PS 11-83 ONE-YEAR OUTCOMES OF THE RANDOMIZED OSLO-RDN STUDY

Abstract

Objective: The blood pressure (BP) lowering effect of renal sympathetic denervation (RDN) in treatment resistant hypertension (TRH) shows variation among the few randomized studies. The duration of antihypertensive effect and long-term effect and safety of RDN require further follow-up. We aimed to report the office and ambulatory (BP) changes and long-term safety at 12-month follow-up. Design and Method: Patients with apparent TRH (n = 65) were referred specifically for RDN and those with secondary and spurious hypertension (n = 26) were excluded. TRH was defined as office systolic BP>140 mmHg despite maximally tolerated doses of at least 3 antihypertensive drugs including a diuretic. Additionally, ambulatory daytime systolic BP > 135 mmHg following witnessed intake of antihypertensive drugs was required, after which 20 patients had normalized BP, indicating poor drug adherence. Patients with true TRH were randomized and underwent RDN with Symplicity catheter (n = 9) versus adjusted drug treatment (n = 10). Results: 24-hour ambulatory systolic and diastolic BPs in the drug adjustment group changed from 151 ± 13/84 ± 7 mmHg (±SD) at baseline to 131 ± 12/75 ± 5 mmHg at 12 months (p < 0.0005 for all), and in the RDN group from 149 ± 9/89 ± 7 to 141 ± 11/83 ± 5 mmHg (p = 0.07 and p = 0.04, respectively). The absolute difference in change between groups in systolic BP was significantly higher in favor of the drug adjustment group (p = 0.01). Office, daytime and nighttime ambulatory BPs changed in parallel to the 24-hour ambulatory BPs. However 2 patients in RDN group considered as a responder since they have sustained reduction of 24-hour ambulatory systolic BP by more than 15 mmHg. There were no significant changes in renal arteries assessed by MRI or CT scans after 12 months follow-up. No deterioration of renal function was found. Conclusions: RDN has inferior BP lowering effects compared to adjusted drug treatment in patients with TRH. However, RDN is safe and this encourages future research to identify characteristics of patients who might respond to RDN.