EMINENT DES vs BMS trial: 12-month Primary Endpoint Data and Subset Analysis

The latest news on the important EMINENT trial were presented on Monday by Yann Gouëffic of the Department of Vascular and Endovascular Surgery at Paris Saint-Joseph Hospital in Paris, France. Dr. Gouëffic is the principal investigator of the randomized controlled trial that pits the Eluvia Drug-Eluting Vascular Stent System (Boston Scientific) against self-expanding bare metal stents (BMS) for the treatment of patients with peripheral artery disease (PAD) and superficial femoral artery (SFA) or popliteal artery (PPA) lesions up to 210 mm in length.

The data Dr. Gouëffic presented included 1-year results from the trial of 775 patients, making it the largest randomized industrial trial of a drug-eluting stent (DES) for the treatment of PAD to date.

The study was a 2:1 randomized, single-blind trial designed to confirm the superior effectiveness of the Eluvia stent versus self-expanding bare nitinol stents. Patients were included with chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4, and with stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA (where the degree of stenosis was ≥70 % by visual angiographic assessment, vessel diameter was 4 to 6 mm, and total lesion length [or series of lesions] was 30 ti 210 mm).

Dr. Gouëffic’s fellow primary investigator Giovanni Torsello of Saint-Franziskus Hospital in Münster, Germany, also presents primary endpoint results during LINC. “In this RCT it was comparison but it was also a hypothesis,” said Dr. Gouëffic, noting that the Eluvia stent did indeed exhibit superiority. “So the primary patency at one year of Eluvia is 85.4% vs 76.3% in the BMS group, which is, of course, significant,” he said.   

The analysis also confirmed a significantly greater rate of sustained clinical improvement without reintervention: 83.0% for patients treated with the Eluvia stent compared to 76.6% for those treated with BMS. Further, there was no significant difference in major adverse events or all-cause mortality rates between patients.

Safety was very important too in the context of the paclitaxel controversy of a few years ago said Professor Gouëffic. “We had no difference in terms of all-cause mortality at 12 months between the two devices – also in terms of amputation, or target limb revascularisation [TLR] etc.,” he explained.

In addition, hypoechogenic halo was measured.  “It is very interesting,” said Dr. Gouëffic. No significant difference was observed between the ELUVIA arm and the BMS arm: “In the Eluvia group halo was 26.1% vs 17.9% in the BMS group,” he said. “In fact, there is no difference between both groups.” He added that in the DES group there was no difference in clinically driven TLR between those who had halo and those who did not (6.7% vs. 6.0%). Halo was also found in the BMS group.

Crucially, Dr. Gouëffic outlined new results looking at demographical differences. “We noticed that in this trial we had predominantly White men – not so many women, nor young, Black or Hispanic people. Ultimately, Dr. Gouëffic said there should be more focus on populations other than White men, especially those where the PAD population can be significant. In men and women over the age of 60, for example, and an estimated 27% of the Black population are expected to have PAD compared to 11% of both the White and the Hispanic population in the US. “So there should be more focus in this research in terms of race, gender, but also social aspects,” he added.

Dr. Gouëffic mentioned a new study sponsored by Boston Scientific – the ELEGANCE international patient registry and post-market clinical study – that will enroll 5,000 patients. No less than 40% women and 40% underrepresented minorities, specifically members of the Black and Hispanic communities will be assessed. The study will look at long-term outcomes of the Ranger drug-coated balloon and the Eluvia DES over 5 years.