Hypertension urgencies in the SPYRAL HTN-OFF MED Pivotal trial.

Michael A Weber; Roland E Schmieder; David E Kandzari; Raymond R Townsend; Felix Mahfoud; Konstantinos Tsioufis; Kazuomi Kario; Stuart Pocock; Fotis Tatakis; Sebastian Ewen; +11 more... James W Choi; Cara East; David P Lee; Adrian Ma; Debbie L Cohen; Robert Wilensky; Chandan M Devireddy; Janice P Lea; Axel Schmid; Martin Fahy; Michael Böhm; (2022) Hypertension urgencies in the SPYRAL HTN-OFF MED Pivotal trial. Clinical Research in Cardiology, 111 (11). pp. 1269-1275. ISSN 1861-0684 DOI: 10.1007/s00392-022-02064-5
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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.


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