Ultrasound renal denervation may be beneficial in hypertension at 6 months
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Ultrasound renal denervation in patients with triple-therapy resistant hypertension remained effective at 6 months, according to new data from RADIANCE-HTN TRIO reported at TCT 2021.
As Healio previously reported, in the main results of RADIANCE-HTN TRIO, ultrasound renal denervation (Paradise, Recor Medical) better lowered 24-hour ambulatory systolic BP at 2 months compared with a sham procedure. At TCT 2021, Ajay J. Kirtane, MD, SM, professor of medicine at Columbia University Vagelos College of Physicians and Surgeons and interventional cardiologist at NewYork-Presbyterian/Columbia University Irving Medical Center, presented 6-month results for 129 patients. Between 2 and 6 months, patients whose home BP remained uncontrolled underwent a standardized stepped-care medication escalation protocol.
At 6 months, the number of antihypertensive medications in each group was similar (renal denervation, 3.8; sham, 4.1; P = .078), but the change in number of antihypertensive medications from baseline was greater in the sham group (0.7 vs. 1.1; P = .045), Kirtane said at a press conference, noting the sham group was more likely to be taking aldosterone antagonists (40% vs. 60.9%; P = .017), and among those who were, the sham group was more likely to be taking a high dose of spironolactone, which can be difficult to tolerate (19% vs. 31%).
“If denervation were to have a greater effect on blood pressure, we would hope to demonstrate less medications be added back to that group compared to the sham control,” Kirtane said at the press conference.
Between baseline and 6 months, mean home systolic BP dropped 11.5 mm Hg in the renal denervation group compared with 8.8 mm Hg in the sham group (difference after adjustment for baseline BP and number of medications, –4.28; 95% CI, –8.06 to –0.49; P = .027), whereas mean office systolic BP fell 10.4 mm Hg in the renal denervation group compared with 11.2 mm Hg in the sham group (difference after adjustment for baseline BP and number of medications, –2.95; 95% CI, –7.89 to 1.99; P = .24), according to the researchers.
Daytime ambulatory systolic BP dropped 11.8 mm Hg in the renal denervation group and 12.3 mm Hg in the sham group from baseline to 6 months (difference after adjustment for baseline BP, –0; 95% CI, –4.6 to 4.5; P = .65), whereas daytime ambulatory diastolic BP dropped 7.9 mm Hg in the renal denervation group and 8.4 mm Hg in the sham group from baseline to 6 months (difference after adjustment for baseline BP, 0.3; 95% CI, –2.8 to 3.4; P = .79), Kirtane said.
Safety outcomes were similar between both groups at 6 months, he said.
“After demonstrating at 2 months that denervation vs. a sham procedure lowers blood pressure in patients with hypertension resistant to a stable combination therapy regimen, at 6 months of blinded follow-up, we found further reductions in both study arms with the addition of a standardized stepped-care antihypertensive regimen,” Kirtane said at the press conference. “In other words, medications can work. However, the blood pressure reductions after renal denervation were achieved with a smaller increase in the number of medications prescribed and less use of aldosterone antagonists compared with sham. Despite this smaller increase, the denervation procedure achieved a lower home systolic blood pressure but a similar ambulatory systolic blood pressure. These results demonstrate the additional effects of pharmacologic intervention with maintenance of a blood pressure-lowering effect of denervation at 6 months, which were very similar to the results of the RADIANCE-HTN SOLO trial.”
Since hypertension can still occur despite lifestyle modifications, “in that light, renal denervation can offer an additional, but not a replacement, option to further lower blood pressure, especially for patients whose blood pressure is uncontrolled despite genuine attempts to institute conventional therapies,” Kirtane said.
Perspective
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Dipti Itchhaporia, MD, FACC, FESC
Past trials have not shown a significant difference between renal denervation and medical therapy. Here, we may see a trend of benefit, but I am not sure if it is significant. The study is underpowered, but we see a positive on the second endpoint. So, we need to conduct a larger trial to see if this is a true trend.
We also need to know if renal denervation has durable results. The durability still has to be demonstrated.
It has been touted that these patients want to have fewer medications, and that may be true, but in this case, renal denervation led to only one less medication, the aldosterone antagonists, and the difference in medications was not statistically significant at 6 months.
The door had been closed on renal denervation previously, and this study may have opened it a little, but we need to have a larger study before we can say we have true data that point the way to go.
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Kirtane AJ, et al. Late-Breaking Clinical Science Session I, in Collaboration with Circulation. Presented at: TCT Scientific Symposium; Nov. 4-6, 2021; Orlando (hybrid meeting).
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