Efficacy of a Drug-Eluting Stent Versus Bare Metal Stents for Symptomatic Femoropopliteal Peripheral Artery Disease: Primary Results of the EMINENT Randomized Trial. Issue 21 (18th October 2022)

• Record Type: Journal Article
• Authors: Gouëffic, Yann; Torsello, Giovanni; Zeller, Thomas; Esposito, Giovanni; Vermassen, Frank; Hausegger, Klaus Armin; Tepe, Gunnar; Thieme, Marcus; Gschwandtner, Michael; Kahlberg, Andrea; Schindewolf, Marc; Sapoval, Marc; Diaz-Cartelle, Juan; Stavroulakis, Konstantinos
• Other Names: Apruzzi Luca author non-byline.; Baccellieri Domenico author non-byline.; Bea Florian author non-byline.; Becquemin Jean-Pierre author non-byline.; Bent Clare author non-byline.; Bertoglio Luca author non-byline.; Bianchini Aurélia author non-byline.; Bieri Thomas author non-byline.; Blessing Erwin author non-byline.; Chaillou Phillipe author non-byline.; Chiesa Roberto author non-byline.; Del Giudice Costantino author non-byline.; Deloose Koen author non-byline.; Desgranges Pascal author non-byline.; Erbel Christian author non-byline.; Espinola-Klein Christine author non-byline.; Esposito Giovanni author non-byline.; Feugier Patrick author non-byline.; Fourneau Inge author non-byline.; Grözinger Gerd author non-byline.; Gschwandtner Michael author non-byline.; Guillemot Loic author non-byline.; Hamady Mohammed author non-byline.; Hausegger Klaus Armin author non-byline.; Heilmeier Britta author non-byline.; Hendriks Jeroen author non-byline.; Jaffer Ounali author non-byline.; Kahlberg Andrea author non-byline.; Kakani Nirmal author non-byline.; Keirse Koen author non-byline.; Kranewitter Christof author non-byline.; Krokidis Miltaidis author non-byline.; Langhoff Ralf author non-byline.; Lee Michael author non-byline.; Lohle Paul author non-byline.; Maene Lieven author non-byline.; Mahnken Andreas author non-byline.; Maiwald Lars author non-byline.; Mascia Daniele author non-byline.; Melloni Andrea author non-byline.; Montorsi Piero author non-byline.; Nice Colin author non-byline.; Oberhuber Alexander author non-byline.; Paetzel Christian author non-byline.; Ramjas Greg author non-byline.; Rammos Christos author non-byline.; Rinaldi Enrico author non-byline.; Rosset Eugenio author non-byline.; Ruiz Salmeron Rafael author non-byline.; Sapoval Marc author non-byline.; Saracino Concetta author non-byline.; Sauguet Antoine author non-byline.; Schäfer Jost Phillipp author non-byline.; Schahab Nadjib author non-byline.; Schindewolf Marc author non-byline.; Settembre Nicola author non-byline.; Simonini Elisa author non-byline.; Sobocinski Jonathan author non-byline.; Steinmetz Eric author non-byline.; Tepe Gunnar author non-byline.; Thaveau Fabien author non-byline.; Thieme Marcus author non-byline.; Torsello Giovanni author non-byline.; van Overhagen Hans author non-byline.; Vermassen Frank author non-byline.; Verbist Jurgen author non-byline.; Zeller Thomas author non-byline.; Zorger Niels author non-byline.;
• Is Part Of: Circulation. Volume 146:Issue 21(2022)
• Page Start: 1564
• Page End: 1576
• Publication Date: 2022-10-18
• Subjects: drug-eluting stents -- endovascular procedures -- paclitaxel -- peripheral arterial disease; Blood -- Circulation -- Periodicals; Cardiovascular system -- Periodicals; Cardiology -- Periodicals; Heart -- Diseases -- Periodicals; Blood Circulation; Cardiovascular System; Vascular Diseases; 616.1
• DOI: 10.1161/CIRCULATIONAHA.122.059606
• Languages: English
• ISSNs: 0009-7322

Abstract

Abstract : Background: A clear patency benefit of a drug-eluting stent (DES) over bare metal stents (BMSs) for treating peripheral artery disease of the femoropopliteal segment has not been definitively demonstrated. The EMINENT study (Trial Comparing Eluvia Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery) was designed to evaluate the patency of the Eluvia DES (Boston Scientific, Marlborough, MA), a polymer-coated paclitaxel-eluting stent, compared with BMSs for the treatment of femoropopliteal artery lesions. Methods: EMINENT is a prospective, randomized, controlled, multicenter European study with blinded participants and outcome assessment. Patients with symptomatic peripheral artery disease (Rutherford category 2, 3, or 4) of the native superficial femoral artery or proximal popliteal artery with stenosis ≥70%, vessel diameter of 4 to 6 mm, and total lesion length of 30 to 210 mm were randomly assigned 2:1 to treatment with DES or BMS. The primary effectiveness outcome was primary patency at 12 months, defined as independent core laboratory–assessed duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion. Primary sustained clinical improvement was a secondary outcome defined as a decrease in Rutherford classification of ≥1 categories compared with baseline without a repeat target lesion revascularization. Health-related quality of life and walking function were assessed. Results: A total of 775 patients were randomly assigned to treatment with DES (n=508) or commercially available BMSs (n=267). Baseline clinical, demographic, and lesion characteristics were similar between the study groups. Mean lesion length was 75.6±50.3 and 72.2±47.0 mm in the DES and BMS groups, respectively. The 12-month incidence of primary patency for DES treatment (83.2% [337 of 405]) was significantly greater than for BMS (74.3% [165 of 222]; P <0.01). Incidence of primary sustained clinical improvement was greater among patients treated with the DES than among those who received a BMS (83.0% versus 76.6%; P =0.045). The health-related quality of life dimensions of mobility and pain/discomfort improved for the majority of patients in both groups (for 66.4% and 53.6% of DES-treated and for 64.2% and 58.1% of BMS-treated patients, respectively) but did not differ significantly. At 12 months, no statistical difference was observed in all-cause mortality between patients treated with the DES or BMS (2.7% [13 of 474] versus 1.1% [3 of 263]; relative risk, 2.4 [95% CI, 0.69–8.36]; P =0.15). Conclusions: By demonstrating superior 1-year primary patency, the results of the EMINENT randomized study support the benefit of using a polymer-based paclitaxel-eluting stent as a first-line stent-based intervention for patients with symptomatic peripheral artery disease attributable to femoropopliteal lesions. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02921230.