title: Stent thrombosis and bleeding complications after implantation of sirolimus-eluting coronary stents in an unselected worldwide population: a report from the e-SELECT (Multi-Center Post-Market Surveillance) registry.
abstract: OBJECTIVE
  The aim of this study was to ascertain the 1-year incidence of stent thrombosis (ST) and major bleeding (MB) in a large, unselected population treated with sirolimus-eluting stents (SES).
  
  
  BACKGROUND
  Stent thrombosis and MB are major potential complications of drug-eluting stent implantation. Their relative incidence and predisposing factors among large populations treated worldwide are unclear.
  
  
  METHODS
  The SES were implanted in 15,147 patients who were entered in a multinational registry. We analyzed the incidence of: 1) definite and probable ST as defined by the Academic Research Consortium; and 2) MB, with the STEEPLE (Safety and efficacy of Enoxaparin in PCI) definition, together with their relation to dual antiplatelet therapy (DAPT) and to 1-year clinical outcomes.
  
  
  RESULTS
  The mean age of the sample was 62 ± 11 years, 30.4% were diabetic, 10% had a Charlson comorbidity index ≥3, and 44% presented with acute coronary syndrome or myocardial infarction. At 1 year, the reported compliance with DAPT as recommended by the European Society of Cardiology guidelines was 86.3%. Adverse event rates were: ST 1.0%, MB 1.0%, mortality 1.7%, myocardial infarction 1.9%, and target lesion revascularization 2.3%. Multivariate analysis identified 9 correlates of ST and 4 correlates of MB. Advanced age and a high Charlson index were associated with an increased risk of both ST and MB. After ST, the 7-day and 1-year all-cause mortality was 30% and 35%, respectively, versus 1.5% and 10% after MB. Only 2 of 13,749 patients (0.015%) experienced both MB and ST during the entire 1-year follow-up period.
  
  
  CONCLUSIONS
  In this worldwide population treated with ≥1 SES, the reported compliance with DAPT was good, and the incidence of ST and MB was low. Stent thrombosis and MB very rarely occurred in the same patient. (The e-SELECT Registry: a Multicenter Post-Market Surveillance; NCT00438919).
authors: La Tour Hospital, 1 Avenue JD Maillard, Geneva, Switzerland. philip.urban@latour.ch
authors: Philip
authors: P
authors: Urban
authors: Alexandre
authors: A
authors: Abizaid
authors: Adrian
authors: A
authors: Banning
authors: Antonio L
authors: AL
authors: Bartorelli
authors: Ana Cebrian
authors: AC
authors: Baux
authors: Vladimír
authors: V
authors: Džavík
authors: Stephen
authors: S
authors: Ellis
authors: Runlin
authors: R
authors: Gao
authors: David
authors: D
authors: Holmes
authors: Myung Ho
authors: MH
authors: Jeong
authors: Victor
authors: V
authors: Legrand
authors: Franz-Josef
authors: FJ
authors: Neumann
authors: Maria
authors: M
authors: Nyakern
authors: Christian
authors: C
authors: Spaulding
authors: Stephen
authors: S
authors: Worthley
mesh_terms: D054058:Acute Coronary Syndrome / Q000453:epidemiology / Q000601:surgery*; D000367:Age Factors; D015897:Comorbidity; D003328:Coronary Thrombosis / Q000453:epidemiology / Q000209:etiology*; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000453:epidemiology / Q000209:etiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000453:epidemiology; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage
chemical_list: D010975:Platelet Aggregation Inhibitors; D020123:Sirolimus