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

Background-Renal sympathetic nerve activation contributes to the pathogenesis of hypertension. Symplicity HTN-2, a multicenter, randomized trial, demonstrated that catheter-based renal denervation produced significant blood pressure lowering in treatment-resistant patients at 6 months after the procedure compared with control, medication-only patients. Longer-term follow-up, including 6-month crossover results, is now presented. Methods and Results-Eligible patients were on >= 3 antihypertensive drugs and had a baseline systolic blood pressure >= 160 mm Hg (>= 150 mm Hg for type 2 diabetics). After the 6-month primary end point was met, renal denervation in control patients was permitted. One-year results on patients randomized to immediate renal denervation (n = 47) and 6-month postprocedure results for crossover patients are presented. At 12 months after the procedure, the mean fall in office systolic blood pressure in the initial renal denervation group (-28.1 mm Hg; 95% confidence interval, -35.4 to -20.7; P < 0.001) was similar to the 6-month fall (-31.7 mm Hg; 95% confidence interval, -38.3 to -25.0; P=0.16 versus 6-month change). The mean systolic blood pressure of the crossover group 6 months after the procedure was significantly lowered (from 190.0 +/- 19.6 to 166.3 +/- 24.7 mm Hg; change, -23.7 +/- 27.5; P < 0.001). In the crossover group, there was 1 renal artery dissection during guide catheter insertion, before denervation, corrected by renal artery stenting, and 1 hypotensive episode, which resolved with medication adjustment. Conclusions-Control patients who crossed over to renal denervation with the Symplicity system had a significant drop in blood pressure similar to that observed in patients receiving immediate denervation. Renal denervation provides safe and sustained reduction of blood pressure to 1 year. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00888433. (Circulation. 2012;126:2976-2982.)