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Hypertension urgencies in the SPYRAL HTN-OFF MED Pivotal trial

The SPYRAL HTN-OFF MED Pivotal trial (https://clinicaltrials.gov/ct2/show/NCT02439749) demonstrated significant reductions in blood pressure (BP) after renal denervation (RDN) compared to sham control in the absence of anti-hypertensive medications. Prior to the 3-month primary endpoint, medications...

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Autores principales: Weber, Michael A., Schmieder, Roland E., Kandzari, David E., Townsend, Raymond R., Mahfoud, Felix, Tsioufis, Konstantinos, Kario, Kazuomi, Pocock, Stuart, Tatakis, Fotis, Ewen, Sebastian, Choi, James W., East, Cara, Lee, David P., Ma, Adrian, Cohen, Debbie L., Wilensky, Robert, Devireddy, Chandan M., Lea, Janice P., Schmid, Axel, Fahy, Martin, Böhm, Michael
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9622517/
https://www.ncbi.nlm.nih.gov/pubmed/35852582
http://dx.doi.org/10.1007/s00392-022-02064-5
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author Weber, Michael A.
Schmieder, Roland E.
Kandzari, David E.
Townsend, Raymond R.
Mahfoud, Felix
Tsioufis, Konstantinos
Kario, Kazuomi
Pocock, Stuart
Tatakis, Fotis
Ewen, Sebastian
Choi, James W.
East, Cara
Lee, David P.
Ma, Adrian
Cohen, Debbie L.
Wilensky, Robert
Devireddy, Chandan M.
Lea, Janice P.
Schmid, Axel
Fahy, Martin
Böhm, Michael
author_facet Weber, Michael A.
Schmieder, Roland E.
Kandzari, David E.
Townsend, Raymond R.
Mahfoud, Felix
Tsioufis, Konstantinos
Kario, Kazuomi
Pocock, Stuart
Tatakis, Fotis
Ewen, Sebastian
Choi, James W.
East, Cara
Lee, David P.
Ma, Adrian
Cohen, Debbie L.
Wilensky, Robert
Devireddy, Chandan M.
Lea, Janice P.
Schmid, Axel
Fahy, Martin
Böhm, Michael
author_sort Weber, Michael A.
collection PubMed
description The SPYRAL HTN-OFF MED Pivotal trial (https://clinicaltrials.gov/ct2/show/NCT02439749) demonstrated significant reductions in blood pressure (BP) after renal denervation (RDN) compared to sham control in the absence of anti-hypertensive medications. Prior to the 3-month primary endpoint, medications were immediately reinstated for patients who met escape criteria defined as office systolic BP (SBP) ≥ 180 mmHg or other safety concerns. Our objective was to compare the rate of hypertensive urgencies in RDN vs. sham control patients. Patients were enrolled with office SBP ≥ 150 and < 180 mmHg, office diastolic BP (DBP) ≥ 90 mmHg and mean 24 h SBP ≥ 140 and < 170 mmHg. Patients had been required to discontinue any anti-hypertensive medications and were randomized 1:1 to RDN or sham control. In this post-hoc analysis, cumulative incidence curves with Kaplan–Meier estimates of rate of patients meeting escape criteria were generated for RDN and sham control patients. There were 16 RDN (9.6%) and 28 sham control patients (17.0%) who met escape criteria between baseline and 3 months. There was a significantly higher rate of sham control patients meeting escape criteria compared to RDN for all escape patients (p = 0.032), as well as for patients with a hypertensive urgency with office SBP ≥ 180 mmHg (p = 0.046). Rate of escape was similar between RDN and sham control for patients without a measured BP exceeding 180 mmHg (p = 0.32). In the SPYRAL HTN-OFF MED Pivotal trial, RDN patients were less likely to experience hypertensive urgencies that required immediate use of anti-hypertensive medications compared to sham control. GRAPHICAL ABSTRACT: [Image: see text]
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spelling pubmed-96225172022-11-02 Hypertension urgencies in the SPYRAL HTN-OFF MED Pivotal trial Weber, Michael A. Schmieder, Roland E. Kandzari, David E. Townsend, Raymond R. Mahfoud, Felix Tsioufis, Konstantinos Kario, Kazuomi Pocock, Stuart Tatakis, Fotis Ewen, Sebastian Choi, James W. East, Cara Lee, David P. Ma, Adrian Cohen, Debbie L. Wilensky, Robert Devireddy, Chandan M. Lea, Janice P. Schmid, Axel Fahy, Martin Böhm, Michael Clin Res Cardiol Original Paper The SPYRAL HTN-OFF MED Pivotal trial (https://clinicaltrials.gov/ct2/show/NCT02439749) demonstrated significant reductions in blood pressure (BP) after renal denervation (RDN) compared to sham control in the absence of anti-hypertensive medications. Prior to the 3-month primary endpoint, medications were immediately reinstated for patients who met escape criteria defined as office systolic BP (SBP) ≥ 180 mmHg or other safety concerns. Our objective was to compare the rate of hypertensive urgencies in RDN vs. sham control patients. Patients were enrolled with office SBP ≥ 150 and < 180 mmHg, office diastolic BP (DBP) ≥ 90 mmHg and mean 24 h SBP ≥ 140 and < 170 mmHg. Patients had been required to discontinue any anti-hypertensive medications and were randomized 1:1 to RDN or sham control. In this post-hoc analysis, cumulative incidence curves with Kaplan–Meier estimates of rate of patients meeting escape criteria were generated for RDN and sham control patients. There were 16 RDN (9.6%) and 28 sham control patients (17.0%) who met escape criteria between baseline and 3 months. There was a significantly higher rate of sham control patients meeting escape criteria compared to RDN for all escape patients (p = 0.032), as well as for patients with a hypertensive urgency with office SBP ≥ 180 mmHg (p = 0.046). Rate of escape was similar between RDN and sham control for patients without a measured BP exceeding 180 mmHg (p = 0.32). In the SPYRAL HTN-OFF MED Pivotal trial, RDN patients were less likely to experience hypertensive urgencies that required immediate use of anti-hypertensive medications compared to sham control. GRAPHICAL ABSTRACT: [Image: see text] Springer Berlin Heidelberg 2022-07-19 2022 /pmc/articles/PMC9622517/ /pubmed/35852582 http://dx.doi.org/10.1007/s00392-022-02064-5 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Original Paper
Weber, Michael A.
Schmieder, Roland E.
Kandzari, David E.
Townsend, Raymond R.
Mahfoud, Felix
Tsioufis, Konstantinos
Kario, Kazuomi
Pocock, Stuart
Tatakis, Fotis
Ewen, Sebastian
Choi, James W.
East, Cara
Lee, David P.
Ma, Adrian
Cohen, Debbie L.
Wilensky, Robert
Devireddy, Chandan M.
Lea, Janice P.
Schmid, Axel
Fahy, Martin
Böhm, Michael
Hypertension urgencies in the SPYRAL HTN-OFF MED Pivotal trial
title Hypertension urgencies in the SPYRAL HTN-OFF MED Pivotal trial
title_full Hypertension urgencies in the SPYRAL HTN-OFF MED Pivotal trial
title_fullStr Hypertension urgencies in the SPYRAL HTN-OFF MED Pivotal trial
title_full_unstemmed Hypertension urgencies in the SPYRAL HTN-OFF MED Pivotal trial
title_short Hypertension urgencies in the SPYRAL HTN-OFF MED Pivotal trial
title_sort hypertension urgencies in the spyral htn-off med pivotal trial
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9622517/
https://www.ncbi.nlm.nih.gov/pubmed/35852582
http://dx.doi.org/10.1007/s00392-022-02064-5
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