title: A randomized comparison of the value of additional stenting after optimal balloon angioplasty for long coronary lesions: final results of the additional value of NIR stents for treatment of long coronary lesions (ADVANCE) study.
abstract: OBJECTIVE
  We sought to investigate the clinical benefit of additional stent implantation after achieving an optimal result of balloon angioplasty (BA) in long coronary lesions (>20 mm).
  
  
  BACKGROUND
  Long coronary lesions are associated with increased early complications and late restenosis after BA. Stenting improves the early outcome, but stent restenosis is also related to both lesion length and stent length.
  
  
  METHODS
  A total of 437 patients with a single native lesion 20 to 50 mm in length were included and underwent BA, using long balloons matched to lesion length and vessel diameter (balloon/artery ratio 1.1) to achieve a diameter stenosis (DS) <30% by on-line quantitative coronary angiography (QCA). "Bail-out stenting" was performed for flow-limiting dissections or >50% DS. Patients in whom an optimal BA result was achieved were randomized to additional stenting (using NIR stents) or no stenting. The primary end point was freedom from major adverse cardiac events (MACE) at nine months, and core laboratory QCA was performed on serial angiograms.
  
  
  RESULTS
  Bailout stenting was necessary in 149 patients (34%) and was associated with a significantly increased risk of peri-procedural infarction (p < 0.02). Among the 288 randomized patients, the mean lesion length was 27+/-9 mm, and the vessel diameter was 2.78+/-0.52 mm. The procedural success rate was 90% for the 143 patients assigned to BA alone (control group), as compared with 93% in the 145 patients assigned to additional stenting (stent group), which resulted in a superior early minimal lumen diameter (0.54 mm, p < 0.001) and led to reduced angiographic restenosis (27% vs. 42%, p = 0.022). Freedom from MACE at nine months was 77% in both groups.
  
  
  CONCLUSIONS
  A strategy of provisional stenting for long coronary lesions led to bailout stenting in one-third of patients, with a threefold increase in peri-procedural infarction. Additional stenting yielded a lower angiographic restenosis rate, but no reduction in MACE at nine months.
authors.affiliation: Erasmus University, Rotterdam, The Netherlands. serruys@card.azr.nl
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: David P
authors.initials: DP
authors.lastname: Foley
authors.forename: Martin Jan
authors.initials: MJ
authors.lastname: Suttorp
authors.forename: Benno J W M
authors.initials: BJ
authors.lastname: Rensing
authors.forename: Harry
authors.initials: H
authors.lastname: Suryapranata
authors.forename: Phillipe
authors.initials: P
authors.lastname: Materne
authors.forename: Arijan
authors.initials: A
authors.lastname: van den Bos
authors.forename: Edouard
authors.initials: E
authors.lastname: Benit
authors.forename: Angelo
authors.initials: A
authors.lastname: Anzuini
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Rutsch
authors.forename: Victor
authors.initials: V
authors.lastname: Legrand
authors.forename: Keith
authors.initials: K
authors.lastname: Dawkins
authors.forename: Michael
authors.initials: M
authors.lastname: Cobaugh
authors.forename: Marco
authors.initials: M
authors.lastname: Bressers
authors.forename: Bianca
authors.initials: B
authors.lastname: Backx
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology; D023921:Coronary Stenosis / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D003402:Creatine Kinase / Q000097:blood; D052279:Creatine Kinase, MB Form; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007527:Isoenzymes / Q000097:blood; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000097:blood / Q000000981:diagnostic imaging / Q000209:etiology; D011446:Prospective Studies; D019919:Prosthesis Implantation / Q000295:instrumentation; D011859:Radiography; D012720:Severity of Illness Index; D015607:Stents; D016896:Treatment Outcome
chemical_list: D007527:Isoenzymes; D003402:Creatine Kinase; D052279:Creatine Kinase, MB Form