Reviwer: Dr. Alper Karakuş

Name of the Study : Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial

Presented Congress:  ACC 21

Full Text Link: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00788-1/fulltext

Background: In the RADIANCE-HTN SOLO study, endovascular renal denervation was shown to reduce blood pressure in patients with mild to moderate hypertension in 2 months of follow-up compared to the sham protocol.

Objective: In light of the results from the RADIANCE-HTN SOLO study, the RADIANCE-HTN TRIO study aimed to evaluate the efficacy and safety of endovascular ultrasonic renal denervation compared to the sham protocol in patients with hypertension resistant to three or more antihypertensive drugs.

Method: 989 patients were followed up from 53 different centers. The patients with mean daytime blood pressure ?135/85 at the end of 4 weeks under a once-daily fixed triple therapy regimen (calcium channel blocker, angiotensin receptor blocker and thiazide diuretic) were included in the study. While renal angiography was performed in 150 patients who met the criteria, 14 patients were excluded from the study because they did not meet the angiographic criteria. 69 patients were randomized to the endovascular ultrasonic renal denervation arm, 67 patients to the sham protocol arm ITT population. The primary efficacy endpoint was the change in daytime ambulatory systolic blood pressure after 2 months of follow-up.

Results: Results showed that daytime ambulatory systolic blood pressure (primary endpoint) was reduced by 8 mm Hg versus 3 mm Hg compared to the sham protocol in the endovascular ultrasonic renal denervation ITT population. The median difference between the groups was –4.5 mm Hg (adjusted p=0.022). Again, in patients with full ambulatory blood pressure data, the median difference between groups was –5.8 mm Hg (adjusted p=0.0051). The effect of endovascular ultrasonic renal denervation appeared to be independent of gender, ethnicity, age, waist circumference, or blood pressure level at enrollment. There was no difference between the groups in terms of safety (death, renal failure, thrombotic event, increase in blood pressure) at 30-day follow-up. However, follow-up of study patients will continue for three years to evaluate the durability, safety, and continued benefit of the endovascular ultrasonic renal denervation procedure.

Conclusion: In patients with hypertension resistant to triple combination therapy recommended in the guideline, the ultrasound-based renal denervation procedure was associated with a significant reduction in daytime ambulatory blood pressure compared to the sham protocol.

Interpretation: These results were consistent with the results of RADIANCE-HTN SOLO and demonstrated its short-term efficacy in blood pressure control. Again, these results suggest that if the blood pressure lowering effect and safety of renal denervation are maintained in the long term, it can be included in the treatment spectrum in patients with resistant hypertension.