Bridging therapy in patients on long-term oral anticoagulants who require surgery: the Prospective Peri-operative Enoxaparin Cohort Trial (PROSPECT).
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.
Dunn
A S
AS
Mount Sinai School of Medicine, New York, NY, USA. andrew.dunn@mountsinai.org
Spyropoulos
A C
AC
Turpie
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AG
D000284:Administration, Oral; D000368:Aged; D000553:Ambulatory Care; D000925:Anticoagulants / Q000008:administration & dosage*; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy / Q000601:surgery; D016063:Blood Loss, Surgical; D015331:Cohort Studies; D017984:Enoxaparin / Q000008:administration & dosage* / Q000633:toxicity; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009656:North America; D019990:Perioperative Care / Q000379:methods*; D013997:Time Factors; D020246:Venous Thrombosis / Q000150:complications / Q000188:drug therapy / Q000601:surgery
D000925:Anticoagulants; D017984:Enoxaparin