View in EDS

Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial.

Saved in:
Bibliographic Details
Title: Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial.
Authors: Mahfoud, Felix (AUTHOR), Kandzari, David E (AUTHOR), Kario, Kazuomi (AUTHOR), Townsend, Raymond R (AUTHOR), Weber, Michael A (AUTHOR), Schmieder, Roland E (AUTHOR), Tsioufis, Konstantinos (AUTHOR), Pocock, Stuart (AUTHOR), Dimitriadis, Kyriakos (AUTHOR), Choi, James W (AUTHOR), East, Cara (AUTHOR), D'Souza, Richard (AUTHOR), Sharp, Andrew S P (AUTHOR), Ewen, Sebastian (AUTHOR), Walton, Antony (AUTHOR), Hopper, Ingrid (AUTHOR), Brar, Sandeep (AUTHOR), McKenna, Pamela (AUTHOR), Fahy, Martin (AUTHOR), Böhm, Michael (AUTHOR)
Source: Lancet. 4/9/2022, Vol. 399 Issue 10333, p1401-1410. 10p.
Abstract: Background: Renal denervation has been shown to lower blood pressure in the presence of antihypertensive medications; however, long-term safety and efficacy data from randomised trials of renal denervation are lacking. In this pre-specified analysis of the SPYRAL HTN-ON MED study, we compared changes in blood pressure, antihypertensive drug use, and safety up to 36 months in renal denervation versus a sham control group.Methods: This randomised, single-blind, sham-controlled trial enrolled patients from 25 clinical centres in the USA, Germany, Japan, the UK, Australia, Austria, and Greece, with uncontrolled hypertension and office systolic blood pressure between 150 mm Hg and 180 mm Hg and diastolic blood pressure of 90 mm Hg or higher. Eligible patients had to have 24-h ambulatory systolic blood pressure between 140 mm Hg and less than 170 mm Hg, while taking one to three antihypertensive drugs with stable doses for at least 6 weeks. Patients underwent renal angiography and were randomly assigned (1:1) to radiofrequency renal denervation or a sham control procedure. Patients and physicians were unmasked after 12-month follow-up and sham control patients could cross over after 12-month follow-up completion. The primary endpoint was the treatment difference in mean 24-h systolic blood pressure at 6 months between the renal denervation group and the sham control group. Statistical analyses were done on the intention-to-treat population. Long-term efficacy was assessed using ambulatory and office blood pressure measurements up to 36 months. Drug surveillance was used to assess medication use. Safety events were assessed up to 36 months. This trial is registered with ClinicalTrials.gov, NCT02439775; prospectively, an additional 260 patients are currently being randomly assigned as part of the SPYRAL HTN-ON MED Expansion trial.Findings: Between July 22, 2015, and June 14, 2017, among 467 enrolled patients, 80 patients fulfilled the qualifying criteria and were randomly assigned to undergo renal denervation (n=38) or a sham control procedure (n=42). Mean ambulatory systolic and diastolic blood pressure were significantly reduced from baseline in the renal denervation group, and were significantly lower than the sham control group at 24 and 36 months, despite a similar treatment intensity of antihypertensive drugs. The medication burden at 36 months was 2·13 medications (SD 1·15) in the renal denervation group and 2·55 medications (2·19) in the sham control group (p=0·26). 24 (77%) of 31 patients in the renal denervation group and 25 (93%) of 27 patients in the sham control group adhered to medication at 36 months. At 36 months, the ambulatory systolic blood pressure reduction was -18·7 mm Hg (SD 12·4) for the renal denervation group (n=30) and -8·6 mm Hg (14·6) for the sham control group (n=32; adjusted treatment difference -10·0 mm Hg, 95% CI -16·6 to -3·3; p=0·0039). Treatment differences between the renal denervation group and sham control group at 36 months were -5·9 mm Hg (95% CI -10·1 to -1·8; p=0·0055) for mean ambulatory diastolic blood pressure, -11·0 mm Hg (-19·8 to -2·1; p=0·016) for morning systolic blood pressure, and -11·8 mm Hg (-19·0 to -4·7; p=0·0017) for night-time systolic blood pressure. There were no short-term or long-term safety issues associated with renal denervation.Interpretation: Radiofrequency renal denervation compared with sham control produced a clinically meaningful and lasting blood pressure reduction up to 36 months of follow-up, independent of concomitant antihypertensive medications and without major safety events. Renal denervation could provide an adjunctive treatment modality in the management of patients with hypertension.Funding: Medtronic. [ABSTRACT FROM AUTHOR]
Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
FullText Text:
  Availability: 0
Header DbId: pbh
DbLabel: Psychology and Behavioral Sciences Collection
An: 157139824
AccessLevel: 6
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial.
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AR" term="%22Mahfoud%2C+Felix%22">Mahfoud, Felix</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kandzari%2C+David+E%22">Kandzari, David E</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kario%2C+Kazuomi%22">Kario, Kazuomi</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Townsend%2C+Raymond+R%22">Townsend, Raymond R</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Weber%2C+Michael+A%22">Weber, Michael A</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Schmieder%2C+Roland+E%22">Schmieder, Roland E</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Tsioufis%2C+Konstantinos%22">Tsioufis, Konstantinos</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Pocock%2C+Stuart%22">Pocock, Stuart</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Dimitriadis%2C+Kyriakos%22">Dimitriadis, Kyriakos</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Choi%2C+James+W%22">Choi, James W</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22East%2C+Cara%22">East, Cara</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22D'Souza%2C+Richard%22">D'Souza, Richard</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Sharp%2C+Andrew+S+P%22">Sharp, Andrew S P</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ewen%2C+Sebastian%22">Ewen, Sebastian</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Walton%2C+Antony%22">Walton, Antony</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Hopper%2C+Ingrid%22">Hopper, Ingrid</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Brar%2C+Sandeep%22">Brar, Sandeep</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22McKenna%2C+Pamela%22">McKenna, Pamela</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Fahy%2C+Martin%22">Fahy, Martin</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Böhm%2C+Michael%22">Böhm, Michael</searchLink> (AUTHOR)
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. 4/9/2022, Vol. 399 Issue 10333, p1401-1410. 10p.
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: <bold>Background: </bold>Renal denervation has been shown to lower blood pressure in the presence of antihypertensive medications; however, long-term safety and efficacy data from randomised trials of renal denervation are lacking. In this pre-specified analysis of the SPYRAL HTN-ON MED study, we compared changes in blood pressure, antihypertensive drug use, and safety up to 36 months in renal denervation versus a sham control group.<bold>Methods: </bold>This randomised, single-blind, sham-controlled trial enrolled patients from 25 clinical centres in the USA, Germany, Japan, the UK, Australia, Austria, and Greece, with uncontrolled hypertension and office systolic blood pressure between 150 mm Hg and 180 mm Hg and diastolic blood pressure of 90 mm Hg or higher. Eligible patients had to have 24-h ambulatory systolic blood pressure between 140 mm Hg and less than 170 mm Hg, while taking one to three antihypertensive drugs with stable doses for at least 6 weeks. Patients underwent renal angiography and were randomly assigned (1:1) to radiofrequency renal denervation or a sham control procedure. Patients and physicians were unmasked after 12-month follow-up and sham control patients could cross over after 12-month follow-up completion. The primary endpoint was the treatment difference in mean 24-h systolic blood pressure at 6 months between the renal denervation group and the sham control group. Statistical analyses were done on the intention-to-treat population. Long-term efficacy was assessed using ambulatory and office blood pressure measurements up to 36 months. Drug surveillance was used to assess medication use. Safety events were assessed up to 36 months. This trial is registered with ClinicalTrials.gov, NCT02439775; prospectively, an additional 260 patients are currently being randomly assigned as part of the SPYRAL HTN-ON MED Expansion trial.<bold>Findings: </bold>Between July 22, 2015, and June 14, 2017, among 467 enrolled patients, 80 patients fulfilled the qualifying criteria and were randomly assigned to undergo renal denervation (n=38) or a sham control procedure (n=42). Mean ambulatory systolic and diastolic blood pressure were significantly reduced from baseline in the renal denervation group, and were significantly lower than the sham control group at 24 and 36 months, despite a similar treatment intensity of antihypertensive drugs. The medication burden at 36 months was 2·13 medications (SD 1·15) in the renal denervation group and 2·55 medications (2·19) in the sham control group (p=0·26). 24 (77%) of 31 patients in the renal denervation group and 25 (93%) of 27 patients in the sham control group adhered to medication at 36 months. At 36 months, the ambulatory systolic blood pressure reduction was -18·7 mm Hg (SD 12·4) for the renal denervation group (n=30) and -8·6 mm Hg (14·6) for the sham control group (n=32; adjusted treatment difference -10·0 mm Hg, 95% CI -16·6 to -3·3; p=0·0039). Treatment differences between the renal denervation group and sham control group at 36 months were -5·9 mm Hg (95% CI -10·1 to -1·8; p=0·0055) for mean ambulatory diastolic blood pressure, -11·0 mm Hg (-19·8 to -2·1; p=0·016) for morning systolic blood pressure, and -11·8 mm Hg (-19·0 to -4·7; p=0·0017) for night-time systolic blood pressure. There were no short-term or long-term safety issues associated with renal denervation.<bold>Interpretation: </bold>Radiofrequency renal denervation compared with sham control produced a clinically meaningful and lasting blood pressure reduction up to 36 months of follow-up, independent of concomitant antihypertensive medications and without major safety events. Renal denervation could provide an adjunctive treatment modality in the management of patients with hypertension.<bold>Funding: </bold>Medtronic. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=157139824
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1016/S0140-6736(22)00455-X
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 10
        StartPage: 1401
    Titles:
      – TitleFull: Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial.
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Mahfoud, Felix
      – PersonEntity:
          Name:
            NameFull: Kandzari, David E
      – PersonEntity:
          Name:
            NameFull: Kario, Kazuomi
      – PersonEntity:
          Name:
            NameFull: Townsend, Raymond R
      – PersonEntity:
          Name:
            NameFull: Weber, Michael A
      – PersonEntity:
          Name:
            NameFull: Schmieder, Roland E
      – PersonEntity:
          Name:
            NameFull: Tsioufis, Konstantinos
      – PersonEntity:
          Name:
            NameFull: Pocock, Stuart
      – PersonEntity:
          Name:
            NameFull: Dimitriadis, Kyriakos
      – PersonEntity:
          Name:
            NameFull: Choi, James W
      – PersonEntity:
          Name:
            NameFull: East, Cara
      – PersonEntity:
          Name:
            NameFull: D'Souza, Richard
      – PersonEntity:
          Name:
            NameFull: Sharp, Andrew S P
      – PersonEntity:
          Name:
            NameFull: Ewen, Sebastian
      – PersonEntity:
          Name:
            NameFull: Walton, Antony
      – PersonEntity:
          Name:
            NameFull: Hopper, Ingrid
      – PersonEntity:
          Name:
            NameFull: Brar, Sandeep
      – PersonEntity:
          Name:
            NameFull: McKenna, Pamela
      – PersonEntity:
          Name:
            NameFull: Fahy, Martin
      – PersonEntity:
          Name:
            NameFull: Böhm, Michael
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 09
              M: 04
              Text: 4/9/2022
              Type: published
              Y: 2022
          Identifiers:
            – Type: issn-print
              Value: 01406736
          Numbering:
            – Type: volume
              Value: 399
            – Type: issue
              Value: 10333
          Titles:
            – TitleFull: Lancet
              Type: main
ResultId 1