{Reference Type}: Randomized Controlled Trial
{Title}: Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications.
{Author}: Kandzari DE;Townsend RR;Kario K;Mahfoud F;Weber MA;Schmieder RE;Pocock S;Tsioufis K;Konstantinidis D;Choi J;East C;Lauder L;Cohen DL;Kobayashi T;Schmid A;Lee DP;Ma A;Weil J;Agdirlioglu T;Schlaich MP;Shetty S;Devireddy CM;Lea J;Aoki J;Sharp ASP;Anderson R;Fahy M;DeBruin V;Brar S;Böhm M; ;
{Journal}: J Am Coll Cardiol
{Volume}: 82
{Issue}: 19
{Year}: 2023 11 7
{Factor}: 27.203
{DOI}: 10.1016/j.jacc.2023.08.045
{Abstract}: Renal denervation (RDN) reduces blood pressure (BP) in patients with uncontrolled hypertension in the absence of antihypertensive medications.<BR>This trial assessed the safety and efficacy of RDN in the presence of antihypertensive medications.<BR>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.<BR>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.<BR>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).