# Sham-gecontroleerde RCT's van renale denervatie: meta-analyse

*geplaatst 2019-04-09 · Hypertensie · Journal of the American College of Cardiology · doi 10.1016/j.jacc.2018.12.082 · https://hartvaat.nl/2019/04/09/sham-gecontroleerde-rct-s-van-renale-denervatie-meta-analyse/*

Meta-analyse van uitsluitend sham-gecontroleerde gerandomiseerde trials van katheter-gebaseerde renale denervatie. Definitief bewijs in het strengste studieontwerp.

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

This meta-analysis of sham-controlled renal denervation trials confirmed a significant blood pressure reduction with catheter-based renal denervation versus sham procedures. By including only rigorously designed studies, the analysis provided the most definitive evidence for the biological efficacy of renal denervation.

## Abstract (original, from the publication)

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.

Auteurs: Partha Sardar, Deepak L Bhatt, Ajay J Kirtane, Kevin F Kennedy, Saurav Chatterjee, Jay Giri, Peter A Soukas, William B White, Sahil A Parikh, Herbert D Aronow

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Bron: Journal of the American College of Cardiology, https://doi.org/10.1016/j.jacc.2018.12.082. Bijgewerkt 2026-07-03T13:27:05Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.