Effectiveness of Radiofrequency Renal Denervation in the United States: Six-Month Primary End Point Results From the SPYRAL AFFIRM Study
Main finding · Change in office systolic BP from baselineResult — go to the resultChange −18.2±22.0 mm HgAuthors' conclusion
In this US postapproval study, the primary end point was met with significant BP reductions following radiofrequency RDN consistent across different measures. In a broader patient population with uncontrolled hypertension, these results reaffirm the safety and efficacy of radiofrequency RDN.
Study context
- Population
- Patients with uncontrolled hypertension: office systolic/diastolic blood pressure (BP) ≥140/90 mm Hg and home systolic BP ≥135 mm Hg; type 1 diabetes, poorly controlled type 2 diabetes (HbA1c >8.0%) or estimated glomerular filtration rate <45 mL/min per 1.73 m 2 excludedpatients treated in the AFFIRM study from 73 US clinical sites
- Participants
- 594 patients
- Comparison
- 6-month change in office systolic BP from baseline compared with a prespecified performance goal (−6.0 mm Hg)
- Renal denervation (RDN)n = 594
- Outcome
- Change in office systolic BP from baseline
- Follow-up
- 6 months
Methodological details73 US clinical sites
- 73 US clinical sites
Main finding
As reported in the abstract
Change
−18.2±22.0 mm Hg
P < 0.001 compared with baseline
Further findings
| Outcome | Change (mm Hg) | P value |
|---|---|---|
| Change in home systolic BP · 6 monthsSix months after RDN vs baseline | −9.4±13.8 | P < 0.001 compared with baseline |
| Change in 24-hour ambulatory systolic BP · 6 monthsSix months after RDN vs baseline | −9.7±16.8 | P < 0.001 compared with baseline |
Baseline clinical characteristics
- Mean (±SD) age
- 57±12 years
- Female
- 45%
- African American
- 27%
- Hispanic
- 11%
- Type 2 diabetes
- 19%
- Mean estimated glomerular filtration rate
- 79±20 mL/min per 1.73m 2
Baseline systolic/diastolic BP
- Office
- 169±21/106±13 mm Hg
- Home
- 158±17/101±13 mm Hg
- 24-hour ambulatory
- 151±18/96±13 mm Hg
Antihypertensive medications prescribed · baseline through 6 months
- Average number at baseline, remained unchanged through 6 months
- 3.6±2.0
Safety
Adverse clinical events · through 6 months
- Adverse clinical events were uncommon
Original publication
Effectiveness of Radiofrequency Renal Denervation in the United States: Six-Month Primary End Point Results From the SPYRAL AFFIRM Study. Circ Cardiovasc Interv. Published 3 November 2026. doi:10.
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