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

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 fondaparinux-treated 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 thromboembolic complications in the rehabilitation center: diagnostic and risk factor stratification tools.

Patients who present "at risk" to physical medicine and rehabilitation centers for venous thromboembolic disease are often challenging if a management strategy is not preestablished. There are many recommendations in the medical literature, with guidelines on prophylaxis techniques and methods that can be used in the physical medicine and rehabilitation patient population. It is important that management strategies be used that further promote the quality of medical care while providing an economic justification. In our institution, we regularly follow a process for stratifying the risk of developing deep venous thrombosis complications in the acute care setting and then continuing appropriate prophylaxis management into the rehabilitation facility. The purpose of this report is to present one method of stratifying patient risk for thromboembolic complications and maintaining appropriate thromboembolic prophylaxis during the risk period. In addition, this report aims to provide practical management recommendations for the PM&R provider.

Deep vein thrombosis and pulmonary embolism in the perioperative patient.

Approximately 500,000 cases of deep vein thrombosis (DVT) and pulmonary embolism (PE) occur in the United States each year. Of those patients who suffer a massive PE, 70% die within the first hour of symptom onset. Thus, early and aggressive intervention is essential. Clinical evaluation of patients is key in assessing clot risk and is aided by a variety of screening devices, with venography as the gold standard. Patients who undergo hip and knee arthroplasty are at highest risk for DVT and PE. However, appropriate prophylaxis can reduce the incidence significantly. Although standard low-dose heparin is considered to be ineffective, positive experience with the administration of the low-molecular weight heparin (LMWH) enoxaparin, because of the speed of its efficacy in postoperative patients at high risk for DVT, has been reported. The dosage of enoxaparin is weight-adjusted and is sometimes combined with warfarin. Tools for risk-factor assessment and suggested prophylactic regimens for patients undergoing total hip and knee replacement are presented.