Abstract 14132: Thirty-Six Month Results in Patients With Resistant Hypertension After Endovascular Ultrasound Renal Denervation in the RADIANCE-HTN TRIO Trial

Abstract

Background: Endovascular ultrasound renal denervation (uRDN) has been shown to reduce blood pressure (BP) and medication burden in patients with resistant hypertension in the multicenter, blinded, randomized, sham-controlled RADIANCE-HTN TRIO trial through 6 months. We report the 36-month safety and durability of treatment effect on office BP (OBP) in the patients treated with uRDN. Methods: Patients with hypertension resistant to a 3-drug single-pill confirmed by daytime ambulatory BP ≥135/85 mmHg were randomized to uRDN (n=69) or sham procedure (n=67). From 2-5 months, if monthly home BP was ≥135/85 mmHg, prespecified standardized stepped-care antihypertensive treatment including an aldosterone antagonist (AA) was started under blinding to treatment assignment. After 6 months, patients were unblinded and received antihypertensive medications (AHM) at treating physicians’ discretion. We assessed changes in OBP of the uRDN group at 36 months vs. baseline and screening. Results: Forty-nine of 69 (71%) patients (age: 53.0 ± 7.4 years; 18% female) originally randomized to uRDN completed their 36-month follow-up. OBP at screening in those patients was 159/103 ± 15/10 mmHg on a mean of 3.9 AHM with 33% of patients on AA. Baseline OBP after starting the single-pill combination was 153/99 mmHg. At 36 months OBP changed by -14.5/-9.0 mmHg from screening (p<0.001 for both) and -8.0/-5.0 mmHg from baseline (p=0.007; p=0.02) on a mean of 3.7 AHM with 41% of patients on AA. At 36 months, OBP change from baseline was irrespective of whether or not patients were taking AA. Given ambulatory BP was used to qualify patients at baseline, some patients had OBP <140/90 mmHg. For those with baseline OBP ≥140/90 (n=39), change in OBP at 36 months from baseline was -12.9/-7.4 mmHg (p<0.001 for both) on mean 3.6 AHM. No new uRDN-related long-term safety concerns were identified. Conclusion: In patients with resistant hypertension, the effectiveness and safety of uRDN were durable to 36 months.