Larger SBP reduction by renal denervation in resistant hypertension patients on combination pill

Endovascular Ultrasound Renal Denervation To Treat Hypertension Resistant To A Fixed Dose Triple Medication Pill: The Randomized Sham-controlled RADIANCE-HTN TRIO Trial

Presented at ACC.21 by Ajay Kirtane (New York, NY, USA)

Introduction and methods

The trial was designed to investigate whether ultrasound-based renal denervation (RDN) can lower blood pressure (BP) after 2 months of the procedure. The patient population consisted of resistant hypertension patients who had to have office BP ≥140/90 on 3+ medications (mean SBP at baseline was >160 mmHg and mean DBP >100 mmHg and mean number of pills was 4). At screening they all were put on a single pill containing 3 guideline-recommended drugs. They were randomized to RDN (n=69) or sham procedure (n=67). Follow-up was 2 months for the primary efficacy endpoint, change in daytime ambulatory SBP. They will be followed for 5 years.

Main results

• At baseline (4 weeks of triple medication combination daily pill) adherence was assessed by urine HPLC-MS/MS measurements and 84% of RDN and 76% of sham control patients were fully adherent.
• The change in SBP (daytime ambulatory)was greater in the RDN group than in the sham control group (-8.0 mmHg vs. -3.0 mmHg, respectively, median between group difference -4.5 mmHg, 95%CI: -8.5 to -0.3, P=0.022).
• In the complete ABPM population (in those who ambulatory SBP could be measured at baseline and 2 months) a similar difference was observed (median between group difference: -5.8 mmHg, 95%CI:-9.7 to -1.6, P=0.005).
• Similar findings were observed for 24 hr BP, nighttime BP and office BP.
• Rate of adverse events was similar between the groups, but longer follow up data are needed.

Conclusion

In patients with resistant hypertension using guideline-recommended triple combination therapy in 1 pill, renal denervation resulted in a 4.5 mmHg greater decrease of daytime ambulatory SBP than a sham control after 2 months.

Kirtane noted that these results are consistent with those in RADIANCE-HTN SOLO in which renal denervation was studied in patients with mild-to-moderate hypertension who were not using medication. Assessment of long term efficacy and safety are ongoing.

Discussion

The discussant Deepak Bhatt, MD (Boston, MA, USA) said that renal denervation for out-of-control hypertension was a hot concept a few years ago. Randomized trials showed great drops in BP (20-30 mmHg) with RDN, but they had no sham control. SIMPLICITY-HTN III was the first with a sham control and showed numerically lower BP with RDN, but no statistically significant lowering. This highlighted the importance of sham controlled trials. Bhatt said it is not easy to do sham controlled trials, but the investigators of RADIANCE-HTN TRIO did a great job. The remaining question is though whether the change in BP is durable. And we have to see whether it is generalizable to the real world interventional cardiologists. The effect size may look small said Bhatt, but in the hypertension field these are meaningful reductions. If these reductions sustain over time, benefit in CV outcomes are suspected. Bhatt concluded that these results put RDN back on the map.

-Our coverage of ACC.21 is based on the information provided during the congress–

The findings of this study were simultaneously published in The Lancet Watch a video by prof. Kirtane on this trial