Renal denervation for treatment of uncontrolled hypertension in an Asian population: results from the Global SYMPLICITY Registry in South Korea (GSR Korea)
Park, SJ; Esler, M; Park, S; Gwon, HC; Mahfoud, F; Kwon, HM; Park, CG; Choi, DJ; Kim, CJ; Mancia, G; Seung, KB; Jang, YS; Kim, BK; Böhm, M; Ahn, TH; Hong, MK; Kim, HS
Abstract
Reports detailing the response of hypertensive patients to renal denervation (RDN) in Asian patients are limited. We evaluated 6- and 12-month outcomes after RDN in an Asian population and compared outcomes to a primarily Caucasian population. The Global SYMPLICITY Registry (GSR) is a prospective, all-comer, worldwide registry that evaluates the safety and effectiveness of RDN and includes the Korean registry substudy (GSR Korea) and a Caucasian subset (GSR Caucasian). Given differences in baseline characteristics among GSR Korea (n=93) as compared with GSR Caucasian (n=169) patients, including lower baseline office systolic blood pressure (SBP), lower body mass index and differences in medications, propensity score adjustment was performed when comparing the change in SBP between subsets. The 6- and 12-month change in SBP in GSR Korea was -19.4±17.2 and -27.2±18.1 mm Hg, respectively (P<0.001 for both vs baseline). GSR Caucasian had a SBP change similar to GSR Korea at 6 months (-20.9±21.4 mm Hg, unadjusted P=0.547, adjusted P=0.998), whereas at 12 months the change was significantly less pronounced (-20.1±23.9 mm Hg, unadjusted P=0.004, adjusted P=0.002). There were no protocol-defined procedure-related adverse events and no chronic adverse events associated with the device in an Asian population. RDN provided a significant reduction in 6- and 12-month office SBP among Asian patients, with a favorable safety profile. The 12-month SBP reduction was larger than that observed in Caucasian patients.
TRIAL REGISTRATION:
ClinicalTrials.gov NCT01534299.
| Journal | J HUM HYPERTENS |
| ISSN | 0950-9240 |
| Published | 01 May 2016 |
| Volume | 30 |
| Issue | 5 |
| Pages | 315-21 |
| DOI | 10.1038/jhh.2015.77 |
| Type | Journal Article |
| Sponsorship |