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Renal denervation superior to ablation in resistant hypertension

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Philipp Lurz

SAN DIEGO — Endovascular ultrasound-based renal sympathetic denervation in patients with resistant hypertension was superior to radiofrequency ablation of the main renal arteries, according to data from the RADIOSOUND-HTN trial presented at TCT 2018.

In contrast, a combined approach of radiofrequency ablation of the main arteries, side branches and accessories was not superior to radiofrequency ablation of the main renal arteries.

“This pilot study precludes definite recommendations regarding the preferable renal denervation approach,” Philipp Lurz, MD, PhD, deputy head of the department of cardiology at the Heart Center Leipzig at University of Leipzig in Germany, said during the press conference.

Researchers analyzed data from 120 patients with resistant hypertension, which was defined as an office systolic BP greater than 160 mm Hg or a diastolic BP greater than 90 mm Hg regardless of treatment with three or more classes of antihypertensive medication, which had to be stable for at least 4 weeks. Patients were required to have a systolic daytime BP greater than 135 mm Hg on ambulatory BP measurement and at least one main renal artery with a diameter of at least 5.5 mm to be included in the study.

MRI was also performed to assess the renal artery anatomy. For patients who could not undergo MRI, duplex ultrasound was performed.

Patients were assigned one of three techniques for renal sympathetic denervation:

• radiofrequency ablation of the main renal artery (n = 39);

• radiofrequency ablation of the main renal artery, accessories and branches (n = 39); or

• ultrasound-based ablation of the main renal artery (n = 42).

Radiofrequency ablation was performed with a multipolar catheter (Symplicity Spyral, Medtronic), and another catheter (Paradise, ReCor Medical) was used for ultrasound renal sympathetic denervation.

Patients were followed up via telephone at 1 month to assess early complications, BP and vital status. Ambulatory BP measurements and either MRI or duplex sonography were repeated at 3 months. Structured patient interviews were conducted to assess for medication adherence and changes at 1 month and 3 months.

The primary endpoint was a change in systolic daytime BP at 3 months, as shown on ambulatory BP measurements. Key secondary endpoints were defined as change in 24-hour systolic ambulatory BP measurements, rate of responders and changes in diastolic BP.

Both groups had balanced clinical baseline characteristics and medication, in addition to balanced baseline BP values for daytime and 24-hour ambulatory BP measurements.

The overall cohort had decreases in daytime systolic and diastolic BP at 3 months of 9.5/6.3 mm Hg (P for both < .001). This was also seen in each treatment group (P for all < .001).

Greater reductions were seen in patients assigned ultrasound ablation compared with those assigned radiofrequency ablation of the main renal artery (–13.2 mm Hg vs. –6.5 mm Hg; mean difference = –6.7; 98.3% CI, –13.2 to –0.2). No significant differences were seen in both radiofrequency ablation groups (–8.3 mm Hg for additional side branch ablation; mean difference = –1.8; 98.3% CI, –8.5 to 4.9) and between the ultrasound group and the side branch ablation group (mean difference = –4.9; 98.3% CI, –11.5 to 1.7).

Systolic BP response greater than 5 mm Hg was seen in 66% of patients assigned radiofrequency ablation of the main renal artery, 73% of those assigned radiofrequency ablation of the main renal artery, accessories and branches, and 67% of patients assigned ultrasound-based ablation of the main renal artery (P = .77).

“Longer follow-up and larger multicenter studies are needed to do head-to-head comparisons, especially to determine long-term safety of these technologies,” Lurz said during the press conference. – by Darlene Dobkowski

References:

Lurz P, et al. Late-Breaking Trials 5. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.

Fengler K, et al. Circulation. 2018;doi:10.1161/CIRCULATIONAHA.118.037654.

Disclosures: Lurz reports he receives speaking and consultant fees from Medtronic and ReCor Medical. Please see the study for all other authors’ relevant financial disclosures.