Ultrasound renal denervation lowers BP in medication-resista
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Ultrasound renal denervation for patients with triple-therapy resistant hypertension successfully lowered 24-hour ambulatory BP compared with those who underwent a sham procedure, a speaker reported.

Researchers suggested that renal denervation may be an alternative to prescribing more antihypertensive therapies to patients with resistant hypertension, according to research presented at the American College of Cardiology Scientific Session and simultaneously published in The Lancet.

“Denervation reduces blood pressure in patients with mild to moderate hypertension, but its blood pressure-lowering effect has not been previously demonstrated with confidence in patients with resistant hypertension,” said researchers. “The objective was to investigate whether this denervation procedure could reduce daytime ambulatory systolic blood pressure in patients with hypertension resistant to a standardized fixed-dose, triple medication pill.”

Ultrasound renal denervation is a transfemoral procedure that involves the use of a ring of ablative energy, at a depth of 1 mm to 6 mm, to interrupt renal nerve traffic, the author said during the presentation. It utilizes water cooling to protect the arterial wall from the two to three 7-second sonications needed to ablate each main renal artery, he said.

For the randomized, international, single-blind RADIANCE-HTN TRIO trial, researchers enrolled 989 patients with BP of 140/90 mm Hg or higher despite three or more antihypertensive medications, including a diuretic, of whom 136 were randomly assigned to renal denervation or a sham procedure.

All participants were switched to a once-daily, fixed-dose, single-pill combination of a calcium channel blocker, an angiotensin receptor blocker and a thiazide diuretic, and after 4 weeks, those with daytime ambulatory BP of at least 135/85 mm Hg were randomly assigned to ultrasound renal denervation or a sham procedure.

The primary endpoint was change in daytime ambulatory systolic BP at 2 months in the intention-to-treat population.

In the intention-to-treat population at 2 months, researchers reported a median between-group difference in systolic BP of –4.5 mm Hg (95% CI, –8.5 to –0.3; P = .022), and among patients with complete ambulatory BP monitoring measurements, a between-group difference of –5.8 mm Hg (95% CI, –9.7 to –1.6; P = .005).

Patients who underwent ultrasound renal denervation were more likely to experience systolic BP decreases of 5 mm Hg (P = .0045) and 10 mm Hg (P = .014) compared with the sham procedure group.

At 2 months, the median difference in office systolic BP among the renal denervation and sham groups was –7 mm Hg (95% CI, –13 to 0; P = .037).

Researchers reported that 2% of the renal denervation group required any additional BP-lowering medications at 2 months compared with 12% of the sham group (P = .1), and 3% of both cohorts experienced reductions in the number of prescribed BP medications (P = 1).

Moreover, 75% of the overall study population were fully adherent to BP-lowering medications at baseline and 2 months.

Within the renal denervation group, the researchers reported one sudden death unrelated to device or procedure at 21 days; one case of transient acute renal injury at 25 days associated with spironolactone use, which was resolved upon discontinuation of spironolactone; and one femoral access-site pseudoaneurysm post-procedure resolved with thrombin injection.

“This study has shown for the first time that renal denervation can effectively lower blood pressure in patients in whom it is uncontrolled despite standardized treatment with three guideline-recommended medications,” researchers said. “Renal denervation 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.”

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