title: Two-year follow-up of the Genous™ endothelial progenitor cell capturing stent versus the Taxus Liberté stent in patients with de novo coronary artery lesions with a high-risk of restenosis: a randomized, single-center, pilot study.
abstract: BACKGROUND
  In the prospective randomized TRIAS pilot study, the bio-engineered Genous™ endothelial progenitor cell capturing stent was compared with the Taxus Liberté™ SR paclitaxel-eluting stent. At 1 yr, a statistically nonsignificant difference in the rates of target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) was observed. We have evaluated the safety and efficacy up to 2 yr.
  
  
  METHODS
  A total of 193 patients with de novo coronary artery lesions carrying a high risk of restenosis were randomized to a Genous stent versus a Taxus stent. Dual antiplatelet therapy was prescribed for ≥1 month after Genous stent implantation and for ≥6 months after a Taxus stent.
  
  
  RESULTS
  Between 1 and 2 yr, patients treated with the Genous stent tended to have fewer episodes of target lesion revascularization (2.0% versus 5.3%), but nearly similar rates of cardiac death (1.0% versus 0%), myocardial infarction (0% versus 1.1%), and stent thrombosis (0% versus 1.1%) when compared with the Taxus stent. As a result, at 2-yr follow-up treatment with the Genous stent compared with the Taxus stent resulted in a nonsignificant difference in target vessel failure (TVR) (20.4% versus 15.8%; risk difference 4.6%, 95% CI -6.2-15.5%). No stent thrombosis was observed in the Genous group compared to five cases (in four patients) in the Taxus group, resulting in a difference as compared with the Taxus stent (risk difference -4.2%; 95%CI -8.2% to -0.2%).
  
  
  CONCLUSIONS
  In the TRIAS pilot study, treatment of coronary artery lesions carrying a high risk of restenosis with the Genous compared with the Taxus stent resulted in a nonsignificant difference of TVR at 2-yr follow-up, with convergence of the Kaplan-Meier curves between 1 and 2 yr. Stent thrombosis was only observed after Taxus stent implantation.
authors.affiliation: Department of Cardiology, Academic Medical Center, University of Amsterdam, The Netherlands. m.a.beijk@amc.uva.nl
authors.forename: Marcel A M
authors.initials: MA
authors.lastname: Beijk
authors.forename: Margo
authors.initials: M
authors.lastname: Klomp
authors.forename: Nan
authors.initials: N
authors.lastname: van Geloven
authors.forename: Karel T
authors.initials: KT
authors.lastname: Koch
authors.forename: José P S
authors.initials: JP
authors.lastname: Henriques
authors.forename: Jan
authors.initials: J
authors.lastname: Baan
authors.forename: Marije M
authors.initials: MM
authors.lastname: Vis
authors.forename: Jan G P
authors.initials: JG
authors.lastname: Tijssen
authors.forename: Jan J
authors.initials: JJ
authors.lastname: Piek
authors.forename: Robbert J
authors.initials: RJ
authors.lastname: de Winter
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003324:Coronary Artery Disease / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology / Q000473:pathology / Q000517:prevention & control*; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D042783:Endothelial Cells / Q000473:pathology*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000473:pathology / Q000517:prevention & control; D009426:Netherlands; D017239:Paclitaxel / Q000008:administration & dosage*; D010865:Pilot Projects; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011446:Prospective Studies; D011474:Prosthesis Design; D018570:Risk Assessment; D012307:Risk Factors; D016037:Single-Blind Method; D013234:Stem Cells / Q000473:pathology*; D015607:Stents; D013927:Thrombosis / Q000209:etiology / Q000473:pathology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D010975:Platelet Aggregation Inhibitors; D017239:Paclitaxel