An analysis of the blood pressure and safety outcomes to renal denervation in African Americans and Non-African Americans in the SYMPLICITY HTN-3 trial

SYMPLICITY HTN-3, the first trial of renal denervation (RDN) versus sham, enrolled 26% African Americans, a prospectively stratified cohort. Although the 6-month systolic blood pressure (SBP) reduction in African Americans (AAs) was similar in the RDN group (-15.5 +/- 25.4 mm Hg, n = 85 vs. -17.8 +/- 29.2, n = 49, P =.641), the sham SBP response was 9.2 mm Hg greater (P =.057) in AAs than non-AAs. In multivariate analyses, sham SBP response was predicted by an interaction between AA and a complex antihypertensive regimen (at least one antihypertensive medication prescribed >= 3 times daily), while in the RDN group, SBP response was predicted by an interaction between AA race and baseline BP >= 180 mm Hg. AA race did not independently predict SBP response in either sham or RDN. There appears to be effect modification by race with individual-level patient characteristics in both treatment aims that affect the observed pattern of SBP responses. (C) 2015 American Society of Hypertension. All rights reserved.