title: Long-term impact of routinely detected early and late incomplete stent apposition: an integrated intravascular ultrasound analysis of the TAXUS IV, V, and VI and TAXUS ATLAS workhorse, long lesion, and direct stent studies.
abstract: OBJECTIVE
  We sought to determine the 2-year impact of early and late-acquired incomplete stent apposition (ISA) on clinical events.
  
  
  BACKGROUND
  The late clinical impact of early or late-acquired ISA in bare-metal stents (BMS) and TAXUS stents (Boston Scientific, Natick, Massachusetts) is debatable.
  
  
  METHODS
  We evaluated 1,580 patients enrolled in the intravascular ultrasound (IVUS) substudies of TAXUS IV, V, VI and TAXUS-ATLAS WH, LL, and DS trials.
  
  
  RESULTS
  There were 96 cases of early ISA in 26 (7.2%) BMS patients, 35 (9.7%) TAXUS Express patients (p = 0.28 vs. BMS), and 35 (7.3%) TAXUS Liberté patients (p = 0.21 vs. TAXUS Express, and p = 1.00 vs. BMS). Major adverse cardiovascular events were similar at 9 months in patients with early ISA versus control subjects with no ISA for BMS (3.8% vs. 15.2%, p = 0.13) and for TAXUS (11.6% vs. 8.8%, p = 0.45). There was no impact of early ISA on stent thrombosis. At 9-month follow-up, there were 36 cases of late-acquired ISA in 7 (2.7%) BMS patients, 17 (3.1%) patients with TAXUS slow-release (TAXUS Express or TAXUS Liberté), and 12 (15.4%) patients receiving TAXUS moderate-release. Over 2 ensuing years, major adverse cardiovascular events were similar in patients with late-acquired ISA versus control subjects with no ISA for BMS (14.3% vs. 7.9%, p = 0.54), TAXUS (overall, 8.3% vs. 8.1% p = 0.87), or TAXUS slow-release formulation (0% vs. 7.9%, p = 0.28). There was no impact of late-acquired ISA on stent thrombosis.
  
  
  CONCLUSIONS
  Neither routinely detected acute ISA nor routinely detected late-acquired ISA in BMS or TAXUS patients was associated with adverse clinical events over long-term follow-up.
authors.affiliation: Medical University of South Carolina, Charleston, South Carolina 29425, USA. steinbe@musc.edu
authors.forename: Daniel H
authors.initials: DH
authors.lastname: Steinberg
authors.forename: Gary S
authors.initials: GS
authors.lastname: Mintz
authors.forename: Lazar
authors.initials: L
authors.lastname: Mandinov
authors.forename: Alan
authors.initials: A
authors.lastname: Yu
authors.forename: Steven G
authors.initials: SG
authors.lastname: Ellis
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.forename: Keith D
authors.initials: KD
authors.lastname: Dawkins
authors.forename: John
authors.initials: J
authors.lastname: Ormiston
authors.forename: Mark A
authors.initials: MA
authors.lastname: Turco
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Weissman
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002318:Cardiovascular Diseases / Q000000981:diagnostic imaging* / Q000209:etiology; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology; D004311:Double-Blind Method; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D013927:Thrombosis / Q000000981:diagnostic imaging / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D002317:Cardiovascular Agents; D008670:Metals; D017239:Paclitaxel