title: Drug eluting stent implantation in patients requiring concomitant vitamin K antagonist therapy. One-year outcome of the worldwide e-SELECT registry.
abstract: BACKGROUND
  Outcome of sirolimus-eluting stent (SES) in patients treated with an antivitamin K (VKA) agent before the PCI procedure is unknown.
  
  
  METHODS
  A total of 7651 patients were selected among 15,147 recipients of SES, included in the worldwide e-SELECT registry, only from those centers which included at least one patient requiring VKA: 296 were pretreated with a VKA agent (VKA group), whereas 7355 patients from the same enrolling medical centers were not (NON-VKA group). The rates of 1) major adverse cardiac events (MACE), including all-cause deaths, myocardial infarction (MI) and target lesion revascularization, 2) stent thrombosis (ST) and 3) major bleeding (MB) in the 2 study groups were compared at 1, 6 and 12 months.
  
  
  RESULTS
  The patients in VKA group were on average older as compared to those in NON-VKA group (67.7 ± 9.9 vs.62.9 ± 10.7, P<0.001). The indications for pre-procedural anticoagulation were atrial fibrillation in 177 (59.8%), presence of a prosthetic valve in 21 (7.1%), embolization of cardiac origin in 17 (5.7%), pulmonary embolism or deep vein thrombosis in 17 (5.7%), and miscellaneous diagnoses in 64 (21.6%) patients. At 1 year, the rates of MACE and MB were higher in the VKA vs. the NON-VKA group (8.3% and 3% vs. 5.3% and 1.2%, P<0.04 and P<0.002, respectively). The 1-year rates of definite and probable ST were remarkably low in both groups (0.38% vs. 1.1%, p=0.4).
  
  
  CONCLUSIONS
  Selected patients anticoagulated with VKA agent may safely undergo SES implantation. Those patients may receive a variety of APT regimen at the cost of a moderate increased risk of MB.
authors.affiliation: Hospital Clinic, Barcelona, Spain. Electronic address: masabate@clinic.ub.es.
authors.forename: Manel
authors.initials: M
authors.lastname: Sabaté
authors.forename: Salvatore
authors.initials: S
authors.lastname: Brugaletta
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.forename: Adrian
authors.initials: A
authors.lastname: Banning
authors.forename: Antonio
authors.initials: A
authors.lastname: Bartorelli
authors.forename: Vladimír
authors.initials: V
authors.lastname: Džavík
authors.forename: Stephen
authors.initials: S
authors.lastname: Ellis
authors.forename: David
authors.initials: D
authors.lastname: Holmes
authors.forename: Runlin
authors.initials: R
authors.lastname: Gao
authors.forename: Myung Ho
authors.initials: MH
authors.lastname: Jeong
authors.forename: Victor
authors.initials: V
authors.lastname: Legrand
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.forename: Maria
authors.initials: M
authors.lastname: Nyakern
authors.forename: Christian
authors.initials: C
authors.lastname: Spaulding
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Stoll
authors.forename: Stephen
authors.initials: S
authors.lastname: Worthley
authors.forename: Philip
authors.initials: P
authors.lastname: Urban
mesh_terms: D000368:Aged; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D019919:Prosthesis Implantation; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage*; D013927:Thrombosis / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D014812:Vitamin K / Q000037:antagonists & inhibitors*
chemical_list: D010975:Platelet Aggregation Inhibitors; D014812:Vitamin K; D020123:Sirolimus
keywords: Anticoagulation; Antivitamin K therapy; Coronary stent; Drug-eluting stent; Hemorrhagic event; Sirolimus-eluting stent; Stent thrombosis