title: Bailout and corrective use of Gianturco-Roubin flex stents after percutaneous transluminal coronary angioplasty: operator reports and angiographic core laboratory verification from the National Heart, Lung, and Blood Institute/New Approaches to Coronary Intervention Registry.
abstract: OBJECTIVE
  We sought to determine the in-hospital clinical outcome and angiographic results of patients prospectively entered into the National Heart, Lung, and Blood Institute/New Approaches to Coronary Intervention (NHLBI/NACI) Registry who received Gianturco-Roubin stents as an unplanned new device.
  
  
  BACKGROUND
  Between August 1990 and March 1994, nine centers implanted Gianturco-Roubin flex stents as an unplanned new device in the initial treatment of 350 patients (389 lesions) who were prospectively enrolled in the NHLBI/NACI Registry.
  
  
  METHODS
  Patients undergoing implantation of the Gianturco-Roubin flex stent were prospectively entered into the Gianturco-Roubin stent portion of the NHLBI/NACI Registry. Only subjects receiving the Gianturco-Roubin stent as a new device in an unplanned fashion are included.
  
  
  RESULTS
  The mean age of the patient group was 61.8 years, and the majority of the patients were men. A history of percutaneous transluminal coronary angioplasty (PTCA) was present in 35.4% of the group, and 16.9% had previous coronary artery bypass graft surgery. Unstable angina was present in 67.7%. Double- or triple-vessel coronary artery disease was present in 55.4%, and the average ejection fraction was 58%. The presence of thrombus was noted in 7.3%, and 7.2% had moderate to severe tortuosity of the lesion. The angiographic success rate was 92%. Individual clinical sites reported that 66.3% of the stents were placed after suboptimal PTCA, 20.3% for abrupt closure and 13.4% for some other technical PTCA failure. Major in-hospital events occurred in 9.7% of patients, including death in 1.7%, Q wave myocardial infarction in 3.1% and emergency bypass surgery in 6%. Abrupt closure of a stented segment occurred in 3.1% of patients at a mean of 3.9 days. Cerebrovascular accident occurred in 0.3%, and transfusion was required in 10.6%. Vascular events with surgical repair occurred in 8.6% of patients.
  
  
  CONCLUSIONS
  Despite these complications, the use of this device for the treatment of a failed or suboptimal PTCA result remains promising given the adverse outcome of abrupt closure with conventional (nonstent) treatment.
authors.affiliation: Department of Medicine, University of Alabama at Birmingham, 35294-0012, USA. ldean@uab.edu
authors.forename: L S
authors.initials: LS
authors.lastname: Dean
authors.forename: C J
authors.initials: CJ
authors.lastname: George
authors.forename: G S
authors.initials: GS
authors.lastname: Roubin
authors.forename: E D
authors.initials: ED
authors.lastname: Kennard
authors.forename: D R
authors.initials: DR
authors.lastname: Holmes
authors.forename: S B
authors.initials: SB
authors.lastname: King
authors.forename: R E
authors.initials: RE
authors.lastname: Vlietstra
authors.forename: J W
authors.initials: JW
authors.lastname: Moses
authors.forename: D
authors.initials: D
authors.lastname: Kereiakes
authors.forename: J P
authors.initials: JP
authors.lastname: Carrozza
authors.forename: S G
authors.initials: SG
authors.lastname: Ellis
authors.forename: J R
authors.initials: JR
authors.lastname: Margolis
authors.forename: K M
authors.initials: KM
authors.lastname: Detre
mesh_terms: D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D003327:Coronary Disease / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009316:National Institutes of Health (U.S.); D012042:Registries; D015607:Stents; D016896:Treatment Outcome; D014481:United States