Patients with PAD are at heightened risk for major cardiovascular and adverse limb events. The mainstay of treatment for patients with peripheral artery disease includes use of antiplatelet agent daily to prevent major adverse cardiovascular events. . Other antithrombotic regimens have been tested in patients with peripheral artery disease including vitamin K antagonists and newer antiplatelet agents including P2Y12 antagonists used alone or in combination with aspirin, but none have been shown to be superior to antiplatelet therapy alone. The peripheral artery disease analysis of the COMPASS trial showed that in stable PAD use of low-dose Rivaroxaban twice a day, together with aspirin once a day, reduced cardiovascular death, myocardial infarction, stroke, and acute limb ischaemia and amputation, compared with aspirin alone.

Patients pursue revascularization procedures to alleviate PAD symptoms and improve function. Post-revascularization PAD population high risk of subsequent vascular complications, particularly ALI. ^{(17, 18)}

The VOYAGER PAD showed significant benefit with Rivaroxaban vascular dose and aspirin post revascularisation as compared to standard antiplatelet therapy.

The Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia recommends low-dose aspirin and Rivaroxaban, 2.5 mg twice daily, to reduce adverse cardiovascular events and lower extremity ischemic events in patients with chronic limb threatening Ischemia. (Grade 2, Level of Evidence B)

PAD patients have different risk profiles throughout the disease spectrum. Therefore, studies in dedicated PAD populations, with a relevant PAD endpoints, are needed to identify optimal strategies to increase the limb salvage rates, amputation free survival and at the same time minimise adverse cardiac and limb events. The aim of the study is to assess the role of low dose Rivaroxaban and aspirin in patients with peripheral artery disease.

AIM:

To assess the role of low dose Rivaroxaban and Aspirin in stable PAD patients and PAD patients post revascularisation.

OBJECTIVE:

Primary: Limb Salvage and amputation free survival in Peripheral arterial disease

Secondary: 

1.    Major adverse cardiac events (MACE): MI, Cardiovascular death,  Stroke

2.    Major adverse limb events (MALE): Acute Limb ischemia, Amputation

3.    Bleeding events

Study design 

Prospective, single centre, Randomised controlled trial