[OP.4C.03] 24H BLOOD PRESSURE MONITORING TO PREDICT AND ASSESS IMPACT OF RENAL DENERVATION: THE DENER-HTN STUDY. (September 2016) - GOSSE, P.
Abstract : Objective: The Renal Denervation for Hypertension (DENERHTN) trial showed that renal denervation (RD) with the Symplicity™ catheter added to a standardized stepped-care antihypertensive treatment (SSAHT) significantly reduced daytime ambulatory SBP by ∼6 mmHg more than the SSAHT alone after 6 months in patients with resistant hypertension. The aim of this analysis is to report in details the ABPM results, and to look for predictors of the BP response to RD. Design and method: 24 h ABPM were performed at baseline and 6 months. For each recording, we calculated the average and standard deviation (SD) of 24 h, daytime and nighttime SBP, DBP and HR, and the smoothness index (SI). Analyses were performed on the per-protocol population to compare the RD group (RDG) to the control group (CG) and responders (daytime SBP reduction > = 20 mmHg) to non-responders. Results: 44/ 53 patients of the RDG and 53/53 of the CG were included. The average number of measurements for each ABPM was 73. The significantly greater ambulatory SBP reduction in the RDG was homogeneous over 24 h with a higher SI (1.4 ± 1.2) than in the CG (0.9 ± 0.6; P = 0.02). SD of 24 h, daytime and nighttime SBP/DBP and HR were not significantly influenced by RD. In a stepwise discriminant analysis, baseline average nighttime SBP, nighttime SDSBP and treatment group were significant predictors of the daytime ambulatory SBP response at 6 months. The first two remained significantly associated to responders (P = 0.005) in the RDG but not in CG. The ROC curves to predict responders in the RDG had an area under the curve of 0.65 (95%CI: 0.488–0.815, P = 0.08) for nighttime SBP and 0.72 (95%CI: 0.566- 0.874, P = 0.01) for nighttime SDSBP. The cut-offs offering best sensitivity+specificity to predict responders were136 mmHg for nighttime SBP and 12 mmHg for nighttime SDSBP. Together, these cut-offs allow adequate classification of 70% of responder patients. Conclusions: This analysis of ABPM data in DENER-HTN confirms the efficacy of RD in lowering BP in patients with resistant hypertension, with an homogenous effect along the 24 h. Baseline nighttime SBP and SDSBP appear as good candidates to predict responders to RD.