In patients with treatment-resistant hypertension, renal denervation (RDN), vs. sham procedure, was associated with a greater reduction in daytime systolic blood pressure (SBP) at two months, with no difference in major adverse effects, according to results from the RADIANCE-HTN TRIO trial presented May 16 during ACC.21 and simultaneously published in The Lancet.

The international study enrolled 989 patients (average age, 53 years; 20% women; 20% were Black) in the U.S., United Kingdom and five European countries. At baseline, the average blood pressure (BP) was 163/104 mm Hg, despite taking an average of four antihypertensive medications. About one-quarter of patients had type 2 diabetes, and the median body mass index was about 32.7 kg/m2.

At study entry, patients were switched to a once daily, fixed-dose, single-pill combination of a calcium channel blocker, angiotensin receptor blocker, and a thiazide diuretic. Adherence to treatment was assessed with urine testing. Then, after four weeks, patients with a daytime ambulatory BP ≥135/85 mm Hg were randomized to ultrasound RDN (n=69) or sham procedure (n=67). Patients and assessors were blinded to the randomization.

Results showed that daytime ambulatory SBP at two months, the primary outcome, was reduced by 8 mm Hg with RDN vs. 3 mm Hg with sham procedure in the intention-to-treat population. The median between-group difference was –4.5 mm Hg (adjusted p=0.022). The benefit of RDN was consistent regardless of sex, ethnicity, age, waist size or blood pressure level at study entry. In patients with complete ambulatory BP data, the median between-group difference was –5.8 mm Hg (adjusted p=0.0051).

Also compared with the sham procedure, 24-hr ambulatory SBP, nighttime ambulatory SBP and office SBP were all significantly lower with RDN.

Regarding safety, no differences were seen for 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, or a severe increase in BP.

The researchers note these results are in line with those from the RADIANCE-HTN SOLO trial in patients with mild to moderate hypertension, confirming that ultrasound RDN can lower BP across a spectrum of hypertension.

"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," says Ajay J. Kirtane, MD, SM, FACC, a co-principal investigator of the trial.

Follow-up of the study patients will continue for three years to assess the durability, safety and ongoing benefit of the RDN procedure.

Clinical Topics: Prevention, Vascular Medicine, Hypertension

Keywords: ACC Annual Scientific Session, ACC21, Aneurysm, Primary Prevention, Hypertension

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