Abstract

Abstract Background Lowering blood pressure (BP) reduces clinical events. Renal denervation (RDN) is under investigation for treatment of uncontrolled hypertension and might represent a particularly attractive option for patients with high cardiovascular (CV) risk. To evaluate this proposal, it is important to determine whether baseline CV risk impacts the efficacy of RDN in lowering BP. Purpose We evaluated whether BP changes after RDN were dependent on baseline CV risk. Methods AHA/ACC Atherosclerosis CV Disease (ASCVD) risk score was calculated for patients in the Global Symplicity Registry (GSR; NCT01534299), a global registry of RDN in patients with uncontrolled hypertension, using baseline office systolic BP, total/HDL cholesterol measurements, diabetic and smoking status, gender, age, and number of baseline anti-hypertensive medications. Patients were separated into 3 groups based on ASCVD risk scores: <10%, ≥10% and <20% and ≥20%. Baseline demographics and 24-hour systolic BP changes at 6 months and 1, 2 and 3 years were compared between groups, as well as rates of adverse events at 3 years. Results Individual ASCVD risk scores were calculated for 1,434 patients in GSR. The median ASCVD risk score was 19.4% and 403 patients had a risk score of <10%, 326 a risk score of ≥10 and <20%, and 705 a risk score ≥20%. Patients with ASCVD risk score ≥20% had a higher baseline office systolic BP, were significantly older, and had higher rates of prior myocardial infarction and/or diabetes (all p<0.0001 compared to patients with lower risk scores). RDN reduced BP similarly across all groups of patients. Changes in 24-hour systolic BP at 6 months and 1, 2 and 3 years are shown in Figure 1. Adverse events at 3 years are shown in Table 1. Adverse events at 3 years ASCVD risk score <10% ASCVD risk score ≥10% & <20% ASCVD risk score ≥20% p-value (N=265) (N=224) (N=468) Death 3 (1.1) 5 (2.2) 41 (8.8) <0.0001 Cardiovascular death 3 (1.1) 2 (0.9) 23 (4.9) 0.0017 Myocardial infarction 6 (2.3) 6 (2.7) 11 (2.4) 0.9513 Stroke 8 (3.0) 9 (4.0) 24 (5.1) 0.3894 Hospitalization for new onset heart failure 4 (1.5) 7 (3.1) 26 (5.6) 0.0194 Values are proportions reported as n (%). Conclusions BP changes after RDN were similar for patients with varying baseline ASCVD risk scores, suggesting uniform BP-lowering efficacy of RDN regardless of patients' baseline CV risk. The impact of baseline risk on clinical event reduction by RDN-induced BP reduction will need to be evaluated in further studies. Acknowledgement/Funding The Global SYMPLICITY Registry is funded by Medtronic.

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