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.
