A novel device that employs renal mapping and selective renal denervation (msRDN) was safe, and while it did not reduce blood pressure (BP) more than a sham procedure, the new device did reduce antihypertensive medication burden for patients with uncontrolled hypertension, a new study demonstrates.
Jie Wang, MD, PhD, of the First Affiliated Hospital with Nanjing Medical University, Nanjing, China, and the Columbia University College of Physicians and Surgeons, New York, presented these results during a late-breaking trial session Wednesday at EuroPCR 2023 in Paris.
Regulation of BP is typically studied in trials related to RDN. However, RDN success intraoperatively is not always evaluated. No pivotal trial—until now—has investigated how RDN might reduce drug burden and achieve office systolic BP (OSBP) <140 mmHg in patients with hypertension, Wang said.
MsRDN uses the SYMPIONEER S1 and the SyMapCath I devices for renal mapping. The Sympathetic Mapping/Ablation of Renal Nerves Trial for Treatment of Hypertension (SMART) study—a prospective, multicenter, single blind, randomized and sham-controlled trial—evaluated 220 patients across 15 hospitals.
Before randomization, patients were placed on standard medication, at least two drugs, for at least 28 days.
Of the 220 patients studied, 110 were assigned to msRenal ablation (mean age=44.25 years, 85.32% male, 96.33% Han race) and 110 were assigned to the sham procedure (mean age=46.84 years, 88.18% male, 98.18% Han race). The combined primary efficacy endpoints were the control rate of patients with OSBP <140 mmHg and the change in the composite index of antihypertensive drugs between the treatment and sham groups.
There were no instances of all-cause mortality in either group, and the msRDN intervention achieved a 99.1% success rate. The OSBP control rates at 6 months were similar, 95.41% for the msRDN group and 92.73% for the sham group (absolute difference: 2.69%; 95% confidence interval [CI]: -4.11% to 9.83%; p=0.429). However, the drug index change significantly favored the msRDN group (msRDN: 4.37 vs. sham: 7.61; absolute difference: -3.25; 95% CI=-5.56 to -0.94; p=0.01).
The device group met both the noninferiority test for OSBP control (p<0.001 for noninferiority) and the superiority test for change in drug index (p for superiority = 0.03).
There were also changes in office and 24-hour ambulatory SBP/diastolic blood pressure (DBP) from baseline to six months, with both groups demonstrated change where p<0.001 for each baseline BP group. However, the drops in OSBP, ODBP and 24-hour ambulatory DBP were actually larger in the sham-control group, and the sham-control group experienced a significantly higher drop in ODBP then the msRDN group (msRDN 13.0 mmHg vs. sham control 15.5 mmHg; p=0.036).
Overall, the therapy reduced drug burdens of hypertension with roughly four targeted ablations per side renal artery, and controlled OSBP <140 mmHg was achieved.