Effects of Catheter-Based Renal Denervation in Hypertension: A Systematic Review and Meta-Analysis.

Abstract

Several sham-controlled trials have investigated the efficacy and safety of catheter-based renal denervation (RDN) with mixed outcomes. We aimed to perform a comprehensive meta-analysis of all randomized, sham-controlled trials investigating RDN with first- and second-generation devices in hypertension. We searched MEDLINE and the Cochrane Library for eligible trials. Outcomes included both efficacy (24-hour and office systolic [SBP] and diastolic blood pressure [DBP]) and safety (all-cause death, vascular complication, renal artery stenosis >70%, hypertensive crisis) of RDN. We performed a study-level, pairwise, random-effects meta-analysis of the summary data. Ten trials comprising 2478 patients with hypertension while being either off or on treatment were included. Compared with sham, RDN reduced 24-hour and office systolic blood pressure by 4.4 mm Hg (95% CI, 2.7 to 6.1; <i>P</i><0.00001) and 6.6 mm Hg (95% CI, 3.6 to 9.7; <i>P</i><0.0001), respectively. The 24-hour and office diastolic blood pressure paralleled these findings (-2.6 mm Hg [95% CI, -3.6 to -1.5]; <i>P</i><0.00001; -3.5 mm Hg [95% CI, -5.4 to -1.6]; <i>P</i>=0.0003). There was no difference in 24-hour and office systolic blood pressure reduction between trials with and without concomitant antihypertensive medication (<i>P</i> for interaction, 0.62 and 0.73, respectively). There was no relevant difference in vascular complications (odds ratio, 1.69 [95% CI, 0.57 to 5.0]; <i>P</i>=0.34), renal artery stenosis (odds ratio, 1.50 [95% CI, 0.06 to 36.97]; <i>P</i>=0.80), hypertensive crisis (odds ratio, 0.65 [95% CI, 0.30 to 1.38]; <i>P</i>=0.26), and all-cause death (odds ratio, 1.76 [95% CI, 0.34 to 9.20]; <i>P</i>=0.50) between RDN and sham groups. Change of renal function based on estimated glomerular filtration rate was comparable between groups (<i>P</i> for interaction, 0.84). There was significant heterogeneity between trials. RDN safely reduces ambulatory and office systolic blood pressure/diastolic blood pressure versus a sham procedure in the presence and absence of antihypertensive medications.