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Effects of renal denervation on blood pressures in patients with hypertension: a systematic review and meta-analysis of randomized sham-controlled trials

Abstract

The efficacy of renal denervation has been controversial, but recent randomized sham-controlled trials demonstrated significant blood pressure reductions after renal denervation in patients with hypertension. We conducted a systematic review and updated meta-analysis to evaluate the effects of renal denervation on ambulatory and office blood pressures in patients with hypertension. Databases were searched up to 25 May 2021 to identify randomized, sham-controlled trials of renal denervation. The primary endpoint was change in 24 h ambulatory systolic blood pressure with renal denervation versus sham control. The secondary endpoints were daytime and nighttime systolic blood pressure, and office systolic blood pressure. A sub-analysis determined outcomes by medication, procedure, and device. From nine trials, 1555 patients with hypertension were randomized to undergo renal denervation (n = 885) or a sham procedure (n = 670). At 2–6 months after treatment, renal denervation significantly reduced 24 h ambulatory systolic blood pressure by 3.31 mmHg (95% confidence interval: −4.69, −1.94) compared with the sham procedure (p < 0.001). Renal denervation also reduced daytime SBP by 3.53 mmHg (−5.28, −1.78; p < 0.001), nighttime SBP by 3.20 mmHg (−5.46, −0.94; p = 0.006), and office SBP by 5.25 mmHg (−7.09, −3.40; p < 0.001) versus the sham control group. There were no significant differences in the magnitude of blood pressure reduction between first- and second-generation trials, between devices, or with or without medication. These data from randomized sham-controlled trials showed that renal denervation significantly reduced all blood pressure metrics in medicated or unmedicated patients with hypertension, including resistant/uncontrolled hypertension. Future trials should investigate the long-term efficacy and safety of renal denervation.

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Acknowledgements

The authors would like to thank Dr Sawako Abe and Eriko Handa in Fukuoka University Medical Library. English language editing assistance was provided by Nicola Ryan, independent medical writer, funded by Jiichi Medical University.

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All authors contributed to the protocol. KT and MA conducted searches, screening and extraction, analyzed the data, YO and KT drafted the paper. KK helped conceive the study, provided valuable clinical expertize. HA designed the meta-analytic code, assisted with screening and extraction as well as providing valuable methodological expertize. SN, HS, HK, and MM provided valuable content expertize and assistance throughout the project. All authors provided valuable input when analyzing and interpreting the results, approved the final paper and provided valuable input in content.

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Correspondence to Hisatomi Arima or Kazuomi Kario.

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KK received speaker fees or works as a consultant to JIMRO Co., Ltd., and Terumo Co; research grant from Otsuka Medical Device Co., Ltd. outside the submitted work. Shinsuke Nanto MD PhD received speaker fees to JIMRO Co., Ltd., and Otsuka Medical Device Co.

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Ogoyama, Y., Tada, K., Abe, M. et al. Effects of renal denervation on blood pressures in patients with hypertension: a systematic review and meta-analysis of randomized sham-controlled trials. Hypertens Res (2021). https://doi.org/10.1038/s41440-021-00761-8

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Keywords

  • Renal denervation
  • Hypertension
  • Sham procedure
  • Meta-analysis

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