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.
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.
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%
- 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%
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
6-month results: For safety reasons, trial participants were off antihypertensive medications for a maximum of 2 months. The following results are for renal denervation vs. sham:
- Percentage receiving antihypertensive medications: 65.2% vs. 84.5%, p = 0.008
- Average number of antihypertensive medications: 0.9 vs. 1.3, p = 0.010
- Change in daytime ambulatory SBP at 6 months: –18.1 mm Hg vs. –15.6 mm Hg; between-group difference of –2.3 mm Hg, 95% CI –6.0 to 1.5 mm Hg, p = 0.24; further adjusted for number of antihypertensive medications: –4.3 mm Hg, 95% CI –7.9 to –0.6, p = 0.024
- Change in daytime ambulatory DBP at 6 months: –10.7 mm Hg vs. –9.7 mm Hg; between-group difference of –1.3 mm Hg, 95% CI –3.7 to 1.2 mm Hg, p = 0.32; further adjusted for number of antihypertensive medications: –2.8 mm Hg, 95% CI –5.1 to –0.5, p = 0.018
- No difference in office SBP between the two arms
- Difference in daytime ambulatory SBP at 12 months compared with baseline for renal denervation vs. sham groups: –16.5 vs. –15.8 mm Hg, p = 0.2
- Difference in 24-hour ambulatory SBP at 12 months compared with baseline: –15.1 vs. –15.3 mm Hg, p = 0.16
- Total number of antihypertensives: 1 vs. 1.4, p = 0.015
- Defined daily dose of antihypertensives: 1.4 vs 2.2, p = 0.007
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. By 6 months, nearly two thirds of patients required antihypertensive therapy even after renal denervation. However, the number and dose of medications required was lower compared with the sham arm. The effect of renal denervation appeared reasonably stable compared with the sham arm out to 12 months.
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.
Azizi M, Daemen J, Lobo MD, et al. 12-Month Results From the Unblinded Phase of the RADIANCE-HTN SOLO Trial of Ultrasound Renal Denervation. JACC Cardiovasc Interv 2020;13:2922-33.
Editorial Comment: Messerli FH, Rexhaj E, Dobner S. Renal Denervation: The Study That Shattered its Halo. JACC Cardiovasc Interv 2020;13:2934-6.
Azizi M, Schmieder RE, Mahfoud F, et al. Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control Following Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTN SOLO Trial. Circulation 2019;139:2542-53.
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.
Keywords: ACC19, ACC Annual Scientific Session, 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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