Denervation of the distal renal arterial branches vs. conventional main renal artery treatment: a randomized controlled trial for treatment of resistant hypertension

Background: Effective treatment of uncontrolled hypertension using catheter-based percutaneous renal denervation may depend strongly on the anatomic strategy applied when delivering therapy. We hypothesized that concentering renal denervation treatment in the distal region of the artery would improve clinical response. Methods and results: We conducted a single-center, double-blind, randomized, controlled, and parallel group study (ClinicalTrials.gov NCT02667912). Fifty-one treatment-resistant hypertensive patients meeting guideline indications were randomized either to 'conventional' treatment restricted to the main renal artery (n = 26) or to 'distal' treatment applied mainly in the distal branches beyond the main bifurcation (n = 25). Computer-based treatment assignment was performed in the catheterization laboratory at the time of the procedure by the interventional radiologist and remained unknown to patients, investigators, and other outcomes assessors for the entire study period. Six months after randomization, the distal therapy group (n = 24) had a significantly greater decrease in the primary outcome, 24-h mean ambulatory SBP, as compared with the conventionally treated group (n = 21): -22.6 +/- 20.0 vs -9.4 +/- 18.7 mmHg; P less than 0.05. No major safety issues were observed in either group. Conclusion: Percutaneous renal denervation treatment was significantly less effective at lowering 24-h blood pressure in treatment-resistant hypertensive patients when therapy was applied conventionally in the trunk of renal artery as compared with when applied to distal segmental branches. This observation is in accordance with previous surgical and anatomical findings showing that most renal nerve fibers are distant from the lumen proximally and become available for endovascular treatment mainly in the distal portion of the vessel.