Renal denervation lowers BP in Black patients with resistant hypertension at 3 years
In Black patients with resistant hypertension, renal denervation was associated with reductions in systolic BP at 3 years, according to new data from the SYMPLICITY HTN-3 trial.
As Healio previously reported, in the main results of SYMPLICITY HTN-3, the renal denervation system (Symplicity, Medtronic) did not significantly lower office systolic BP at 6 months compared with a sham procedure. Cardiology Today Intervention Section Editor Deepak L. Bhatt, MD, MPH, director of Mount Sinai Heart and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at The Icahn School of Medicine at Mount Sinai, presented 3-year results in Black patients from the trial at Cardiovascular Research Technologies.
“Among Black patients, a prespecified subgroup, there was an unexpected larger reduction in systolic blood pressure in sham control patients related to their complex antihypertensive medication regimen such that there was no significant reduction in systolic BP between groups [at 6 months], though there was in the remainder of the patients,” Bhatt said during a presentation. “Recent 3-year analysis of the overall HTN-3 population demonstrated that renal denervation patients had significantly greater reductions in systolic BP compared with sham control patients through long-term follow-up. In this analysis, we assessed the 3-year outcomes among Black patients.”
The analysis included 140 Black patients (mean age, 53 years; 48% men), of whom 90 were assigned to the renal denervation group and 50 were assigned to the sham group. All patients had resistant hypertension, defined as office systolic BP of at least 160 mm Hg and 24-hour ambulatory systolic BP of at least 135 mm Hg, and were on at least three antihypertensive medications, including one diuretic.
All clinicians and patients were unmasked after 6 months, after which patients in the sham group were allowed to receive renal denervation if they wanted to and still met the trial’s inclusion criteria, Bhatt said.
In Black patients, prescribed medication burden at 3 years did not differ between the renal denervation and sham groups (P = .96), whereas in non-Black patients, there was a trend toward reduced medication burden at 3 years in the renal denervation group (P = .1), he said.
At 3 years, Black patients in the renal denervation group had more of a decrease in office systolic BP compared with Black patients in the sham group (–30.5 mm Hg vs. –7.8 mm Hg; difference, –24.9 mm Hg; P < .0001), and the treatment effect was similar in the non-Black patients (P for interaction = .52), according to the researchers.
There were similar results with office diastolic BP, Bhatt said.
The change in 24-hour ambulatory systolic BP at 3 years was –23.5 mm Hg for Black patients in the renal denervation group and –1.9 mm Hg for Black patients in the sham group (difference, –23 mm Hg; P < .0001), which trended toward more of a treatment effect than observed in non-Black patients (P for interaction = .057), he said.
Safety events were infrequent and did not differ between the groups.
“Renal denervation demonstrated safety among Black patients with no long-term complications,” Bhatt said during the presentation. “Despite neutral results potentially due to confounding factors among Black patients at the primary endpoint of 6 months, renal denervation was associated with significant systolic BP reductions through 3 years among Black patients compared with those in the sham control group. Non-Black renal denervation patients similarly had significant BP reductions through 36 months compared with sham control.”
The renal denervation system is not yet approved for commercial use in the United States.
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Bhatt DL, et al. Late-Breaking Trials | Session One. Presented at: Cardiovascular Research Technologies; Feb. 25-28, 2023; Washington, D.C.
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