Cardiovascular Risk Reduction After Renal Denervation According to Time in Therapeutic Systolic Blood Pressure Range

Abstract

Background: Renal denervation (RDN) has been shown to lower blood pressure (BP), but its effects on cardiovascular events have only been preliminarily evaluated. Time in therapeutic range (TTR) of BP is associated with cardiovascular events.

Objectives: This study sought to assess the impact of catheter-based RDN on TTR and its association with cardiovascular outcomes in the GSR (Global SYMPLICITY Registry).

Methods: Patients with uncontrolled hypertension were enrolled and treated with radiofrequency RDN. Office and ambulatory systolic blood pressure (OSBP and ASBP) were measured at 3, 6, 12, 24, and 36 months postprocedure and used to derive TTR. TTR through 6 months was assessed as a predictor of cardiovascular events from 6 to 36 months using a Cox proportional hazard regression model.

Results: As of March 1, 2022, 3,077 patients were enrolled: 42.2% were female; mean age was 60.5 ± 12.2 years; baseline OSBP was 165.6 ± 24.8 mm Hg; and baseline ASBP was 154.3 ± 18.7 mm Hg. Patients were prescribed 4.9 ± 1.7 antihypertensive medications at baseline and 4.8 ± 1.9 at 36 months. At 36 months, mean changes were -16.7 ± 28.4 and -9.0 ± 20.2 mm Hg for OSBP and ASBP, respectively. TTR through 6 months was 30.6%. A 10% increase in TTR after RDN through 6 months was associated with significant risk reductions from 6 to 36 months of 15% for major adverse cardiovascular events (P < 0.001), 11% cardiovascular death (P = 0.010), 15% myocardial infarction (P = 0.023), and 23% stroke (P < 0.001).

Conclusions: There were sustained BP reductions and higher TTR through 36 months after RDN. A 10% increase in TTR through 6 months was associated with significant risk reductions in major cardiovascular events from 6 to 36 months. (Global SYMPLICITY Registry [GSR] DEFINE; NCT01534299).

Keywords: cardiovascular death; hypertension; myocardial infarction; risk reduction; stroke.

Conflict of interest statement

Funding Support and Author Disclosures This study was funded by Medtronic. Prof Mahfoud has received support from the Deutsche Gesellschaft für Kardiologie, Deutsche Forschungsgemeinschaft (SFB TRR219), and Deutsche Herzstiftung; and has received scientific support and/or speaker honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Medtronic and ReCor Medical. Prof Mancia has received speaker fees from Servier, Sanofi, Medtronic, Menarini, Merck, and Recordati. Prof Schmieder has received speaker and consulting honoraria from Medtronic, ReCor Medical , and Ablative Solutions; and has received research grants given to his institution from Medtronic, ReCor Medical, and Ablative Solutions. Prof Narkiewicz has received speaker and consulting honoraria from Berlin-Chemie/Menarini, Egis, Idorsia, Gedeon Richter, Krka, Medtronic, Novo Nordisk, Polpharma, Recordati, Sandoz, and Servier. Prof Schlaich has received support from a National Health and Medical Research Council Senior Research Fellowship; and has received consulting fees and/or travel and research support from Medtronic, Abbott, Novartis, Servier, Pfizer, and Boehringer Ingelheim. Dr Ribichini has received consulting fees and research support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, and Volcano-Philips. Dr Weil has received support from Medtronic, ReCor Medical, Novartis, and AstraZeneca. Dr Kao has received honoraria from Asahi INTECC, Terumo, MicroPort, and Abbott; has received research grants from Medtronic, Elixir, and Abiomed; and is a member of Medtronic International Advisory Board. Dr Rodriguez-Leor has received speaker fees from Medtronic. Dr Noory has received speaker fees from Medtronic. Dr Ong has received speaker and consultant fees from Medtronic; and his institution received educational grants from Medtronic. Dr Zirlik has received consulting fees and/or research support from Medtronic, Abbott, Edwards, Abiomed, Cardiac Dimensions, Novartis, AstraZeneca, Astellas, Sanofi, Boehringer Ingelheim, Pfizer, Janssen Cilag, Novo Nordisk, Amgen, Bristol Myers Squibb, and Daichi-Sankyo. Dr Almerri is a member of the Advisory Committee in the Gulf Cooperation Council; and has received speaker and proctor honoraria from Medtronic. Dr Sharif has received speaker and consulting fees and research support from Medtronic. Dr Lauder has received speaker honoraria from Medtronic and ReCor Medical. Ms Wanten is an employee of Medtronic. Mr Fahy is an employee of Medtronic. Prof Böhm has received support from the Deutsche Forschungsgemeinschaft (German Research Foundation; TTR 219, project number 322900939); and has received personal fees from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Medtronic, Novartis, ReCor Medical, Servier, and Vifor during the conduct of the study. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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