However, UFH and LMWHs differ in their half-life and acquisition cost. Because of their decreased binding to platelet factor 4, LMWHs have a lower incidence of thrombocytopenia and heparin-induced thrombocytopenia when compared to UFH. LMWHs are known to have better bioavailability after subcutaneous administration, a longer half-life, and a more predictable response and provide flexible outpatient dosing. Drugs and devices that do not have FDA approval at present but are likely to gain approval will be systematically identified and evaluated only if they gain regulatory approval in the United States. We will also evaluate the use of antiplatelet agents, such as aspirin and clopidogrel, as well as the anticoagulant warfarin, which may be used off label for this indication. We will evaluate drugs and devices that currently are available in the United States and either are FDA approved for VTE prophylaxis or are being used off label for this indication. 6-9 Fondaparinux, a synthetic pentasaccharide, is also available as an option for thromboprophylaxis. The pharmacologic agents include unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH e.g., enoxaparin, dalteparin, and tinzaparin) that are delivered subcutaneously. A small proportion of these are approved for primary prophylaxis of VTE, but others may be considered or used off label for this purpose (Table 1). Food and Drug Administration (FDA) for various indications. There are a number of antithrombotic drugs and antithrombotic mechanical devices that are approved by the U.S. 5 Pharmacologic Agents and Medical Devices Used for Thromboprophylaxis 4 Accordingly, the comparative effectiveness and safety of interventions for the prevention and treatment of VTE are among the national priorities for comparative effectiveness research. 3 Thus VTE is an important patient safety issue that results in significant morbidity, mortality, and health care cost.
1,2 The cost of hospitalization for another medical condition has been shown to increase with the diagnosis of DVT (approximately $10,000) or PE ($20,000). 1 Two-thirds of all VTE cases are nonfatal and result in hundreds of thousands of hospitalizations, whereas approximately one-third of these cases are fatal and result in an estimated 300,000 deaths each year. There are significant adverse consequences of DVT and PE. Adverse Consequences of Venous Thromboembolism population, the number of cases of VTE is likely to rise. 1,2 The average annual incidence of DVT in the United States ranges from 48 to 122 per 100,000. Pulmonary embolism (PE) resulting from deep vein thrombosis (DVT), collectively known as venous thromboembolism (VTE), affects an estimated 900,000 Americans each year and results in significant morbidity and mortality. Background Prevalence of Venous Thromboembolism
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