4120Distal renal denervation in segmental branches of renal artery versus conventional main trunk therapy: 12 months study in patients with resistant hypertension

Abstract

Purpose: To investigate whether anatomical optimization of endovascular renal denervation by redistributing treatment from main trunk to segmental branches of renal artery may cause significant and sustainable increase of antihypertensive efficacy of the intervention. Methods: Fifty five patients meeting criteria of true resistant hypertension were randomized either to “conventional” renal denervation restricted to the main renal artery (n=27) or to “distal” treatment applied mainly in segmental branches beyond the bifurcation (n=28). Computer-based treatment assignment was performed in the catheterization laboratory at the time of the procedure and remained unknown to patients and outcomes assessors for the entire study period. Office and ambulatory BP, renal blood flow, and renal function were assessed at baseline, 6, and 12 months following randomization. Optional ABPM was done in some patients 1 month post procedure. Baseline antihypertensive pharmacotherapy was maintained as strictly as possible during the study (NCT02667912). Results: Forty seven patients completed 12 months follow-up (23 after distal denervation and 24 after conventional main trunk therapy). Intention-to-treat analysis was done by Last Observation Carried Forward method using 6 and 1 month follow-up data in 5 later and 2 early dropouts, respectively; 1 subject not having post-procedure data was excluded. A significantly greater decrease of 24-hour mean systolic BP was found in the distal therapy group as compared to the group of conventional renal denervation: -22.1±20.6 vs -11.5±16.4 mmHg; P<0.05. No major safety issues were observed in either group. Conclusion: Optimization of endovascular renal denervation by redistributing treatment from main trunk to segmental branches of renal artery causes significant increase of blood pressure lowering effect of the intervention sustainable through 12 months.