Ultrasound renal denervation reduces BP in treatment-resistant hypertension: RADIANCE-HTN TRIO
USA: Ultrasound renal denervation compared with a sham procedure reduced blood pressure at 2 months in patients with hypertension resistant to a standardized triple combination pill, according to six-month outcomes from the RADIANCE-HTN TRIO Trial.
Based on the findings, the researchers suggested that renal denervation might be an alternative to the addition of further antihypertensive medications in patients with resistant hypertension provided blood pressure-lowering effect and safety of renal denervation are maintained in the long term.
The study findings were presented at the TCT 2021, the 33rd annual scientific symposium of the Cardiovascular Research Foundation (CRF), and subsequently published in The Lancet.
Endovascular renal denervation is known to reduce blood pressure in mild-to-moderate hypertension. However, its efficacy with true resistant hypertension has not been shown. Prof Michel Azizi, Université de Paris, Paris, France, and colleagues, therefore, aimed to assess the efficacy and safety of endovascular ultrasound renal denervation in patients with hypertension resistant to three or more antihypertensive medications (treatment-resistant hypertension).
For this purpose, the researchers designed a randomized, international, multicentre, single-blind, sham-controlled trial performed at 28 tertiary centres in the USA and 25 in Europe. Patients aged 18–75 years with office blood pressure of at least 140/90 mm Hg despite three or more antihypertensive medications including a diuretic were included. Eligible patients were switched to a once-daily, fixed-dose, single-pill combination of a calcium channel blocker, an angiotensin receptor blocker, and a thiazide diuretic. Following 4 weeks of standardized therapy, patients with daytime ambulatory blood pressure of at least 135/85 mm Hg were randomly assigned (1:1) by computer (stratified by centres) to ultrasound renal denervation or a sham procedure.
Addition of antihypertensive medications was allowed if specified blood pressure thresholds were exceeded. The primary endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Safety was also assessed in the intention-to-treat population.
989 participants were enrolled between March 11, 2016, and March 13, 2020, and 136 were randomly assigned to renal denervation (n=69) or a sham procedure (n=67).
The study revealed the following findings:
- Full adherence to the combination medications at 2 months among patients with urine samples was similar in both groups (42 [82%] of 51 in the renal denervation group vs 47 [82%] of 57 in the sham procedure group; p=0·99).
- Renal denervation reduced daytime ambulatory systolic blood pressure more than the sham procedure (−8·0 mm Hg vs –3·0 mm Hg); the median between-group difference was –5·8 mm Hg among patients with complete ambulatory blood pressure data.
- There were no differences in safety outcomes between the two groups.
The researchers concluded that compared with a sham procedure, ultrasound renal denervation reduced blood pressure at 2 months in patients with hypertension resistant to a standardized triple combination pill.
Reference:
The study titled, "Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial," is published in The Lancet.
DOI: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00788-1/fulltext
