Original Investigation
Renal Denervation in High-Risk Patients With Hypertension

https://doi.org/10.1016/j.jacc.2020.04.036Get rights and content
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Abstract

Background

Renal denervation (RDN) is under investigation for treatment of uncontrolled hypertension and might represent an attractive treatment for patients with high cardiovascular (CV) risk. It is important to determine whether baseline CV risk affects the efficacy of RDN.

Objectives

The purpose of this study was to assess blood pressure (BP) reduction and event rates after RDN in patients with various comorbidities, testing the hypothesis that RDN is effective and durable in these high-risk populations.

Methods

BP reduction and adverse events over 3 years were evaluated for several high-risk subgroups in the GSR (Global proSpective registrY for syMPathetic renaL denervatIon in seleCted IndicatIons Through 3 Years Registry), an international registry of RDN in patients with uncontrolled hypertension (n = 2,652). Comparisons were made for patients age ≥65 years versus age <65 years, with versus without isolated systolic hypertension, with versus without atrial fibrillation, and with versus without diabetes mellitus. Baseline cardiovascular risk was estimated using the American Heart Association (AHA)/American College of Cardiology (ACC) atherosclerosis cardiovascular disease (ASCVD) risk score.

Results

Reduction in 24-h systolic BP at 3 years was −8.9 ± 20.1 mm Hg for the overall cohort, and for high-risk subgroups, BP reduction was −10.4 ± 21.0 mm Hg for resistant hypertension, −8.7 ± 17.4 mm Hg in patients age ≥65 years, −10.2 ± 17.9 mm Hg in patients with diabetes, −8.6 ± 18.7 mm Hg in isolated systolic hypertension, −10.1 ± 20.3 mm Hg in chronic kidney disease, and −10.0 ± 19.1 mm Hg in atrial fibrillation (p < 0.0001 compared with baseline for all). BP reduction in patients with measurements at 6, 12, 24, and 36 months showed similar reductions in office and 24-h BP for patients with varying baseline ASCVD risk scores, which was sustained to 3 years. Adverse event rates at 3 years were higher for patients with higher baseline CV risk.

Conclusions

BP reduction after RDN was similar for patients with varying high-risk comorbidities and across the range of ASCVD risk scores. The impact of baseline risk on clinical event reduction by RDN-induced BP changes could be evaluated in further studies. (Global proSpective registrY for syMPathetic renaL denervatIon in seleCted IndicatIons Through 3 Years Registry; NCT01534299)

Key Words

blood pressure
cardiovascular risk
device-based hypertension therapy
hypertension
renal denervation

Abbreviations and Acronyms

AF
atrial fibrillation
ASCVD
atherosclerotic cardiovascular disease
BP
blood pressure
CV
cardiovascular
DM
diabetes mellitus
ISH
isolated systolic hypertension
RDN
renal denervation
SBP
systolic blood pressure

Cited by (0)

The Global SYMPLICITY Registry is funded by Medtronic. Prof. Mahfoud is supported by Deutsche Gesellschaft für Kardiologie and Deutsche Forschungsgemeinschaft; and has received speaker honoraria from Medtronic and ReCor. Prof. Mancia has received speaker fees from Boehringer Ingelheim, Ferrer, Gedeon Richter, Medtronic Vascular, Menarini, Merck Healthcare KGaA, Neopharmed-Gentili, Novartis, Recordati, Sanofi, and Servier. Prof. Schmieder has received speaker and consulting honoraria from Medtronic, ReCor, Ablative Solutions, and Rox Medical. Prof. Narkiewicz has received speaker honoraria from Adamed, Berlin-Chemie/Menarini, Egis, Gedeon Richter, Krka, Polpharma, Sandoz, and Servier; and has received honoraria or consultation fees from Medtronic, Servier, Krka, Berlin-Chemie/Menarini, Egis, Sandoz, Idorsia, Polpharma, and Gedeon Richter. Prof. Ruilope has served as an advisor/speaker for Medtronic. Prof. Schlaich is supported by an NHMRC Senior Research Fellowship; and has received consulting fees and/or travel and research support from Medtronic, Abbott, Novartis, Servier, Pfizer, and Boehringer Ingelheim. Prof. Zeller has received honoraria from Abbott Vascular, B. Braun, Biotronik, Boston Scientific, Cook Medical, Gore & Associates, Medtronic, Philips-Spectranetics, TriReme, Veryan, and Shockwave; has received consulting fees from Boston Scientific, Cook Medical, Gore & Associates, Medtronic, Spectranetics, Veryan, Intact Vascular, MedAlliance, and Vesper Medical; and owns stock in QT Medical. Prof. Stawowy has received consultancy and lecture honoraria from Amgen, Novartis, San, Bristol-Myers Squibb/Pfizer, Daiichi-Sankyo, Bayer, Boehringer Ingelheim, BerlinChemie, B. Braun, Springer Nature, Medtronic, and AstraZeneca. Dr. Cohen is an employee of and owns stock in Medtronic. Mr. Fahy is an employee of Medtronic. Prof. Böhm is supported by the Deutsche Forschungsgemeinschaft (DFG, TRR-219, S-01, M-03, M-05); and has received personal fees from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Servier, Medtronic, Vifor, Novartis, and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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© 2020 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.