- Question
- Does catheter-based renal denervation lower blood pressure in hypertensive patients who are not taking antihypertensive medications, compared with a sham procedure?
- Design
- International, prospective, 1:1 randomized, single-blinded, sham-controlled trial conducted at 44 sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the UK and the USA. A total of 331 patients were randomized. A Bayesian design with an informative prior was used, combining evidence from the pilot and pivotal trials.
- Population
- Hypertensive patients with office systolic blood pressure of 150 mm Hg to less than 180 mm Hg, assessed in the absence of antihypertensive medications.
- Intervention
- Catheter-based renal denervation (n=166) using the Symplicity Spyral multi-electrode system.
- Control
- Sham procedure (n=165), consisting of renal angiography.
- Primary outcome
- Baseline-adjusted change in 24-hour systolic blood pressure (ambulatory monitoring) from baseline to 3 months after the procedure. The secondary endpoint was the baseline-adjusted change in office systolic blood pressure.
- Results
- The treatment difference between groups in 24-hour systolic blood pressure was -3.9 mm Hg (Bayesian 95% credible interval -6.2 to -1.6), with a posterior probability of superiority above 0.999. For office systolic blood pressure the difference was -6.5 mm Hg (-9.6 to -3.5).
- Safety
- No major device-related or procedure-related safety events occurred up to 3 months.
- Conclusion
- Catheter-based renal denervation was superior to a sham procedure in safely lowering blood pressure in the absence of antihypertensive medications.
- Why it matters
- It provided sham-controlled evidence, free from drug confounding, that renal denervation has a real though modest blood pressure-lowering effect, supporting its consideration as a therapeutic option in hypertension.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 18, 2026