Early uncontrolled studies reported large blood pressure reductions in subjects with resistant hypertension treated with renal denervation, however these results were not confirmed in several of the latest publications.
Aim
The aim of the current study was to evaluate the effectiveness of RDN in controlled studies comparing RDN to either a sham procedure or to medical therapy.
Method
Only controlled studies were included in the analysis. Both the unadjusted and control-adjusted BP changes were calculated.
Results
We identified 11 publications of which only 3 were double-blinded RCTs with a sham control, while 8 were open label studies where the control group was treated with medical therapy. Only 2 studies assessed adherence to medical therapy with robust methodologies. Office BP reduction (− 18/8 mmHg) significantly overestimated ABPM change (− 9/− 5 mmHg), with high heterogeneity between the included studies. When the treatment effect was adjusted for the BP change in the control group, BP changes became non significant (ABPM: − 1.8 for systolic BP [95% CI − 4.5 to 0.9] and − 0.6 for diastolic BP [95% CI − 2.3 to 1.2]). These results were confirmed when only the sham-controlled studies were analysed.
Conclusions
In spite of promising results in early reports, renal denervation fails to show superiority to a sham procedure or to medical therapy in recently published controlled studies. Lack of a sham control in most publications and heterogeneity in assessment of treatment adherence may account for part the variability reported in the studies.
Graphical abstract
Renal denervation fails to show superiority to a sham procedure or to medical therapy in recently published controlled studies.
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