SPYRAL HTN-ON MED
Renal Denervation With the Symplicity Spyral System in Uncontrolled Hypertension on Antihypertensive Medications (pivotal/Expansion cohort)
Doente / População Intervenção / Exposição Comparação Desfecho
In 337 patients with uncontrolled hypertension on 1-3 antihypertensive drugs, radiofrequency renal denervation did not significantly lower 24-hour ambulatory systolic blood pressure at 6 months versus a sham procedure (-1.9 mmHg, 95% CI -4.4 to 0.5).
N
337
Desenho
Prospective, randomised, sham-controlled, blinded trial (Bayesian design)
Desfecho
Baseline-adjusted change in mean 24-hour ambulatory systolic BP at 6 months (RDN vs sham)
Relevância
3
ResultadoNeutral for the primary endpoint: 24-hour ambulatory systolic BP change -6.5 mmHg (RDN) vs -4.5 mmHg (sham), difference -1.9 mmHg (95% CI -4.4 to 0.5; P=0.12). Office systolic BP favoured RDN (-4.9 mmHg; P=0.0015).
Kandzari DE, et al. J Am Coll Cardiol. 2023;82(19):1809-1823. 10.1016/j.jacc.2023.08.045
Discussão e crítica
Primary 24-hour ambulatory BP endpoint not met, confounded by greater medication up-titration in the sham arm. Secondary/office signals plus a strong safety profile supported subsequent FDA approval and cautious guideline inclusion of renal denervation.