In the final follow-up of the randomized SYMPLICITY HTN-3 trial presented Sept. 18 during TCT 2022 and simultaneously published in the Lancet, researchers noted significant reductions in blood pressure and no signs of late-emerging complications from renal artery denervation in patients with treatment-resistant hypertension.

Approximately 1,400 patients with treatment-resistant hypertension were enrolled in the trial. Of these, 535 we randomly assigned to receive renal artery denervation (n=364) or sham control (n=171). Following the primary endpoint assessment at six months, eligible patients in the sham control group who met the inclusion criteria could cross over to receive renal artery denervation – subsequently referred to as the crossover group.

In the final 36-month follow-up report, data were available for 219 patients from the original renal artery denervation group, 63 patients from the crossover group and 300 patients in the sham/non-crossover group. Deepak L. Bhatt, MD, MPH, FACC, who presented the findings, and colleagues highlighted overall findings showing significant reductions in office and 24 -hour ambulatory systolic and diastolic, night-time, morning and daytime blood pressure. They also noted that patients in the renal artery denervation group spent nearly twice as much time in the therapeutic blood pressure range "than patients in the sham control group … despite a similar medication burden."

In other findings, rates of adverse events were similar across all groups and no late-emerging complications from renal artery denervation were observed. The rate of the composite safety endpoint to 48 months, including all-cause death, new-onset end-stage renal disease, significant embolic event resulting in end-organ damage, vascular complication, renal artery reintervention, and hypertensive emergency was 15% in the renal artery denervation group, 14% in the crossover group, and 14% in the non-crossover group.

"This is the longest safety analysis of the renal artery denervation procedure in a randomized trial setting and highlights the procedure's overall safety," said Bhatt, et al.

"These data support the growing body of evidence of favorable, durable, and safe long-term results of renal artery denervation, with the potential for larger reductions in blood pressure with longer durations of follow-up," said Bhatt, et al. "Renal artery denervation might offer an additional treatment option for patients with uncontrolled, resistant hypertension outside of lifestyle modification and use of maximally tolerated antihypertensive medications."

Clinical Topics: Prevention, Hypertension

Keywords: Transcatheter Cardiovascular Therapeutics, TCT22, Hypertension, Catheters, Sympathectomy, Blood Pressure Monitoring, Ambulatory

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