From the Guidelines
Anticoagulation therapy is not generally indicated for patients with Peripheral Arterial Disease (PAD), and instead, antiplatelet therapy is the standard approach. According to the most recent guidelines, including the 2024 ESC guidelines for the management of peripheral arterial and aortic diseases 1, and the 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS guideline for the management of lower extremity peripheral artery disease 1, antiplatelet therapy with aspirin or clopidogrel is recommended to reduce the risk of major adverse cardiovascular events (MACE) in patients with symptomatic PAD.
Some key points to consider in the management of PAD include:
- The use of single antiplatelet therapy, such as aspirin or clopidogrel, to reduce the risk of MACE in patients with symptomatic PAD 1.
- The potential benefits and risks of adding low-dose anticoagulation with rivaroxaban to low-dose aspirin in patients with PAD and high ischemic risk, but non-high bleeding risk 1.
- The importance of lifestyle modifications, such as smoking cessation and exercise, in improving symptoms and reducing the risk of cardiovascular events in patients with PAD.
It's also important to note that while anticoagulation can effectively prevent clots, PAD is primarily a disease of reduced blood flow due to arterial narrowing, not excessive clotting. The risks of full anticoagulation, particularly the increased bleeding risk, generally outweigh the potential benefits in PAD patients who don't have other indications for such therapy. However, some PAD patients may require anticoagulation for other reasons, such as atrial fibrillation or a history of venous thromboembolism, and in these cases, anticoagulation would be prescribed based on those specific conditions, not for PAD itself.
From the FDA Drug Label
1.8 Reduction of Risk of Major Thrombotic Vascular Events in Patients with Peripheral Artery Disease (PAD), Including Patients after Lower Extremity Revascularization due to Symptomatic PAD XARELTO, in combination with aspirin, is indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology) in adult patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD.
Anticoagulation therapy is indicated in patients with Peripheral Arterial Disease (PAD) to reduce the risk of major thrombotic vascular events.
- The recommended dosage is 2.5 mg twice daily, plus aspirin (75–100 mg) once daily.
- This indication is specifically mentioned in the drug label for rivaroxaban 2.
From the Research
Indications for Anticoagulation Therapy in PAD
- Anticoagulation therapy is not universally indicated for all patients with Peripheral Arterial Disease (PAD) 3, 4, 5, 6, 7.
- Asymptomatic PAD does not warrant anticoagulant or antiplatelet treatment 3, 4.
- Patients with ischemic lower extremity symptoms, such as intermittent claudication or critical limb ischemia, should be offered platelet antiaggregation with either low-dose aspirin or clopidogrel 3, 4, 5, 6.
Specific Anticoagulation Therapies
- Combined treatment with aspirin and low-dose of the direct oral anticoagulant (DOAC) rivaroxaban should be considered in symptomatic PAD patients at high risk for recurrent ischemic events and in patients having undergone endovascular or open surgical intervention for PAD 3, 4, 7.
- Rivaroxaban (2.5 mg b.i.d.) plus aspirin (100 mg daily) has been shown to reduce total mortality and cardiovascular mortality in PAD patients 4, 7.
- Anticoagulant treatment with either one of the DOACs (apixaban, dabigatran, edoxaban, and rivaroxaban) or warfarin should be recommended for patients with cardiogenic embolization to lower extremity arteries 3.
Considerations and Risks
- The use of anticoagulation therapy in PAD patients should be weighed against the risk of bleeding 3, 4, 6, 7.
- Dual antiplatelet therapy (DAPT) with clopidogrel and aspirin does not provide benefit over single antiplatelet therapy (SAPT) with aspirin alone and is associated with increased risk of major bleeding 4.
- The combination of antiplatelets and anticoagulants has emerged as a potential antithrombotic alternative to antiplatelets alone, but results from real-world studies are needed to confirm observations 7.