Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial

Interim analysis (n=80) found significant differences in 3-month change in 24-h ambulatory and office BP from baseline in favour of renal denervation vs sham control. There were no major adverse events in either group.

After 3 month follow up, the mean difference between the groups favoured renal denervation for 3-month change in both office and 24-h blood pressure from baseline: 24-h SBP −5·0 mm Hg (95% CI −9·9 to −0·2; p=0·0414), 24-h DBP −4·4 mm Hg (−7·2 to −1·6; p=0·0024), office SBP −7·7 mm Hg (−14·0 to −1·5; p=0·0155), and office DBP −4·9 mm Hg (−8·5 to −1·4; p=0·0077). Baseline-adjusted analyses showed similar findings.

 

An accompanying editorial notes that the magnitude of the difference in mean 24-h SBP between the groups suggests that most patients in the treatment group would still need oral antihypertensive treatment. However, renal denervation may offer a new paradigm for the treatment of hypertension.