EMINENT: Better Patency With DES Over BMS for Fem-Pop Lesions
Patency was better with the paclitaxel DES at 1 year and, importantly, mortality rates were not significantly different.
A drug-eluting stent is a better choice for treating superficial femoral and proximal popliteal lesions in terms of sustained efficacy in comparison with a BMS, according to 1-year results from the EMINENT trial presented last week at VIVA 2021.
Data pitting DES against BMS as primary treatment for femoropopliteal PAD lesions are scarce and limited to trial subsets or bailout arms, as in the case of ZILVER PTX, noted Yann Gouëffic, MD, PhD (Groupe Hospitalier Paris St. Joseph, France), in his presentation. He said EMINENT was designed to build on promising data from the IMPERIAL trial, which compared the Eluvia DES (Boston Scientific) and the ZILVER PTX DES (Cook Medical) and showed superiority of the former in terms of primary patency at 1 year (86.8% vs 77.5%; P = 0.01). Gouëffic said those results indicated that Eluvia might be the best candidate to go head-to-head against a BMS for efficacy.
While endovascular therapy is considered the first choice for femoropopliteal lesions < 250 mm, Gouëffic said the optimal treatment algorithm remains unclear, as does the role—and safety—of DES. While drug-coated balloons have been shown to outperform BMS, the role of DES in PAD with regard to long-term patency and cost requires further investigation.
EMINENT included 775 patients from 58 centers in 10 European countries. Patients with lesions in the superficial femoral and/or proximal popliteal arteries were randomly assigned to treatment with Eluvia DES (n = 508) or one of eight commercially available BMS (n = 267). This particular DES is a self-expanding polymer-based stent that elutes 0.167 µg/mm2 of paclitaxel in a sustained manner up to 1 year, at which point 90% of the drug is released. Mean lesion length was 75.6 mm in the DES group and 72.2 mm in the BMS group.
As Gouëffic reported, primary patency at 12 months was greater in the DES arm at 83.2% compared with 74.3% of the BMS group (P = .0077), which was confirmed in a Kaplan Meier analysis (84.5% vs 76.3%; log-rank P = 0.0087). There was no difference in clinical events committee-adjudicated major adverse events (all-cause death, target-limb major amputation, and/or TLR) between the DES and BMS (P = 0.9912) and no difference in rates of all-cause death (P = 0.1528) at 12 months.
For his part, Gouëffic said based on the results from IMPERIAL and now EMINENT, “Eluvia DES should be considered as a stent of choice for treating SFA and/or proximal popliteal lesions of intermediate length.”
Comparison Data Needed to Make Choices
Looking closer at causes of death, there also were no differences between the treatment arms in terms of cardiac, vascular, or nonvascular death. There were numerically more deaths in the DES arm, however, at five versus one for BMS. Gouëffic said these deaths were attributed to pre-existing malignancies in two cases, infections/sepsis in two cases, and trauma in one case.
Compared with the BMS, patients in the DES group also had a greater likelihood of improvement in Rutherford class by at least one category without TLR (83% vs 76.6%; P = 0.0450).
“I'd be really interested to see long-term, past 1-year results, with this comparison study,” noted Sara Royce, PhD (US Food and Drug Administration, Silver Spring, MD), who served as a panelist. She added that positive results from a longer look at the data “would help support the safety of these devices and also determine future clinical trial design.”
Gouëffic agreed. “I think we need this to in fact make the choice, and we have also always the risks in each treatment, and we have some [future] arguments to discuss about the benefits of the device.”
Importantly, he noted, EMINENT thus far suggests no difference in mortality between a paclitaxel-based stent and a non-drug-coated stent. Concerns about a long-term paclitaxel mortality signal in PAD patients were first raised by a meta-analysis in 2018 that indicated an increased rate of death in comparison to nondrug stents or balloons beginning at 2 to 3 years postprocedure. As the FDA and others have recommended, EMINENT will follow patients to 5 years to collect safety and efficacy data.
Gouëffic, Y. The EMINENT study: primary results of the randomized trial of Eluvia DES vs bare metal stents. Presented at: VIVA 2021. October 6, 2021. Las Vegas, NV.
- Gouëffic reports honoraria and/or consulting for BD, Veryan, W.L. Gore, Boston Scientific, Abbott Vascular, Biotronik, Cook Medical, GE Healthcare, Penumbra, Terumo, and Cardinal Health; and funding to his institution from Abbott Vascular, Boston Scientific, W.L. Gore, Veryan, and Cook Medical.