Abstract
Background: Catheter-based renal denervation has significantly reduced blood pressure in previous studies. Following a positive pilot trial, the SPYRAL HTN-OFF MED (SPYRAL Pivotal) trial was designed to assess the efficacy of renal denervation in the absence of antihypertensive medications. Methods: In this international, prospective, single-blinded, sham-controlled trial, done at 44 study sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the UK, and the USA, hypertensive patients with office systolic blood pressure of 150 mm Hg to less than 180 mm Hg were randomly assigned 1:1 to either a renal denervation or sham procedure. The primary efficacy endpoint was baseline-adjusted change in 24-h systolic blood pressure and the secondary efficacy endpoint was baseline-adjusted change in office systolic blood pressure from baseline to 3 months after the procedure. We used a Bayesian design with an informative prior, so the primary analysis combines evidence from the pilot and Pivotal trials. The primary efficacy and safety analyses were done in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT02439749. Findings: From June 25, 2015, to Oct 15, 2019, 331 patients were randomly assigned to either renal denervation (n=166) or a sham procedure (n=165). The primary and secondary efficacy endpoints were met, with posterior probability of superiority more than 0·999 for both. The treatment difference between the two groups for 24-h systolic blood pressure was −3·9 mm Hg (Bayesian 95% credible interval −6·2 to −1·6) and for office systolic blood pressure the difference was −6·5 mm Hg (−9·6 to −3·5). No major device-related or procedural-related safety events occurred up to 3 months. Interpretation: SPYRAL Pivotal showed the superiority of catheter-based renal denervation compared with a sham procedure to safely lower blood pressure in the absence of antihypertensive medications. Funding: Medtronic.
| Original language | English |
|---|---|
| Pages (from-to) | 1444-1451 |
| Number of pages | 8 |
| Journal | The Lancet |
| Volume | 395 |
| Issue number | 10234 |
| DOIs | |
| State | Published - May 2 2020 |
Bibliographical note
Funding Information:The trial is sponsored by Medtronic (Santa Rosa, CA, USA) and was designed in collaboration with the US Food and Drug Administration by the steering committee and sponsor. MB, FM, and SE are supported by the Deutsche Forschungsgemeinschaft (DFG, TTR 219, S-01, M-03, M-05). The manuscript was written by the lead author with significant contributions from the trial's executive committee and all co-authors. The funder assisted with figure and table generation, copy editing and formatting. We thank Beth Ferri and Jessica Dries-Devlin for editorial assistance; Laura Mauri for expert review of the manuscript; Manuela Negoita for contributions to trial design; Graeme Hickey for statistical analysis oversight; Denise Jones, Pamela McKenna, Daiki Yasuhara, and Marianne Wanten for clinical trial oversight.
Funding Information:
The trial is sponsored by Medtronic (Santa Rosa, CA, USA) and was designed in collaboration with the US Food and Drug Administration by the steering committee and sponsor. MB, FM, and SE are supported by the Deutsche Forschungsgemeinschaft (DFG, TTR 219, S-01, M-03, M-05). The manuscript was written by the lead author with significant contributions from the trial's executive committee and all co-authors. The funder assisted with figure and table generation, copy editing and formatting. We thank Beth Ferri and Jessica Dries-Devlin for editorial assistance; Laura Mauri for expert review of the manuscript; Manuela Negoita for contributions to trial design; Graeme Hickey for statistical analysis oversight; Denise Jones, Pamela McKenna, Daiki Yasuhara, and Marianne Wanten for clinical trial oversight.
Publisher Copyright:
© 2020 Elsevier Ltd
ASJC Scopus subject areas
- Medicine (all)