A Study of the ReCor Medical Paradise System in Stage II Hypertension - RADIANCE II
Contribution To Literature:
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.
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).
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.
- 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
- 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
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
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. 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.
Presented by Dr. Ajay J. Kirtane at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2022), Boston, MA, September 18, 2022.
Clinical Topics: Arrhythmias and Clinical EP, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Vascular Medicine, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Interventions and Imaging, Interventions and Vascular Medicine, Angiography, Echocardiography/Ultrasound, Nuclear Imaging, Hypertension
Keywords: Ablation Techniques, Angiography, Antihypertensive Agents, Blood Pressure, Diabetes Mellitus, Type 2, Endovascular Procedures, Glomerular Filtration Rate, Hypertension, Primary Prevention, Renal Artery Obstruction, TCT22, Transcatheter Cardiovascular Therapeutics, Ultrasonography, Interventional, Vascular Diseases
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