Efficacy and safety of short-term (3 days) enoxaparin in preventing venous thromboembolism after gastric cancer surgery: A single-center, prospective cohort study
- PMID: 33892160
- DOI: 10.1016/j.ijsu.2021.105946
Efficacy and safety of short-term (3 days) enoxaparin in preventing venous thromboembolism after gastric cancer surgery: A single-center, prospective cohort study
Abstract
Background: Pharmacologic prophylaxis such as enoxaparin for venous thromboembolism (VTE) is rarely used in Japan, even following abdominal cancer surgery, for which it is recommended in relevant guidelines (at least 7 days of use) along with mechanical prophylaxis with intermittent pneumatic compression. Reasons for enoxaparin's unpopularity include concerns over postoperative bleeding and its inconvenience in clinical practice. Here, we conducted a prospective clinical study of short-term (3 days) use of enoxaparin, which is considered to minimally impact postoperative management without increasing bleeding risk.
Methods: Gastric cancer patients who underwent gastrectomy received enoxaparin for 3 days from postoperative day (POD) 1-4. The primary endpoint was the incidence of deep vein thrombosis (DVT), which was examined primarily via Doppler ultrasonography of the lower limbs between POD 8 and 14. The planned sample size was 70, which was calculated based on an estimated incidence rate of 9% and an upper limit of incidence rate of 20%, with alpha of 0.05 and beta of 0.2.
Results: A total of 70 gastric cancer patients were enrolled, and ultimately, 68 patients received the protocol intervention and DVT evaluation. Sixty-seven patients completed 6 enoxaparin injections, but 1 patient did not complete the course due to abdominal bleeding after initiation. The incidence of DVT was 4.4% (3/68), and the 95% upper confidence interval was 12.2%, lower than the 20% threshold we set as the upper limit of DVT incidence. DVT was detected only in the peripheral veins of the lower extremities in all 3 affected patients. The incidence of bleeding-related complications, which were not severe, was 1.5% (1/68).
Conclusions: Short-term (3 days) use of enoxaparin was shown to be effective and safe for VTE prophylaxis, comparable to regular use (at least 7 days), in postoperative management of gastric cancer surgery.
Keywords: Enoxaparin; Gastric cancer surgery; Prevention; Short-term use; Venous thromboembolism.
Copyright © 2021 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.
Comment in
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Commentary on: Efficacy and safety of short-term (3 days) enoxaparin in preventing venous thromboembolism after gastric cancer surgery: A single-center, prospective cohort study [Int J Surg 021 Epub ahead of Print].Int J Surg. 2021 Aug;92:106026. doi: 10.1016/j.ijsu.2021.106026. Epub 2021 Jul 16. Int J Surg. 2021. PMID: 34280562 No abstract available.
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A commentary on "Efficacy and safety of short-term (3 days) enoxaparin in preventing venous thromboembolism after gastric cancer surgery: A single-center, prospective cohort study" (Int J Surg 2021; 89:105946).Int J Surg. 2021 Nov;95:106032. doi: 10.1016/j.ijsu.2021.106032. Epub 2021 Jul 24. Int J Surg. 2021. PMID: 34311127 No abstract available.
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A commentary on "Efficacy and safety of short-term (3 days) enoxaparin in preventing venous thromboembolism after gastric cancer surgery: A single-center, prospective cohort study" (Int J Surg 2021; 89:105946).Int J Surg. 2021 Nov;95:106122. doi: 10.1016/j.ijsu.2021.106122. Epub 2021 Sep 21. Int J Surg. 2021. PMID: 34555508 No abstract available.
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