Efficacy and Safety of Catheter-Based Radiofrequency Renal Denervation in Chinese Patients With Uncontrolled Hypertension: The Randomized, Sham-Controlled, Multi-Center Iberis-HTN Trial.,Circulation

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Efficacy and Safety of Catheter-Based Radiofrequency Renal Denervation in Chinese Patients With Uncontrolled Hypertension: The Randomized, Sham-Controlled, Multi-Center Iberis-HTN Trial.
Circulation ( IF 35.5 ) Pub Date : 2024-09-04 , DOI: 10.1161/circulationaha.124.069215
Xiongjing Jiang ₁ , Felix Mahfoud ₂ , Wei Li ₃ , Hui Dong ₁ , Jing Yu ₄ , Shuhua Yu ₅ , Xiaoping Chen ₆ , Peijian Wang ₇ , Zhiqiang Li ₈ , Lucas Lauder ₂ , Zhifang Wang ₉ , Zheng Ji ₁₀ , Yifei Dong ₁₁ , Bing Han ₁₂ , Zhiming Zhu ₁₃ , Yulin Chen ₁₄ , Jianzhong Xu ₁₅ , Xingsheng Zhao ₁₆ , Weidong Fan ₁₇ , Wen Xie ₁₈ , Brad Hubbard ₁₉ , Xi Hu ₂₀ , Kazuomi Kario ₂₁ , Runlin Gao ₁

Affiliation

Fuwai Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences (X.J., H.D., R.G.).
Department of Cardiology and Cardiovascular Research Institute Basel, University Heart Center, University Hospital Basel, Switzerland (F.M., L.L).
Medical Research & Biometrics Center, National Center for Cardiovascular Diseases, The Chinese Academy of Medical Sciences (W.L.).
Lanzhou University Second Hospital, China (J.Y.).
Zhengzhou Central Hospital Affiliated to Zhengzhou University, China (S.Y.).
West China Hospital, Sichuan University, China (X.C.).
The First Affiliated Hospital of Chengdu Medical Collage, China (P.W.).
Affiliated Hospital of Hebei University (Z.L.).
Xinxiang Central Hospital, China (Z.W.).
Tangshan Workers' Hospital (Z.J.).
The Second Affiliated Hospital of Nanchang University (Y.D.).
Xuzhou Central Hospital (B. Han).
Daping Hospital, The Third Military Medical University (Z.Z.).
The Affiliated Hospital of Hangzhou Normal University (Y.C.).
Ruijin Hospital, Shanghai Jiaotong University School of Medicine (J.X.).
Inner Mongolia Autonomous Region People's Hospital (X.Z.).
Henan Provincial Chest Hospital (W.F.).
Hospital of Chengdu University of Traditional Chinese Medicine (W.X.).
EastPoint Innovation Center, Hangzhou, China (B. Hubbard).
Shanghai Angiocare Medical Technology, China (H.H.).
Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi Japan (K.K.).

BACKGROUND Renal denervation (RDN) can lower blood pressure (BP) in patients with hypertension in both the presence and absence of medication. This is a 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; Shanghai Angiocare Medical Technology, 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://www.clinicaltrials.gov; Unique identifier: NCT02901704.

更新日期：2024-09-04

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