HypertensionRandomised controlled trial
Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications
- Randomised controlled trial
- prospective
- sham-controlled
- patient- and assessor-blinded
- 56 clinical centers worldwide
- Bayesian trial design
Authors' conclusion
There was no significant difference between groups in the primary analysis. However, multiple secondary endpoint analyses favored RDN over sham control.
Study context
- Population
- Patients with uncontrolled hypertension prescribed 1 to 3 antihypertensive medications
- Participants
- 206 vs 131
- Comparison
- Radiofrequency renal denervation (RDN) vs sham control procedure
- RDNn = 206
- Sham controln = 131reference
- Primary endpoint
- Baseline-adjusted change in mean 24-hour ambulatory SBP between groups
- Follow-up
- 6 months
Primary result
Change in mean 24-h ambulatory SBP
Treatment difference
−1.9 mm Hg
95% CI −4.4 to 0.5
P = 0.12
By group
RDN
−6.5
mean change · ± 10.7 · mm Hg
Sham control
−4.5
mean change · ± 10.3 · mm Hg
RDN vs Sham control
treatment difference −1.9 mm Hg (95% CI −4.4 to 0.5); P = 0.12
As reported in the abstract
- No significant difference between groups in the primary efficacy analysis (Bayesian); posterior probability of superiority
- 0.51
- Bayesian treatment difference
- −0.03 mm Hg [95% CI: −2.82 to 2.77 mm Hg]
Secondary outcomes
| Outcome | adjusted treatment difference (mm Hg) | P value |
|---|---|---|
| Office SBP · 6 months | −4.9 | P = 0.0015 |
Night-time blood pressure (BP) and win ratio
- Night-time BP reductions and win ratio analysis favored RDN
Safety
Adverse safety events
- Adverse safety events among 253 assessed patients
- 1
Original publication
Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications. J Am Coll Cardiol. Published 7 November 2023. doi:10.1016/j.jacc.2023.08.045
Summarised from the published abstract; every number is checked against it