A Study of the ReCor Medical Paradise System in Stage II Hypertension - RADIANCE II

Oct 26, 2023
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC; Kim A. Eagle, MD, MACC
Trial Sponsor:
ReCor Medical
Date Presented:
10/26/2023
Date Published:
10/26/2023
Date Updated:
10/26/2023
Original Posted Date:
09/18/2022
References

Contribution To Literature:

Highlighted text has been updated as of October 26, 2023.

The RADIANCE II trial showed that, among patients with stage II HTN, renal denervation with the Paradise endovascular ultrasound renal denervation system resulted in a greater reduction in both systolic BP and diastolic BP 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 stage II hypertension (HTN).

Study Design

Patients were randomized in a 2:1 fashion to either renal denervation (n = 150) or a sham procedure (n = 74). 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.

  • Total number of enrollees: 224
  • Duration of follow-up: 2 months

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 with clinical symptoms before the 2-month evaluation, in which case patients received escape antihypertensive treatment.

Inclusion criteria:

  • Age 18-75 years
  • Uncontrolled HTN with a history of medication treatment on 0-2 antihypertensive medications
  • Off-med daytime ambulatory BP ≥135/85 and <170/105 mm Hg
  • No prior cardiovascular or cerebrovascular events
  • No type 1 or uncontrolled type 2 diabetes
  • Estimated glomerular filtration rate (eGFR) ≥40 mL/min/m2
  • Eligible renal artery anatomy

Exclusion criteria:

  • Known, uncorrected causes of secondary HTN other than sleep apnea
  • Type 1 diabetes mellitus or uncontrolled type 2 diabetes
  • eGFR of <40 mL/min/m2
  • Brachial circumference ≥42 cm
  • Repeat (>1) hospitalization for hypertensive crisis within 12 months prior to screening period, or any hospitalization for hypertensive crisis within 3 months prior to screening period
  • Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea

Other salient features/characteristics:

  • Office BP prior to washout: 156/102 mm Hg
  • 24-hour ambulatory BP prior to washout: 144/88 mm Hg

Principal Findings:

The primary outcome, baseline adjusted daytime ambulatory systolic BP at 2 months, in renal denervation vs. sham groups, was: –7.9 mm Hg vs. –1.8 mm Hg; between-group difference of –6.3 mm Hg (95% confidence interval –9.3 to –3.2 mm Hg, p < 0.0001).

Secondary outcomes for renal denervation vs. sham:

  • New-onset renal artery stenosis: 0
  • All-cause mortality at 30 days: 0

Six-month pooled analysis of RADIANCE-HTN SOLO, RADIANCE-HTN TRIO, and RADIANCE II: 506 patients were randomized to ultrasound renal denervation (uRDN) (n = 293) or sham (n = 213). Between baseline to 6 months, change in antihypertensive medications was lower for uRDN vs. sham (1.1 vs. 1.3, p = 0.001), and fewer additional antihypertensive medications were prescribed to uRDN patients vs. sham patients (66.3% vs. 77%, p = 0.002). The unadjusted between-group difference in daytime ambulatory systolic BP was similar at 6 months (–16.3 vs. –15.1 mm Hg, difference = –1.9 mm Hg; p = 0.33), but the baseline and medication-adjusted between-group difference at 6 months was –3.0 mm Hg (p = 0.033) in favor of uRDN plus antihypertensive medications. Similar reductions were noted for office and home BP. No new safety concerns were identified.

Interpretation:

The results of this trial indicate that, among patients with stage II HTN, renal denervation with the Paradise endovascular ultrasound renal denervation system resulted in a greater reduction in both systolic BP and diastolic BP at 2 months compared with a sham procedure. Of note, patients were off all antihypertensive medications during this 2-month period.

Overall reductions are similar to those noted in SPYRAL HTN-OFF MED, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO trials. Six-month results suggest durability of uRDN compared with sham controls. Overall BP reductions are modest and achievable with medication intensification but suggest that uRDN may be a reasonable alternative for BP management. Regression to the mean is an important consideration in HTN trials, and thus, these results need to be replicated in a larger cohort with longer follow-up; the sham design is also important.

References:

Aziz M, Sharp AS, Fisher ND, et al., on behalf of the RADIANCE Investigators. Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure at 6 Months Following Medication Escalation: The RADIANCE Clinical Trial Program. Circulation 2023;Oct 26:[Epub ahead of print].

Presented by Dr. Ajay J. Kirtane at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2023), San Francisco, CA, October 26, 2023.

Presented by Dr. Ajay J. Kirtane at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2022), Boston, MA, September 18, 2022.

Clinical Topics: Valvular Heart Disease, Invasive Cardiovascular Angiography and Intervention

Keywords: Heart Valve Diseases, Structural Intervention, TCT23, Transcatheter Cardiovascular Therapeutics


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