Key result
Renal denervation fails to reduce 24-hour ambulatory systolic BP at 6 months versus sham control.
Why the study?
Renal denervation reduces blood pressure without medications, but its safety and efficacy in the presence of antihypertensive medications required assessment.
Does radiofrequency renal denervation reduce 24-hour ambulatory systolic BP in patients with uncontrolled hypertension taking 1 to 3 antihypertensive medications?
RCT (n=337)
patient- and assessor-blinded
randomized
Yes
Does radiofrequency renal denervation reduce 24-hour ambulatory systolic BP in patients with uncontrolled hypertension taking 1 to 3 antihypertensive medications?
Mean Difference: -1.9 (95% CI -4.4–0.5)
Absolute Event Rate: -6.5% vs -4.5%
p-value: p=0.12
Radiofrequency renal denervation did not significantly reduce 24-hour ambulatory systolic BP compared to a sham procedure at 6 months in patients on 1-3 antihypertensive medications, though secondary office BP endpoints favored the intervention.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The present study, SPYRAL HTN-ON MED, is a prospective, randomized, sham-controlled patient-and assessor-blinded trial which investigated the safety and efficacy of RDN in patients taking antihypertensive drugs. The present study included 206 patients, mean age 55.2 years, randomized to RDN, and 131 patients, mean age 54.6 years, randomized to a sham control group. The primary efficacy endpoint was the baseline-adjusted change in mean 24-hour ambulatory systolic BP at 6 months between the 2 groups using a Bayesian trial design and analysis. The treatment difference in mean 24-hour ambulatory systolic BP from baseline to 6 months was -6.5mmHG for the RDN group and -4.5mmHG for the sham control group (p not significant).”
RDN was not superior to sham for 24-hour ambulatory SBP reduction; challenges its role in medicated uncontrolled hypertension and prior positive trials.
BACKGROUND Renal denervation (RDN) reduces blood pressure (BP) in patients with uncontrolled hypertension in the absence of antihypertensive medications. OBJECTIVES This trial assessed the safety and efficacy of RDN in the presence of antihypertensive medications. METHODS SPYRAL HTN-ON MED is a prospective, randomized, sham-controlled, patient- and assessor-blinded trial enrolling patients from 56 clinical centers worldwide. Patients were prescribed 1 to 3 antihypertensive medications. Patients were randomized to radiofrequency RDN or sham control procedure. The primary efficacy endpoint was the baseline-adjusted change in mean 24-hour ambulatory systolic BP at 6 months between groups using a Bayesian trial design and analysis. RESULTS The treatment difference in the mean 24-hour ambulatory systolic BP from baseline to 6 months between the RDN group (n = 206; -6.5 ± 10.7 mm Hg) and sham control group (n = 131; -4.5 ± 10.3 mm Hg) was -1.9 mm Hg (95% CI: -4.4 to 0.5 mm Hg; P = 0.12). There was no significant difference between groups in the primary efficacy analysis with a posterior probability of superiority of 0.51 (Bayesian treatment difference: -0.03 mm Hg [95% CI: -2.82 to 2.77 mm Hg]). However, there were changes and increases in medication intensity among sham control patients. RDN was associated with a reduction in office systolic BP compared with sham control at 6 months (adjusted treatment difference: -4.9 mm Hg; P = 0.0015). Night-time BP reductions and win ratio analysis also favored RDN. There was 1 adverse safety event among 253 assessed patients. CONCLUSIONS There was no significant difference between groups in the primary analysis. However, multiple secondary endpoint analyses favored RDN over sham control. (SPYRAL HTN-ON MED Study [Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications]; NCT02439775).
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Kandzari et al. (2023) conducted an RCT in uncontrolled hypertension (n=337). Radiofrequency renal denervation vs. Sham control procedure was evaluated on baseline-adjusted change in mean 24-hour ambulatory systolic BP at 6 months (MD -1.9 mm Hg, 95% CI -4.4 to 0.5, p=0.12). Renal denervation did not significantly reduce 24-hour ambulatory systolic BP at 6 months compared to sham control (treatment difference -1.9 mm Hg; 95% CI -4.4 to 0.5; P=0.12).
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