Changes in blood pressure after crossover to ultrasound renal denervation in patients initially treated with sham in the RADIANCE-HTN SOLO trial

Background: The multicentre, randomised, sham-controlled RADIANCE-HTN SOLO trial reported the blood pressure (BP)-lowering efficacy and safety of ultrasound renal denervation (RDN) in the absence (2 months) and presence (6 and 12 months) of antihypertensive medications in patients with mild-to-moderate hypertension. Aims: The aim of this report was to evaluate patients originally assigned to the sham group who crossed over to RDN. Methods: After the primary endpoint was met, patients in the sham arm who remained uncontrolled were allowed to cross over to receive RDN. All patients were unblinded and treated with standard of care medications at the time of crossover. Ambulatory BP was evaluated 2 and 6 months after crossover. Results: Among 72 subjects of the sham arm, 33 underwent ultrasound RDN after an average follow-up of 23 +/- 6 months. Prior to crossover, patients had a daytime ambulatory BP of 144.1 +/- 10.1/89.9 +/- 8.4 mmHg and received 1.2 +/- 0.8 antihypertensive medications. Mean change in daytime ambulatory BP from pre-crossover to 2 and 6 months post RDN was -11.2 +/- 13.7/-7.1 +/- 8.9 mmHg (n=33; p<0.001; p<0.001) and -10.8 +/- 17.3/-7.8 +/- 11.6 mmHg (n=27; p=0.002; p<0.001). The number of antihypertensive medications did not change from pre-crossover baseline to 2 and 6 months. Eighteen of 33 (54.5%) patients had their day-time ambulatory BP controlled (<135/85 mmHg) at 2 months and 44.4% (12/27) at 6 months post RDN. No major procedure-related adverse events occurred. Conclusions: During unblinded long-term follow-up of the RADIANCE-HTN SOLO study, patients originally assigned to a sham procedure who remained uncontrolled had significant reductions in BP following crossover treatment with ultrasound RDN.

Automated summary

In the RADIANCE-HTN SOLO study, patients originally assigned to a sham procedure who crossed over to receive ultrasound RDN treatment showed significant reductions in blood pressure during long-term follow-up, with no major procedure-related adverse events.