Hypertension urgencies in the SPYRAL HTN-OFF MED Pivotal trial

• Type of Material: Article
• Authors: Michael A Weber, State University of New York; Roland E Schmieder, Univ Hosp Erlangen; David E Kandzari, Piedmont Heart Institute; Raymond R Townsend, University of Pennsylvania; Felix Mahfoud, Saarland University; Konstantinos Tsioufis, National and Kapodistrian University of Athens; Kazuomi Kario, Jichi Medical University; Stuart Pocock, London School of Hygiene & Tropical Medicine; Fotis Tatakis, Natl & Kapodistrian Univ Athens; Sebastian Ewen, Saarland Univ; James W Choi, Jack & Jane Hamilton Heart & Vasc Hosp; Cara East, Jack & Jane Hamilton Heart & Vasc Hosp; David P Lee, Stanford Hospital and Clinics; Adrian Ma, Stanford Hospital and Clinics; Debbie L Cohen, University of Pennsylvania; Robert Wilensky, University of Pennsylvania; Chandan Devireddy, Emory University; Janice Lea, Emory University; Axel Schmid, University Hospital Erlangen; Martin Fahy, Medtronic PLC; Michael Böhm, Saarland Univ
• Language: English
• Date: 2022-07-19
• Publisher: SPRINGER HEIDELBERG
• Publication Version: Final Published Version
• Copyright Statement: © The Author(s) 2022
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1007/s00392-022-02064-5
• Title of Journal or Parent Work: CLINICAL RESEARCH IN CARDIOLOGY
• Volume: 111
• Issue: 11
• Start Page: 1269
• End Page: 1275
• Grant/Funding Information: Medtronic PLC, Santa Rosa, CA, USA.
• Keywords: Life Sciences & Biomedicine; BLOOD-PRESSURE VARIABILITY; ADHERENCE; RENAL DENERVATION; Hypertensive urgency; Cardiovascular System & Cardiology; Blood pressure; Cardiac & Cardiovascular Systems; Hypertension; Science & Technology; Renal denervation
• Research Categories: Health Sciences, Medicine and Surgery

Abstract

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: [Figure not available: see fulltext.].