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.
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Acknowledgements
We thank JiSun Yun and Marianne Wanten for study management, Nicole Brilakis, Colleen Gilbert and Sidney A Cohen for editorial assistance, and Martin Fahy and Minglei Liu for statistical analysis oversight (all from Medtronic, Inc.). This study was sponsored by Medtronic, Inc. Trial Registration: clinicaltrials.gov Identifier: NCT01534299.
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M Böhm received research support and speaker fees from Medtronic, Inc., and St Jude Medical. F Mahfoud received speaker honoraria from Medtronic, Inc., St Jude Medical and Boston Scientific, and is supported by the Deutsche Hochdruckliga and Deutsche Gesellschaft für Kardiologie. G Mancia is a consultant for Medtronic, Inc. M Esler received research support, honoraria and travel support from Medtronic, Inc. All other authors have no conflict of interest to declare.
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Kim, BK., Böhm, M., Mahfoud, F. et al. Renal denervation for treatment of uncontrolled hypertension in an Asian population: results from the Global SYMPLICITY Registry in South Korea (GSR Korea). J Hum Hypertens 30, 315–321 (2016). https://doi.org/10.1038/jhh.2015.77
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DOI: https://doi.org/10.1038/jhh.2015.77
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