Peripheral artery disease (PAD) affects millions globally, with a significant proportion also having diabetes mellitus (DM), leading to a heightened risk of major adverse limb events (MALE) and major adverse cardiovascular events (MACE). Despite revascularization procedures, these risks persist, highlighting the need for effective anticoagulation therapy.

To evaluate the effectiveness of dual anticoagulation therapy with aspirin and low dose rivaroxaban in reducing MALE and MACE in patients with type 2 diabetes and PAD undergoing lower limb revascularization.

This is a prospective study of 101 T2DM patients with PAD and ischemic diabetic foot ulcer (DFU) undergoing lower limb revascularization procedures who received dual anticoagulation with aspirin 75 mg and rivaroxaban 2.5 mg twice daily. Clinical characteristics and biochemical parameters were measured. All the individuals were followed up for one year post revascularization procedure and major adverse limb events (MALE) and major adverse cardiovascular events (MACE), were assessed. MALE included either major or minor amputation or requirement of revascularization procedure. MACE included cardiovascular death, non-fatal myocardial infarction and non-fatal stroke.

The median age was 62 years and diabetes duration of 11 years. Most were male (93%) with hypertension (70.3%) and smokers (53.5%). Arterial angioplasty was the most common revascularization procedure (97%). At one year, MALE occurred in 61.4% (16.8% major amputations and 45.6% minor amputations) and 15.8% showed wound healing and MACE occurred in 33.7% of patients. Twenty-three patients (22.8%) died, primarily from CAD (65.2%).

Patients with T2DM and PAD undergoing revascularization remain at high risk for MALE and MACE despite dual anticoagulation and a significant mortality rate.