Sustained strong blood pressure lowering and preserved renal function during 3 year after anatomically optimized distal renal denervation according to the double blind randomized controlled study

Abstract

Abstract Aim To evaluate long-term safety and efficacy of anatomically optimized distal renal denervation (RDN). Methods We assessed major adverse cardiovascular and renal events; changes in BP (office, ambulatory), and renal function (serum creatinine, eGFR) over 3 year follow-up extension of our double blind, randomized controlled study of the efficacy and safety of distal RDN versus conventional main trunk treatment in patients with true resistant hypertension (NCT02667912). Results Of 55 randomized patients (28/27, distal/main trunk RDN, respectively), 47 (23/24) were assessed at 1 year, and 39 (21/18) - at 3-year post-procedure. During 3-year follow-up 2 fatal and 2 non-fatal strokes were observed in distal RDN group versus one heart failure death and 2 non-fatal strokes in group of main trunk treatment. In distal RDN arm BP remained powerfully and significantly lowered both at 1 and 3 years post-procedure: −18.0 (95% CI −27.6; −8.5) and −16.9 (95% CI −27.3; −6.5) mmHg, 24h ambulatory systolic. During 1st year this potent BP lowering effect was accompanied by moderate eGFR decrease: −8.9 (95% CI −14.8; −3.1) ml/min/sq.m, however, this decrease was later reduced to non-significant −6.5 (95% CI −13.2; 0.3) ml/min/sq.m at 3 year post-procedure signaling some improvement in renal function after 1st year despite sustained strong BP lowering. In group of main trunk intervention BP only moderately decreased at 1 year −12.1 (95% CI −19.2; −5.0) mmHg, in parallel with small non-significant change in eGFR: −1.3 (95% CI −6.6; 4.0) ml/min/sq.m. Subsequently, BP lowering effect weakened and lost significance at 3 years post-procedure: −8.5 (95% CI −19.7; 2.2) mmHg. In contrast, eGFR continued to decline and reached significant −5.0 (95% CI −9.6; −0.3) ml/min/sq.m at the end of the study. Five patients developed new onset chronic kidney disease after main trunk RDN versus 3 patients – after distal RDN. The number of concomitant antihypertensive medications did not significantly changed in either group. Conclusion Our data demonstrate strong long-term BP lowering efficacy of distal RDN and, also, the potential of this procedure to prevent the decline of renal function in patients with resistant hypertension. Funding Acknowledgement Type of funding sources: None.