RADIANCE: BP lowering with renal denervation maintained at 6 months

Across the RADIANCE trials, individuals treated with renal denervation remain to have a lower medication burden throughout the 6-month follow-up period even after the reintroduction of blood pressure (BP)-lowering drugs.

“Each of the three independently powered trials of the RADIANCE-HTN program previously showed that ultrasound renal denervation … safely reduced BP at 2 months versus a sham procedure in patients with mild-to-moderate hypertension off-medications or [those] with resistant hypertension on triple-drug fixed-dose combination therapy,” reported senior study author Dr Ajay Kirtane of Columbia University Irving Medical Center, New York, New York, US.

“The present individual patient data analysis demonstrates that after initiating standardized medication regimen for hypertension control from the 2nd month postprocedure onwards, there was less addition of these medication in the renal denervation group compared with sham … and the BP-lowering effect of renal denervation versus sham was maintained throughout the 6-month follow-up,” Kirtane added.

A total of 293 patients in the renal denervation group and 213 in the sham group from the RADIANCE-HTN SOLO, RADIANCE-HTN TRIO, and RADIANCE II trials were included in the pooled analysis. The mean age of the population overall was 54.1 years, and 70 percent were men. Baseline daytime ambulatory, home, and office systolic (S)BP levels were 150.5, 151.0, and 155.5 mm Hg, respectively.

The patients in the RADIANCE trials underwent a 4-week washout or stabilization of BP medications. The primary BP-lowering efficacy endpoint of renal denervation versus sham was evaluated at 2 months after randomization (ie, 3 months after antihypertensive therapy washout or stabilization), during which no new BP-lowering medications were added except for when BP remained too high. This was done in order to isolate the effect of renal denervation on BP. In case of persistence or recurrence of uncontrolled hypertension, the patients were initiated on a standardized medication escalation protocol from the 2nd month through the 5th month.

Over the 6-month follow-up, BP levels dropped in both treatment groups, but significantly fewer patients in the renal denervation than in the sham group received a BP-lowering medication prescription (p=0.004). Moreover, the renal denervation group received much fewer additional medication prescriptions (p=0.001). [Azizi, et al, TCT 2023]

The medication-adjusted daytime ambulatory SBP at 6 months was lower by 3.0 mm Hg (95 percent confidence interval [CI], –5.7 to –0.2; p=0.033) in the renal denervation group than in the sham group. Home and office SBP levels were also significantly reduced in the renal denervation group, with the reduction from baseline being greater by 5.4 mm Hg (95 percent CI, –6.8 to –4.0; p<0.001) and 5.2 mm Hg (–7.1 to –3.3; p<0.001), respectively, relative to the sham group.

There was no heterogeneity between trials, according to Kirtane.

Regarding the safety of renal denervation, the frequency of safety outcomes, whether related or not to the procedure, remained low and did not increase between 2 and 6 months, he added. No new incidence of renal artery stenosis ≥50 percent was documented.

“One of the key questions often asked about renal denervation is whether it is durable, especially in comparison to (or in combination with) antihypertensive medications. [The present] data support the role of [renal denervation] as a useful adjunct to established antihypertensive therapies,” Kirtane stated in a news release.