Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program
Pooled result · Daytime ambulatory SBP (baseline- and medication-adjusted)Result — go to the resultBetween-group difference −3.0 mm Hg 95% CI −5.7 to −0.2Authors' conclusion
This individual patient-data analysis of 506 patients included in the RADIANCE trials demonstrates the maintenance of BP-lowering efficacy of uRDN versus sham at 6 months, with fewer added AHTs.
Study context
- Population
- Patients with mild to moderate hypertension not on AHT or with hypertension resistant to standardized triple AHT
- Participants
- 506 patients · 3 trials
- Comparison
- Ultrasound renal denervation (uRDN) vs Sham
- uRDNn = 293
- Shamn = 213reference
- Outcome
- Baseline- and AHT-adjusted change in daytime ambulatory SBP
- Follow-up
- 6 months
Methodological detailssham-controlled, individual patient data, Blinded sequential addition of standardized AHT from 2 to 5 months if home blood pressure (BP) ≥135/85 mm Hg
- Sham-controlled
- Individual patient data
- Blinded sequential addition of standardized AHT from 2 to 5 months if home BP ≥135/85 mm Hg
Pooled result
As reported in the abstract
Daytime ambulatory SBP (baseline- and medication-adjusted)
Between-group difference
−3.0 mm Hg
95% CI −5.7 to −0.2
P = 0.033
uRDN vs Sham
between-group difference −3.0 mm Hg (95% CI −5.7 to −0.2); P = 0.033
Further pooled results
| Outcome | Between-group difference (mm Hg) (CI) | P value | |
|---|---|---|---|
| Home SBP (adjusted) · over 6 months | −5.4 (−6.8 to −4.0) | P < 0.001 | |
| Office SBP (adjusted) · over 6 months | −5.2 (−7.1 to −3.3) | P < 0.001 | |
| −10−505Difference, mm Hg (linear scale) |
AHT prescription · 2 to 6 months
- Fewer uRDN patients prescribed AHT
- P = 0.004
- Fewer additional AHT prescribed with uRDN vs sham
- P = 0.001
Safety
Safety outcomes · 6 months
- Safety outcomes were few and did not differ between groups
Original publication
Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program. Circulation. Published 26 October 2023. doi:10.
Summarised from the published abstract; every number is checked against it