A systematic review, meta-analysis, and meta regression of the sham controlled renal denervation randomized controlled trials

Renal denervation (RD) has been investigated as a novel blood pressure (BP) lowering treatment for hypertension. The primary objective of this meta-analysis was to assess the efficacy of RD and factors that may associate with treatment effect heterogeneity. The primary outcomes were raw mean differences (RMD) in 24-hour ambulatory, daytime ambulatory, nighttime, and office systolic BP (SBP) and diastolic BP (DBP) between sham control and RD. A prespecified subgroup analysis was performed comparing studies with follow-up less than versus greater than 4 months. If inter-study heterogeneity was found for any of the above outcomes, additional analyses were performed to assess potential moderator variables. Ten sham-controlled randomized trials were identified and included 1,544 participants, followed for a mean of 4.20 months. RD was associated with a statistically significant reduction in all SBP and DBP measures except for nighttime SBP (-2.64 mmHg; 95% confidence interval (CI) -5.84 to 0.56, p = 0.11) and nighttime DBP (- 1.21 mmHg; 95% CI -3.17 to 0.75, p = 0.23). Mild to moderate inter-study heterogeneity was identified for three outcomes (office SBP and nighttime SBP and DBP). Studies that followed patients for longer than 4 months had numerically lower reductions in most BP outcomes; however, there were no statistically significant interactions between subgroups. Compared to a sham procedure, RD was associated with statistically significant reductions in most measures of SBP and DBP that were within bounds of what would be expected from standard blood pressure lowering medications.