Results Patients were enrolled at 44 centres in 9 countries. A total of 331 patients were randomised to RDN (N=166) and sham control (N=165). The primary and secondary efficacy endpoints were met, with Bayesian posterior probability of superiority >0.999. The treatment differences were -3.9 mmHg for 24-hour SBP and -6·5 mmHg for office SBP between RDN and sham control groups. Treatment differences in 24-hour and office diastolic pressure at 3 months were -3.1 mmHg and -4.4 mmHg, respectively.

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... ductions in BP after RDN were consistent throughout 24 hours. There were no major procedural safety events to 3 months. Conclusions Results from the SPYRAL HTN-OFF MED Pivotal trial, first reported at ACC2020, demonstrate the efficacy of catheter-based RDN compared to sham control to safely lower BP in the absence of anti-hypertensive medications.