A Study of the ReCor Medical Paradise System in Clinical Hypertension - RADIANCE-HTN SOLO

Contribution To Literature:

The results of this trial indicate that, among patients with mild to moderate hypertension, renal denervation with the Paradise endovascular ultrasound renal denervation system resulted in a greater reduction in both SBP and DBP at 2 months compared with a sham procedure.

Description:

The goal of the trial was to assess the safety and efficacy of renal denervation compared with sham control among patients with mild to moderate systolic and diastolic hypertension.

Study Design

Patients with mild to moderate systolic and diastolic hypertension were randomized in a 1:1 fashion to either renal denervation (n = 74) or a sham procedure (n = 72). All patients underwent a 4-week period prior to randomization during which all antihypertensive medications were discontinued. After the post-randomization qualifying renal angiogram, patients assigned to the renal denervation group underwent immediate endovascular ultrasound nerve ablation, whereas those randomized to the sham group had no further endovascular procedures. Renal nerve ablation was done with the Paradise endovascular ultrasound renal denervation system. A minimum of two sonications of 7 seconds each were delivered in the main branch of the right and left renal artery, separated longitudinally by 5 mm, according to individual treatment plans developed on the basis of the pre-randomization computed tomography or magnetic resonance angiography.

All patients remained off antihypertensive medications until 2 months after randomization unless office blood pressure (BP) reached 180/110 mm Hg or home BP reached 170/105 mm Hg before the 2-month evaluation, in which case patients received escape antihypertensive treatment.

  • Total screened: 803
  • Total number of enrollees: 146
  • Duration of follow-up: 2 months
  • Mean patient age: 54 years
  • Percentage female: 42%
  • White race: 77%

Inclusion criteria:

  • Age 18–75 years
  • Combined systolic–diastolic hypertension that was either uncontrolled on zero to two antihypertensive medications (average seated office systolic BP [SBP] and diastolic BP [DBP] of ≥140/90 mm Hg, but <180/110 mm Hg) or controlled on one to two antihypertensive medications (average seated office BP <140/90 mm Hg) were eligible for the run-in phase.
  • Estimated glomerular filtration rate (eGFR) ≥40 ml/min/1.73 m²
  • No history of cardiovascular or cerebrovascular events
  • During run-in phase, subsequent daytime ambulatory SBP of ≥135 mm Hg and DBP ≥85 mm Hg and <170/105 mm Hg
  • Suitable anatomy on angiography

Other salient features:

  • Office BP prior to washout: 143/93 mm Hg
  • ≥2 anti-HTN agents at baseline: 39%
  • Obstructive sleep apnea: 10%

Principal Findings:

The primary outcome, daytime ambulatory SBP at 2 months in renal denervation vs. sham groups, was –8.5 mm Hg vs. –2.2 mm Hg; between-group difference of –6.3 mm Hg, 95% confidence interval [CI] –9.4 to –3.1 mm Hg, p = 0.0001

Secondary outcomes for renal denervation vs. sham:

  • Daytime ambulatory DBP at 2 months: –5.1 mm Hg vs. –2.6 mm Hg; between-group difference of –2.6 mm Hg, 95% CI –4.6 to –0.6 mm Hg, p = 0.01
  • 24-hour ambulatory SBP at 2 months: –7.0 mm Hg vs. –3.1 mm Hg; between-group difference of –4.1 mm Hg, 95% CI –7.1 to –1.2 mm Hg, p = 0.006
  • Need for antihypertensive treatment after 2 months: 55% vs. 79%, p = 0.002
  • At 2 months, no patients had renal artery stenosis >50%
  • Change in eGFR = –0.6, p = 0.75

Interpretation:

The results of this trial indicate that, among patients with mild to moderate hypertension, renal denervation with the Paradise endovascular ultrasound renal denervation system resulted in a greater reduction in both SBP and DBP at 2 months compared with a sham procedure. Of note, patients were off all antihypertensive medications during this 2-month period. Overall reductions were similar to those noted in the SPYRAL HTN-OFF MED study. Results are contrary to SYMPLICITY HTN-3, which was a larger trial. Regression to the mean is an important consideration in hypertension trials, and thus, these results need to be replicated in a larger cohort with longer follow-up; the sham design is also important.

References:

Azizi M, Schmieder RE, Mahfoud F, et al. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet 2018;391:2335-45.

Editorial Comment: Kjeldsen SE, Esler MD. Take a blood pressure pill or undergo renal denervation? Lancet 2018;391:2298-300.

Clinical Topics: Diabetes and Cardiometabolic Disease, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Vascular Medicine, Interventions and Imaging, Interventions and Vascular Medicine, Angiography, Echocardiography/Ultrasound, Magnetic Resonance Imaging, Hypertension

Keywords: Antihypertensive Agents, Blood Pressure, Denervation, Endovascular Procedures, Glomerular Filtration Rate, Hypertension, Hypertension, Renal, Magnetic Resonance Angiography, Primary Prevention, Renal Artery Obstruction, Sonication, Systole, Ultrasonography, Vascular Diseases


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