The addition of pharmacologic interventions to endovascular ultrasound renal denervation (RDN) can lead to further blood pressure (BP) reductions after 6-month follow-up, according to newly published data from the RADIANCE-HTN TRIO Trial. Six-month follow-up for the trial, which previously showed successful 2-month follow-up results in May, was reported on Thursday at Transcatheter Cardiovascular Therapeutics (TCT) 2021 in Orlando, Florida. Speaking at a press conference, Ajay Kirtane, MD, SM, from Columbia University Irving Medical Center and New York-Presbyterian Hospital, noted that after demonstrating that RDN reduced BP compared to a sham procedure at 2-month follow-up in patients with hypertension resistant to a stable and uniform regimen of combination triple therapy, data from 6-month blinded follow-up shows that further BP reductions were seen in both study arms with the addition of a standardized stepped-care antihypertensive treatment (SSAHT) but that BP reductions after RDN were achieved with a smaller increase in additional medications. “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,” commented Kirtane, explaining that aldosterone antagonists are the first step in the escalation protocol for high blood pressure. "In other words, there were a greater number of medications added back to the sham group compared to the denervation group," he said. "Despite that, blood pressures remained lower – especially regarding home blood pressure – in the denervation group compared to the sham." Kirtane said that in light of the findings, RDN can offer an additional – but not a replacement – option to further lower BP, especially for patients whose BP is uncontrolled despite genuine attempts to institute conventional therapies. “These results demonstrate the additional effects of pharmacologic intervention with maintenance of a BP-lowering effect of endovascular ultrasound RDN at six months.” Trial details The international study initially recruited 989 participants aged 18 to 75 years with office BP of at least 140/90 mmHg despite three or more antihypertensive medications including a diuretic. Patients were recruited from 28 tertiary centers in the U.S. and 25 in Europe and were switched to a once-daily, fixed-dose, single-pill combination of a calcium channel blocker, an angiotensin receptor blocker, and a thiazide diuretic. After 4 weeks of standardized therapy, 136 patients with daytime ambulatory BP of at least 135/85 mmHg were randomly assigned (1:1) to ultrasound RDN or a sham procedure. Previous 2-month data showed that RDN reduced daytime ambulatory systolic BP more than the sham procedure, with the benefit persisting regardless of sex, ethnicity, age, waist size or blood pressure level at study entry. New data from 6-month follow-up now show that during months 2-5, the addition of SSAHT was recommended sequentially, with the addition of: spironolactone 25 mg/day; bisoprolol 10 mg/day; full dose of a centrally acting α2 receptor agonist; and an α1 receptor blocker if monthly measured home BP was ≥135/85 mm Hg. The goal was to achieve BP control in both the sham and RDN groups. Data presented at TCT 2021 showed the increase in anti-hypertensive medications at 6 months following the addition of the SSAHT was 0.7 ± 1.0 for RDN and 1.1 ± 1.1 for sham (p=0.045). Furthermore, the use of aldosterone antagonists at 2 months was 3% for RDN and 11% for sham (p=0.16). Home BP was lower in patients initially randomized to RDN when adjusted for baseline BP and number of medications (-4.28 mmHg, p=0.027), he said, adding that there were no differences in safety outcomes between groups. Kirtane added 6-month data showed no significant difference in ambulatory BP between RDN and sham but noted that this was likely due to the increased use of medication in the sham group. “The benefit in denervation occurred early between 0-2 months with the denervation procedure. [Whereas] the difference between sham groups was observed between 2-6 months, coincident with the greater initiation of the step care regimen,” he said. “So more medications, but ultimately the blood pressures achieved similar ratings overall.” The study was funded by ReCor Medical, manufacturer of the ultrasound RDN device.