EMINENT Trial: Results of Eluvia DES vs Bare Metal Stent for SFA at 1 Year

In a late-breaking session at ISET 2022, Gunnar Tepe, MD, from the Department of Diagnostic and Interventional Radiology at RoMed Kliniken in Rosenheim, Germany, presented results of the EMINENT trial, a prospective randomized controlled trial (RCT) that compared the drug-eluting Eluvia stent (Boston Scientific) with bare metal stents in more than 700 patients and 58 centers in 10 European countries. It was the largest industry-sponsored RCT of drug-eluting stents for superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) lesions to date. The Eluvia drug-eluding stent (DES) uses an Innova stent platform of self-expanding Nitinol, a PROMUS polymer biostable fluorinated polymer matrix, and a paclitaxel dose density of 0.167µg/mm². Drug release from the Eluvia DES is sustained over time; >90% of drug is released at 1 year.

Almost 800 patients were randomly assigned to either receive the Eluvia stent or the bare metal stent,” Tepe explained. The baseline lesion and patient characteristics are seen in the slides below.

In the primary endpoint, the Eluvia DES performed better according to the primary patency rate compared with bare metal stents, 83.2% vs 70.3%. “When the patients were recalled back to the hospital and an ultrasound was done, the difference between those 2 stents became evident, with a significant benefit for the DES,” Tepe said. In the 775 patients enrolled, there was statistically superior primary patency for the Eluvia DES vs bare metal stent at 1 year, and significantly greater improvement in clinical outcomes without reinterventions. No significant differences in major adverse event rates were seen, including mortality, through 1 year. Systematic imaging with blinded core lab adjudication revealed hypoechogenic halo in both study arms with similar occurrence rates.

“Eluvia is the first DES to show superior 1-year primary patency compared with a bare metal stent,” Dr. Tepe concluded. “The Eluvia DES should be considered the stent of choice for treating SFA and/or PPA lesions of intermediate length, based on data from EMINENT and IMPERIAL RCTs.”