Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials
An erratum to this article was published (JAMA Cardiol, 1 Aug 2023 ↗)
Pooled result · dASBPResult — go to the resultMean difference −5.9 mm Hg 95% CI −8.1 to −3.8Authors' conclusion
Results of this patient-level pooled analysis suggest that BP reductions with uRDN were consistent across HTN severity in sham-controlled trials designed with a 2-month primary end point to standardize medications across randomized groups.
Study context
- Population
- Patients with mild to moderate hypertension (HTN) on no medications or HTN resistant to standardized triple-combination therapy
- Participants
- 506 patients · 3 RCTs
- Comparison
- Ultrasound renal denervation vs sham procedure
- Ultrasound renal denervation (uRDN)n = 293
- Shamn = 213reference
- Outcome
- Baseline-adjusted change in daytime ambulatory SBP (daytime ambulatory systolic BP (dASBP)) between groups
- Follow-up
- 2 months
Methodological detailssham-controlled, 3 trials (RADIANCE II, RADIANCE-HTN SOLO, RADIANCE-HTN TRIO)
- Sham-controlled
- 3 trials (RADIANCE II, RADIANCE-HTN SOLO, RADIANCE-HTN TRIO)
Pooled result
dASBP
Mean difference
−5.9 mm Hg
95% CI −8.1 to −3.8
P < 0.001
By group
uRDN vs Sham
mean difference −5.9 mm Hg (95% CI −8.1 to −3.8); P < 0.001
As reported in the abstract
Further pooled results
mm Hg
| Outcome | uRDN | Sham | Mean difference (mm Hg) (95% CI) | |
|---|---|---|---|---|
| Office SBP change | −10.4 | −3.4 | −6.4 (−9.1 to −3.6) | |
| Home SBP change | −8.4 | −1.4 | −6.8 (−8.7 to −4.9) | |
| −10−505Difference, mm Hg (linear scale) |
Prespecified subgroups
- Blood pressure (BP) reductions with uRDN vs sham consistent across prespecified subgroups
Predictors of larger BP response to uRDN
- Higher baseline BP and heart rate, and orthostatic hypertension
Safety
Early safety end points
- No differences between groups
Original publication
Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials. JAMA Cardiol. Published 1 May 2023. doi:10.
Summarised from the published abstract; every number is checked against it