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Bridging therapy in patients on long‐term oral anticoagulants who require surgery: the Prospective Peri‐operative Enoxaparin Cohort Trial (PROSPECT)
Author(s) -
DUNN A. S.,
SPYROPOULOS A. C.,
TURPIE A. G. G.
Publication year - 2007
Publication title -
journal of thrombosis and haemostasis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.947
H-Index - 178
eISSN - 1538-7836
pISSN - 1538-7933
DOI - 10.1111/j.1538-7836.2007.02729.x
Subject(s) - medicine , atrial fibrillation , surgery , warfarin , prospective cohort study , thrombosis , incidence (geometry) , rivaroxaban , major bleeding , deep vein , perioperative , cohort , anticoagulant , dabigatran , anesthesia , physics , optics
Summary. Background: The peri‐operative management of patients on oral anticoagulants (OACs) is a common clinical problem. Our aim was to determine the incidence of major bleeding during peri‐operative administration of treatment‐dose enoxaparin and the impact of the extensiveness of the procedure on the risk of bleeding. Methods: We performed a prospective cohort study of 260 patients at 24 North American sites on OACs for atrial fibrillation or a history of deep vein thrombosis (DVT) requiring invasive or surgical procedures whose treating physician felt that bridging therapy was required. Warfarin was withheld, and once‐daily s.c. enoxaparin (1.5 mg kg −1 ) was given peri‐operatively. Patients were followed for 28 days after OAC was therapeutic. Results: Major bleeding was observed in nine of 260 patients (3.5%, 95% CI: 1.6–6.5). The bleeding risk varied markedly by extensiveness of procedure: the incidence of major bleeding for invasive procedures, minor surgery and major surgery was 0.7% (95% CI: 0.02–3.7), 0% (95% CI: 0–5.0), and 20.0% (95% CI: 9.1–35.7), respectively. There were five thromboembolic events in total (1.9%, 95% CI: 0.6–4.4). There were four arterial events (2.3%, 95% CI: 0.6–5.7) in 176 patients with atrial fibrillation, and one venous event (1.0%, 95% CI: 0.03–5.7) in 96 patients with prior DVT. Conclusions: Bridging therapy with once‐daily therapeutic‐dose enoxaparin administered primarily in an outpatient setting has a low incidence of major bleeding for patients undergoing invasive procedures and minor surgery. Further studies are needed to optimize the bridging strategy for patients undergoing major surgery.