Fondaparinux combined with intermittent pneumatic compression vs. intermittent pneumatic compression alone for prevention of venous thromboembolism after abdominal surgery: a randomized, double‐blind comparison

Abstract

Summary. Background: The benefit of combined mechanical and pharmacologic methods for venous thromboembolism prevention after abdominal surgery has not been clearly established. Objectives: To compare the efficacy and safety of fondaparinux in conjunction with intermittent pneumatic compression vs. intermittent pneumatic compression alone in this context. Patients and Methods: This was a randomized, double-blind, placebo-controlled superiority trial. Patients aged at least 40 years undergoing abdominal surgery were randomized to receive either fondaparinux 2.5 mg or placebo s.c. for 5-9 days, starting 6-8 h postoperatively. All patients received intermittent pneumatic compression. The primary efficacy outcome was venous thromboembolism up to day 10. The main safety outcomes were major bleeding and all-cause mortality. Follow-up lasted 32 days. Results: Of the 1309 patients randomized, 842 (64.3%) were evaluable for efficacy. The venous thromboembolism rate was 1.7% (7/424) in the fondaparinux-treated patients and 5.3% (22/418) in the placebo-treated patients (odds ratio reduction 69.8%; 95% confidence interval 27.9-87.3; P = 0.004). Fondaparinux significantly reduced the proximal deep vein thrombosis rate from 1.7% (7/417) to 0.2% (1/424; P = 0.037). Major bleeds occurred in 1.6% (10/635) and 0.2% (1/650) of fondaparinuxtreated and placebo-treated patients, respectively (P = 0.006), none being fatal or involving a critical organ. By day 32, eight patients (1.3%) receiving fondaparinux and five (0.8%) receiving placebo had died. Conclusions: In patients undergoing abdominal surgery and receiving intermittent pneumatic compression, fondaparinux 2.5 mg reduced the venous thromboembolism rate by 69.8% as compared to pneumatic compression alone, with a low bleeding risk as compared to placebo.

Prevention of VTE in Nonorthopedic Surgical Patients

“…13 Two of other abdominal surgery. 19 In this study, the risk of any VTE (including asymptomatic DVT) was 69% lower in the fondaparinux group, and fondaparinux was associated with a possible reduction in the risk of proximal DVT (RR, 0.14; 95% CI, 0.02-1.14), but there was only one case of symptomatic VTE in each of the treatment groups. Major bleeding was more common among those who received fondaparinux (RR, 10.2; 95% CI, 1.31-79.7), but differences between the groups in fatal bleeding and bleeding requiring reoperation were neither confi rmed nor excluded.…”

Major Bleeding, Mortality, and Efficacy of Fondaparinux in Venous Thromboembolism Prevention Trials

“…14 In 4 trials the comparator was enoxaparin (40 mg once daily in 2 trials and 30 mg twice daily in 2 trials), 10 -13 in 1 trial the comparator was dalteparin 5000 IU once daily, 15 and in 3 trials the comparator was placebo. 14,16,17 …”

“…10 -17 Two trials involved patients undergoing hip fracture surgery, 11,14 2 hip replacement surgery, 12,13 1 major knee surgery, 10 2 elective abdominal surgery, 15,17 and 1 acutely ill high-risk medical patients. 16 …”

Safety and Efficacy of Fondaparinux for Prophylaxis of Venous Thromboembolism after Colorectal Cancer Resection: A Propensity Score Matched Analysis

“…Several clinical trials have demonstrated not only its antithrombotic efficacy but also its favorable safety profile, including its prevention of VTE in patients undergoing major orthopedic surgery or high-risk abdominal surgery [3,4]. In the randomized, double-blinded APOLLO study, the combination of intermittent pneumatic compression (IPC) and FPX reduced the incidence of VTE after abdominal surgery by 69.8% relative to IPC alone, with a low bleeding risk compared to placebo [5]. However, there are few studies evaluating the safety and efficacy of FPX after CRC surgery.…”