Sham-Controlled Randomized Trials of Catheter-Based Renal Denervation in Patients With Hypertension

Background: There are conflicting data regarding the relative effectiveness of renal sympathetic denervation (RSD) in patients with hypertension. Objectives: The purpose of this study was to evaluate the blood pressure (BP) response after RSD in sham-controlled randomized trials. Methods: Databases were searched through June 30, 2018. Randomized trials (RCTs) with ≥50 patients comparing catheter-based RSD with a sham control were included. The authors calculated summary treatment estimates as weighted mean differences (WMD) with 95% confidence intervals (CIs) using random-effects meta-analysis. Results: The analysis included 977 patients from 6 trials. The reduction in 24-h ambulatory systolic blood pressure (ASBP) was significantly greater for patients treated with RSD than sham procedure (WMD −3.65 mm Hg, 95% CI: −5.33 to −1.98; p < 0.001). Compared with sham, RSD was also associated with a significant decrease in daytime ASBP (WMD −4.07 mm Hg, 95% CI: −6.46 to −1.68; p < 0.001), office systolic BP (WMD −5.53 mm Hg, 95% CI: −8.18 to −2.87; p < 0.001), 24-h ambulatory diastolic BP (WMD −1.71 mm Hg, 95% CI: −3.06 to −0.35; p = 0.01), daytime ambulatory diastolic BP (WMD −1.57 mm Hg, 95% CI: −2.73 to −0.42; p = 0.008), and office diastolic BP (WMD −3.37 mm Hg, 95% CI: −4.86 to −1.88; p < 0.001). Compared with first-generation trials, a significantly greater reduction in daytime ASBP was observed with RSD in second-generation trials (6.12 mm Hg vs. 2.14 mm Hg; p interaction = 0.04); however, this interaction was not significant for 24-h ASBP (4.85 mm Hg vs. 2.23 mm Hg; p interaction = 0.13). Conclusions: RSD significantly reduced blood pressure compared with sham control. Results of this meta-analysis should inform the design of larger, pivotal trials to evaluate the long-term efficacy and safety of RSD in patients with hypertension.