Percutaneous Renal Denervation in Patients With Treatment-Resistant Hypertension: Final 3-Year Report of the Symplicity HTN-1 Study
What is the long-term safety and efficacy of renal denervation?
The authors reported the 3-year results of the Symplicity HTN-1 trial. This open-label study enrolled 153 patients, of whom 111 consented to follow-up for 36 months. Eligible patients had a systolic blood pressure of 160 mm Hg or higher and were taking at least three antihypertensive drugs, including a diuretic, at the optimum doses. Changes in office systolic blood pressure and safety were assessed every 6 months and reported every 12 months.
Complete data for 3-year follow-up were available for 88 patients. At baseline, the average age was 57 years, 42% of the patients were women, 28% had type 2 diabetes mellitus, and the mean estimated glomerular filtration rate was 85 ml/min per 1.73 m2. The average blood pressure was 175/98 (standard deviation, 16/14) mm Hg. At 36 months, significant decline in systolic (–32.0 mm Hg; 95% confidence interval, –35.7 to −28.2) and diastolic (–14.4 mm Hg; 95% confidence interval, –16.9 to –11.9) blood pressure was observed. Systolic blood pressure declined by 10 mm Hg or more in 85% of patients at 12 months, 83% at 24 months, and 93% at 36 months. One new renal artery stenosis requiring stenting and three deaths unrelated to renal denervation occurred during follow-up.
The authors concluded that renal denervation is associated with a sustained reduction in blood pressure at 3 years.
Renal denervation is one of the most innovative advances for treatment of refractory hypertension of the last decade. The procedure is relatively safe, and this study demonstrates a sustained reduction in blood pressure with this approach. The results of the sham-controlled Symplicity HTN-3 study will define the clinical effectiveness of this procedure, and should be available in the near future.
Keywords: Denervation, Renal Artery Obstruction, Diabetes Mellitus, Type 2, Diuretics, Glomerular Filtration Rate, Blood Pressure, Confidence Intervals, Neurosurgical Procedures, Angioplasty, Balloon, Coronary, Hypertension
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