Bemiparin versus unfractionated heparin as bridging therapy in the perioperative management of patients on vitamin K antagonists: the BERTA study.

Abstract

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.

• Authors: Amparo Santamaría, Arantxa Ugarriza, Carmen Muñoz, Isabel De Diego, Francisca López-Chulia, Carmen Benet, Javier Martínez-González, Natividad Gómez, Elena Pina, Xavier Ortín, Pascual Marco, Franciso Javier Roncalés, Jordi Fontcuberta
• Journal: Clinical drug investigation (Clin Drug Investig) Vol. 33 Issue 12 Pg. 921-8 (Dec 2013) ISSN: 1179-1918 [Electronic] New Zealand
• PMID: 24127170 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anticoagulants
• Heparin, Low-Molecular-Weight
• Vitamin K
• Heparin
• bemiparin

Topics

• Aged
• Aged, 80 and over
• Anticoagulants (therapeutic use)
• Female
• Heparin (therapeutic use)
• Heparin, Low-Molecular-Weight (therapeutic use)
• Humans
• Male
• Perioperative Care
• Treatment Outcome
• Vitamin K (antagonists & inhibitors)