The SPYRAL AFFIRM Global Clinical Study of Renal Denervation With the Symplicity Spyral Renal Denervation System in Subjects With Uncontrolled Hypertension

doi:10.1161/CIRCINTERVENTIONS.126.017422

SPYRAL AFFIRM

Patient / Population Intervention / Exposure Comparison Outcome

In US patients with uncontrolled hypertension, radiofrequency renal denervation reduced office systolic blood pressure at 6 months from baseline, with no change in medication.

N

594patients

Design

Prospective, single-arm, global post-approval study (Medtronic; 97 sites) of radiofrequency renal denervation with the Symplicity Spyral system; TCT presents the US cohort

Endpoint

Change in office systolic blood pressure at 6 months

ResultChange in office systolic BP at 6 months -18.2±22.0 mm Hg (P<0.001 compared with baseline). The prespecified performance goal was -6.0 mm Hg. Home systolic BP changed by -9.4±13.8 mm Hg and 24-hour ambulatory systolic BP by -9.7±16.8 mm Hg (P<0.001 compared with baseline). Baseline office, home and 24-hour ambulatory BP were 169±21/106±13, 158±17/101±13 and 151±18/96±13 mm Hg. Patients took an average of 3.6±2.0 antihypertensive medications at baseline, and this remained unchanged through 6 months. Adverse clinical events through 6 months were uncommon.

Kandzari DE, Kario K, et al. Circ Cardiovasc Interv. 2026; published online 3 November. 10.1161/CIRCINTERVENTIONS.126.017422

Discussion & critique

In a broad US population of 594 patients that included 27% African American patients and 19% with type 2 diabetes, renal denervation lowered office, home and ambulatory systolic BP at 6 months with no change in medication. The study is single-arm and has no sham control, so regression to the mean, placebo effects and changes in adherence cannot be separated from the treatment effect. The endpoint is a 6-month blood pressure surrogate, not cardiovascular events. The abstract states that adverse events were uncommon but gives no event rates, and it gives the performance goal without stating the formal comparison against it.