医学
随机对照试验
血压
随机化
动态血压
回廊的
舒张期
去神经支配
内科学
外科
作者
Xiongjing Jiang,Felix Mahfoud,Wěi Li,Hui Dong,Jing Yu,Shuhua Yu,Xiaoping Chen,Jindong Wan,Zhiqiang Li,Lucas Lauder,Zhifang Wang,Zheng Ji,Yifei Dong,Bing Han,Zhiming Zhu,Yulin Chen,Jianzhong Xu,Xingsheng Zhao,Weidong Fan,Wen Xie,Brad Hubbard,Xi Hu,Kazuomi Kario,Runlin Gao
出处
期刊:Circulation
[Ovid Technologies (Wolters Kluwer)]
日期:2024-09-04
标识
DOI:10.1161/circulationaha.124.069215
摘要
BACKGROUND: Renal denervation (RDN) can lower blood pressure (BP) in patients with hypertension in both the presence and absence of medication. This is the first sham-controlled trial investigating the safety and efficacy of RDN in China. METHODS: This prospective, multicenter, randomized, patient- and outcome-assessor-blinded, sham-controlled trial investigated radiofrequency RDN in patients with hypertension on standardized triple antihypertensive therapy. Eligible patients were randomized 1:1 to undergo RDN using a multi-electrode radiofrequency catheter (Iberis; AngioCare, Shanghai, China) or a sham procedure. The primary efficacy outcome was the between-group difference in baseline-adjusted change in mean 24-hour ambulatory systolic BP from randomization to 6 months. RESULTS: Of 217 randomized patients (mean age, 45.3±10.2 years; 21% female), 107 were randomized to RDN and 110 were randomized to sham control. At 6 months, there was a greater reduction in 24-hour systolic BP in the RDN (−13.0±12.1 mm Hg) compared with the sham control group (−3.0±13.0 mm Hg; baseline-adjusted between-group difference, −9.4 mm Hg [95% CI, −12.8 to −5.9]; P <0.001). Compared with sham, 24-hour diastolic BP was lowered by −5.0 mm Hg ([95% CI, −7.5 to −2.4]; P <0.001) 6 months after RDN, and office systolic and diastolic BP was lowered by −6.4 mm Hg ([95% CI, −10.5 to −2.3]; P =0.003) and −5.1 mm Hg ([95% CI, −8.2 to −2.0]; P =0.001), respectively. One patient in the RDN group experienced an access site complication (hematoma), which resolved without sequelae. No other major device- or procedure-related safety events occurred through follow-up. CONCLUSIONS: In this trial of Chinese patients with uncontrolled hypertension on a standardized triple pharmacotherapy, RDN was safe and reduced ambulatory and office BP at 6 months compared with sham. REGISTRATION: URL: https://clinicaltrials.gov ; Unique identifier: NCT02901704.