Effect of Heart Rate on the Outcome of Renal Denervation in Patients With Uncontrolled Hypertension
Michael Böhm, Konstantinos Tsioufis, David E Kandzari, Kazuomi Kario, Michael A Weber, Roland E Schmieder, Raymond R Townsend, Saarraaken Kulenthiran, Christian Ukena, Stuart Pocock, Sebastian Ewen, Joachim Weil, Martin Fahy, Felix Mahfoud, Michael Böhm, Konstantinos Tsioufis, David E Kandzari, Kazuomi Kario, Michael A Weber, Roland E Schmieder, Raymond R Townsend, Saarraaken Kulenthiran, Christian Ukena, Stuart Pocock, Sebastian Ewen, Joachim Weil, Martin Fahy, Felix Mahfoud
Abstract
Background: Sham-controlled trials demonstrated safety and efficacy of renal denervation (RDN) to lower blood pressure (BP). Association of baseline heart rate with BP reduction after RDN is incompletely understood.
Objectives: The purpose of this analysis was to evaluate the impact of baseline heart rate on BP reduction without antihypertensive medications in the SPYRAL HTN-OFF MED (Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications) Pivotal trial.
Methods: Patients removed from any antihypertensive medications were enrolled with office systolic blood pressure (SBP) ≥150 and <180 mm Hg and randomized 1:1 to RDN or sham control. Patients were separated according to baseline office heart rate <70 or ≥70 beats/min. BP changes from baseline to 3 months between treatment arms were adjusted for baseline SBP using analysis of covariance.
Results: Scatter plots of 3-month changes in 24-hour and office SBP illustrate a wide range of changes in SBP for different baseline heart rates. Treatment difference at 3 months between RDN and sham control with baseline office heart rate ≥70 beats/min for 24-hour SBP was -6.2 mm Hg (95% CI: -9.0 to -3.5 mm Hg) (P < 0.001) and for baseline office heart rate <70 beats/min it was -0.1 mm Hg (-3.8 to 3.6 mm Hg) (P = 0.97) with an interaction P value of 0.008. Results were similar for changes in office, daytime, and nighttime SBP at 3 months, with a greater reduction in SBP with baseline office heart rate ≥70 beats/min.
Conclusions: Reduction in mean office, 24-hour, daytime, and nighttime SBP for RDN at 3 months was greater with baseline office heart rate ≥70 than <70 beats/min, suggesting an association between baseline heart rate and BP reduction after RDN. (SPYRAL PIVOTAL-SPYRAL HTN-OFF MED Study; NCT02439749).
Keywords: blood pressure; heart rate; hypertension; renal denervation; sympathetic activation.
Conflict of interest statement
Funding Support and Author Disclosures The trial is sponsored by Medtronic and was designed in collaboration with the U.S. Food and Drug Administration by the steering committee and sponsor. Profs Böhm, Ukena, Ewen, and Mahfoud are supported by the Deutsche Forschungsgemeinschaft (SFB TTR219, S-01, M-03, M-05). Prof. Böhm has received consulting fees from Abbott Vascular, Bayer AG, Amgen, AstraZeneca, Servier, Medtronic, Vifor, and Boehringer Ingelheim. Dr Tsioufis has received honoraria for advisory boards and lectures from Medtronic, Servier, Bayer, Menarini, Novartis, AstraZeneca, Boehringer Ingelheim, Pfizer, Pythagoras, Sanofi, and Amgen. Dr Kandzari has received institutional research/grant support from Medtronic CardioVascular and Ablative Solutions; and has received personal consulting honoraria from Medtronic CardioVascular. Prof. Kario has received scientific support and speaker honoraria from Daiichi-Sankyo, Sanwa Chemical, Boehringer Ingelheim, Omron Healthcare, A & D Inc, Fukudadenshi Inc, Medtronic, and ReCor Medical. Prof. Weber has received consulting fees from Medtronic, ReCor, and Ablative Solutions. Prof. Schmieder has received consultant fees from Medtronic and ReCor; and has received grant support from Medtronic, ReCor, and Ablative Solutions. Prof. Townsend has received consultant fees from Medtronic, Axio, and Regeneron. Dr Pocock has received consultant fees from Medtronic. Prof. Weil has received honoraria from Medtronic, Novartis, ReCor, Cardinal Health, Bayer, and AstraZeneca. Mr Fahy is an employee of and shareholder for Medtronic. Prof. Mahfoud is supported by Deutsche Gesellschaft für Kardiologie; and has received scientific support and speaker honoraria from Bayer, Boehringer Ingelheim, Medtronic, and ReCor Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed