• George L Bakris, Raymond R Townsend, John M Flack, Sandeep Brar, Sidney A Cohen, Ralph D'Agostino, David E Kandzari, Barry T Katzen, Martin B Leon, Laura Mauri, Manuela Negoita, William W O'Neill, Suzanne Oparil, Krishna Rocha-Singh, Deepak L Bhatt, and SYMPLICITY HTN-3 Investigators.
• ASH Comprehensive Hypertension Center, University of Chicago Medicine, Chicago, Illinois. Electronic address: gbakris@medicine.bsd.uchicago.edu.
• J. Am. Coll. Cardiol. 2015 Apr 7;65(13):1314-21.

BackgroundResults of the SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial confirmed the safety but not the efficacy of renal denervation for treatment-resistant hypertension at 6 months post procedure.ObjectivesThis study sought to analyze the 12-month SYMPLICITY HTN-3 results for the original denervation group, the sham subjects who underwent denervation after the 6-month endpoint (crossover group), and the sham subjects who did not undergo denervation after 6 months (non-crossover group).MethodsEligible subjects were randomized 2:1 to denervation or sham procedure. Subjects were unblinded to their treatment group after the 6-month primary endpoint was ascertained; subjects in the sham group meeting eligibility requirements could undergo denervation. Change in blood pressure (BP) at 12 months post randomization (6 months for crossover subjects) was analyzed.ResultsThe 12-month follow-up was available for 319 of 361 denervation subjects and 48 of 101 non-crossover subjects; 6-month denervation follow-up was available for 93 of 101 crossover subjects. In denervation subjects, the 12-month office systolic BP (SBP) change was greater than that observed at 6 months (-15.5 ± 24.1 mm Hg vs. -18.9 ± 25.4 mm Hg, respectively; p = 0.025), but the 24-h SBP change was not significantly different at 12 months (p = 0.229). The non-crossover group office SBP decreased by -32.9 ± 28.1 mm Hg at 6 months, but this response regressed to -21.4 ± 19.9 mm Hg (p = 0.01) at 12 months, increasing to 11.5 ± 29.8 mm Hg.ConclusionsThese data support no further reduction in office or ambulatory BP after 1-year follow-up. Loss of BP reduction in the non-crossover group may reflect decreased medication adherence or other related factors. (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]; NCT01418261).Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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