Abstract
Background: Catheter-based renal denervation (RDN) is a guideline-recommended therapy for uncontrolled hypertension. Late-term follow-up among RDN trials is essential to characterize the durability of efficacy, and further study is needed to ascertain the proportion of patients experiencing a clinical benefit.
Aims: We evaluated 36-month blood pressure (BP) changes after radiofrequency (RF)-RDN across four clinical studies from the Symplicity program and determined the proportion of patients who experience a clinical benefit.
Methods: Data were pooled from the Global SYMPLICITY Registry (GSR) DEFINE, SPYRAL First-In-Human, SPYRAL HTN-OFF MED, and -ON MED trials. All patients were treated with RF-RDN (SpyralTM, Medtronic). 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-h ambulatory (A)SBP 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 either 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 nine in ten patients experienced a clinical benefit. These findings suggest a long-term efficacy and safety of RF-RDN across a broad spectrum of patients with uncontrolled hypertension.
