乌鸦传媒

Deferring ultrasound-based renal denervation did not hamper the extent of blood pressure (BP) lowering achieved and appeared safe in the short term, trial analysis suggested.

Among 31 RADIANCE-HTN SOLO trial participants who crossed over from the sham arm to renal denervation more than 1 year after randomization, daytime ambulatory BP fell by 11.2/7.1 mm Hg after 2 months and 12.2/8.6 mm Hg after 6 months -- with no change in number of antihypertensive medications -- compared to measurements taken at the pre-crossover follow-up.

"These results are consistent with the primary SOLO results," according to Ajay Kirtane, MD, of New York-Presbyterian/Columbia University Medical Center in New York City. He presented the crossover study during the , which replaced this year's cancelled EuroPCR conference.

"However, there was no drug titration protocol between 2-6 months for crossover patients, so this may provide some added insight into 6-month durability after renal denervation," Kirtane continued.

investigators had previously reported a modest impact on daytime ambulatory systolic BP at 2 months for the renal denervation group of 6.3 mm Hg more than seen with a sham procedure (P<0.001).

The 146 study participants had undergone a 4-week antihypertensive medication washout before randomization. Hypertensive patients remained off medication for 2 months unless BP climbed too high. At 2-5 months, antihypertensive medication was stepped up if monthly home BP was 135/85 mm Hg or higher.

Through 6 months, the crossover group experienced zero safety events (e.g., death, end-stage renal disease, embolic events resulting in end-organ damage, vascular complications requiring intervention, hypertensive crisis, new renal artery stenosis >70%).

"Observations from sham patients who crossed over suggest that there was no harm in deferring renal denervation until an attempt at medication escalation had occurred," commented Herbert Aronow, MD, MPH, of Lifespan Cardiovascular Institute and Brown University in Providence, Rhode Island.

"In its current iteration, while renal denervation may reduce the number of antihypertensive medications needed, it does not eliminate the need for these agents altogether," he noted.

For the present analysis, Kirtane and colleagues identified the 31 people who crossed from sham to renal denervation as of January 2020. Crossover was allowed after 12 months' follow-up for those who still had daytime ambulatory systolic BP 135 mm Hg or higher or diastolic BP 85 mm Hg or higher.

This cohort was roughly comparable to the overall sham group in baseline characteristics.

Crossover occurred at a mean of 23 months after randomization. At this point, patients had daytime ambulatory BP averaging 145/90 mm Hg and were on 1.2 antihypertensive medications.

Renal denervation with the Paradise system was successful in all 31 people.

"Crossover subjects and physicians were unblinded, so these data are subject to behavioral and/or medication-related effects that contribute to the observed results," Kirtane cautioned.

"While RADIANCE-HTN SOLO produced favorable short-term outcomes, more data are needed to establish the long-term safety and efficacy of endovascular ultrasound-mediated renal denervation," Aronow said.

Researchers are also probing radiofrequency-based ablation and alcohol infusion as other modalities of renal denervation for hypertension.

Comment