title: Bemiparin versus unfractionated heparin as bridging therapy in the perioperative management of patients on vitamin K antagonists: the BERTA study.
abstract: OBJECTIVE
  The management of patients on vitamin K antagonist therapy who require an invasive procedure is problematic. A randomised, controlled, double-blind clinical trial was designed to compare the efficacy and safety of bemiparin, a low molecular weight heparin (LMWH), with unfractionated heparin (UFH) as bridging therapy: the BERTA (BEmiparin Randomised Trial on bridging Anticoagulants) study.
  
  
  METHODS
  Two hundred and six patients on long-term oral anticoagulation therapy (OAT) requiring an invasive procedure were randomized to receive bridging therapy with bemiparin + matching placebo or UFH. OAT was resumed on day 1. The study medication was continued for 5-6 days after the procedure. The primary efficacy endpoint was the combined incidence of arterial and venous thromboembolic events. The primary safety endpoint was the incidence of major bleeding within 10 days after the invasive procedure.
  
  
  RESULTS
  There were no thromboembolic events in the bemiparin group, but two events (2.2 %) occurred in the UFH group. No major bleeding occurred in either group, but minor bleeding occurred in four patients (4.3 %) and six patients (6.1 %) in the bemiparin and UHF groups, respectively. No deaths and no cases of severe thrombocytopenia occurred during the whole study period.
  
  
  CONCLUSIONS
  Despite its small size, the BERTA study is the first randomised, double-blind clinical trial comparing UFH with a fixed high-risk thromboprophylactic dose of an LMWH as bridging therapy. There were no thromboembolic events and fewer bleeding episodes in the bemiparin group than in the UFH group, hence we suggest that bemiparin is at least as safe as UFH as bridging therapy.
authors.affiliation: Hospital de la Santa Creu i Sant Pau Barcelona, Barcelona, Spain, msantamaria@santpau.cat.
authors.forename: Amparo
authors.initials: A
authors.lastname: Santamaría
authors.forename: Arantxa
authors.initials: A
authors.lastname: Ugarriza
authors.forename: Carmen
authors.initials: C
authors.lastname: Muñoz
authors.forename: Isabel
authors.initials: I
authors.lastname: De Diego
authors.forename: Francisca
authors.initials: F
authors.lastname: López-Chulia
authors.forename: Carmen
authors.initials: C
authors.lastname: Benet
authors.forename: Javier
authors.initials: J
authors.lastname: Martínez-González
authors.forename: Natividad
authors.initials: N
authors.lastname: Gómez
authors.forename: Elena
authors.initials: E
authors.lastname: Pina
authors.forename: Xavier
authors.initials: X
authors.lastname: Ortín
authors.forename: Pascual
authors.initials: P
authors.lastname: Marco
authors.forename: Franciso Javier
authors.initials: FJ
authors.lastname: Roncalés
authors.forename: Jordi
authors.initials: J
authors.lastname: Fontcuberta
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use*; D005260:Female; D006493:Heparin / Q000627:therapeutic use*; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D019990:Perioperative Care; D016896:Treatment Outcome; D014812:Vitamin K / Q000037:antagonists & inhibitors*
chemical_list: D000925:Anticoagulants; D006495:Heparin, Low-Molecular-Weight; D014812:Vitamin K; D006493:Heparin; C411345:bemiparin