Key result
Ultrasound renal denervation reduces office systolic BP by ~15 mmHg at 36 months in resistant hypertension.
Why the study?
The long-term durability and safety of ultrasound renal denervation in patients with hypertension resistant to combination therapy were not established.
Does endovascular ultrasound renal denervation provide durable long-term reduction in blood pressure up to 36 months in patients with resistant hypertension?
RCT (n=136)
Double-blind up to 6 months, then open-label
1:1
Yes
Does endovascular ultrasound renal denervation provide durable long-term reduction in blood pressure up to 36 months in patients with resistant hypertension?
Endovascular ultrasound renal denervation demonstrates durable office blood pressure reduction up to 36 months in patients with resistant hypertension without late safety concerns.
Suggests durable BP lowering with ultrasound renal denervation in resistant hypertension; leaves open randomized confirmation of outcomes.
Endovascular ultrasound renal denervation (uRDN) reduced blood pressure (BP) compared to sham at 2 months in patients with resistant hypertension in the multicenter, blinded, randomized, sham-controlled RADIANCE-HTN TRIO trial. This analysis evaluates longer-term outcomes of patients randomized to uRDN. Patients with resistant hypertension to a 3-drug combination pill were randomized to uRDN (n = 69) or sham (n = 67). From 2-5 months, patients followed a standardized anti-hypertensive medication (AHM) titration protocol. At 6 months, patients were unblinded and received AHM per standard of care. In the uRDN group, 71% (49/69) completed 36-month follow-up. Screening office BP was 159/103 on 3.9 AHM. Baseline office BP on the single-pill combination was 153/99 mmHg. At 36 months, office BP changed by -14.5 ± 26.1/-9.0 ± 14.8 mmHg from screening (p < 0.001 for both) and -8.0 ± 24.5/-5.0 ± 14.6 mmHg from baseline (p = 0.007; p = 0.022) on 3.7 AHM. The efficacy of uRDN was durable to 36 months in patients with resistant hypertension with no safety concerns.
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Bloch et al. (2024) conducted an RCT in Resistant hypertension (n=136). Endovascular ultrasound renal denervation (uRDN) vs. Sham was evaluated on Change in mean office systolic blood pressure from screening to 36 months (-14.5 ± 26.1 mmHg, p=<0.001). Endovascular ultrasound renal denervation produced a durable mean reduction in office systolic blood pressure of 14.5 mmHg from screening to 36 months in patients with resistant hypertension.
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