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

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.