SYMPLICITY Follow-up HTN-3 supports renal radiofrequency denervation for uncontrolled BP


September 18 2022

3 minutes to read

source:

Bhat Del et al. Late clinical science in vascular disease and hypertension: Session 3, in collaboration with Journal of the American Medical Association. Presented at: TCT Scientific Symposium; 16-19 September 2022; Boston (mixed meeting).

Disclosures:
The study was funded by Medtronic. Bhatt reports on various financial relationships with the industry, including receiving institutional research funding from Medtronic.


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BOSTON – Renal radiofrequency denervation for uncontrolled hypertension appears to show a sustained 3-year reduction in blood pressure in the setting of maximal antihypertensive therapy, a speaker reports.

Long-term and final follow-up results of the SYMPLICITY HTN-3 Radiofrequency Trial Renal nerve removal for resistant hypertension using a first-generation catheter (Symplicity Flex, Medtronic) presented at TCT 2022 and simultaneously published in scalpel.

Deepak El Bhatt

“In this final follow-up to the SIMPLICITY HTN-3 trial, the largest and longest-running randomized clinical trial of renal denervation to date, we demonstrated that renal denervation was safe with long-term follow-up, with no late complications.” Cardiology today Intervention Section Editor Deepak L. Bhatt, MD, MPHExecutive Director of the Interventional Cardiology Programs at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School, said during a press conference. “Despite potential confounding factors, significant reductions were observed after denervation versus in-office control and ambulatory blood pressure up to 3 years, regardless of medications.”

The image-controlled SYMPLICITY HTN-3 trial enrolled 364 patients with uncontrolled hypertension to undergo radiofrequency renal denervation and compared in-office BP changes at 6 months with those of 171 patients who underwent a placebo procedure.

Resistant hypertension was defined as in-clinic systolic blood pressure of 160 mm Hg or greater and 24-hour ambulatory systolic blood pressure of 135 mm Hg. All participants were taking at least 3 antihypertensive medications at enrollment.

Like Healio Previously mentionedthe SYMPLICITY HTN-3 trial initially met its primary safety endpoint, but missed its primary efficacy endpoint—the change in office systolic blood pressure at 6 months—with no significant difference between the denervation and sham groups (-14.13 vs. -11.74 mm). Mercury ; s for diff = .26).

The present trial evaluated long-term outcomes among participants in the denervation arm who were followed for 5 years. Those in the phantom arm were followed for 4 years.

Basically, the trial participants took an average of 10 doses of antihypertensive medication per day. By 3 years, average daily doses were reduced to about eight doses per day for the denervation arm (s = .005), while the dummy arm remained relatively unchanged. The average number of classes of antihypertensive drugs taken by either arm also remained unchanged.

At baseline, 41.5% of patients in the denervation arm had a systolic blood pressure greater than 180 mm Hg and 58.5% had a systolic blood pressure between 160 mm Hg and 180 mm Hg.

At 36 months, participants in the nerve removal arm had a mean difference in systolic blood pressure of -22.1 mm Hg compared to the sham group (s <.0001). The reduction in office systolic blood pressure observed in the denervation arm was stable up to 4 years (median difference from baseline, -31.9 mm Hg) and 5 years (median difference from baseline, -30.9 mm Hg). Bhatt explained that although changes in systolic blood pressure due to denervation appeared permanent over time, there were not enough participants in the sham arm at 5 years for an adequate analysis.

At 3 years of age, participants in the nerve removal arm had a mean 24-h ambulatory systolic blood pressure difference of -16.5 mm Hg compared to the sham person (s <.0001). The 24-hour ambulatory systolic blood pressure drop also appeared to be persistent for up to 4 years (mean difference from baseline, -16.3 mm Hg); However, too few patients remained in the sham arm for Bhatt and colleagues to perform a suitable analysis.

“There is still an indication that there is no attenuation of the effect of renal denervation. If something happens, [there is] “Even the suggestion is to amplify the effect,” Bhatt said during the press conference.

After 6 months, a crossover group of 101 patients initially assigned to renal denervation shampoos. At baseline, 45.5% of patients in the sham arm had a systolic blood pressure of more than 180 mm Hg and 54.5% had a systolic blood pressure between 160 and 180 mm Hg.

After 36 months of denervation, the proportion of cross-sectional participants with systolic blood pressure of more than 180 mm Hg decreased to 28.6% and the proportion with systolic blood pressure between 160 and 180 mm Hg decreased to 12.7%.

“These findings support that permanent reductions in blood pressure with radiofrequency renal denervation in the presence of maximum medical treatment can be safely achieved,” Bhatt said during the press conference.

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