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.