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PREVENTION OF VENOUS THROMBOEMBOLISM WITH POST-OPERATIVE ENOXAPARIN: PRELIMINARY RESULTS OF THE PSEF VENOUS THROMBOEMBOLISM PREVENTION STUDY (VTEPS)
Christine Fisher, MD1, Christopher Pannucci, MD MS2, George Dreszer, MD3, Steven H. Bailey, MD4, Jennifer B. Hamill, MPH5, Edwin G. Wilkins, MD2, Loree K. Kalliainen, MD3, Ronald E. Hoxworth, MD4, Andrea L. Pusic, MD MHS6, J. Peter Rubin, MD1.
1University of Pittsburgh, Pittsburgh, PA, USA, 2University of Michigan, Ann Arbor, MI, USA, 3Regions Hospital, Minneapolis, MN, USA, 4University of Texas Southwestern, Dallas, TX, USA, 5JBH Consulting, Shohola, PA, USA, 6Memorial Sloan-Kettering, New York, NY, USA.
Venous thromboembolism (VTE) is a major patient safety issue. The Venous Thromboembolism Prevention Study (VTEPS) is an ongoing, multisite study designed to analyze whether post-operative enoxaparin prevents symptomatic VTE in adult plastic surgery patients.
We performed an interim analysis of an ongoing, multicenter study. The VTEPS Network includes four tertiary care facilities. VTEPS patient eligibility criteria include age ≥ 18, general anesthesia, and post-operative admission. The previously validated Caprini risk tool was used to quantify VTE risk. Patients with Caprini scores ≥3 received post-operative enoxaparin prophylaxis started 6-8 hours after surgery and continued for the duration of inpatient stay. The VTEPS control patients received an operation between 2006 and 2008 and met eligibility criteria as above. These historic control patients received no heparin products or warfarin for 60 days after surgery. The primary study outcome was symptomatic, imaging-confirmed VTE which occurred within 60 days of surgery.
2637 patients were included in this interim analysis, including 1658 controls and 979 enoxaparin patients (Figure 1). Among high risk patients with Caprini score ≥7, post-operative enoxaparin was associated with over 50% reduction in VTE risk (4.59% vs. 2.02%, p=0.079) and was associated with significant risk reduction (OR 0.36, p=0.039) when controlling for length of stay >48 hours. Stratified analysis (Figure 2) demonstrated notable risk reduction in patients with Caprini >8 (10.29% vs. 4.35%, p=0.142), Caprini 7-8 (2.97% vs. 0.98%, p=0.140), and Caprini 5-6 (1.33% vs. 0.83%, p=0.492) who received post-operative enoxaparin. Overall VTE rate was not significantly different between control and enoxaparin groups (1.45% vs. 1.12%, p=0.483). However, there is a strong trend toward decreased VTE rates in the highest risk patients (Caprini score ≥7) at the time of this interim analysis.
Post-operative enoxaparin prevents symptomatic, post-operative VTE in plastic surgery patients at high risk (Caprini score ≥7) when controlling for length of stay. There is a strong trend toward reduction in VTE events among high risk patients at the time of this interim analysis. VTEPS continues to accrue patients and will be better powered to detect any differences between groups when all cohorts have been analyzed.
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