Rivaroxaban and Aspirin combo reduces vascular risk in Lower Extremity PAD: JAMA

Hence, Eric Kaplovitch and colleagues from the Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada conducted the study to quantify the risk of major vascular events and investigate the response to treatment with low-doserivaroxaban and aspirin among patients with symptomatic LE-PAD based on clinical presentation and comorbidities.

A total of 4129 patients with symptomatic LE-PAD with a mean age of 66.8 years; out of which 2932 were men were enrolled in the trial. A combination of low-dose rivaroxaban and aspirin compared with aspirin alone was administered. Thirty-month incidence risk of myocardial infarction, stroke and cardiovascular death (MACE), major adverse limb events (MALE) including major vascular amputation, and bleeding were evaluated for.

The following results were noted-

2. The 30-month Kaplan-Meier incidence risk of MACE or MALE, including major amputation, was 22.6% in those with prior amputation (this outcome was observed in 54 patients), 17.6% (n = 15) in those with Fontaine III or IV symptoms, and 11.8% (n = 142) in those with previous peripheral artery revascularization, classifying these features as high-risk limb presentations.
3. The 30-month incidence risk of MACE or MALE, including major amputation, was 14.1% (n = 118) in those with kidney dysfunction, 13.5% (n = 67) in those with heart failure, 13.4% (n = 199) in those with diabetes, and 12.8% (n = 222) in those with polyvascular disease, classifying these features as high-risk comorbidities.
4. Among patients with either high-risk limb presentations or high-risk comorbidities, treatment with rivaroxaban and aspirin compared with aspirin alone was associated with an estimated 4.2% (95% CI, 1.9%-6.2%) absolute risk reduction for MACE or MALE, including major amputation, at 30 months.
5. Although the estimated absolute risk increase of major bleeding was higher with rivaroxaban and aspirin in combination than aspirin alone (2.0% [95% CI, 0.5%-3.9%]) for patients with either high-risk limb presentation or high-risk comorbidity, the estimated absolute risk increase of fatal or critical organ bleeding was low in this high-risk group (0.4% [95% CI, 0.2%-1.8%]), such that the net clinical benefit was estimated to be 3.2% (95% CI, 0.6%-5.3%).

Therefore, the authors concluded that "Patients with LE-PAD with high-risk limb presentations or high-risk comorbidities had a high incidence of major vascular events. For these patients, treatment with rivaroxaban and aspirin in combination compared with aspirin alone led to a large absolute reduction in vascular risk."