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  • Until questions on intraprocedural efficacy control, renal nerve distribution and predictors of BP response are answered, the interpretation of clinical trials on renal denervation will remain uncertain

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Therapeutics
Randomised controlled trial
Until questions on intraprocedural efficacy control, renal nerve distribution and predictors of BP response are answered, the interpretation of clinical trials on renal denervation will remain uncertain
  1. Luca Donazzan,
  2. Sebastian Ewen,
  3. Michael Böhm
  1. Klinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Homburg, Germany
  1. Correspondence to: Professor Michael Böhm, Klinik für Innere Medizin III, Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätsklinikum des Saarlandes, Kirrberger Str. 1, Geb. 40, Homburg/Saar D-66421, Germany; michael.boehm{at}uks.eu

https://doi.org/10.1136/ebmed-2014-110028

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    Commentary on: Bhatt DL, Kandzari DE, O'Neill WW, et al. A controlled trial of renal denervation for resistant hypertension. N Engl J Med 2014;370:1393–401.OpenUrlCrossRefPubMedWeb of Science

    Context

    Percutaneous renal artery denervation (RDN) has recently been developed as an invasive technique to reduce blood pressure (BP) in patients with resistant hypertension. It is based on the principle of interrupting sympathetic renal afferent and efferent nerves, thereby reducing sympathetic activity. Several studies and registries documented a significant reduction in office and ambulatory BP after RDN and a persisting BP response during long-term follow-up.1 ,2 However, the recently published Symplicity HTN-3 study failed to meet its primary efficacy end point, while the primary safety end point was met.

    Methods

    HTN-3 was a prospective, 2:1 randomised, single-blinded trial comparing the safety and efficacy of RDN to an invasive sham procedure (renal artery angiography with sedation) using the Symplicity Flex System. Only 535 of 1441 initially evaluated patients could satisfy the inclusion criteria of office systolic BP (SBP) ≥160 mm Hg and ambulatory SBP ≥135 mm Hg after …

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    Footnotes

    • Contributors LD, SE and MB have substantially contributed to the drafting of the commentary. All authors have approved the final version of the manuscript to be published.

    • Competing interests MB was the investigator of the Symplicity HTN-1 and HTN-2 trial. He has also received speaker honorarium and consultancy fees from Medtronic/Ardian, St. Jude, Boston Scientific, and Cordis. He is supported by Deutsche Forschungsgemeinschaft (KFO 196) and by Deutsche Gesellschaft für Kardiologie. SE is supported by Deutsche Hochdruckliga. The institution has received scientific support from Medtronic/Ardian.

    • Provenance and peer review Not commissioned; internally peer reviewed.