In patients with uncontrolled hypertension who are not receiving antihypertensive drugs, catheter-based renal denervation significantly lowers blood pressure (BP) levels compared with a sham procedure. This finding from the SPYRAL HTN-OFF MED Pivotal trial was presented at the virtual ACC 2020 Scientific Sessions.

Investigators of the international, randomized, sham-controlled, proof-of-concept SPYRAL HTN-ON MED trial had previously showed that renal denervation in the main renal arteries significantly reduced BP compared with a sham procedure. The subsequent SPYRAL Pivotal trial was designed to evaluate the efficacy of renal denervation in patients who were not receiving antihypertensive medication. Patients with office systolic BP (SBP) of 150–180 mmHg were randomly assigned to renal denervation (n = 166) or a sham procedure (n = 165). The primary and secondary efficacy end points were changes in 24-h SBP and office SBP, respectively, from baseline to 3 months after the procedure.

At 3 months, both end points were met with a posterior probability of superiority >0.999. The treatment difference between the two groups was −3.9 mmHg (Bayesian 95% credible interval −6.2 mmHg to −1.6 mmHg) for 24-h SBP and −6.5 mmHg (−9.6 mmHg to −3.5 mmHg) for office SBP, both favouring the renal denervation group. Importantly, treatment differences between groups for 24-h SBP were consistent among all the baseline characteristic subgroups assessed. No major device-related or procedure-related adverse events were observed in either treatment group.

“The SPYRAL Pivotal trial is, to the best of our knowledge, the largest randomized trial to show the superiority of catheter-based renal denervation, compared with a sham procedure, to lower blood pressure in the absence of antihypertensive medications,” comment the investigators. “Long-term efficacy and safety will continue to be followed up for 3 years.”