Long-term clinical benefit after radiofrequency renal denervation: pooled 36-month results from the SPYRAL Clinical Program

BACKGROUND: Catheter-based renal denervation (RDN) is a guideline-recommended therapy for uncontrolled hypertension. Late-term follow-up among RDN trials is essential to characterise the durability of its efficacy, and further study is needed to ascertain the proportion of patients experiencing a clinical benefit. AIMS: We aimed to evaluate 36-month blood pressure (BP) changes after radiofrequency (RF)-RDN across four clinical studies from the SPYRAL programme and to determine the proportion of patients who experienced a clinical benefit. METHODS: Data were pooled from the Global SYMPLICITY Registry DEFINE, SPYRAL First-In-Human, and SPYRAL HTN-OFF MED and -ON MED trials. All patients were treated with RF-RDN (Symplicity Spyral). Medications, BP changes, and adverse events were evaluated through 36 months. RESULTS: A total of 2,137 patients treated with RF-RDN using the Spyral device were included in the analysis. Baseline office systolic (OS)BP was 163±23 mmHg, baseline 24-hour ambulatory systolic (AS)BP was 152±17 mmHg, and the baseline number of antihypertensive medications was 3.8±2.1. At 36 months, the number of medications was 3.5±1.9, and reductions in OSBP and ASBP were significant (-18.1±23.4 mmHg and -13.3±17.6 mmHg, respectively; p<0.0001). Overall, adverse event rates were low. The proportion of patients who experienced a reduction in OSBP ≥10 mmHg, ASBP ≥5 mmHg, and/or ≥1 medication was 88% at 36 months. CONCLUSIONS: In this large, pooled cohort of Spyral RF-RDN patients, there were significant BP reductions through 36 months with few adverse events. Additionally, nearly 9 out of 10 patients experienced a clinical benefit. These findings suggest the long-term efficacy and safety of RF-RDN across a broad spectrum of patients with uncontrolled hypertension.