title: Acute stent thrombosis after primary percutaneous coronary intervention: insights from the EUROMAX trial (European Ambulance Acute Coronary Syndrome Angiography).
abstract: OBJECTIVE
  This study sought to determine clinical, procedural, and treatment factors associated with acute stent thrombosis (AST) in the EUROMAX (European Ambulance Acute Coronary Syndrome Angiography) trial.
  
  
  BACKGROUND
  Bivalirudin started during transport for primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction significantly reduced major bleeding compared with heparin with or without glycoprotein IIb/IIIa inhibitors (GPI), but it was associated with an increase in AST.
  
  
  METHODS
  We compared patients with (n = 12) or without AST (n = 2,184) regarding baseline, clinical, and procedural characteristics and antithrombotic treatment strategies (choice of P2Y12 inhibitor, post-primary PCI bivalirudin infusion dose [0.25 mg/kg/h, or BIV-LOW] vs. [1.75 mg/kg/h, or BIV-PCI] vs. heparin ± GPI). Logistic regression was performed to identify independent correlates of AST.
  
  
  RESULTS
  The overall AST rate was 0.6% and was higher with bivalirudin than with heparin ± GPI (1.1% vs. 0.2%; p = 0.007). Median time to AST was 2.3 h (interquartile range: 1.9 to 2.8 h). Patients with AST had less hypertension (2 of 14 [14.0%] vs. 961 of 2,182 [44.0%]; p = 0.03), and more frequently received GPI (11 of 14 [78.6%] vs. 880 of 2,183 [40.3%]; p = 0.004). Multivariate analysis using Firth penalized maximum likelihood estimation found hypertension (odds ratio [OR]: 0.24, 95% confidence interval [CI]: 0.07 to 0.92; p = 0.037) and BIV-LOW (OR: 5.8, 95% CI: 1.5 to 22.2; p = 0.010) predictive of AST. Choice of P2Y12 inhibitor had no impact on AST. Compared with heparin ± GPI, AST rates were higher for BIV-LOW (11 of 670 [1.6%] vs. 2 of 947 [0.2%]; p = 0.008), but not different for BIV-PCI (1 of 244 [0.4%]; p = 0.588).
  
  
  CONCLUSIONS
  In this post-hoc analysis from EUROMAX, AST occurred very early and was not mitigated by the novel P2Y12 inhibitors. Prolonging the bivalirudin infusion at the PCI dose (but not at a lower dose) appeared to mitigate the risk of AST.
authors.affiliation: Department of Medicine, Division of Cardiology, Nykoebing F Hospital Nykoebing, Denmark. Electronic address: pc@docclemme.dk.
authors.forename: Peter
authors.initials: P
authors.lastname: Clemmensen
authors.affiliation: Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Wiberg
authors.affiliation: Department of Cardiology, Isala Klinieken, Zwolle, the Netherlands.
authors.forename: Arnoud
authors.initials: A
authors.lastname: Van't Hof
authors.affiliation: The Medicines Company, Parsippany, New Jersey.
authors.forename: Efthymios N
authors.initials: EN
authors.lastname: Deliargyris
authors.affiliation: Hôpital Cardiologique-Centre Hospitalier Universitaire Bordeaux, Université de Bordeaux, Pessac, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Coste
authors.affiliation: St. Antonius Hospital, Nieuwegein, the Netherlands.
authors.forename: Jurrien
authors.initials: J
authors.lastname: Ten Berg
authors.affiliation: Ospedale Santa Maria della Misericordia di Perugia, Perugia, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Cavallini
authors.affiliation: Clinical Research Department, University of Caen, Caen, France.
authors.forename: Martial
authors.initials: M
authors.lastname: Hamon
authors.affiliation: Department of Cardiology and Cardio Vascular Interventions, University Hospital, Jagiellonian University, Krakow, Poland.
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.affiliation: Klinikum Ludwigshafen, Ludwigshafen, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Zeymer
authors.affiliation: Hôpital de Bourges, Bourges, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Tabone
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Steen D
authors.initials: SD
authors.lastname: Kristensen
authors.affiliation: The Medicines Company, Parsippany, New Jersey.
authors.forename: Debra
authors.initials: D
authors.lastname: Bernstein
authors.affiliation: The Medicines Company, Parsippany, New Jersey.
authors.forename: Prodromos
authors.initials: P
authors.lastname: Anthopoulos
authors.affiliation: The Medicines Company, Parsippany, New Jersey.
authors.forename: Jayne
authors.initials: J
authors.lastname: Prats
authors.affiliation: Université Paris-Diderot, Sorbonne Paris-Cité, Paris, France; Cardiology, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France; Institut National de la Santé et de la Recherche Médicale U1148, Paris, France; National Heart and Lung Institute, Imperial College, Imperial College School of Medicine, Royal Brompton Hospital, London, United Kingdom.
authors.forename: Philippe Gabriel
authors.initials: PG
authors.lastname: Steg
mesh_terms: D000368:Aged; D000552:Ambulances; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D017023:Coronary Angiography; D003328:Coronary Thrombosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000517:prevention & control*; D004334:Drug Administration Schedule; D005060:Europe; D005260:Female; D006493:Heparin / Q000008:administration & dosage; D006629:Hirudins / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000628:therapy*; D016017:Odds Ratio; D010446:Peptide Fragments / Q000008:administration & dosage* / Q000009:adverse effects; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects* / Q000295:instrumentation*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D011237:Predictive Value of Tests; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin
keywords: ST-segment elevation myocardial infarction; bivalirudin; percutaneous coronary intervention; stent thrombosis