Key result
Radiofrequency renal denervation cuts 24-hour ambulatory systolic BP by ~9 mm Hg vs sham.
Why the study?
Does radiofrequency renal denervation reduce 24-hour ambulatory systolic blood pressure in Chinese patients with uncontrolled hypertension on standardized triple antihypertensive therapy?
RCT (n=217)
patient- and outcome-assessor-blinded
1:1
Yes
Does radiofrequency renal denervation reduce 24-hour ambulatory systolic blood pressure in Chinese patients with uncontrolled hypertension on standardized triple antihypertensive therapy?
Mean Difference: -9.4 (95% CI -12.8–-5.9)
Absolute Event Rate: -13% vs -3%
p-value: p=<0.001
Radiofrequency renal denervation significantly reduces 24-hour ambulatory and office blood pressure at 6 months compared to a sham procedure in Chinese patients with uncontrolled hypertension on triple pharmacotherapy.
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.
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Jiang et al. (2024) conducted an RCT in uncontrolled hypertension (n=217). Radiofrequency renal denervation vs. Sham procedure was evaluated on baseline-adjusted change in mean 24-hour ambulatory systolic BP from randomization to 6 months (MD -9.4 mm Hg, 95% CI -12.8 to -5.9, p=<0.001). Radiofrequency renal denervation significantly reduced 24-hour ambulatory systolic blood pressure compared with a sham procedure at 6 months (between-group difference -9.4 mm Hg; P<0.001).
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