RADIANCE II: endovascular ultrasound renal denervation as a treatment for hypertension
Hypertension continues to be a major international health problem. While pharmacotherapy and lifestyle changes remain the mainstay of treatment, a small proportion of patients are “resistant” to these treatments and, for these patients, therapeutic options are few. Renal denervation went out of vogue following the SYMPLICITY HTN-3 trial, but optimisation of the technique has revived interest in establishing any role for its use for patients with resistant hypertension.
The RADIANCE II trial sought to assess the efficacy and safety of optimised ultrasound renal denervation as an alternative treatment, building upon the work of the RADIANCE-HTN SOLO trial (a study of the ReCor Medical Paradise System in clinical hypertension) and the RADIANCE-HTN TRIO trial (which sought to assess the efficacy and safety of endovascular ultrasound renal denervation in patients with hypertension resistant to three or more antihypertensive medications). RADIANCE II was designed to control for the “confounding” influence of antihypertensive medications in patients with hypertension.
This trial was conducted between January 14th 2019 and March 25th 2022 in a number of centres in the US and Europe (Belgium, France, Germany, Holland, Poland and the UK). It was a sham-controlled, randomised (2:1) clinical trial, which included 224 patients who had been withdrawn from antihypertensive medications.
Patients aged 18 years to 75 years with hypertension (seated office systolic blood pressure [BP] ≥140 mmHg and diastolic BP ≥90 mmHg despite taking up to two antihypertensive medications) were eligible, if they had an ambulatory systolic BP/diastolic BP ≥135/85 mmHg and a systolic BP/diastolic BP <170/105 mmHg after a four-week washout of their medications. Patients with an estimated glomerular filtration rate ≥40 mL/min/1.73 m² and with suitable renal artery anatomy were randomised 2:1 to undergo ultrasound renal denervation or a sham procedure. Patients were to abstain from antihypertensive medications until the two-month follow-up, unless pre-specified BP criteria were exceeded and were associated with clinical symptoms.
The primary efficacy outcome was the mean change in daytime ambulatory systolic BP at two months. The primary safety composite outcome of major adverse events included death, kidney failure, and major embolic, vascular, cardiovascular, cerebrovascular and hypertensive events at 30 days, and renal artery stenosis >70% detected at six months. The secondary outcomes included mean change in 24-hour ambulatory systolic BP, home systolic BP, office systolic BP and all diastolic BP parameters at two months.
Among 1038 eligible patients, 150 were randomised to ultrasound renal denervation and 74 to a sham procedure (mean age, 55 years [SD, 9.3 years]; 28.6% female; and 16.1% self-identified as Black or African American). The reduction in daytime ambulatory systolic BP was greater with ultrasound renal denervation (mean, −7.9 mmHg [SD, 11.6 mmHg]) compared to the sham procedure (mean, −1.8 mmHg [SD, 9.5 mmHg]) (baseline-adjusted between-group difference, −6.3 mmHg [95% CI, −9.3 to −3.2 mmHg]; P<0.001), with a consistent effect of ultrasound renal denervation throughout the 24-hour circadian cycle. Among seven secondary BP outcomes, six were significantly improved with ultrasound renal denervation compared to the sham procedure and no major adverse events were reported in either group. However, the authors note that the patients will need to be followed up for longer to assess the longer-term effects.
Read the full paper here.
