MO085: 10-Year Clinical Events Avoided in Diabetic and Chronic Kidney Disease Hypertension Patients Treated With Radiofrequency Renal Denervation: Projections Based on 3-Year Data From the Global Symplicity Registry

Abstract

Abstract BACKGROUND AND AIMS Clinical event rates over 3 years have been published for patients with uncontrolled hypertension treated with radiofrequency renal denervation (RDN) in the Global SYMPLICITY Registry (GSR). We estimated 10-year clinical event reductions following RDN versus a simulated control group without RDN, for the type 2 diabetes (T2DM) and chronic kidney disease (CKD) subgroups and the full GSR cohort. METHOD A Markov model based on Framingham and other multivariate risk equations [1] was used to compare projected 10-year clinical events [stroke, myocardial infarction (MI), cardiovascular death (CVD), heart failure (HF), all-cause death (ACD) and a composite of major adverse cardiac events (MACE, calculated as sum of stroke, MI and CVD)] for RDN patients versus a hypothetical control for the T2DM subgroup (n = 1007; 64 ± 10 years), the CKD subgroup (n = 630; 65 ± 12 years), and for all GSR patients (n = 2651; 61 ± 12 years). The simulated control assumed maintenance of baseline office systolic blood pressure (oSBP) over time. The model was calibrated to 3-year stroke and MI events reported in the GSR and used published meta-regression data [2] to calculate risk reduction based on cohort-specific changes in oSBP from baseline. Relative risks (RRs), events avoided, and numbers needed to treat (NNTs) were calculated at 3 and 10 years, along with the ratio of 10- versus 3-year projected events avoided. RESULTS Ten-year MACE rates were 35.8% versus 48.5% (-12.7%, RR = 0.74) for RDN versus simulated control for all patients, 40.5% versus 54.0% (-13.5%, RR = 0.75) for the T2DM subgroup and 48.4% versus 61.3% (-12.9%, RR = 0.79) for the CKD subgroup. Across the studied subgroups, avoided stroke events contributed the most to overall event reductions. RRs of events were lowest for HF (0.53–0.61) and highest for all-cause death (0.88–0.90) across the three subgroups (Table 1). Ten-year NNTs for MACE were comparable between the three cohorts, estimated between 7 and 8. The ratio of 10- versus 3-year events avoided ranged from 4.44 to 4.87 for stroke, 3.74 to 3.96 for MI and 4.22 to 5.20 for MACE across studied cohorts. CONCLUSION Based on 10-year model projections from the GSR, RDN may lead to meaningful clinical event reductions in diabetic and chronic kidney disease patients. Ten-year events avoided can be expected to be 3 to 5 times higher than those recently reported for a 3-year horizon.