Long-Term Safety and Efficacy of Renal Denervation: 24-Month Results From the SPYRAL HTN-ON MED Trial
Primary result · Change in ambulatory systolic BPResult — go to the resultDifference −5.7 mm HgAuthors' conclusion
RDN produced significantly greater ambulatory and office systolic BP reductions at 24 months compared with sham control, despite higher antihypertensive medication use in the control group.
Study context
- Population
- Hypertensive patients with office systolic blood pressure (BP) of 150 to 180 mm Hg, diastolic BP ≥90 mm Hg and 24-hour ambulatory systolic BP of 140 to 170 mm Hg, prescribed 1 to 3 antihypertensive medicationspatients enrolled
- Participants
- 337 patients
- Comparison
- Renal denervation (RDN) vs sham control
Methodological detailsprespecified analysis, 56 clinical centers, global enrollment
- Prespecified analysis
- 56 clinical centers
- Global enrollment
Primary result
Change in ambulatory systolic BP · 24 months
Difference
−5.7 mm Hg
P = 0.039
Change by group
RDN
−12.1
mean reduction · SD 15.3 · mm Hg · n = 176
Sham control
−7.0
mean reduction · SD 13.1 · mm Hg · n = 33
As reported in the abstract
Further findings
| Outcome | RDN | Sham control | Difference (mm Hg) | P value |
|---|---|---|---|---|
| Change in office systolic BP · 24 monthsGreater reduction with RDN | mean reduction −17.4 (SD 16.1) mm Hg · n = 187 | mean reduction −9.0 (SD 19.4) mm Hg · n = 35 | −8.7 | P = 0.0034 |
| Antihypertensive medications · 24 monthsIncreased significantly more in the sham group | 1.8 versus 2.4 | 1.7 versus 2.7 | P = 0.046 |
Sensitivity analyses accounting for missing sham patient BP values due to crossover
- 24-hour ambulatory systolic BP, in favor of RDN
- P = 0.023
- Office systolic BP, in favor of RDN
- P < 0.0001
Safety
Clinical adverse events; renal artery stenosis · through 24 months
- Clinically adverse events were rare
- No instances of renal artery stenosis
Original publication
Long-Term Safety and Efficacy of Renal Denervation: 24-Month Results From the SPYRAL HTN-ON MED Trial. Circ Cardiovasc Interv. Published 20 May 2025. doi:10.
Summarised from the published abstract; every number is checked against it