Paclitaxel-Eluting Stent for Treating Symptomatic Femoropopliteal PAD

In patients with symptomatic femoropopliteal peripheral artery disease (PAD), the patency benefit of using a drug-eluting stent (DES) as a first-line stent-based intervention has been demonstrated in the EMINENT (Trial Comparing Eluvia Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery; ClinicalTrials.gov Identifier: NCT02921230) study, according to results published in the journal Circulation.

The investigators sought to evaluate the patency of Eluvia™ DES (Boston Scientific; Marlborough, Massachusetts), a polymer-coated, paclitaxel-eluting stent, compared with that of a bare metal stent (BMS) for the treatment of femoropopliteal artery lesions. EMINENT is a prospective, randomized, controlled, multicenter European study that included blinded participants and an outcome assessment. All study participants were randomly assigned in a 2:1 ratio to treatment with Eluvia DES or BMS.

Individuals with symptomatic PAD (Rutherford category 2, 3, or 4) of the native femoral artery or the proximal popliteal artery with stenosis of 70% or more, vessel diameter of 4 to 6 mm, and total lesion length of 30 to 210 mm were included in the study. The primary efficacy outcome was primary patency at 12 months, which was defined as an independent core laboratory–assessed duplex ultrasound peak systolic velocity ratio of 2.4 or less without clinically driven target lesion revascularization or surgical bypass of the target lesion.

A secondary study outcome was a reduction in Rutherford classification of 1 or more categories, compared with baseline, without a repeat velocity ratio of 2.4 or less in the absence of clinically driven target lesion revascularization. The researchers evaluated health-related quality of life and walking function as well.

A total of 775 patients from 58 sites in 10 European countries were enrolled in EMINENT between October 2016 and March 2020. Overall, 508 individuals were assigned to the DES group and 267 to the BMS group. Completion of 12-month follow-up visits was reported in 453 participants from the DES arm and 249 from the BMS arm.

The mean lesion length was 75.6 [SD, 50.3] mm vs 72.2 [SD, 47.0] mm in the DES and BMS groups, respectively. Results of the study showed that the 12-month incidence of primary patency for DES treatment was significantly greater with DES treatment than with BMS treatment (83.2% vs 74.3%, respectively; P <.01). Further, the incidence of primary sustained clinical improvement was significantly higher in the DES arm compared with the BMS arm (83.0% vs 76.6%, respectively; P =.045).

Although health-related quality of life dimensions of mobility and pain/discomfort improved among the majority of participants in both groups (66.4% and 53.6%, respectively, in the DES group vs 62.4% and 58.1%, respectively,  in the BMS group), the results were not statistically significant. At the 12-month follow-up, no statistically significant difference was reported in all-cause mortality between participants in the DES arm vs those in the BMS arm (2.7% vs 1.1%, respectively; relative risk, 2.4; 95% CI, 0.69-8.36; P =.15).

Among study limitations are the poor representation of women and non-White populations in the analysis. Further, with study inclusion eligibility limited to those with Rutherford category 2 to 4, the sample is representative of patients with PAD and intermittent claudication or rest pain, but not of those with chronic limb-threatening ischemia with tissue loss.  Further, the study is reflective of common practice in a limited geographic region.

“High-level evidence supports the 1-year benefit of polymer-based paclitaxel elution over bare metal stents to treat superficial femoral artery or proximal popliteal artery lesions,” the study authors wrote.

Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.