TitleUltrasound-Based Renal Denervation Safely Reduces BP in Patients With Treatment-Resistant Hypertension
By Walter Alexander
VIRTUAL -- May 20, 2021 -- Compared with a sham procedure, ultrasound-based renal denervation safely reduced blood pressure (BP) in patients with hypertension resistant to a standardised single tablet combination of 3 guideline-recommended medications, according to a study presented at the Virtual 70th Annual Scientific Sessions of the American College of Cardiology (ACC).
In the RADIANCE-HTN TRIO study, ultrasound-based renal denervation was associated with a reduction of 8.0 mm Hg in daytime ambulatory systolic BP in patients with resistant hypertension. The BP-lowering effect of renal denervation was consistent for 24-hour, night-time, and office systolic BP, reported Ajay J. Kirtane, MD, Columbia University Irving Medical Center, New York, New York.
The study included 989 patients (mean age, 53 years) from the United States and Europe. Of the patients, 80% were male, median body mass index was about 32.7, and roughly a fourth had type 2 diabetes. At study entry, included patients were taking an average of 4 anti-hypertensive medications, yet still had an average BP of 163/144 mm Hg.
At study onset, all patients were switched from their existing regimens to a once-daily triple medication single tablet containing a calcium channel blocker, an angiotensin receptor blocker, and a thiazide diuretic. After 4 weeks on the single tablet, those patients whose BP on ambulatory BP monitoring was still 135/85 mm Hg or higher underwent non-invasive imaging to ensure the suitability of their renal arteries for renal denervation. A total of 136 patients were then randomised to ultrasound-based renal denervation (n = 69) or a sham procedure (n = 67).
During 2 months of follow-up, patients continued to take the 3-drug polypill, with adherence assessed via urine samples. Change in daytime ambulatory systolic BP was the primary efficacy endpoint.
In the intent-to-treat population, the change in daytime systolic BP at 2 months was -8.0 mm Hg in the renal denervation group and -3.0 mm Hg in the sham group. (P = .022). In the complete ambulatory BP population, the renal denervation change was -9.7 mm Hg versus -3.0 in the sham group (P = .005). The same pattern was observed according to changes in office and home systolic BP assessments.
Dr. Kirtane noted that 75% of subjects were fully adherent to medications at both baseline and at 2 months.
No differences in major adverse events were observed between the treatment arms.
“Renal denervation offers an additional tool that we can use to help these patients to achieve better overall control of hypertension, especially if longer-term data support the durability and safety of the procedure,” said Dr. Kirtane.
[Presentation title: Endovascular Ultrasound Renal Denervation to Treat Hypertension Resistant to a Fixed Dose Triple Medication Pill: the Randomized Sham-Controlled RADIANCE-HTN TRIO Trial. Presentation number 407-16]