title: Incomplete stent apposition after implantation of paclitaxel-eluting stents or bare metal stents: insights from the randomized TAXUS II trial.
abstract: BACKGROUND
  The clinical impact of late incomplete stent apposition (ISA) for drug-eluting stents is unknown. We sought to prospectively investigate the incidence and extent of ISA after the procedure and at 6-month follow-up of paclitaxel-eluting stents in comparison with bare metal stents (BMS) and survey the clinical significance of ISA over a period of 12 months.
  
  
  RESULTS
  TAXUS II was a randomized, double-blind study with 536 patients in 2 consecutive cohorts comparing slow-release (SR; 131 patients) and moderate-release (MR; 135 patients) paclitaxel-eluting stents with BMS (270 patients). This intravascular ultrasound (IVUS) substudy included patients who underwent serial IVUS examination after the procedure and at 6 months (BMS, 240 patients; SR, 113; MR, 116). The qualitative and quantitative analyses of ISA were performed by an independent, blinded core laboratory. More than half of the instances of ISA observed after the procedure resolved at 6 months in all groups. No difference in the incidence of late-acquired ISA was observed among the 3 groups (BMS, 5.4%; SR, 8.0%; MR, 9.5%; P=0.306), with a similar ISA volume (BMS, 11.4 mm3; SR, 21.7 mm3; MR, 8.5 mm3; P=0.18). Late-acquired ISA was the result of an increase of vessel area without change in plaque behind the stent. Predictive factors of late-acquired ISA were lesion length, unstable angina, and absence of diabetes. No stent thrombosis occurred in the patients diagnosed with ISA over a period of 12 months.
  
  
  CONCLUSIONS
  The incidence and extent of late-acquired ISA are comparable in paclitaxel-eluting stents and BMS. ISA is a pure IVUS finding without clinical repercussions.
authors.affiliation: Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Kengo
authors.initials: K
authors.lastname: Tanabe
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Muzaffer
authors.initials: M
authors.lastname: Degertekin
authors.forename: Eberhard
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authors.lastname: Grube
authors.forename: Giulio
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authors.lastname: Guagliumi
authors.forename: Wilhelm
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authors.lastname: Urbaszek
authors.forename: Johannes
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authors.lastname: Bonnier
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Lablanche
authors.forename: Tomasz
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authors.lastname: Siminiak
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authors.lastname: Nordrehaug
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authors.lastname: Figulla
authors.forename: Janusz
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authors.lastname: Drzewiecki
authors.forename: Adrian
authors.initials: A
authors.lastname: Banning
authors.forename: Karl
authors.initials: K
authors.lastname: Hauptmann
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.forename: Nico
authors.initials: N
authors.lastname: Bruining
authors.forename: Ronald
authors.initials: R
authors.lastname: Hamers
authors.forename: Angela
authors.initials: A
authors.lastname: Hoye
authors.forename: Jurgen M R
authors.initials: JM
authors.lastname: Ligthart
authors.forename: Clemens
authors.initials: C
authors.lastname: Disco
authors.forename: Jörg
authors.initials: J
authors.lastname: Koglin
authors.forename: Mary E
authors.initials: ME
authors.lastname: Russell
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
mesh_terms: D000368:Aged; D020099:Coated Materials, Biocompatible / Q000627:therapeutic use; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D019919:Prosthesis Implantation / Q000009:adverse effects / Q000592:standards*; D012307:Risk Factors; D015607:Stents / Q000009:adverse effects*; D018084:Ultrasonography, Interventional
chemical_list: D020099:Coated Materials, Biocompatible; D017239:Paclitaxel