Medtronic today announced new clinical data from the Global SYMPLICITY registry (GSR) indicating that renal denervation with the Medtronic Symplicity renal denervation system was associated with clinically significant and sustained blood pressure reductions in a real-world hypertensive patient population through three years. Results from the prospective, single-arm, global, observational study are being presented as a late-breaking clinical trial session at EuroPCR 2021 (18–20 May, virtual).
The study analysed nearly 3,000 patients with uncontrolled hypertension (HTN) and other comorbidities typical in HTN patients (chronic kidney disease, diabetes). Patients were treated with the Symplicity renal denervation system utilising the single electrode Symplicity catheter or the Symplicity Spyral multi-electrode catheter, and their outcomes were analysed up to three years post procedure. RDN with the radiofrequency based Symplicity renal denervation system is a minimally-invasive procedure intended to regulate overactivity of nerves that lead to and from the kidney, which play an important role in blood pressure control.
The GSR study results demonstrated the Symplicity renal denervation System led to significant and clinically meaningful reductions in blood pressure that were sustained out to three years postprocedure. Patients experienced a mean reduction of 16.7mmHg office systolic blood pressure (OSBP) at three years compared to baseline.
Investigators also evaluated the benefit of renal denervation within various patient subgroups using a clinical composite endpoint; a retrospective analysis comprised of both OSBP, 24-hour ambulatory blood pressure (ABPM), and medication burden. They found a consistent benefit of renal denervation in patients with versus without diabetes, chronic kidney disease, or patients who were 65 years and above. The similar clinical composite endpoint was used in a recent EuroIntervention publication that showed patients were nearly three times more likely to benefit from renal denervation compared to remaining on a regime of anti-hypertensive medications alone (Win Ratio=2.78, p<0.001).
“As we continue to expand our clinical data around renal denervation for uncontrolled hypertension management, we wanted to broaden our understanding of the long-term benefits for our patients who suffer from multiple chronic conditions and are typically prescribed multiple medications,” said Felix Mahfoud, cardiologist at Saarland University Hospital in Homburg, Germany and principal investigator in the study. “With this new analysis, we can now help patients continue to see the real-world benefits of renal denervation.”
EuroPCR: New analysis on estimated risk reduction from Symplicity renal denervation system
In addition to the late-breaking clinical trial results at EuroPCR, investigators also reported a new analysis estimating the reduction in clinical events in patients treated with the Symplicity renal denervation system. The analysis used the clinical events observed at three years in the Global SYMPLICITY registry and put these in perspective with a modelled control. The results showed a 26% relative risk reduction in major cardiovascular events (MACE) over three years for the full study cohort treated with renal denervation, and a 34% reduction for patients suffering from resistant hypertension over the same timeframe.
Medtronic expands renal denervation real-world data collection with the new GSR-DEFINE study
Building on the success of GSR and continuing its commitment to providing real-world evidence for the Symplicity Spyral renal denervation system, Medtronic also announced today launch of the GSR-DEFINE study. This new phase of patient data collection aims to enrol an additional 2,000 patients suffering from uncontrolled hypertension, who will be treated with the Medtronic Symplicity Spyral multi-electrode renal denervation catheter. The study will collect data for a subgroup of patients out to five years.
About the Medtronic Symplicity Spyral clinical programme
Along with the GSR and GSR-DEFINE studies, the Medtronic Symplicity global clinical programme also includes the SPYRAL HTN-OFF MED PIVOTAL and SPYRAL HTN-ON MED trials, both prospectively powered, randomised, sham-controlled studies evaluating patients with uncontrolled blood pressure in the absence and presence of prescribed anti-hypertensive medications respectively.
Approved for commercial use in more than 60 countries around the world, the Symplicity Spyral renal denervation system is limited to investigational use in the USA, Japan, and Canada.