The Prospective Peri-operative Enoxaparin Cohort Trial (PROSPECT)

Reference: Dunn AS, Spyropoulos AC, Turpie AG. Bridging therapy in patients on long-term oral anticoagulants who require surgery: the Prospective Peri-operative Enoxaparin Cohort Trial (PROSPECT). Journal of Thrombosis and Haemostasis. 2007 Nov;5(11):2211-2218.

Summary: Due to limited data on the incidence of peri-operative thromboemobolic and bleeding during bridge therapy, there is no agreement on optimal peri-operative management of patients on oral anticoagulants (OACs). Dunn et al sought to “examine the incidence of major bleeding of a peri-operative strategy using once-daily therapeutic-dose enoxaparin administered primarily at home, and the effect, if any, of the extensiveness of the procedure on the risk of bleeding during bridge therapy” (p.2211-2212).

The study involved 24 sites in North America between January 2002 and August 2003. The figure below shows the study’s peri-operative management protocol (p.2212): periop mgmt2

 

Safety outcomes:

  • Incidence of major bleeding while on enoxaparin or in the 24 hours following cessation of enoxaparin treatment
    • Occurred in 3.5% (95% CI: 1.6-6.5)
    • Invasive procedures: 1.4%
    • Minor surgery: 0%
    • Major surgery:  27.5%
  • Rate of minor bleeding while on enoxaparin, or within 24 hours of discontinuation
    • Occurred in 108 patients (41.5%, 95% CI:35.7-47.6)
    • Invasive procedures: 44.6%
    • Minor surgery: 47.2%
    • Major surgery: 20.0%

Efficacy outcomes:

  • Incidence of arterial thromboembolic events for patients with afib
    • 4 events out of 176 patients (2.3%, 95% CI: 0.6-5.7)
    • 2 TIAs, 0 strokes, 2 patients had peripheral arterial thromboembolic events
  • Incidence of venous thromboembolic events for patients with a history of DVT.
    • 1 event out of 96 patients (1.0%, 95% CI: 0.03-5.7)
    • None fatal

Bleeding risk is high when bridging therapy is done peri-operatively in major surgery. In this study, there were 8 instances of major bleeding among 40 total patients in major surgery. Out of 220 invasive procedures or minor surgery, there was only 1 major bleeding event.

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