title: Optimal coronary balloon angioplasty with provisional stenting versus primary stent (OCBAS): immediate and long-term follow-up results.
abstract: OBJECTIVE
  This study sought to compare two strategies of revascularization in patients obtaining a good immediate angiographic result after percutaneous transluminal coronary angioplasty (PTCA): elective stenting versus optimal PTCA. A good immediate angiographic result with provisional stenting was considered to occur only if early loss in minimal luminal diameter (MLD) was documented at 30 min post-PTCA angiography.
  
  
  BACKGROUND
  Coronary stenting reduces restenosis in lesions exhibiting early deterioration (>0.3 mm) in MLD within the first 24 hours (early loss) after successful PTCA. Lesions with no early loss after PTCA have a low restenosis rate.
  
  
  METHODS
  To compare angiographic restenosis and target vessel revascularization (TVR) of lesions treated with coronary stenting versus those treated with optimal PTCA, 116 patients were randomized to stent (n=57) or to optimal PTCA (n=59). After randomization in the PTCA group, 13.5% of the patients crossed over to stent due to early loss (provisional stenting).
  
  
  RESULTS
  Baseline demographic and angiographic characteristics were similar in both groups of patients. At 7.6 months, 96.6% of the entire population had a follow-up angiographic study: 98.2% in the stent and 94.9% in the PTCA group. Immediate and follow-up angiographic data showed that acute gain was significantly higher in the stent than in the PTCA group (1.95 vs. 1.5 mm; p < 0.03). However, late loss was significantly higher in the stent than the PTCA group (0.63+/-0.59 vs. 0.26+/-0.44, respectively; p=0.01). Hence, net gain with both techniques was similar (1.32< or =0.3 vs. 1.24+/-0.29 mm for the stent and the PTCA groups, respectively; p=NS). Angiographic restenosis rate at follow-up (19.2% in stent vs. 16.4% in PTCA; p=NS) and TVR (17.5% in stent vs. 13.5% in PTCA; p=NS) were similar. Furthermore, event-free survival was 80.8% in the stent versus 83.1% in the PTCA group (p=NS). Overall costs (hospital and follow-up) were US $591,740 in the stent versus US $398,480 in the PTCA group (p < 0.02).
  
  
  CONCLUSIONS
  The strategy of PTCA with delay angiogram and provisional stent if early loss occurs had similar restenosis rate and TVR, but lower cost than primary stenting after PTCA.
authors.affiliation: Cardiac Unit Otamendi/Anchorena Hospital, Buenos Aires, Argentina. selfcare@pinos.com
authors.forename: A
authors.initials: A
authors.lastname: Rodríguez
authors.forename: F
authors.initials: F
authors.lastname: Ayala
authors.forename: V
authors.initials: V
authors.lastname: Bernardi
authors.forename: O
authors.initials: O
authors.lastname: Santaera
authors.forename: E
authors.initials: E
authors.lastname: Marchand
authors.forename: C
authors.initials: C
authors.lastname: Pardiñas
authors.forename: C
authors.initials: C
authors.lastname: Mauvecin
authors.forename: D
authors.initials: D
authors.lastname: Vogel
authors.forename: L C
authors.initials: LC
authors.lastname: Harrell
authors.forename: I F
authors.initials: IF
authors.lastname: Palacios
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000191:economics / Q000592:standards; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000191:economics / Q000628:therapy*; D003365:Costs and Cost Analysis; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012189:Retrospective Studies; D015607:Stents / Q000191:economics / Q000592:standards; D016896:Treatment Outcome