Efficacy and safety of catheter-based radiofrequency renal denervation in Chinese patients with uncontrolled hypertension: the randomized, sham-controlled, multi-center Iberis-HTN trial

L. Lauder (Basel)¹, X. Jiang (Beijing)², W. Li (Beijing)³, H. Dong (Beijing)², J. Yu (Lanzhou)⁴, X. Chen (Chengdu)⁵, P. Wang (Chengdu)⁶, Z. Wang (Xinxiang)⁷, Y. Dong (Nanchang)⁸, B. Han (Xuzhou)⁹, Z. Zhu (Daping)¹⁰, Y. Chen (Hangzhou)¹¹, J. Xu (Shanghai)¹², X. Zhao (Hohhot)¹³, W. Xie (Chengdu)¹⁴, B. Hubbard (Chengdu)¹⁵, X. Hu (Shanghai)¹⁶, K. Kario (Tochigi)¹⁷, R. Gao (Beijing)², F. Mahfoud (Basel)^1
1Universitätsspital Basel Abt. für Kardiologie Basel, Schweiz; ²Fuwai Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences Department of Cardiology Beijing, China; ³Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College Medical Research and Biometrics Center Beijing, China; ⁴Lanzhou University Second Hospital Department of Cardiology Lanzhou, China; ⁵West China Hospital, Sichuan University Department of Cardiology Chengdu, Deutschland; ⁶The First Affiliated Hospital of Chengdu Medical Collage Department of Cardiology Chengdu, China; ⁷Xinxiang Central Hospital Department of Cardiology Xinxiang, Deutschland; ⁸The Second Affiliated Hospital of Nanchang University Department of Cardiology Nanchang, China; ⁹Xuzhou Central Hospital Division of Cardiology Xuzhou, China; ¹⁰Daping Hospital, The Third Military Medical University Center for Hypertension and Metabolic Diseases Daping, China; ¹¹Hangzhou Normal University Department of Cardiology Hangzhou, China; ¹²Ruijin Hospital, Shanghai Jiaotong University School of Medicine Department of Cardiovascular Medicine Shanghai, China; ¹³Inner Mongolia People’s Hospital Cardiology Department Hohhot, China; ¹⁴Hospital of Chengdu University of Traditional Chinese Medicine Department of Cardiology Chengdu, China; ¹⁵WestPoint Innovation Center Cardiovascular Research Department Chengdu, China; ¹⁶Shanghai Bio-heart Biological Technology Co., Ltd. Clinical Department Shanghai, China; ¹⁷Jichi Medical School Department of Cardiology Tochigi, Japan

Background: Renal denervation (RDN) can lower blood pressure (BP) in patients with hypertension in 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 six months.
Results: Of 217 randomized patients (mean age 45.3±10.2 years, 21% female), 107 were randomized to RDN and 110 to sham control. At six months, there was a greater reduction in 24-hour systolic BP in the RDN (-13.0±12.1 mmHg) when compared with the sham control group (-3.0±13.0 mmHg; baseline-adjusted between-group difference -9.4 mmHg; 95% CI: -12.8 to -5.9; p<0.001) (Figure). Compared with sham, 24-hour diastolic BP was lowered by -5.0 mmHg (95% CI: -7.5 to -2.4; p<0.001) six months after RDN, and office systolic and diastolic BP by -6.4 mmHg (95% CI: -10.5 to -2.3; p=0.003) and -5.1 mmHg (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 sequela. No other major device-related or procedural-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 six months compared with sham.