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)=180mmHg 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<180mmHg, office diastolic BP (DBP)=90mmHg and mean 24h SBP=140 and<170mmHg. 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 3months. 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=180mmHg (p=0.046). Rate of escape was similar between RDN and sham control for patients without a measured BP exceeding 180mmHg (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.

View details for DOI 10.1007/s00392-022-02064-5

View details for PubMedID 35852582