Internal Medicine, Universitätsklinikum des Saarlandes, Saarland, University, Homburg/Saar, Germany.
J Hypertens. 2021 Sep 1;39(9):1733-1741. doi: 10.1097/HJH.0000000000002933.
This ESH Position Paper 2021 with updated proposed recommendations was deemed necessary after the publication of a set of new pivotal sham-controlled randomized clinical trials (RCTs), which provided important information about the efficacy and safety of endovascular device-based renal denervation (RDN) for hypertension treatment. RDN is effective in reducing or interrupting the sympathetic signals to the kidneys and decreasing whole body sympathetic activity. Five independent, fully completed, sham-controlled RCTs provide conclusive evidence that RDN lowers ambulatory and office blood pressure (BP) to a significantly greater extent than sham treatment. BP-lowering efficacy is evident both in patients with and without concomitant antihypertensive medication. The average decrease of 10 mmHg in office BP is estimated to lower the incidence of cardiovascular events by 25-30%, based on meta-analyses of RCTs using pharmacological treatment. Neither peri-procedural, nor short-term or long-term adverse events or safety signals (available up to 3 years) have been observed. Implementing RDN as an innovative third option in the armamentarium of antihypertensive treatment requires a structured process that ensures the appropriate performance of the endovascular RDN procedure and adequate selection of hypertensive patients. The latter should also incorporate patients' perspective and preference that needs to be respected in a shared decision-making process.
这份 ESH 立场文件 2021 年版对建议进行了更新,这是在一系列新的关键性假手术对照随机临床试验 (RCT) 发表后提出的,这些 RCT 提供了有关血管内设备为基础的肾脏去神经治疗(RDN)治疗高血压的疗效和安全性的重要信息。RDN 可有效减少或中断肾脏的交感神经信号,降低全身交感神经活性。五项独立、完全完成的假手术对照 RCT 提供了确凿的证据,表明 RDN 可显著降低动态和诊室血压(BP)。RDN 对伴有或不伴有伴随降压药物的患者均具有降压作用。根据使用药物治疗的 RCT 的荟萃分析,诊室 BP 降低 10mmHg 估计可使心血管事件的发生率降低 25-30%。在接受假手术治疗的患者中,未观察到围手术期、短期或长期不良事件或安全信号(最长可达 3 年)。将 RDN 作为降压治疗的创新性第三种选择实施,需要一个确保血管内 RDN 程序适当执行和适当选择高血压患者的结构化过程。后者还应纳入患者的观点和偏好,在共同决策过程中需要尊重这些观点和偏好。