Medtronic has announced the launch of the EMBRACE trial, a randomised, multicentre trial evaluating its Symplicity Spyral renal denervation system added to staged percutaneous coronary intervention (PCI) versus staged PCI alone in patients with uncontrolled hypertension and multivessel coronary artery disease.
Led by Roxana Mehran (Icahn School of Medicine at Mount Sinai, New York, USA) and Felix Mahfoud (University Hospital Basel, Basel, Switzerland) the trial will assess its primary endpoint at two years, with a total follow-up extending to three years. Clinical effectiveness with radiofrequency renal denervation will be assessed using a composite endpoint that includes cardiovascular death, stroke, myocardial infarction (MI), and hospitalisation for heart failure or hypertensive crisis, among others.
“Uncontrolled hypertension is a major driver of coronary artery disease progression and recurrent ischemic events,” said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. “The EMBRACE study complements our robust clinical programme to benefit complex patients with high blood pressure and coronary artery disease. These patients are called out in global guidelines as needing more aggressive hypertension management. Our physician-initiated studies, including the EMBRACE study, strongly reflect the priorities of the cardiovascular clinical community.”
The study will enrol 1,000 patients with multivessel disease and uncontrolled hypertension undergoing staged PCI and will take place across 55 sites in up to 20 countries including the USA, Europe and Asia.
“PCI is no longer the end of the journey—it’s the beginning of a broader strategy to address residual cardiovascular risk,” said Mehran. “Uncontrolled hypertension remains a key driver of recurrent events, and EMBRACE explores a potential ‘sweet spot’ where revascularisation and renal denervation can be combined to move from intervention to prevention.”
This is an investigator-initiated study that is funded by Medtronic.
“Continuing to build on the evidence base of Symplicity, we are excited to partner with Dr Mehran and Dr Mahfoud for the EMBRACE trial to help understand if the approach will more aggressively bend the cardiovascular risk curve in high cardiovascular risk patients,” said Jason Fontana, vice president and general manager of Medtronic’s Renal Denervation business.
Separately, Medtronic has also announced new insights for the Symplicity Spyral renal denervation system. Michael Böhm (University of the Saarland, Homburg/Saar, Germany), presented results from a pooled analysis of the SPYRAL HTN ON- and -OFF MED trials at the American College of Cardiology’s annual scientific session (ACC.26; 28–30 March, New Orleans, USA).
The pooled analysis of 388 patients randomised to renal denervation and 315 to sham control showed renal denervation patients had a significantly lower rate of hypertensive urgencies (40%) compared to sham control patients through three years.
Additionally, the cumulative mean hypertensive urgency incidence at three years was 0.21 vs. 0.39 per patient in renal denervation vs Sham (HR 0.60 [95% CI:0.40, 0.90]) (p=0.014). Renal denervation patients also had a statistically significant lower medication burden compared to sham at three years (3.7±4.3 vs. 6.0±11.2; p=0.003).
