Benefits and risks of preventing thromboembolism with enoxaparin in patients with general surgery in real world--the CLEVER study

Clin Appl Thromb Hemost. 2013 Jun;19(3):282-8. doi: 10.1177/1076029612461067. Epub 2012 Oct 11.

Abstract

Background: We aimed to document enoxaparin use in real world and identify the risk factors for bleeding complications.

Methods: Postauthorization study in 448 surgical patients receiving enoxaparin prophylaxis. Complete compression ultrasound (CCUS) was performed at day 10 ± 3.

Results: During treatment, 11 of 448 patients had suspected deep venous thrombosis (DVT) but none confirmed. One patient had symptoms of pulmonary embolism ([PE] 0.22%; 95% confidence interval [CI] -0.21-0.66). There were no asymptomatic cases detected upon CCUS. At the 90-day follow-up, 4 (0.9%) of the 440 patients had DVT symptoms (95% CI 0.02-1.80) and none had PE; 5.4% had major and 11.6% any type of bleeding complications. Major bleeding was more frequent in those with kidney disease (odds ratio [OR] 5.53), those who are bedridden (OR 5.49), those with peridural indwelling catheters (OR 4.01), and those on nonsteroidal anti-inflammatory drugs (OR 3.33).

Conclusions: Enoxaparin is effective and safe in surgical patients to prevent venous thromboembolism.

Keywords: complete compression ultrasound; enoxaparin; major bleeding; predictors; surgery; venous thromboembolism.

MeSH terms

  • Adult
  • Aged
  • Anticoagulants / therapeutic use*
  • Enoxaparin / adverse effects
  • Enoxaparin / therapeutic use*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Venous Thromboembolism / epidemiology
  • Venous Thromboembolism / prevention & control*
  • Venous Thrombosis / prevention & control

Substances

  • Anticoagulants
  • Enoxaparin