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Renal denervation for treatment of uncontrolled hypertension in an Asian population: results from the Global SYMPLICITY Registry in South Korea (GSR Korea)

Journal of Human Hypertension volume 30, pages 315–321 (2016)Cite this article

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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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Authors and Affiliations

  1. Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea

    B-K Kim, S Park, M-K Hong & Y S Jang

  2. Department of Internal Medicine and Cardiology, Universitätsklinikum des Saarlandes, Homburg, Germany

    M Böhm & F Mahfoud

  3. Center of Epidemiology and Clinical Trials, University of Milano-Bicocca, Monza, Italy

    G Mancia

  4. Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, Korea

    M-K Hong & Y S Jang

  5. Division of Cardiology, Seoul National University College of Medicine, Seoul, Korea

    H-S Kim

  6. Division of Interventional Cardiology, University of Ulsan College of Medicine, Seoul, Korea

    S-J Park

  7. Division of Cardiology, Korea University College of Medicine, Seoul, Korea

    C G Park

  8. Department of Cardiovascular Medicine, Catholic University of Korea, Seoul, Korea

    K B Seung

  9. Department of Internal Medicine, Sungkyunkwan University School of Medicine, Seoul, Korea

    H-C Gwon

  10. Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam-si, Korea

    D-J Choi

  11. Division of Cardiology, Gachon University of Medicine and Science, Incheon, Korea

    T H Ahn

  12. Cardiovascular Center, Kyung Hee University Hospital at Gangdong, Seoul, Korea

    C J Kim

  13. Division of Cardiology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea

    H M Kwon

  14. Baker IDI Heart and Diabetes Institute, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia

    M Esler

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  1. B-K Kim
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  14. C J Kim
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  16. M Esler
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Corresponding author

Correspondence to Y S Jang.

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Competing interests

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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