Endovascular therapy in femoropopliteal territory has become the standard, mainly with self-expanding stents, aimed at preventing early vascular recoil and late constrictive remodeling.
Randomized studies have shown that the use of Paclitaxel drug eluting stents (DES) reduces the number of new revascularizations (even though these studies compared mostly against conventional balloons, which is why we have yet to measure impact with the contemporary self-expanding DES)
The aim of this study (EMINENT) was to compare the ELUVIA (polymer-based paclitaxel eluting stent) vs BMS for the treatment of the superficial femoral artery or proximal popliteal artery in lesions with up to 210 mm total lesion length (tandem lesions allowed).
It was a multicenter, international study randomizing patients 2:1, including symptomatic patients (Rutherford 2, 3 and 4) with lesion length from 30 to 210 mm. It excluded patients in dialysis, vessels previously treated with stents or surgery and those receiving plaque modifying treatments (atherectomy, laser or debulking). They used stents up to 120 mm (after having discontinued the 150 mm stents).
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Efficacy primary end point was primary patency at one year. Secondary end points included sustained clinical improvement (Rutherford) and adverse effects.
775 patients from 10 European countries were enrolled, 508 received DES stenting and 267 BMS. Most patients were men (70%), mean lesion size was 75.6 mm and 40% were occlusions.
DES showed greater primary patency at 12 months vs BMS (83.2% vs 74.3%, Difference 8.9%, CI 95% 21.1-15.7%; P<0.01). The absence of adverse effects at 12 months did not differ significantly (88.2% vs 88.2%, P=0.99), both in all-cause mortality (difference 1.6, CI 95% -0.3-3.6; P=0.15) and new revascularization (-1-8%; CI 95% -6.3-2.7%; P=0.43).
Conclusions
The EMINENT is the largest randomized study to date showing the efficacy of DES in femoropopliteal territory. Comparing 775 patients, at 12 months there was a difference in primary patency of 8.9%, without major adverse effects.
Prior studies on DES such as the BATTLE and the Zilver PTX had not been specifically designed to compare against BMS. This is the main difference with the EMINENT. These data support the use of polymer-based paclitaxel DES in patients with femoropopliteal disease.
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Original Title: Efficacy of a Drug-Eluting Stent Versus Bare Metal Stents for Symptomatic Femoropopliteal Peripheral Artery Disease: Primary Results of the EMINENT Randomized Trial.
Reference: Gouëffic, Yann et al. “Efficacy of a Drug-Eluting Stent Versus Bare Metal Stents for Symptomatic Femoropopliteal Peripheral Artery Disease: Primary Results of the EMINENT Randomized Trial.” Circulation, 101161CIRCULATIONAHA122059606. 18 Oct. 2022, doi:10.1161/CIRCULATIONAHA.122.059606.
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