A novel, six-electrode renal denervation (RDN) device showed significantly reduced office systolic blood pressure at 6 months post-procedure in patients with uncontrolled hypertension despite taking antihypertensive medication as compared to patients who underwent a sham procedure, according to new randomized trial results.

Fei Gao, MD, of Beijing Anzhen Hospital, reported these findings during a late-breaking trial presentation Wednesday at EuroPCR 2023 in Paris.

The study evaluated the safety and efficacy of the Netrod Six-Electrode Radiofrequency Renal Denervation System to treat uncontrolled hypertension.

The device featured a controllable basketlike catheter that can be used in vessels of varying size (3-12 mm), has intelligent wall contact feedback and provides simultaneous ablation through six electrodes in all quadrants.

The multicenter, randomized, sham-controlled, blinded study randomized 205 patients in a 2-to-1 ratio to undergo RDN with the Netrod device (n=139) or sham control (n=66). Patients had to have uncontrolled hypertension (office blood pressure between 150/90 mmHg and 180/110 mmHg and mean systolic blood pressure of at least 135 mmHg on 24-hour ambulatory blood pressure monitoring after taking two antihypertensive drugs on a stable dose for at least 4 weeks.

Before randomization, potential patients were placed on a standardized regimen of nifedipine gastrointestinal therapeutic system and hydrochlorothiazide for 4 weeks. Urine mass spectrometry was used to assess patient drug adherence.

There was no statistical difference between the groups at baseline. Both groups had a baseline office systolic blood pressure of about 160 mmHg and 24-hours ambulatory systolic blood pressure of about 151 mmHg.

The trial met its primary endpoint, with an reduction in office systolic blood pressure significantly greater in the RDN group than that of the sham-control group at 6 months post-procedure (25.2 ± 13.9 mmHg vs. 6.2 ± 12.5 mmHg, p<0.01), with a between-group difference of 19.0 mmHg (95% confidence interval: 15.0, 23.0).

Similarly, the office diastolic blood pressure and 24-hour ambulatory systolic/diastolic blood pressure reduction at 6 months were both significantly greater in the RDN group than in the sham-control group.

Gao added that device- or procedure-related serious adverse events were “rare.”

During follow-up, she said, the patients’ physicians were allowed to adjust blood pressure medication if needed, but in the 7 days before the 6-month follow-up visit, the patients had to be shifted back to the original standard two-drug regimen per study protocol.

“The unique design of the Netrod RDN system allows it to provide a safe and efficient RDN procedure with continuous energy field that enables all quadrant ablations,” Gao said. “This is the first clinical trial to demonstrate the safety and efficacy of this novel RDN device.”

William Wijns, MD, PhD, of the National University of Ireland, Galway, the EuroPCR press conference moderator, commented after Gao’s presentation that the results were “very impressive” and “the largest difference I’ve ever seen reported” between an RDN device and a sham procedure in hypertensive patients.