Radiofrequency renal denervation confers sustained BP reduction at 36 months
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WASHINGTON — In patients with treatment-resistant hypertension, despite taking one to three BP-lowering medications, radiofrequency renal denervation conferred BP reduction out to 36 months, researchers reported.
The 36-month findings of the SPYRAL HTN-ON MED trial of the radiofrequency renal denervation catheter (Symplicity Spyral, Medtronic) were presented at the American College of Cardiology Scientific Session and simultaneously published in The Lancet.
“Hypertension continues to be the leading cause of death worldwide. Poor adherence to antihypertensive medication is frequently observed and highlights the need for additional treatment options,” Felix Mahfoud, MD, cardiologist at Saarland University Hospital in Homburg, Germany, and member of the SPYRAL HTN executive committee, told Healio. “Catheter-based renal denervation has been demonstrated to safely lower BP in sham-controlled trials out to 6 months and in real-world patients out to 3 years. However, data from randomized sham-controlled trials on long-term safety and efficacy are lacking and challenging to obtain. Against this background, this trial investigated the long-term safety and efficacy of catheter-based renal denervation in patients with uncontrolled hypertension who were taking one to three antihypertensive drugs.”
All patients had office systolic BP 150 mm Hg to 180 mm Hg, office diastolic BP 90 mm Hg or higher and 24-hour ambulatory systolic BP 140 mm Hg to 170 mm Hg.
The researchers randomly assigned 80 patients (mean age, 53 years; 84% men) to receive radiofrequency renal denervation or a sham procedure.
At 36 months, the number of medications taken was similar between the groups (renal denervation, 3; sham, 3.1; P = .76) and the medication burden, based on number of medications, class and dose, was numerically higher in the sham group (7.6 vs. 10.3; P = .26), according to the researchers.
The renal denervation group had greater lowering of 24-ambulatory systolic BP at 36 months compared with the sham group (–18.7 mm Hg vs. –8.6 mm Hg; P = .004), Mahfoud and colleagues found.
The renal denervation group also had significantly lower systolic BP in the morning, during the daytime, during nighttime and in the office at 36 months compared with the sham group, according to the researchers.
The percentage of patients with 24-hour systolic BP less than 140 mm Hg at 36 months was 83.3% in the renal denervation group and 43.8% in the sham group (P = .002), Mahfoud said during a presentation.
There were no safety issues related to the treatment, he said.
“Radiofrequency renal denervation compared to sham control demonstrated clinically meaningful and statistically significant BP reductions independent of concomitant antihypertensive medications out to 36 months, without safety issues,” Mahfoud told Healio. “Given the long-term safety and efficacy, renal denervation provides an attractive adjunctive treatment modality in the management of hypertension.”
He told Healio that a 5 mm Hg reduction in mean office BP reduces the RR for stroke mortality by 10% and the RR for ischemic heart disease mortality by 7%.
References:
- Lewington S, et al. Lancet. 2002;doi:10.1016/S0140-6736(02)11911-8.
- Mahfoud F, et al. Lancet. 2022;doi:10.1016/S0140-6736(22)00455-X.
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Mahfoud F, et al. Featured Clinical Research III. Presented at: American College of Cardiology Scientific Session; April 2-4, 2022; Washington, D.C. (hybrid meeting).
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