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

Lucas Lauder (Homburg/Saar)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 (Homburg/Saar)1

1Universitätsklinikum des Saarlandes Innere Medizin III - Kardiologie, Angiologie und internistische Intensivmedizin Homburg/Saar, Deutschland; 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.

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