title: Propensity Score Analysis Comparing Clinical Outcomes of Drug-Eluting vs Bare Nitinol Stents in Femoropopliteal Lesions.
abstract: OBJECTIVE
  To present a propensity score matching analysis comparing the 1-year outcomes of de novo femoropopliteal lesions treated with drug-eluting stents (DES) or bare nitinol stents (BNS).
  
  
  METHODS
  A retrospective review was conducted of 452 limbs in 389 patients (mean age 74±8 years; 284 men) treated with DES implantation and 1808 limbs in 1441 patients (mean age 72±9 years; 1023 men) implanted with BNS for de novo femoropopliteal lesions. One-year follow-up data were available on all patients. The primary endpoint was 12-month restenosis assessed by duplex ultrasonography or follow-up angiography within ±2 months. Secondary endpoint was major adverse limb events (MALE) including major amputation, any reintervention, and restenosis.
  
  
  RESULTS
  The BNS group was more likely to have current smoking, chronic total occlusion, and poor below-the-knee runoff. The stratification analysis demonstrated that diabetes mellitus (DM) and reference vessel diameter (RVD) had a significant interaction on the association of DES vs BNS implantation with restenosis (interaction p<0.05). Thus, the population was stratified into 4 subgroups (1: -DM, RVD ≥5 mm, 2: +DM, RVD ≥5 mm, 3: -DM, RVD <5 mm, and 4: +DM, RVD <5 mm); the RVD threshold was empirically determined. There were no significant intergroup differences in baseline variables after matching. There was no significant difference in restenosis risk between DES and BNS in the RVD ≥5 mm subgroup regardless of the presence of DM. The DES group had a significantly higher restenosis risk in the RVD <5 mm subgroup regardless of the presence of DM. No significant difference was observed in the risk of major amputation, reintervention, or MALE in any subgroup.
  
  
  CONCLUSIONS
  These results suggest that a first-generation DES was not superior to a conventional BNS for femoropopliteal lesions.
authors.affiliation: Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan sogacchy@yahoo.co.jp.
authors.forename: Yoshimitsu
authors.initials: Y
authors.lastname: Soga
authors.affiliation: Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Osaka, Japan Department of Diabetes Care Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Mitsuyoshi
authors.initials: M
authors.lastname: Takahara
authors.affiliation: Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Iida
authors.affiliation: Division of Cardiology, Tokyo General Hospital, Tokyo, Japan.
authors.forename: Masatsugu
authors.initials: M
authors.lastname: Nakano
authors.affiliation: Cardiovascular Center, General Takatsu Central Hospital, Kawasaki, Japan.
authors.forename: Yasutaka
authors.initials: Y
authors.lastname: Yamauchi
authors.affiliation: Department of Cardiovascular Medicine, Omihachiman Community Medical Center, Omihachiman, Japan.
authors.forename: Kan
authors.initials: K
authors.lastname: Zen
authors.affiliation: Cardiovascular Division, Department of Internal Medicine, Morinomiya Hospital, Morinomiya, Japan.
authors.forename: Daizo
authors.initials: D
authors.lastname: Kawasaki
authors.affiliation: Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Ando
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D000671:Amputation, Surgical; D003251:Constriction, Pathologic; D054855:Drug-Eluting Stents; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D007564:Japan; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D057216:Propensity Score; D011474:Prosthesis Design; D012008:Recurrence; D012042:Registries; D019233:Retreatment; D012189:Retrospective Studies; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014654:Vascular Patency
chemical_list: D000497:Alloys; C013616:nitinol
keywords: adverse events; diabetes; drug-eluting stent; femoropopliteal segment; nitinol stent; peripheral artery disease; reference vessel diameter; reintervention; restenosis; stenosis; stent