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Cardiovascular Risk Reduction After Renal Denervation According to Time in Therapeutic Systolic Blood Pressure Range

Mahfoud F 1 , Mancia G 2 , Schmieder RE 3 , Ruilope L 4 , Narkiewicz K 5 , Schlaich M 6 Show all authors , Williams B 7 , Ribichini F 8 , Weil J 9 , Kao HL 10 , Rodriguez-Leor O 11 , Noory E 12 , Ong TK 13 , Unterseeh T 14 , de Araújo Gonçalves P 15 , Zirlik A 16 , Almerri K 17 , Sharif F 18 , Lauder L 19 , Wanten M 20 , Fahy M 20 , Böhm M 19

Affiliations 

  • 1 Saarland University Hospital, Homburg/Saar, Germany. Electronic address: felix.mahfoud@uks.eu
  • 2 University of Milano-Bicocca, Milan, Italy
  • 3 University Hospital Erlangen, Erlangen, Germany
  • 4 Hospital Universitario 12 de Octubre and Centro de Investigación Biomédica en Red Enfermedades Cardiovasculares, Madrid, Spain; School of Doctoral Studies and Research, Universidad Europea de Madrid, Madrid, Spain
  • 5 Medical University of Gdansk, Gdansk, Poland
  • 6 Dobney Hypertension Centre, Medical School-Royal Perth Hospital Unit, The University of Western Australia, Perth, Western Australia, Australia
  • 7 University College London and National Institute for Health Research University College London Hospitals Biomedical Research Centre, London, United Kingdom
  • 8 Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy
  • 9 Sana Kliniken Lübeck GmbH, Lübeck, Germany
  • 10 National Taiwan University Hospital, Taipei, Taiwan
  • 11 Hospital Germans Trias i Pujol, Barcelona, Spain
  • 12 Universitäts-Herzzentrum Freiburg, Bad Krozingen, Germany
  • 13 Sarawak General Hospital, Kuching, Malaysia
  • 14 Institut Hospitalier Jacques Cartier, Massy, France
  • 15 Centro Hospitalar de Lisboa Ocidental/Hospital de Santa Cruz, Carnaxide, Portugal
  • 16 Medical University Graz, Graz, Austria
  • 17 Chest Disease Hospital, Shuwaikh, Kuwait
  • 18 University Hospital Galway and National University of Ireland Galway, Galway, Ireland
  • 19 Saarland University Hospital, Homburg/Saar, Germany
  • 20 Medtronic PLC, Santa Rosa, California, USA
J Am Coll Cardiol, 2022 Nov 15;80(20):1871-1880.
PMID: 36357087 DOI: 10.1016/j.jacc.2022.08.802

Abstract

BACKGROUND: Renal denervation (RDN) has been shown to lower blood pressure (BP), but its effects on cardiovascular events have only been preliminarily evaluated. Time in therapeutic range (TTR) of BP is associated with cardiovascular events.

OBJECTIVES: This study sought to assess the impact of catheter-based RDN on TTR and its association with cardiovascular outcomes in the GSR (Global SYMPLICITY Registry).

METHODS: Patients with uncontrolled hypertension were enrolled and treated with radiofrequency RDN. Office and ambulatory systolic blood pressure (OSBP and ASBP) were measured at 3, 6, 12, 24, and 36 months postprocedure and used to derive TTR. TTR through 6 months was assessed as a predictor of cardiovascular events from 6 to 36 months using a Cox proportional hazard regression model.

RESULTS: As of March 1, 2022, 3,077 patients were enrolled: 42.2% were female; mean age was 60.5 ± 12.2 years; baseline OSBP was 165.6 ± 24.8 mm Hg; and baseline ASBP was 154.3 ± 18.7 mm Hg. Patients were prescribed 4.9 ± 1.7 antihypertensive medications at baseline and 4.8 ± 1.9 at 36 months. At 36 months, mean changes were -16.7 ± 28.4 and -9.0 ± 20.2 mm Hg for OSBP and ASBP, respectively. TTR through 6 months was 30.6%. A 10% increase in TTR after RDN through 6 months was associated with significant risk reductions from 6 to 36 months of 15% for major adverse cardiovascular events (P < 0.001), 11% cardiovascular death (P = 0.010), 15% myocardial infarction (P = 0.023), and 23% stroke (P < 0.001).

CONCLUSIONS: There were sustained BP reductions and higher TTR through 36 months after RDN. A 10% increase in TTR through 6 months was associated with significant risk reductions in major cardiovascular events from 6 to 36 months. (Global SYMPLICITY Registry [GSR] DEFINE; NCT01534299).

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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