title: Long-term angiographic and clinical outcome after implantation of a balloon-expandable stent in the native coronary circulation. Palmaz-Schatz Stent Study Group.
abstract: OBJECTIVE
  The purpose of this study was to examine the long-term clinical and angiographic outcome after coronary stent implantation.
  
  
  BACKGROUND
  Previous reports have shown a discordance between the excellent initial angiographic results and subsequent adverse clinical events after coronary artery stenting.
  
  
  METHODS
  Single Palmaz-Schatz stents were electively implanted in the native coronary arteries of 300 consecutive patients. Angiograms were obtained at baseline, after balloon angioplasty, after stent implantation and at 6 months after implantation. Films were analyzed by a panel of angiographers utilizing an automated edge detection program. Clinical events, including death, myocardial infarction, coronary bypass surgery and repeat angioplasty, were recorded for 1 year.
  
  
  RESULTS
  Although there were no acute in laboratory vessel closures, stent thrombosis occurred in 14 patients (4.7%) at a mean +/- SD of 5 +/- 3 days after implantation. Two hundred fifty-eight (90%) of 286 eligible patients had follow-up angiography at 6.1 +/- 2.2 months after stent implantation. Minimal lumen diameter increased from 0.80 +/- 0.39 mm at baseline to 1.65 +/- 0.51 mm after angioplasty and further increased to 2.55 +/- 0.49 mm after stent placement (p = 0.0001). At follow-up there was a 0.85-mm late loss in lumen diameter, with a final minimal lumen diameter at 6 months of 1.70 +/- 0.71 mm. Restenosis, defined as > or = 50% diameter stenosis at follow-up, occurred in 14% of patients with previously untreated lesions and in 39% of patients with previous angioplasty (p < 0.001). Clinical events after 1 year for the entire group of 300 patients included death in 0.7%, myocardial infarction in 3.7%, bypass grafting in 8% and repeat angioplasty in 13%. Freedom from any adverse clinical event was 80% for all treated patients and 87% for those with previously untreated lesions.
  
  
  CONCLUSIONS
  Elective use of this balloon-expandable stent in the native coronary circulation is associated with a low restenosis rate by quantitative angiography in previously untreated lesions and a favorable clinical outcome with an excellent event-free survival rate at 1 year.
authors.affiliation: Department of Medicine, Jefferson Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania 19107.
authors.forename: M P
authors.initials: MP
authors.lastname: Savage
authors.forename: D L
authors.initials: DL
authors.lastname: Fischman
authors.forename: R A
authors.initials: RA
authors.lastname: Schatz
authors.forename: P S
authors.initials: PS
authors.lastname: Teirstein
authors.forename: M B
authors.initials: MB
authors.lastname: Leon
authors.forename: D
authors.initials: D
authors.lastname: Baim
authors.forename: S G
authors.initials: SG
authors.lastname: Ellis
authors.forename: E J
authors.initials: EJ
authors.lastname: Topol
authors.forename: J W
authors.initials: JW
authors.lastname: Hirshfeld
authors.forename: M W
authors.initials: MW
authors.lastname: Cleman
mesh_terms: D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography / Q000379:methods; D003327:Coronary Disease / Q000000981:diagnostic imaging* / Q000453:epidemiology / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007091:Image Processing, Computer-Assisted; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology; D012008:Recurrence; D013193:Stainless Steel; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D013193:Stainless Steel