Efficacy and safety of sympathetic mapping and ablation of renal nerves for the treatment of hypertension (SMART): 6-month follow-up of a randomised, controlled trial

作者：Jie Wang, Yuehui Yin, Chengzhi Lu, Zhibing Lu, Jialu Hu, Yue Wang, Junbo Ge, Hong Jiang, Chen Yao, Xiaoyan Yan, Wei Ma, Xiaoyong Qi, Yi Dang, Shaoliang Chen, Jiancheng Zhu, Dongmei Wang, Chao Ding, Weimin Wang, Jian Liu, Yanbin Wang, Hui Li, Zhenhua Pan, Kaijun Cui, Chengzong Li, Xinjian Liang, Weijie Chen, Paul A. Sobotka, Jingjing Zhang, Murray Esler, Ningling Sun, Chen Minglong, Yong Huo · 发表于：EClinicalMedicine · 年份：2024 · DOI：10.1016/j.eclinm.2024.102626 · 被引用次数：25 · 研究领域：Blood Pressure and Hypertension Studies、Renal and Vascular Pathologies、Dialysis and Renal Disease Management

BackgroundPrevious trials of renal denervation (RDN) have been designed to investigate reduction of blood pressure (BP) as the primary efficacy endpoint using non-selective RDN without intraoperatively verified RDN success. It is an unmet clinical need to map renal nerves, selectively denervate renal sympathetic nerves, provide readouts for the interventionalists and avoid futile RDN. We aimed to examine the safety and efficacy of renal nerve mapping/selective renal denervation (msRDN) in patients with uncontrolled hypertension (HTN) and determine whether antihypertensive drug burden is reduced while office systolic BP (OSBP) is controlled to target level (＜140 mmHg).MethodsWe conducted a randomized, prospective, multicenter, single-blinded, sham-controlled trial. The study combined two efficacy endpoints at 6 months as primary outcomes: The control rate of patients with OSBP ＜140 mmHg (non-inferior outcome) and change in the composite index of antihypertensive drugs (Drug Index) in the treatment versus Sham group (superior outcome). This design avoids confounding from excess drug-taking in the Sham group. Antihypertensive drug burden was assessed by a composite index constructed as: Class N (number of classes of antihypertensive drugs) × (sum of doses). 15 hospitals in China participated in the study and 220 patients were enrolled in a 1:1 ratio (msRDN vs Sham). The key inclusion criteria included: age (18–65 years old), history of essential HTN (at least 6 months), heart ra...