title: Randomized comparison between polymer-free versus polymer-based paclitaxel-eluting stent: two-year final clinical results.
abstract: BACKGROUND
  Most drug-eluting stents currently in use are coated with a polymer carrying the drug that is released for several weeks. However, a durable polymer may provoke hypersensitive reaction, delayed artery healing, and eventually stent thrombosis. The aim of this study was to investigate the safety and efficacy of a polymer-free paclitaxel-eluting stent (PF-PES) versus a polymer-based PES (PB-PES).
  
  
  RESULTS
  Eligible patients undergoing percutaneous coronary intervention were randomized 1:1 to receive either PF-PES or PB-PES. The primary end point was late loss at 9 months. Intravascular ultrasound analysis at 9 months and final 2-year clinical follow-up were also performed. From October 2007 to April 2009, 164 patients were enrolled and randomized into 2 groups (PF-PES: n = 84; PB-PES: n = 80). Mean in-stent lumen loss was 0.90 ± 0.59 mm for PF-PES and 0.49 ± 0.52 mm for PB-PES (P < 0.001). Mean neointimal area by intravascular ultrasound was higher in PF-PES than in PB-PES (1.42 ± 1.09 versus 0.51 ± 0.61 mm(2); P < 0.001). At 2 years, a composite end point of all-cause death, any myocardial infarction, and target vessel revascularization occurred in 36.9% for PF-PES and 16.3% for PB-PES (P = 0.004), mainly driven by a higher rate of target vessel revascularization (PF-PES: 35.7%; PB-PES: 13.8%; P = 0.001). One late stent thrombosis was observed in PF-PES.
  
  
  CONCLUSIONS
  Compared with PB-PES, PF-PES was associated with increased neointimal proliferation and subsequent clinical restenosis. Polymer plays an essential role in the performance of drug-eluting stents.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifier: NCT01375855.
authors.affiliation: From the Thorax Institute, Department of Cardiology, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain (Y.S., S.B., M.S.); Cardiology Department, Interventional Cardiology Unit, Sant Pau Hospital, Barcelona, Spain (C.C., L.A.-C., V.M.-Y., V.M., J.G.-P.); Cardiology Department, Interventional Cardiology Unit, Vall d'Hebron Hospital, Barcelona, Spain (B.G.d.B.); Cardiology Department, Interventional Cardiology Unit, Virgen de Macarena Hospital, Sevilla, Spain (R.R.-S.); Cardiology Department, Interventional Cardiology Unit, Juan Ramon Jimenez Hospital, Huelva, Spain (J.D.); and Cardiology Department, Interventional Cardiology Unit, Virgen de la Arrixaca Hospital, Murcia, Spain (E.P.).
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Shiratori
authors.affiliation: From the Thorax Institute, Department of Cardiology, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain (Y.S., S.B., M.S.); Cardiology Department, Interventional Cardiology Unit, Sant Pau Hospital, Barcelona, Spain (C.C., L.A.-C., V.M.-Y., V.M., J.G.-P.); Cardiology Department, Interventional Cardiology Unit, Vall d'Hebron Hospital, Barcelona, Spain (B.G.d.B.); Cardiology Department, Interventional Cardiology Unit, Virgen de Macarena Hospital, Sevilla, Spain (R.R.-S.); Cardiology Department, Interventional Cardiology Unit, Juan Ramon Jimenez Hospital, Huelva, Spain (J.D.); and Cardiology Department, Interventional Cardiology Unit, Virgen de la Arrixaca Hospital, Murcia, Spain (E.P.).
authors.forename: Clarissa
authors.initials: C
authors.lastname: Cola
authors.affiliation: From the Thorax Institute, Department of Cardiology, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain (Y.S., S.B., M.S.); Cardiology Department, Interventional Cardiology Unit, Sant Pau Hospital, Barcelona, Spain (C.C., L.A.-C., V.M.-Y., V.M., J.G.-P.); Cardiology Department, Interventional Cardiology Unit, Vall d'Hebron Hospital, Barcelona, Spain (B.G.d.B.); Cardiology Department, Interventional Cardiology Unit, Virgen de Macarena Hospital, Sevilla, Spain (R.R.-S.); Cardiology Department, Interventional Cardiology Unit, Juan Ramon Jimenez Hospital, Huelva, Spain (J.D.); and Cardiology Department, Interventional Cardiology Unit, Virgen de la Arrixaca Hospital, Murcia, Spain (E.P.).
authors.forename: Salvatore
authors.initials: S
authors.lastname: Brugaletta
authors.affiliation: From the Thorax Institute, Department of Cardiology, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain (Y.S., S.B., M.S.); Cardiology Department, Interventional Cardiology Unit, Sant Pau Hospital, Barcelona, Spain (C.C., L.A.-C., V.M.-Y., V.M., J.G.-P.); Cardiology Department, Interventional Cardiology Unit, Vall d'Hebron Hospital, Barcelona, Spain (B.G.d.B.); Cardiology Department, Interventional Cardiology Unit, Virgen de Macarena Hospital, Sevilla, Spain (R.R.-S.); Cardiology Department, Interventional Cardiology Unit, Juan Ramon Jimenez Hospital, Huelva, Spain (J.D.); and Cardiology Department, Interventional Cardiology Unit, Virgen de la Arrixaca Hospital, Murcia, Spain (E.P.).
authors.forename: Luis
authors.initials: L
authors.lastname: Alvarez-Contreras
authors.affiliation: From the Thorax Institute, Department of Cardiology, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain (Y.S., S.B., M.S.); Cardiology Department, Interventional Cardiology Unit, Sant Pau Hospital, Barcelona, Spain (C.C., L.A.-C., V.M.-Y., V.M., J.G.-P.); Cardiology Department, Interventional Cardiology Unit, Vall d'Hebron Hospital, Barcelona, Spain (B.G.d.B.); Cardiology Department, Interventional Cardiology Unit, Virgen de Macarena Hospital, Sevilla, Spain (R.R.-S.); Cardiology Department, Interventional Cardiology Unit, Juan Ramon Jimenez Hospital, Huelva, Spain (J.D.); and Cardiology Department, Interventional Cardiology Unit, Virgen de la Arrixaca Hospital, Murcia, Spain (E.P.).
authors.forename: Victoria
authors.initials: V
authors.lastname: Martín-Yuste
authors.affiliation: From the Thorax Institute, Department of Cardiology, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain (Y.S., S.B., M.S.); Cardiology Department, Interventional Cardiology Unit, Sant Pau Hospital, Barcelona, Spain (C.C., L.A.-C., V.M.-Y., V.M., J.G.-P.); Cardiology Department, Interventional Cardiology Unit, Vall d'Hebron Hospital, Barcelona, Spain (B.G.d.B.); Cardiology Department, Interventional Cardiology Unit, Virgen de Macarena Hospital, Sevilla, Spain (R.R.-S.); Cardiology Department, Interventional Cardiology Unit, Juan Ramon Jimenez Hospital, Huelva, Spain (J.D.); and Cardiology Department, Interventional Cardiology Unit, Virgen de la Arrixaca Hospital, Murcia, Spain (E.P.).
authors.forename: Bruno García
authors.initials: BG
authors.lastname: del Blanco
authors.affiliation: From the Thorax Institute, Department of Cardiology, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain (Y.S., S.B., M.S.); Cardiology Department, Interventional Cardiology Unit, Sant Pau Hospital, Barcelona, Spain (C.C., L.A.-C., V.M.-Y., V.M., J.G.-P.); Cardiology Department, Interventional Cardiology Unit, Vall d'Hebron Hospital, Barcelona, Spain (B.G.d.B.); Cardiology Department, Interventional Cardiology Unit, Virgen de Macarena Hospital, Sevilla, Spain (R.R.-S.); Cardiology Department, Interventional Cardiology Unit, Juan Ramon Jimenez Hospital, Huelva, Spain (J.D.); and Cardiology Department, Interventional Cardiology Unit, Virgen de la Arrixaca Hospital, Murcia, Spain (E.P.).
authors.forename: Rafael
authors.initials: R
authors.lastname: Ruiz-Salmeron
authors.affiliation: From the Thorax Institute, Department of Cardiology, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain (Y.S., S.B., M.S.); Cardiology Department, Interventional Cardiology Unit, Sant Pau Hospital, Barcelona, Spain (C.C., L.A.-C., V.M.-Y., V.M., J.G.-P.); Cardiology Department, Interventional Cardiology Unit, Vall d'Hebron Hospital, Barcelona, Spain (B.G.d.B.); Cardiology Department, Interventional Cardiology Unit, Virgen de Macarena Hospital, Sevilla, Spain (R.R.-S.); Cardiology Department, Interventional Cardiology Unit, Juan Ramon Jimenez Hospital, Huelva, Spain (J.D.); and Cardiology Department, Interventional Cardiology Unit, Virgen de la Arrixaca Hospital, Murcia, Spain (E.P.).
authors.forename: Jose
authors.initials: J
authors.lastname: Díaz
authors.affiliation: From the Thorax Institute, Department of Cardiology, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain (Y.S., S.B., M.S.); Cardiology Department, Interventional Cardiology Unit, Sant Pau Hospital, Barcelona, Spain (C.C., L.A.-C., V.M.-Y., V.M., J.G.-P.); Cardiology Department, Interventional Cardiology Unit, Vall d'Hebron Hospital, Barcelona, Spain (B.G.d.B.); Cardiology Department, Interventional Cardiology Unit, Virgen de Macarena Hospital, Sevilla, Spain (R.R.-S.); Cardiology Department, Interventional Cardiology Unit, Juan Ramon Jimenez Hospital, Huelva, Spain (J.D.); and Cardiology Department, Interventional Cardiology Unit, Virgen de la Arrixaca Hospital, Murcia, Spain (E.P.).
authors.forename: Eduardo
authors.initials: E
authors.lastname: Pinar
authors.affiliation: From the Thorax Institute, Department of Cardiology, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain (Y.S., S.B., M.S.); Cardiology Department, Interventional Cardiology Unit, Sant Pau Hospital, Barcelona, Spain (C.C., L.A.-C., V.M.-Y., V.M., J.G.-P.); Cardiology Department, Interventional Cardiology Unit, Vall d'Hebron Hospital, Barcelona, Spain (B.G.d.B.); Cardiology Department, Interventional Cardiology Unit, Virgen de Macarena Hospital, Sevilla, Spain (R.R.-S.); Cardiology Department, Interventional Cardiology Unit, Juan Ramon Jimenez Hospital, Huelva, Spain (J.D.); and Cardiology Department, Interventional Cardiology Unit, Virgen de la Arrixaca Hospital, Murcia, Spain (E.P.).
authors.forename: Vicens
authors.initials: V
authors.lastname: Martí
authors.affiliation: From the Thorax Institute, Department of Cardiology, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain (Y.S., S.B., M.S.); Cardiology Department, Interventional Cardiology Unit, Sant Pau Hospital, Barcelona, Spain (C.C., L.A.-C., V.M.-Y., V.M., J.G.-P.); Cardiology Department, Interventional Cardiology Unit, Vall d'Hebron Hospital, Barcelona, Spain (B.G.d.B.); Cardiology Department, Interventional Cardiology Unit, Virgen de Macarena Hospital, Sevilla, Spain (R.R.-S.); Cardiology Department, Interventional Cardiology Unit, Juan Ramon Jimenez Hospital, Huelva, Spain (J.D.); and Cardiology Department, Interventional Cardiology Unit, Virgen de la Arrixaca Hospital, Murcia, Spain (E.P.).
authors.forename: Juan
authors.initials: J
authors.lastname: García-Picart
authors.affiliation: From the Thorax Institute, Department of Cardiology, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain (Y.S., S.B., M.S.); Cardiology Department, Interventional Cardiology Unit, Sant Pau Hospital, Barcelona, Spain (C.C., L.A.-C., V.M.-Y., V.M., J.G.-P.); Cardiology Department, Interventional Cardiology Unit, Vall d'Hebron Hospital, Barcelona, Spain (B.G.d.B.); Cardiology Department, Interventional Cardiology Unit, Virgen de Macarena Hospital, Sevilla, Spain (R.R.-S.); Cardiology Department, Interventional Cardiology Unit, Juan Ramon Jimenez Hospital, Huelva, Spain (J.D.); and Cardiology Department, Interventional Cardiology Unit, Virgen de la Arrixaca Hospital, Murcia, Spain (E.P.). masabate@clinic.ub.es.
authors.forename: Manel
authors.initials: M
authors.lastname: Sabaté
mesh_terms: D000368:Aged; D023903:Coronary Restenosis / Q000453:epidemiology; D023921:Coronary Stenosis / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D058426:Neointima / Q000000981:diagnostic imaging; D017239:Paclitaxel; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011108:Polymers / Q000009:adverse effects; D011446:Prospective Studies; D012307:Risk Factors; D016037:Single-Blind Method; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D018366:Vasculitis, Leukocytoclastic, Cutaneous / Q000453:epidemiology
chemical_list: D011108:Polymers; D017239:Paclitaxel
keywords: coronary restenosis; drug-eluting stents; paclitaxel; randomized controlled trial