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CLINICAL STATEMENTS AND GUIDELINES

Circulation. 2024;149:e1313–e1410. DOI: 10.1161/CIR.0000000000001251 June 11, 2024 e1337

The factors favoring addition of antiplatelet medication, antithrombotic medication, or both are balanced against the risk of bleeding. The VOYAGER PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) showed that the risk of ischemic limb events, and the overall primary endpoint, was reduced by low-dose rivaroxaban in combination with low-dose aspirin in patients without a previous stroke or increased risk of bleeding.7 Dual antiplatelet therapy after endovascular revascularization is supported indirectly by data from percutaneous coronary intervention and its use in major trials of endovascular revascularization using different devices for PAD.8–11 Similarly, limited data from percutaneous coronary interventions support the use of single antiplatelet therapy after endovascular revascularization in patients on full-dose anticoagulation for another indication (eg, atrial fibrillation or venous thromboembolism).12,13

Recommendation-Specific Supportive Text 1-3.	 Single antiplatelet therapy reduces the risk of

MACE in patients with symptomatic PAD with or without previous revascularization. Although aspirin has historically been used as the antiplatelet agent for prevention of MACE among patients with PAD, recent trials have shown the efficacy of P2Y12 inhibitors in this patient population.1–4,23 Single antiplatelet therapy with clopidogrel had improved efficacy compared with aspirin for prevention of MACE in the CAPRIE (Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events) trial, with similar rates of bleeding.4 Single antiplatelet therapy with the P2Y12 inhibitor ticagrelor had similar rates of efficacy and safety outcomes compared with clopidogrel in the EUCLID (Examining Use of Ticagrelor in Peripheral Artery Disease) trial, although rates of adverse events in those treated with ticagrelor were higher.23 A recent meta-analysis of trials in patients with CAD, cerebrovascular disease, or PAD suggested that the value of single antiplatelet therapy with P2Y12 inhibitors was similar to aspirin.24

4 The COMPASS (Cardiovascular Outcomes for

People Using Anticoagulation Strategies) trial assessed low-dose anticoagulation with rivaroxaban (2.5 mg twice daily) in addition to low-dose aspirin in patients with CVD who did not have a high risk of bleeding, history of hemorrhagic or lacunar stroke, severe kidney disease, or need for dual antiplatelet or anticoagulation therapy.5 In this study, low-dose rivaroxaban added to low-dose aspirin reduced the risk of MACE and MALE.5 In a subgroup analysis of the COMPASS trial among patients with symptomatic PAD, carotid disease, or CAD with an abnormal ABI, this regimen also reduced the risk of MACE and MALE but with an increase in risk of major bleeding.25 In another subgroup analysis of the COMPASS trial in patients with PAD, this regimen reduced the risk of MALE but with an increase in risk of major bleeding.6

5 The use of antiplatelet agents after lower extremity

endovascular or surgical revascularization is common clinical practice, although this has not been well studied in placebo-controlled trials. Small historical trials and a subsequent meta-analysis provide support for the use of single antiplatelet therapy in this setting.1 The use of antiplatelet therapy after revascularization is recommended because revascularization is generally reserved for patients with symptomatic PAD. Furthermore, contemporary studies evaluating paclitaxel-coated devices for revascularization in patients with PAD have mandated dual antiplatelet therapy in all patients.8,9 In the VOYAGER PAD trial, aspirin monotherapy was mandated at the time of revascularization procedures, and the combination of low-dose aspirin and low-dose rivaroxaban led to an improvement in the risk of MALE.7

6 The VOYAGER PAD trial assessed a regimen of

low-dose rivaroxaban (2.5 mg twice daily) in addition to low-dose aspirin in patients within 10 days of lower extremity revascularization who were not on anticoagulation for another indication or had planned P2Y12 receptor antagonist use.7 Patients at high risk for bleeding, including those with previous stroke or intracranial hemorrhage, intracranial tumor or vascular abnormality, or gastrointestinal bleeding in the previous 6 months, were excluded. This regimen reduced the risk of a composite endpoint of MACE and MALE compared with aspirin alone, mainly driven by lower rates of ALI.7

7 Dual antiplatelet therapy after endovascular revas-

cularization for PAD is extrapolated from the use of this regimen after percutaneous coronary intervention. Trials assessing drug-eluting stents and drug-coated balloons for revascularization of PAD generally recommended and required dual antiplatelet therapy for 2 to 6 months after revascularization.8,9 Observational studies have suggested a potential benefit of dual antiplatelet therapy compared with single antiplatelet therapy after revascularization, particularly among the subgroup of patients with CLTI.10,11

8 The combination of full-intensity oral anticoagula-

tion and dual antiplatelet therapy, known as “triple therapy,” is associated with an increased risk of bleeding complications. Recent trials in patients with an indication for full-intensity oral anticoagulation who undergo percutaneous coronary intervention support the use of single antiplatelet

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