Analysis of the Global SYMPLICITY registry DEFINE (GSR DEFINE), presented at EuroPCR 2023 (16–19 May, Paris France), reaffirms the safety and efficacy of renal denervation for the management of hypertension, an investigator has stated.
GSR Define is a prospective, all-comer observational study conducted at 247 sites, across 55 countries outside of the USA, to document the long-term safety and effectiveness of renal denervation in a real world patient population with hypertension.
To date, 3,332 patients have been enrolled (1,101 with Spyral) out of 5,000. The analysis assessed blood pressure and cardiovascular events three years post renal denervation.
Findings demonstrated that Medtronic radiofrequency renal denervation is a safe and effective adjunctive treatment independent of antihypertensive medication regimen, the company highlighted in a press release.
The findings include sustained and clinically meaningful blood pressure reductions in patients with uncontrolled hypertension and prescribed an average of 4.6 anti-hypertensive medication classes.
Reductions in office systolic BP (SBP) and 24-hr ambulatory SBP at three years were -16.7mmHg and -9.1mmHg, respectively. The study also demonstrated efficacy in a variety of hypertensive patients, including those prescribed a wide number and class combination of antihypertensive (0-3 vs. ≥4 medication at baseline (p=0.69)).
“With this new analysis, we are continuing to see [the] Symplicity blood pressure procedure as a significant, safe, and sustained treatment to manage hypertension, with the largest and longest reported follow-up of any trial of its kind,” said Felix Mahfoud (Saarland University Hospital, Homburg, Germany) and principal investigator of the GSR DEFINE Registry. “These findings offer new insights into RDN blood pressure-lowering efficacy and suggest that RDN should be considered, regardless of the medication regime.”
Additionally, cost-effectiveness data demonstrated that radiofrequency renal denervation is projected to be cost-effective in the UK National Health Service (NHS) healthcare system and substantially below the £20,000 willingness-to pay threshold for the UK National Institute for Health and Care Excellence (NICE) healthcare system.