Renewal of renal denervation begins as a potential treatment for patients with drug-resistant hypertension.
Renal denervation with ultrasound energy produced an average incremental drop of 4.5 mm Hg in daytime, ambulatory, and diurnal systolic blood pressure, compared with simulated treatment after 2 months of follow-up in a randomized study of 136 patients with hypertension. drug-resistant a standardized single-pill, three-drug regimen during the study.
The results “confirm that renal denervation by ultrasound can lower blood pressure in a spectrum of hypertension,” he concluded Ajay J. Kirtane, MD, at the annual scientific sessions of the American College of Cardiology. Renal denervation procedures involve placing a endovascular catheter bilaterally inside the patient’s renal arteries and using short pulses of energy to ablate the neurons involved in blood pressure regulation.
An old “hot concept”
“Renal denervation was a hot concept a few years ago, but it had only been tested in studies without false control,” and initial tests with simulated controls did not show a significant benefit from the intervention, he noted. Deepak L. Bhatt, MD, an interventional cardiologist and professor of medicine at Harvard Medical School in Boston who did not participate in the study. Significant reductions in systolic blood pressure reported with renal denervation, compared with control patients in this study, “are credible” due to the inclusion of a true control cohort, he added. “This really exciting find puts kidney denervation back on the map,” Dr. Bhatt during a press conference.
Dr. Bhatt added that while the median incremental 4.5 mm Hg reduction in daytime, ambulatory, and daytime systolic blood pressure compared to control patients (the main goal of the study) may seem modest, ” in the world of hypertension it is a “significant reduction” that, if maintained in the long term, is expected to produce significant cuts in adverse cardiovascular events such as heart failure, stroke and IM.
“The question is whether the effects are lasting,” Dr. Bhatt, who helped lead the first controlled trial by simulating renal denervation, SIMNICITY HTN-3, which did not show a significant reduction in blood pressure, compared with controls that used radiofrequency energy to ablate renal nerves. A more recent study that used a different radiofrequency catheter and simulated controls showed a significant effect on reducing systolic blood pressure in the SPYRAL HTN-OFF WITH Pivotal trial, which by design did not keep patients on any antihypertensive medication after their renal denervation procedure.
Dr. Kirtane noted that although the mean reduction in systolic blood pressure, compared with controls treated by a simulated procedure, was 4.5 mm Hg, the mean total reduction in systolic blood pressure after 2 months in actively treated patients was 8.0 mm Hg compared to their initial blood pressure.
Simultaneously with his report, the results also appeared in an article published online (Lancet. 2021, May 16;doi: 10.1016 / S0140-6736 (21) 00788-1).
Denervation along with a single daily pill of three drugs
He TRIO RADIANCE-HTN the study was conducted in 53 centers in the United States and Europe and randomized 136 adults with a blood pressure of 140/90 mm Hg measured in the office despite being on a stable regimen of at least three antihypertensive drugs, including a diuretic. The enrolled cohort had a mean age of 52 years and had a mean clearance pressure of about 162/104 mm Hg, although it had an average of four agents, although only one-third of the enrolled patients were in treatment. with a mineralocorticoid receptor (ARM) antagonist such as spironolactone.
At the time of enrollment and 4 weeks prior to their denervation procedure, all patients switched to a uniform drug regimen of a single daily, oral pill containing calcium channel blocker amlodipine, valsartan, or olmesartan, an angiotensin receptor blocker, and the diuretic hydrochlorothiazide without other pharmacological treatment being allowed, except in unusual and predetermined clinical circumstances. All patients remained on this pharmacological regimen during the initial 2-month follow-up period unless their blood pressure exceeded 180/110 mm Hg during measurement at the office.
Denervation treatment was well tolerated, although patients reported brief, transient, and “minor” pain associated with the procedure that did not affect blinding treatment or have persistent consequences, said Dr. Kirtane, a professor. of Medicine at Columbia Medical Center in New York. York.
One of the reasons for using the ultrasound power supply instead of radio frequency to ablate the nerves of the renal arteries is that the ultrasound approach exerts a more uniform effect, allowing for effective treatment without the need for repositioning. catheter in more distal branches of the renal arteries, said Dr. Kirtane, who is also director of the Columbia Cardiac Catheterization Laboratory.
But each method has its advantages, he added.
He also admitted that additional issues need to be addressed as to which patients are best suited for renal denervation. “We need to find out in which patients we can apply device-based treatment,” Dr. Kirtane said during the press conference. Patients with drug-resistant hypertension often do not receive treatment with MRA due to adverse effects, and many of these patients are not usually evaluated for primary aldosteronism.
At SYMPLICITY HTN-3, “approximately half of the patients who were apparently ineligible were not eligible” when they began treatment with an ARM, Dr. Bhatt noted. “A little spironolactone can go a long way” toward resolving treatment-resistant hypertension in many patients, he said.
RADIANCE-HTN TRIO was sponsored by ReCor Medical, the company that develops the tested ultrasound catheter. Dr. Kirtane has received travel and meal expenses from ReCor Medical and several other companies, and Columbia has received funding for research from ReCor Medical and several companies related to the research it has conducted. Dr. Bhatt has nothing to do with ReCor Medical. He has been a consultant and has received fees from K2P, Level Ex and MJH Life Sciences; he has been an advisor to Cardax, Cereno Scientific, Myokardia, Novo Nordisk, Phase Bio and PLx Pharma; and has received funding for research from numerous companies.
This article originally appeared on MDedge.com, which is part of the Medscape professional network.