Durable Strong Efficacy and Favorable Long-Term Renal Safety of the Anatomically Optimized Distal Renal Denervation According to the 3 Year Follow-Up Extension of the Double-Blind Randomized Controlled Trial

Background: We previously confirmed the superiority of our anatomically optimized distal renal denervation (RDN) over the conventional mode of the procedure in a 6-month randomized controlled trial (NCT02667912). To assess the long-term effects of distal RDN we extended the follow-up of our study to three years. Methods: BP, serum creatinine, eGFR were measured at one and three years after randomization; major adverse renal events were assessed over the entire study period. Findings: Of 55 randomized patients, 47 (23/24, distal/main trunk RDN, respectively) were assessed at one-year and 39 (21/18) at three-years post-procedure. Twenty-four-hour ambulatory systolic BP remained powerfully lowered after distal RDN both at one and three years assessments(mean change from baseline: -18.0, 95% CI -27.6 to -8.5; p 0·05. After main trunk RDN, the decrease of 24h systolic BP was only moderate at one year: -12·1, 95% CI -19·2 to -5·0; p 0.05. Accordingly eGFR did not change at one year: -1·3, 95% CI -6·6 to 4·0; p>0·05, but continued to decline and reached a significant decrease at three years: -5·0, 95% CI -9·6 to -0·3; p<0·05. Interpretation: Our data demonstrate the durable strong BP-lowering efficacy and favorable long-term renal safety of distal RDN. Clinical Trial Registration Details: The study was registered in ClinicalTrials.gov (NCT02667912). Funding Information: There was no funding source for this study. Declaration of Interests: The authors declare no potential conflict of interest relevant to this research. Ethics Approval Statement: The study complies with all relevant ethical regulations for studies involving human subjects. Ethical approval was obtained from the Committee for Biomedical Ethics of the Tomsk Research Institute of Cardiology. All patients provided written informed consent prior to inclusion in the study.