Nighttime & Early Morning BP Controlled by Renal Denervation

LONDON — Clinically meaningful reductions in blood pressure (BP) at night and throughout the circadian cycle were seen with radiofrequency renal denervation (RF RDN) at 24 months, according to data from a study aimed at reducing cardiovascular risk in patients with uncontrolled hypertension.

The results were presented at the European Society of Cardiology (ESC) Congress 2024 by Konstantinos Tsioufis, MD, PhD, professor of cardiology at the National and Kapodistrian University of Athens, Athens, Greece. They showed that at 24 months post intervention, BP dropped by 12.0 and 14.8 mm Hg in the nighttime (1-6 AM) and morning (7-9 AM), respectively.

“The nighttime blood pressure was further reduced at 24 months over the 12-month results despite the number of blood pressure medications remaining similar,” he reported. “By reducing the nocturnal hypertension, there will also be incremental benefits on the cardiovascular system.”

“Renal denervation reduces nighttime blood pressure preferentially, in particular the early morning blood pressure, and we know that nocturnal blood pressure is more dangerous for cardiovascular events,” Tsioufis said.

Reductions in daytime (9 AM-9 PM) and office BP were 13.8 and 19.3 mm Hg, respectively, at 24 months.

He added that the number of hypertension medications was similar at 12 and 24 months post intervention and pointed out that unlike BP medications that do not control BP over 24 hours, RDN is always active.

Data were drawn from the SPYRAL HTN-OFF MED Pivotal (n=182) and SPYRAL HTN-ON MED (n=206) trials. Both included patients with mean 24-hour systolic BP ≥ 140 to <170 mm Hg using ambulatory BP monitoring. The first group was not on medications, and the second group was on one to three medications for the first 3 months. Their mean body mass index was 31.3, and mean age was 54 years; 96% patients with resistant hypertension had nocturnal hypertension (> 120/70 mm Hg).

RF RDN was carried out using the latest generation Symplicity Spyral multielectrode catheter passed via the femoral artery in the groin and advanced to the renal arteries, where RF energy is delivered to the renal nerves.

12-Month Outcomes From the Global SYMPLICITY Registry

In the same session, Markus Schlaich, MD, professor of medicine and nephrologist at the Royal Perth Hospital, The University of Western Australia, presented 12-month outcomes that assessed BP and renal function in patients with uncontrolled hypertension and varying renal function following RF RDN.

Drawing on data from 3332 patients in the observational GSR DEFINE trial, the researchers found significant systolic BP reductions out to 12 months after RF RDN while maintaining renal function. Systolic BP improved across the three groups of renal function (estimated glomerular filtration rate [eGFR], <45, ≥ 45 to <60, ≥ 60 mL/min/1.73 m²) without an increase in antihypertensive medications.

The 24-hour BP changes from baseline were −5.7, −7.1, and −8.5 mm Hg, respectively, in the three eGFR groups.

“We’ve found the intervention works for all groups and does not adversely affect kidney function but achieves a significant and clinically meaningful blood pressure reduction, measured by both office and ambulatory blood pressure,” Schlaich reported. “This is very reassuring and indicates that this is a good approach for these difficult-to-control patients.”

Co-moderator Anastasia S. Mihailidou, PhD, senior hospital scientist at Royal North Shore Hospital, Kolling Institute, and Macquarie University, Sydney, Australia, commented on the studies. “It’s an exciting time for the availability of new treatment options for high blood pressure, the major risk factor for cardiovascular disease and death,” she told Medscape Medical News.

“High nighttime systolic BP is an independent risk factor for cardiovascular disease. The RDN procedure resulted in clinically significant reductions sustained up to 2 years post procedure,” she said commenting on the study presented by Tsioufis.

Turning to Schlaich’s findings, she added that the results were “very promising since these patients have poor control of hypertension and die of cardiovascular disease. Further, appropriately designed studies are required to confirm these findings from this global registry, but renal denervation is an option for high BP that persists after guideline-recommended medication adjustments have been implemented. There are certainly promising options for treatment for the patients and physicians.”

Mihailidou received honoraria for education seminars from Medtronic last year. Tsioufis did not have any financial disclosures. Schlaich received funding and travel support from Medtronic.