{"title":"导管射频肾脏去神经治疗中国未控制高血压患者的有效性和安全性：随机、假对照、多中心 Iberis-HTN 试验。","authors":"Xiongjing Jiang, Felix Mahfoud, Wei Li, Hui Dong, Jing Yu, Shuhua Yu, Xiaoping Chen, Peijian Wang, 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","doi":"10.1161/CIRCULATIONAHA.124.069215","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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]; <i>P</i><0.001). Compared with sham, 24-hour diastolic BP was lowered by -5.0 mm Hg ([95% CI, -7.5 to -2.4]; <i>P</i><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]; <i>P</i>=0.003) and -5.1 mm Hg ([95% CI, -8.2 to -2.0]; <i>P</i>=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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Registration: </strong>URL: https://clinicaltrials.gov; Unique identifier: NCT02901704.</p>","PeriodicalId":10331,"journal":{"name":"Circulation","volume":null,"pages":null},"PeriodicalIF":35.5000,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of Catheter-Based Radiofrequency Renal Denervation in Chinese Patients With Uncontrolled Hypertension: The Randomized, Sham-Controlled, Multi-Center Iberis-HTN Trial.\",\"authors\":\"Xiongjing Jiang, Felix Mahfoud, Wei Li, Hui Dong, Jing Yu, Shuhua Yu, Xiaoping Chen, Peijian Wang, 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\",\"doi\":\"10.1161/CIRCULATIONAHA.124.069215\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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]; <i>P</i><0.001). Compared with sham, 24-hour diastolic BP was lowered by -5.0 mm Hg ([95% CI, -7.5 to -2.4]; <i>P</i><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]; <i>P</i>=0.003) and -5.1 mm Hg ([95% CI, -8.2 to -2.0]; <i>P</i>=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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Registration: </strong>URL: https://clinicaltrials.gov; Unique identifier: NCT02901704.</p>\",\"PeriodicalId\":10331,\"journal\":{\"name\":\"Circulation\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":35.5000,\"publicationDate\":\"2024-09-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Circulation\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1161/CIRCULATIONAHA.124.069215\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Circulation","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1161/CIRCULATIONAHA.124.069215","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
摘要
背景：肾脏去神经支配（RDN）可在高血压患者服药或不服药的情况下降低血压。这是中国首次对肾脏去神经支配疗法的安全性和有效性进行假对照试验：这项前瞻性、多中心、随机、患者和结果评估者盲法假对照试验研究了射频降压网对接受标准化三联降压治疗的高血压患者的疗效。符合条件的患者按 1:1 随机分配到使用多电极射频导管（Iberis；AngioCare，中国上海）或假手术进行 RDN 治疗。主要疗效指标是随机分组至6个月期间，经基线调整后的24小时卧床平均收缩压变化的组间差异：在217名随机患者中（平均年龄为45.3±10.2岁；21%为女性），107人随机接受了RDN治疗，110人随机接受了假对照治疗。6个月时，RDN组（-13.0±12.1 mm Hg）与假对照组（-3.0±13.0 mm Hg；基线调整后组间差异为-9.4 mm Hg [95% CI, -12.8 to -5.9]；PPP=0.003）和-5.1 mm Hg（[95% CI, -8.2 to -2.0]；P=0.001）相比，24小时收缩压降低幅度更大。RDN 组中有一名患者发生了入路部位并发症（血肿），但并无后遗症。随访期间未发生其他与器械或手术相关的重大安全事件：在这项针对接受标准化三联药物治疗的中国未控制高血压患者的试验中，RDN 是安全的，与假药相比，RDN 可在 6 个月内降低非卧床血压和诊室血压：URL：https://clinicaltrials.gov；唯一标识符：NCT02901704。
Efficacy and Safety of Catheter-Based Radiofrequency Renal Denervation in Chinese Patients With Uncontrolled Hypertension: The Randomized, Sham-Controlled, Multi-Center Iberis-HTN Trial.
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.
期刊介绍：
Circulation is a platform that publishes a diverse range of content related to cardiovascular health and disease. This includes original research manuscripts, review articles, and other contributions spanning observational studies, clinical trials, epidemiology, health services, outcomes studies, and advancements in basic and translational research. The journal serves as a vital resource for professionals and researchers in the field of cardiovascular health, providing a comprehensive platform for disseminating knowledge and fostering advancements in the understanding and management of cardiovascular issues.
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