PMID- 24127170
OWN - NLM
STAT- MEDLINE
DCOM- 20140623
LR  - 20211021
IS  - 1179-1918 (Electronic)
IS  - 1173-2563 (Linking)
VI  - 33
IP  - 12
DP  - 2013 Dec
TI  - Bemiparin versus unfractionated heparin as bridging therapy in the perioperative 
      management of patients on vitamin K antagonists: the BERTA study.
PG  - 921-8
LID - 10.1007/s40261-013-0141-6 [doi]
AB  - BACKGROUND AND 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. CONCLUSION: 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.
FAU - Santamaria, Amparo
AU  - Santamaria A
AD  - Hospital de la Santa Creu i Sant Pau Barcelona, Barcelona, Spain, 
      msantamaria@santpau.cat.
FAU - Ugarriza, Arantxa
AU  - Ugarriza A
FAU - Munoz, Carmen
AU  - Munoz C
FAU - De Diego, Isabel
AU  - De Diego I
FAU - Lopez-Chulia, Francisca
AU  - Lopez-Chulia F
FAU - Benet, Carmen
AU  - Benet C
FAU - Martinez-Gonzalez, Javier
AU  - Martinez-Gonzalez J
FAU - Gomez, Natividad
AU  - Gomez N
FAU - Pina, Elena
AU  - Pina E
FAU - Ortin, Xavier
AU  - Ortin X
FAU - Marco, Pascual
AU  - Marco P
FAU - Roncales, Franciso Javier
AU  - Roncales FJ
FAU - Fontcuberta, Jordi
AU  - Fontcuberta J
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
RN  - 0 (Anticoagulants)
RN  - 0 (Heparin, Low-Molecular-Weight)
RN  - 12001-79-5 (Vitamin K)
RN  - 9005-49-6 (Heparin)
RN  - PUE0TO3XDR (bemiparin)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Anticoagulants/*therapeutic use
MH  - Female
MH  - Heparin/*therapeutic use
MH  - Heparin, Low-Molecular-Weight/*therapeutic use
MH  - Humans
MH  - Male
MH  - Perioperative Care
MH  - Treatment Outcome
MH  - Vitamin K/*antagonists & inhibitors
EDAT- 2013/10/16 06:00
MHDA- 2014/06/24 06:00
CRDT- 2013/10/16 06:00
PHST- 2013/10/16 06:00 [entrez]
PHST- 2013/10/16 06:00 [pubmed]
PHST- 2014/06/24 06:00 [medline]
AID - 10.1007/s40261-013-0141-6 [doi]
PST - ppublish
SO  - Clin Drug Investig. 2013 Dec;33(12):921-8. doi: 10.1007/s40261-013-0141-6.