@article {38862,
	title = {Efficacy of a drug-eluting Stent versus bare metal stents for symptomatic      femoropopliteal peripheral artery disease: Primary results of the EMINENT
      randomized trial
},
	journal = {Circulation},
	volume = {146},
	year = {2022},
	month = {2022},
	pages = {1564-1576},
	publisher = {Ovid Technologies (Wolters Kluwer Health)},
	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{\textpm}50.3 and 72.2{\textpm}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.
},
	keywords = {drug-eluting stents, endovascular procedures, Paclitaxel, peripheral arterial disease},
	isbn = {0009-7322},
	url = {http://dx.doi.org/10.1161/CIRCULATIONAHA.122.059606https://www.ncbi.nlm.nih.gov/pubmed/36254728},
	author = {Gou{\"e}ffic, Yann and Torsello, Giovanni and Zeller, Thomas and Esposito, Giovanni and Vermassen, Frank and Hausegger, Klaus Armin and Tepe, Gunnar and Thieme, Marcus and Gschwandtner, Michael and Kahlberg, Andrea and Schindewolf, Marc and Sapoval, Marc and Diaz-Cartelle, Juan and Stavroulakis, Konstantinos and EMINENT Investigators}
}
