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

Abstract

BACKGROUND\nThere are conflicting data regarding the relative effectiveness of renal sympathetic denervation (RSD) in patients with hypertension.\n\n\nOBJECTIVES\nThe purpose of this study was to evaluate the blood pressure (BP) response after RSD in sham-controlled randomized trials.\n\n\nMETHODS\nDatabases were searched through June 30, 2018. Randomized trials (RCTs) with\xa0≥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.\n\n\nRESULTS\nThe 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\xa0-3.65\xa0mm\xa0Hg, 95% CI:\xa0-5.33 to\xa0-1.98; p\xa0< 0.001). Compared with sham, RSD was also associated with a significant decrease in daytime ASBP (WMD\xa0-4.07\xa0mm\xa0Hg, 95% CI:\xa0-6.46 to\xa0-1.68; p\xa0< 0.001), office systolic BP (WMD\xa0-5.53\xa0mm\xa0Hg, 95% CI:\xa0-8.18 to\xa0-2.87; p\xa0< 0.001), 24-h ambulatory diastolic BP (WMD\xa0-1.71\xa0mm\xa0Hg, 95% CI:\xa0-3.06 to\xa0-0.35; p\xa0=\xa00.01), daytime ambulatory diastolic BP (WMD\xa0-1.57\xa0mm\xa0Hg, 95% CI:\xa0-2.73 to\xa0-0.42; p\xa0=\xa00.008), and office diastolic BP (WMD\xa0-3.37\xa0mm\xa0Hg, 95% CI:\xa0-4.86 to\xa0-1.88; p\xa0< 0.001). Compared with first-generation trials, a significantly greater\xa0reduction in daytime ASBP was observed with RSD in second-generation trials (6.12\xa0mm\xa0Hg vs. 2.14\xa0mm\xa0Hg; p\xa0interaction\xa0=\xa00.04); however, this interaction was not significant for 24-h ASBP (4.85\xa0mm\xa0Hg vs. 2.23\xa0mm\xa0Hg; p\xa0interaction\xa0=\xa00.13).\n\n\nCONCLUSIONS\nRSD 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.