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Results of the 6-month follow-up from RADIANCE-HTN TRIO suggest the addition of antihypertensive medications following renal denervation could contribute to further blood pressure lowering in patients with treatment-resistant hypertension.
Data from the RADIANCE-HTN TRIO trial reported at TCT 2021 suggest the addition of pharmacologic intervention could provide an additive effect in regard to the blood pressure-lowering seen with renal denervation in the trial.
Presented as a late-breaker, results of the study demonstrate the addition of blood pressure-lowering medications could further reduce blood pressure, with a mean reduction of 12.3 mmHg from baseline at 6 months compared to the 8-mmHg reduction observed from baseline to 2 months.
“Blood pressure reductions after RDN were achieved with a smaller increase in additional medications prescribed and less use of aldosterone antagonists compared with a sham procedure,” said Ajay J Kirtane, MD, SM, professor of medicine at the Columbia University Vagelos College of Physicians and Surgeons and director at New-York-Presbyterian/Columbia University Irving Medical Center’s Cardiac Catheterization Laboratories, in a statement. “These results demonstrate the additional effects of pharmacologic intervention with maintenance of a BP-lowering effect of endovascular ultrasound RDN at six months.”
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. 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 renal denervation or sham procedure.
Overall, 989 patients were enrolled and 136 underwent randomization. Of these, 69 were randomized to renal denervation and 67 were randomized to the sham procedure. Those who underwent randomization had a mean age of 53 years, 80% were men, and a mean blood pressure at study entry of 163/104 mmHg.
With 2-month results, which were presented at ACC 2021 and published in the Lancet, indicating renal denervation was associated with an 8-mmHg reduction in diastolic blood pressure overall and a 4.5 mmHg greater reduction compared to the sham procedure. For months 2-5, patients underwent blinded medication titration protocol, which consisted of the addition of spironolactone 25 mg/d, bisoprolol 10 mg/d, full dose of a centrally acting alpha-2 receptor agonist, and an alpha-1 receptor blocker if monthly measured home blood pressure was at or above 135/85 mm Hg, with the goal of achieving blood pressure control in both groups. The 6-month follow-up included assessments of ambulatory blood pressure home blood pressure office blood pressure, and duplex driven CTA/MRA.
Upon analysis, results suggested the mean increase in antihypertensive medications at 6 months was 0.7±1.0 for the renal denervation arm compared to 1.1±1.1 for the sham arm (P=.045). Investigators noted the use of aldosterone antagonists at 2 months was 3% and 11% among the renal denervation and sham arms, respectively. By 6 months, this figure grew to 40% among the renal denervation arm and 60.9% among the sham arm (P =.017).
When examining outcomes, results indicated the addition of the medication titration protocol resulted in further decreases in blood pressure for both arms. At 6 months, the overall change from baseline in diastolic ambulatory blood pressure was -11.8±14.2 mmHg among the renal denervation arm and -12.3±14.2 among the sham treatment arm (P=.65). After adjustment for baseline blood pressure and number of medications, patients randomized to renal denervation had lower home blood pressure than those randomized to sham treatment, with a difference of -4.28 mmHg observed between the group (P=.027).
This study, “Six-Month Outcomes of a Randomized Trial of Renal Denervation Versus a Sham Procedure: Blinded Medication Titration for Resistant Hypertension in the RADIANCE-TRIO Trial,” was presented at TCT 2021.