Renal Sympathetic Denervation for Treatment of Drug-Resistant Hypertension: One-Year Results From the Symplicity HTN-2 Randomized, Controlled Trial

Study Questions:

What is the 1-year outcome of patients undergoing renal denervation?

Methods:

The authors reported the 1-year results of the Symplicity HTN-2 study. This study randomized resistant hypertension patients who had a baseline systolic blood pressure (SBP) ≥160 mm Hg (≥150 mm Hg for type 2 diabetics) and were on ≥3 antihypertensive drugs. After the 6-month primary endpoint was met, renal denervation in control patients was permitted.

Results:

A total of 47 patients who underwent renal denervation at randomization had follow-up to 1 year, whereas 35 control patients who crossed over per protocol were followed for 6 months. At 12 months after the procedure, the mean fall in office SBP in the initial renal denervation group (-28 mm Hg; p < 0.001) was similar to the 6-month fall (-32 mm; p = 0.16 vs. 6-month change). The mean SBP of the crossover group 6 months after the procedure was significantly lowered (from 190 ± 20 to 166 ± 25 mm Hg; change, -24 ± 28; p < 0.001). In the crossover group, there was one renal artery dissection during guide catheter insertion, which occurred before denervation and was treated by renal artery stenting, and one hypotensive episode, which resolved with medication adjustment. The majority of patients in the initial renal denervation group experienced a reduction in SBP with a reduction in SBP of ≥10 mm Hg (83.7% at 6 months and 78.7% at 12 months). The crossover group demonstrated similar outcomes with a fall in SBP of ≥10 mm Hg at 6 months after renal denervation in 62.9%.

Conclusions:

The authors concluded that renal denervation with the Symplicity system was associated with a significant and sustained drop in blood pressure.

Perspective:

The follow-up data from the Symplicity HTN-2 trial provide further evidence on the safety of renal denervation and the sustained reduction in blood pressure that it produces. Although currently the therapy is being evaluated in compliant patients, the greatest benefit of this therapy may be in noncompliant patients where the sustained benefit of a one-time procedure could result in long-term reduction in cardiovascular mortality and morbidity.

Keywords: Renal Artery, Follow-Up Studies, Denervation, Coronary Angiography, Cardiology, Sympathectomy, Blood Pressure, Kidney, Neurosurgical Procedures, Hypertension


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