Results of RADIANCE-HTN TRIO suggest ultrasound renal denervation could improve blood pressure control in patients with refractory hypertension, suggesting RDN was associated with a mean reduction of 8 mmHg from baseline a 4.5 mmHg improvement over sham procedure.
New research presented at the American College of Cardiology’s 70th Annual Scientific Session (ACC.21) suggests a simple procedure could provide relief for patients with hypertension refractory to combination therapy.
Named RADIANCE-HTN TRIO, results from the randomized, sham-controlled trial demonstrated ultrasound renal denervation (RDN) was associated with mean systolic blood pressure reduction of 8 mmHg from baseline and 4.5 mmHg compared to the sham procedure among patients with blood pressure refractory to triple combination therapy.
“This study has shown for the first time that RDN can effectively lower blood pressure in patients in whom it is uncontrolled despite standardized treatment with three guideline-recommended medications,” said co-investigator Ajay Kirtane, MD, professor of medicine at Columbia University Vagelos College of Physicians and Surgeons and an interventional cardiologist at New York-Presbyterian/Columbia University Irving Medical Center, in a statement.
Funded by ReCor Medical, RADIANCE-HTN TRIO was designed as a randomized, multicenter, single-blind, sham-controlled trial that randomized more than 130 patients from 53 medical centers in the US and Europe with a blood pressure of at least 140/90 mmHg despite a regimen of 3 or more antihypertensive agents, including a diuretic. Released less than a year after RADIANCE-HTN SOLO was published, the studies provide insight into the potential to improve blood pressure control in a difficult-to-treat population.
For the purpose of analysis, patients were recruited for the trial and switched to a single, fixed-dose, daily combination pill that contained amlodipine 10 mg, valsartan 160 mg, and hydrochlorothiazide 25 mg. After 4 weeks, patients with a daytime ambulatory blood pressure of at least 135/85 mmHg were randomly assigned in a 1:1 ratio the ultrasound RDN or sham procedure.
In total, 989 patients were enrolled and 136 underwent randomization, with 69 randomized to RDN and 67 to the sham procedure. During the trial’s 2-month follow-up period, patients were asked to continue taking the daily combination pill and urine samples were assessed to evaluate adherence to the pill.
The overall trial population had a mean age of 53 years, 80% were men, and the mean blood pressure at study entry was 163/104 mmHg. Additionally, investigators pointed out the average number of antihypertensive medications among participants at study entry was 4, the median BMI of the population was 32.7 kg/m2, and approximately 25% of patients had type 2 diabetes.
Results of the investigators’ analyses indicated full adherence to the combination medication was similar between the study arms, with rates greater than 80% in both groups. At the conclusion of the trial, results suggested RDN was associated with a greater reduction in daytime ambulatory systolic blood pressure than the sham procedure (-8.0 mmHg [IQR, -16.4 to 0.0] vs -3.0 mmHg [-10.3 to 1.8]; median between-group difference, -4.5 mmHg; 95% CI, -8.5 to -0.3; adjusted P=.022). Additionally, in analyses of patients with complete ambulatory blood pressure data, the median between-group difference was 5.8 mmHg in favor of RDN (95% CI, -9.7 to -1.6; adjusted P=.0051).
Investigators pointed out their safety analysis indicated there were no differences in major adverse events occurring within 30 days of the procedure, including death from any cause, kidney failure, a blood clot, any complications involving the veins or arteries serving the kidneys that required treatment, between the study arms.
“RDN offers an additional tool that we could use to help these patients, hopefully achieving better overall control of hypertension, especially if longer-term data support the durability and safety of the procedure,” Kirtane said.
This study, “Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial,” was presented at ACC.21 and simultaneously published in The Lancet.