SYMPLICITY HTN-2: BP benefits of renal denervation sustained out to 3 years
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A cohort of patients with treatment-resistant hypertension experienced reductions in BP at 3 years after undergoing renal denervation, according to results from the SYMPLICITY HTN-2 trial.
Murray D. Esler, MBBS, PhD, of the Baker IDI Heart and Diabetes Institute, Melbourne, and colleagues conducted the randomized controlled trial to evaluate the long-term outcomes associated with renal artery denervation in a cohort of 106 patients with resistant hypertension.
Patients were assigned renal denervation or medical therapy alone. By the 6-month mark, 37 patients in the control group crossed over to receive renal denervation.
Outcome measures included office BP, antihypertensive medication use and safety events. The researchers evaluated these outcomes every 6 months for 3 years.
Murray D. Esler
Forty of 52 patients in the initial renal denervation group had follow-up data available at 36 months. For the crossover group, 6-month data were available for 30 of 37 patients.
The researchers noted that baseline BP was 184 ± 19/99 ± 16 mm Hg among all patients who received treatment.
A decrease of 34 mm Hg in systolic BP (95% CI, –40 to –27) was reported at 30 months after the procedure, along with a decrease of 13 mm Hg in diastolic BP (95% CI, –16 to –10).
By 36 months, patients in the initial renal denervation group experienced a reduction in systolic BP of –33 mm Hg (95% CI, –40 to –25) and a reduction in diastolic BP of –14 mm Hg (95% CI, –17 to –10).
One hematoma occurred, as did one renal artery dissection before delivery. The dissection was treated successfully, according to the procedural results. Analysis of later complications indicated two incidences of acute renal failure, which fully resolved, and 15 hypertensive events that required hospitalization. There were three fatalities reported.
“We have demonstrated that renal artery nerve ablation results in sustained lowering of blood pressure out to at least 3 years (30 months for crossover subjects) in a selected population of subjects with severe, treatment-resistant hypertension,” Esler and colleagues wrote. “This long-term benefit occurred with minimal procedural or late safety concerns and was not associated with increased drug therapy.”
Disclosure: The study was supported by Medtronic. Several researchers report associations with Medtronic.