title: Outcomes of unselected recipients of sirolimus-eluting stents: the Cypher stent U.S. post-marketing surveillance registry.
abstract: OBJECTIVE
  To examine the 1-year safety and clinical outcomes associated with the post-marketing early unselected use of sirolimus-eluting stents (SES) in the United States.
  
  
  BACKGROUND
  The safety and effectiveness of SES has been assessed in selected patients enrolled in pivotal randomized trials. This PMS registry was initiated to examine the safety and effectiveness of SES in an unselected population.
  
  
  METHODS
  Consecutive patients who underwent implantation of > or = 1 SES at 38 participating U.S. centers were enrolled in this registry. Results were compared according to "off-" versus "on-label" use of SES. Multivariate regression analyses were carried out in search of predictors of 1- year MACE and stent thrombosis.
  
  
  RESULTS
  The mean age of the 2,067 patients (3,367 treated lesions) was 63.7 years. The 12-month follow up was completed by 1,964 patients (95%). SES were implanted for "offlabel" indications in 1,173 patients (57%). The 12-month rates of MACE and TLR in that subgroup were 9.2% and 6.2% (p < 0.001 vs. "on-label" indications). Rate of definite/probable stent thrombosis was 1.6% ("off-label") vs. 0.6% ("on-label"), p = 0.026. The rates of MACE, TLR and stent thrombosis in 640 diabetics (31%) were 9.4%, 5.8% and 1.3% (p = 0.021, NS and NS vs. non-diabetics, respectively). Number of lesions, insulin-dependent diabetes and unstable angina were predictors of stent thrombosis.
  
  
  CONCLUSIONS
  The "off-label" use of SES was associated with higher 1-year cumulative rates of MACE than "on-label" indications, although rates were similar to those seen in historical premarketing randomized trials. None of the "off-label" indications were independent predictors of MACE or stent thrombosis.
authors.affiliation: University Hospitals Case Medical Center, Cardiovascular Dept., Cleveland, OH 44106-6031, USA.
authors.forename: Hiram
authors.initials: H
authors.lastname: Bezerra
authors.forename: Emerson
authors.initials: E
authors.lastname: Perin
authors.forename: Peter
authors.initials: P
authors.lastname: Berger
authors.forename: Peter
authors.initials: P
authors.lastname: Block
authors.forename: Stephen
authors.initials: S
authors.lastname: Ramee
authors.forename: Stanley
authors.initials: S
authors.lastname: Katz
authors.forename: Mirle
authors.initials: M
authors.lastname: Kellet
authors.forename: Eric
authors.initials: E
authors.lastname: Dippel
authors.forename: Gary
authors.initials: G
authors.lastname: Schaer
authors.forename: Suzanne
authors.initials: S
authors.lastname: Britto
authors.forename: Sidney
authors.initials: S
authors.lastname: Cohen
authors.forename: Marco
authors.initials: M
authors.lastname: Costa
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000401:mortality; D003922:Diabetes Mellitus, Type 1 / Q000401:mortality; D054855:Drug-Eluting Stents; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality; D056687:Off-Label Use; D011358:Product Surveillance, Postmarketing; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage*; D016896:Treatment Outcome; D014481:United States
chemical_list: D005343:Fibrinolytic Agents; D007166:Immunosuppressive Agents; D020123:Sirolimus