title: Frequency and prognostic significance of access site and non-access site bleeding and impact of choice of antithrombin therapy in patients undergoing primary percutaneous coronary intervention. The EUROMAX trial.
abstract: BACKGROUND
  The overall impact of post percutaneous coronary intervention (PCI) bleeding on long term prognosis after acute coronary syndromes (ACS) has been established, but it may differ between access and non-access related bleeding events. The impact of antithrombin choice on bleeding may also differ according to the origin of the bleed. We sought to determine the origin of bleeding relative to the access site, its prognostic significance and the respective impact of antithrombin therapy in the EUROMAX trial.
  
  
  METHODS
  We performed a blinded review of the case records of all TIMI major or minor bleeds in the EUROMAX trial and assigned them in one of 2 categories: access site bleeds (ASB), or rest of bleeds (ROB). Incidence of bleeding for each category was assessed according to randomization to antithrombotic treatment.
  
  
  RESULTS
  A total of 231 out of 2198 patients suffered a TIMI major/minor bleed (10.5%) and ASB accounted for 48.5%, while ROB for 51.5% of the bleeds. Thirty day mortality was 2.5% (50/1967) for patients without a bleed, 2.7% (3/112, p=0.76 vs. no bleed) for patients with ASB, and 10.9% (13/119, p<0.0001 vs. no bleed) for ROB patients. The use of bivalirudin reduced both ASB and ROB with relative risk reductions of 34% and 46% respectively.
  
  
  CONCLUSIONS
  In contemporary primary PCI, bleeding originates with equal frequency either at or away from the access site. Access site bleeds were not associated with an excess in 30day mortality, but the rest of the bleeds were. Bivalirudin is associated with a lower risk of bleeding irrespective of origin.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier NCT01087723.
authors.affiliation: Isala, Department of Cardiology, Zwolle, The Netherlands.
authors.forename: Sinem
authors.initials: S
authors.lastname: Kilic
authors.affiliation: Isala, Department of Cardiology, Zwolle, The Netherlands. Electronic address: v.r.c.derks@isala.nl.
authors.forename: Arnoud W J
authors.initials: AW
authors.lastname: Van't Hof
authors.affiliation: St. Antonius Hospital, Department of Cardiology, Nieuwegein, The Netherlands.
authors.forename: Jurrien
authors.initials: J
authors.lastname: Ten Berg
authors.affiliation: Cardiology Department, Hospital General Universitario Gregorio Marañon, Madrid, Spain.
authors.forename: Ana Ayesta
authors.initials: AA
authors.lastname: Lopez
authors.affiliation: Klinikum Ludwigshafen, Ludwigshafen, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Zeymer
authors.affiliation: Clinical Research Department, University of Caen, Caen, France.
authors.forename: Martial
authors.initials: M
authors.lastname: Hamon
authors.affiliation: Services d'Aide Médicale Urgente, Service Mobile d'Urgence et de Réanimation Urgences, Centre Hospitalier, Chateauroux, France.
authors.forename: Louis
authors.initials: L
authors.lastname: Soulat
authors.affiliation: The Medicines Company, Parsippany, NJ, United States.
authors.forename: Debra
authors.initials: D
authors.lastname: Bernstein
authors.affiliation: The Medicines Company, Parsippany, NJ, United States.
authors.forename: Efthymios N
authors.initials: EN
authors.lastname: Deliargyris
authors.affiliation: Université Paris-Diderot, Sorbonne Paris Cité, INSERM Unité-1148, Département Hospitalo-Universitaire Fibrosis Inflammation Remodeling, and Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France; NHLI, Royal Brompton Hospital, Imperial College, London, UK.
authors.forename: Phillippe Gabriel
authors.initials: PG
authors.lastname: Steg
mesh_terms: D000368:Aged; D000991:Antithrombins / Q000009:adverse effects*; D000066491:Clinical Decision-Making; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D006470:Hemorrhage / Q000139:chemically induced / Q000175:diagnosis* / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects*; D011379:Prognosis; D017534:Radial Artery / Q000601:surgery*; D016037:Single-Blind Method
chemical_list: D000991:Antithrombins
keywords: Access site; Bivalirudin; Bleeding; Percutaneous coronary intervention; Thrombolysis in myocardial infarction (TIMI)