Radiofrequency renal denervation (RDN) utilizing the Symplicity Spyral device may effectively lower in-office systolic blood pressure (BP) at six months, according to results from the SPYRAL AFFIRM study presented at TCT 2026 and simultaneously published in Circulation: Cardiovascular Interventions.

David E. Kandzari, MD, FACC, et al., conducted a prospective, multicenter, observational single-arm study enrolled 594 patients (mean age, 57 years; 45% women) in the primary U.S. cohort across 73 clinical sites. Eligibility included an office systolic/diastolic BP ≥140/90 mm Hg and a home systolic BP ≥135 mm Hg. The patient population was 69% White, 27% Black, 11% Hispanic and 3% Asian; 19% had type 2 diabetes, and 17% had an estimated glomerular filtration rate <60 mL/min/1.73 m2.

Baseline systolic/diastolic office, home and 24-hour ambulatory BP were 169/106, 158/101 and 151/96, respectively, and patients were prescribed an average of 3.6 antihypertensive medications at baseline, with medication use remaining stable through six months.

Results showed that at six months, office, home and 24-hour ambulatory systolic BP decreased by 18.2, 9.4 and 9.7 mm Hg, respectively (all p<0.001 vs. baseline). The 18.2 mm Hg reduction in office systolic BP significantly exceeded the prespecified performance goal of 6.0 mm Hg (p<0.001).

At six months, 86.1% of evaluable patients experienced a clinical benefit, defined as either ≥10 mm Hg office systolic BP reduction, ≥5 mm Hg home systolic BP reduction, or a reduction of ≥1 antihypertensive medication. Adverse clinical events were uncommon: at six months, MI occurred in 0.7%, stroke in 0.5% and major bleeding in 0.2% of patients. There were no deaths, new-onset end-stage renal disease or significant embolic events.

Investigators note that this was the largest U.S. RDN trial to date. They write that "evaluating the safety and efficacy of this specific therapy in a broader demographic spectrum of patients is essential for determining its clinical applicability in the U.S. health care setting."

However, they add that the study's single-arm design without a sham-control comparator and its lack of medication adherence testing were limitations.

Keywords: Transcatheter Cardiovascular Therapeutics, TCT26, Diabetes Mellitus, Type 2, Kidney Failure, Chronic, Blood Pressure, Denervation, Hemorrhage, Stroke