[OP.7D.05] DISTAL RENAL DENERVATION VERSUS CONVENTIONAL MODE OF THE INTERVENTION: A RANDOMISED CONTROLLED TRIAL

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Abstract

Objective:

Surgical and recently anatomical studies demonstrated a fan-like form of renal plexus converging toward renal gate. Therefore, a number of fibers adjacent to the artery and available for endovascular ablation is rather small in proximal portion of renal artery but grows to maximum in its distal part. To evaluate whether denervation treatment in the distal part of renal artery is more effective than conventional mode of the intervention.

Design and method:

We developed a distal mode of RDN targeting segmental branches of renal artery and compared it to conventional RDN in a single-blind 1:1 randomized controlled parallel group study in patients with resistant hypertension. Inclusion criteria were: men and women 18–80 years, systolic BP equal or greater 160 or diastolic BP equal or greater 100 mmHg despite at least 3 antihypertensive drugs including a diuretic, written informed consent. Exclusion criteria were: secondary hypertension, 24h-mean systolic BP < 135 mmHg, eGFR < 30 mL/min/1.73m2, extended RA disease, other clinically important disorders significantly increasing risk of the intervention (investigator's assessment). The primary study outcome was a between-group difference in the decrease of 24h-mean systolic BP from baseline to 6 month follow-up.

Results:

Of 45 patients (aged 55.7 ± 8.6, 19 men) included in the study 41 patients (23 treated by distal RDN and 18 – by conventional mode) completed 6 months follow-up. The only complication was femoral pseudoaneurysm in distal RDN group. 24h-mean BP decreased powerfully in the distal treatment group: −22.4/−11.8 (SD 20.5/12.7) mmHg, p = 0.0001/0.0003 (systolic/diastolic respectively) and only slightly in the conventional RDN group: −8.7/−5.7 (SD 18.8/9.2), p = 0.07/0.02. The between-group difference was statistically significant for the lowering of 24h-mean systolic BP (p = 0,036).

Conclusions:

Superiority of distal RDN over conventional mode of the intervention confirms better availability of renal nerves in distal part of renal artery. RDN technology development needs to be urgently re-directed to creating devices for use in segmental branches of renal artery.

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