Clinical Event Reductions by ASCVD Risk Score in Hypertension Patients treated with Renal Denervation: A Model-based Estimate based on 3-Year Data from the Global Symplicity Registry
Presenter
Jan B. Pietzsch, PhD, Wing Tech Inc., Menlo Park, CA
Jan B. Pietzsch, PhD, Wing Tech Inc., Menlo Park, CA, Roland E. Schmieder, MD, University Hospital Erlangen, Erlangen, Germany, Felix Mahfoud, MD, Universität des Saarlandes, Homburg/Saar, Germany, Bryan Williams, MD, Institute of Cardiovascular Sciences, University College London,, London, United Kingdom, Giuseppe Mancia, MD, University of Milano-Bicocca and Policlinico di Monza, Monza, Italy, Krzystzof Narkiewicz, MD, PhD, Medical University of Gdansk, Gdansk, Poland, Luis Ruilope, MD, PhD, Hospital Universitario 12 de Octubre and CIBERCV and School of Doctoral Studies and Research, Universidad Europea de Madrid, Madrid, Spain, Markus Schlaich, MD, Dobney Hypertension Centre, School of Medicine–Royal Perth Hospital Unit, The University of Western Australia, Perth, Australia and Michael Böhm, MD, Saarland University Hospital, Homburg/Saar, Germany
Keywords: Renal Denervation
Background
Renal denervation (RDN) has been shown to lower systolic blood pressure (SBP) in multiple sham- controlled trials of patients with uncontrolled hypertension and might represent an attractive treatment for patients with high cardiovascular (CV) risk. We estimated potential clinical event reductions with RDN treatment based on recently reported 3-year follow-up from the Global Symplicity Registry (GSR).
Methods
BP reduction and adverse events were reported out to 3 years of follow-up and compared for GSR patients with baseline atherosclerotic CV disease (ASCVD) risk scores of <10%, 10% to <20%, and ≥20%. Relative risks (RR) for stroke, myocardial infarction (MI), CV death, new-onset end-stage renal disease (ESRD), and death were obtained for these average office SBP (oSBP) reductions from a published meta-regression analysis. Then, clinical event estimates for maintained baseline oSBP from the GSR-reported clinical endpoints at 3 years and the obtained RRs were calculated, facilitating estimation of 3-year absolute event reductions and numbers needed to treat (NNT) for individual endpoints and a major CV event (MACE) composite of stroke, MI, and CV death.
Results
NNTs to avoid 1 MACE over 3 years ranged from 24 (≥20% cohort) to 61 (<10% cohort). Corresponding events avoided per 1,000 patients treated with RDN over the 3-year horizon were 16 (<10% cohort), 23 (10% to <20% cohort), and 42 (≥20% cohort). See Table.
Conclusions
Across the spectrum of CV risk, RDN treatment might lead to meaningful event reductions at time horizons as short as 3 years. Reductions are most pronounced in highest risk patients.
