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Uses

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Treatment/Secondary Prevention of Venous Thrombosis and Pulmonary Embolism

Used as follow-up to initial heparin anticoagulation for treatment of proximal DVT or nonmassive acute pulmonary embolism; initiate concomitantly with full-dose IV or adjusted-dose sub-Q unfractionated heparin or a weight-based dosage of sub-Q low molecular weight (LMW) heparin. May consider thrombolytic therapy in those with massive pulmonary embolism with hemodynamic instability or severe ileofemoral thrombosis.

LMW heparin or sub-Q unfractionated heparin used as alternative therapy for secondary prevention of DVT and pulmonary embolism when warfarin is contraindicated or inconvenient.

Secondary prevention of DVT and pulmonary embolism in patients with concurrent cancer; LMW heparin preferred in such patients.

Secondary prevention of venous thromboembolism or pulmonary embolism associated with reversible or time-limited risk factors (e.g., transient immobilization, trauma, surgery, pharmacologic doses of estrogen, central venous catheter).

Secondary prevention of venous thromboembolism associated with thrombophilic conditions (e.g., combined factor V Leiden and prothrombin 20210 gene mutations).

Secondary prevention of venous thromboembolism in children with ongoing risk factors such as active nephrotic syndrome, ongoing asparaginase therapy, or lupus anticoagulant.

Prophylaxis in General Surgery

American College of Chest Physicians (ACCP) prefers other drug therapies (LMW heparin or low-dose unfractionated heparin) or non-drug therapies (intermittent pneumatic compression, elastic stockings) in most moderate- to high-risk general surgery patients†.

Prophylaxis in Hip-Replacement Surgery

Short-term prophylaxis in patients undergoing hip-replacement surgery as one of several therapeutic options (fondaparinux, LMW heparin).

Consider extended prophylaxis (≤28–35 days) in patients undergoing hip-replacement surgery who have ongoing risk factors for venous thromboembolism (e.g., obesity, delayed mobilization, cancer, history of venous thromboembolism).

Prophylaxis in Hip-fracture Surgery

Short-term prophylaxis in patients undergoing hip-fracture surgery†, as one of several therapeutic options (fondaparinux, LMW heparin).

Consider extended prophylaxis (≤28–35 days) in patients undergoing hip-fracture surgery who have ongoing risk factors for venous thromboembolism (e.g., obesity, delayed mobilization, cancer, history of venous thromboembolism).

Prophylaxis in Knee-replacement Surgery

Short-term prophylaxis in patients undergoing knee-replacement surgery† as one of several therapeutic options (LMW heparin, fondaparinux, intermittent pneumatic compression).

Prophylaxis in Trauma

Prevention of thromboembolism in the rehabilitation phase of acute spinal cord injury†, as an alternative to continued therapy with an LMW heparin.

Prevention of thromboembolism in other types of trauma† after initial treatment with an LMW heparin in patients with an ongoing risk of venous thromboembolism requiring extended hospital stays.

Continued prophylaxis with warfarin or an LMW heparin after hospital discharge suggested by ACCP in selected patients with impaired mobility.

Embolism Associated with Atrial Fibrillation/Flutter

Prophylaxis of thromboembolic episodes in patients with persistent or paroxysmal atrial fibrillation who are at high risk for stroke (e.g., history of stroke, TIA, or systemic embolism; poor left ventricular systolic function and/or CHF; hypertension; diabetes mellitus; >75 years of age) or as alternative to aspirin in patients with persistent or paroxysmal atrial fibrillation and no other high-risk factors.

Prevention of thromboembolism in patients with atrial flutter† with or without mitral valve stenosis. Use alone or in combination with aspirin in patients with atrial flutter and prosthetic heart valves.

Patients with “lone” atrial fibrillation should be offered aspirin rather than warfarin because of their relatively low risk of stroke. ACCP, ACC, and AHA state that patients who decline therapy with warfarin or who are extremely poor candidates for oral anticoagulation also should be offered aspirin, except when contraindicated.

Short-term prevention of thromboembolism in patients with atrial fibrillation (>48 hours) who are at high risk for stroke after open-heart surgery.

Thromboprophylaxis during Cardioversion of Atrial Fibrillation/Flutter

Prevention of embolization in patients undergoing pharmacologic or electrical cardioversion of atrial fibrillation/flutter†.

Embolism Associated with Valvular Heart Disease

Prevention of thromboembolism associated with various types of valvular heart disease†, in combination with or as alternative to low-dose aspirin; choice of antithrombotic therapy depends on risks of thromboembolism versus hemorrhagic complications from such therapy.

Many experts recommend long-term oral anticoagulation with warfarin therapy in patients with rheumatic mitral valve disease† and atrial fibrillation or a history of systemic embolism (e.g., stroke). Add low-dose aspirin therapy in patients with atrial fibrillation or history of systemic embolism who have a breakthrough embolic event despite prophylactic anticoagulation; may use another oral platelet-aggregation inhibitor (e.g., dipyridamole, clopidogrel) if aspirin not tolerated.

Consider long-term anticoagulation in patients with rheumatic mitral valve disease† and normal sinus rhythm who have a left atrial diameter >5.5 cm (high risk of atrial fibrillation).

Prophylaxis with warfarin (target INR 2.5, range 2–3) recommended by ACC/AHA in selected high-risk patients with mitral valve prolapse† and atrial fibrillation (i.e., those ≥65 years of age or those with mitral valve regurgitation, hypertension, or a history of heart failure). Patients <65 years of age with mitral valve prolapse and atrial fibrillation who do not have these risk factors for thromboembolism and those with mitral valve prolapse and unexplained TIAs should be considered for low-dose aspirin therapy. Also consider long-term warfarin prophylaxis in patients with mitral valve prolapse who have atrial fibrillation, a history of systemic embolism (e.g., stroke), or recurrent TIAs despite aspirin therapy.

Adjusted-dose warfarin also recommended by some clinicians for prevention of thromboembolic events in patients with mitral valve regurgitation and concomitant atrial fibrillation or a history of systemic embolism.

Long-term antithrombotic therapy generally not recommended in patients with mitral annular calcification who lack a history of thromboembolism or atrial fibrillation. However, ACCP suggests that long-term warfarin therapy be given to patients with mitral annular calcification complicated by systemic embolism not documented to be calcific embolism or in those who have atrial fibrillation.

Generally should not initiate anticoagulant therapy in patients with uncomplicated infective endocarditis involving a native valve because of the risk of hemorrhage and lack of documented efficacy.

Oral anticoagulant therapy recommended in patients undergoing mitral valvuloplasty beginning 3 weeks prior to the procedure and continuing for 4 weeks following the procedure.

Generally should not initiate long-term anticoagulant therapy in patients with aortic arch valve disease unless warranted by a coexisting condition. However, ACCP states that patients with mobile aortic atheromas and aortic plaques >4 mm (as measured by transesophageal echocardiography) should receive long-term anticoagulation with warfarin.

Thromboembolism Associated with Prosthetic Heart Valves

Follow-up anticoagulation after unfractionated heparin or an LMW heparin for prevention of thromboembolic complications associated with heart valve replacement.

Risk of systemic embolism is higher with prosthetic mechanical than with bioprosthetic heart valves, higher with first-generation mechanical (e.g., caged ball, caged disk) valves than with newer mechanical (e.g., bileaflet, Medtronic Hall tilting disk) heart valves, higher with more than one prosthetic valve, and higher with prosthetic mitral than with aortic valves; risk also increases in the presence of atrial fibrillation. Lifelong prophylaxis required in all patients with mechanical heart valves because of associated high risk of thromboembolism.

Combination therapy with aspirin recommended in patients with mechanical heart valves and additional risk factors (e.g., atrial fibrillation, left atrial enlargement, endocardial damage, low ejection fraction).

Combination therapy with aspirin recommended in patients with first-generation mechanical heart valves.

Short-term (3 months) prophylaxis in patients with a bioprosthetic valve in the mitral position; follow-up with long-term aspirin therapy in patients with no continuing risk factors who are in normal sinus rhythm.

Short-term (3 months) prophylaxis with warfarin or aspirin in patients with a bioprosthetic valve in the aortic position; follow-up with aspirin in patients with no continuing risk factors who are in normal sinus rhythm.

Short-term prophylaxis in patients with a bioprosthetic valve and evidence of a left atrial thrombus.

Long-term prophylaxis in patients with a bioprosthetic valve and other risk factors (e.g., atrial fibrillation, prior thromboembolism, left ventricular dysfunction, hypercoagulable states).

Generally should not initiate anticoagulant therapy in patients with uncomplicated infective endocarditis involving a bioprosthetic heart valve because of the risk of hemorrhage and lack of documented efficacy. However, ACCP states that patients with mechanical prosthetic valves receiving long-term anticoagulation who develop infective endocarditis generally should remain on anticoagulant therapy unless there are specific contraindications, keeping in mind the substantial risk of intracranial hemorrhage.

Treatment of “breakthrough” thromboembolic events in patients with prosthetic heart valves receiving thromboprophylaxis. Combination therapy with aspirin recommended in patients with breakthrough embolic event despite warfarin therapy.

Thromboembolism Following ST-Segment Elevation MI

Used as adjunctive therapy with platelet-aggregation inhibitors (e.g., aspirin, clopidogrel) after coronary artery reperfusion for the prevention of early reocclusion and death.

Used short-term with an LMW heparin in the treatment of DVT or pulmonary embolism following MI in hospitalized patients.

Used in selected patients to reduce the incidence of thromboembolic events such as stroke or systemic embolization following MI. ACC and AHA recommend follow-up anticoagulation (3 months) at hospital discharge and adjunctive aspirin after initiation of unfractionated heparin or an LMW heparin in patients at high risk for systemic emboli. ACCP suggests oral anticoagulation and aspirin following MI for 3 months in those at high risk for embolism.

ACC and AHA recommend long-term anticoagulation alone or with aspirin at hospital discharge in patients without stent implantation who have coexisting conditions (i.e., atrial fibrillation, left ventricular thrombus, cerebral emboli, extensive wall motion abnormality) that warrant such therapy.

Used as an alternative to clopidogrel in patients who are unable to take daily aspirin therapy and who do not have a stent implanted.

Primary Prevention of Thromboembolic Events in CAD

Used to reduce the incidence of cardiovascular events and mortality† in patients at high risk for CAD.

Thromboembolism Associated with Other Cardiovascular Diseases

Used in conjunction with aspirin to prevent thrombi and infarction in children with Kawasaki disease†.

Used as primary prophylaxis for thrombotic complications in children with dilated cardiomyopathy† awaiting a cardiac transplant.

May be used as primary prevention of thromboembolic events in children undergoing Fontan surgery for congenital univentricular heart lesions†; use with aspirin (5 mg/kg daily) as follow-up to heparin therapy.

Cerebral Thromboembolism

Secondary prevention in patients with TIAs† or mild ischemic stroke and concurrent atrial fibrillation, provided no contraindications to therapy exist.

Used in conjunction with aspirin for prevention of recurrent stroke in patients at high risk for recurring cerebral embolism from other cardiac sources (e.g., mechanical prosthetic heart valves, recent MI, left ventricular thrombus, dilated cardiomyopathies, marantic endocarditis, extensive wall-motion abnormalities). Follow-up anticoagulation after heparin or an LMW heparin in patients with recent MI and acute ischemic stroke and cardiac sources of embolism.

Has been used as follow-up anticoagulation after heparin therapy for the prevention of embolism in paralyzed or immobile patients with progressive stroke† (when the suspected mechanism is thromboembolic) or stroke-in-evolution†. However, use of heparin or an LMW heparin not recommended by ACCP in patients with a stroke-in-evolution because of lack of conclusive data on efficacy and safety.

Short-term (3–6 months) follow-up anticoagulation with warfarin or an LMW heparin after heparin or an LMW heparin in children with arterial ischemic stroke from cardiac sources† or vascular dissection. May initiate aspirin following completion of anticoagulation.

Long-term antithrombotic therapy generally not recommended in asymptomatic patients with a patent foramen ovale or atrial septal aneurysm unless such patients have unexplained system embolism or TIAs and demonstrable venous thrombosis or pulmonary embolism. Treatment of suspected DVT in patients with cryptogenic stroke and patent foramen ovale†. ACCP suggests use of antiplatelet agents over warfarin in patients with cryptogenic stroke and patent foramen ovale without DVT.

ACCP suggests either oral anticoagulation or antiplatelet agents for secondary prophylaxis in patients with cryptogenic stroke and mobile arch thrombi†.

Oral anticoagulation (3–6 months) recommended by ACCP as follow-up to unfractionated heparin or an LMW heparin in patients with acute cerebral venous sinus thrombosis†.

Thrombosis Associated with CABG

Prevention of saphenous vein or internal mammary artery graft occlusion following CABG†. ACCP recommends use in combination with aspirin when other coexisting conditions (e.g., heart valve replacement) warrant such therapy.

Prevention of Stent Thrombosis and Restenosis Following PCI

Has been used short-term for prevention of stent thrombosis after stent placement† or long-term (1–6 months) for prevention of restenosis following PCI†. Since warfarin has no apparent advantages over antiplatelet therapy, not routinely recommended by ACCP after PCI if no other indications for anticoagulation exist.

Arterial Occlusive Disease

Has been used in selected patients with peripheral arterial occlusive disease†, but ACCP currently recommends against use of anticoagulants for intermittent claudication.

Treatment/Secondary Prevention in Arterial Vascular Surgery

ACCP recommends long-term follow-up oral anticoagulation after initial heparin treatment in patients undergoing embolectomy†.

ACCP recommends long-term oral anticoagulation in postsurgical patients following pulmonary thromboendarterectomy† and in patients ineligible for such a procedure.

Prevention (combined with aspirin therapy) of embolism in selected (high risk for graft thrombosis and limb loss) patients after infrainguinal femoropopliteal or distal vein bypass†.

Heparin-Induced Thrombocytopenia

Has been administered as follow-up treatment of heparin-induced thrombocytopenia† when substantial recovery has occurred (i.e., platelet counts ≥ 100,000–150,000/mm³ and are stable) after therapy with a direct thrombin inhibitor (e.g., lepirudin, bivalirudin, argatroban). Overlap therapy for approximately 5 days until an adequate response to warfarin is obtained.