Rivaroxaban and Aspirin in Patients with Symptomatic Lower Extremity Peripheral Artery Disease A Subanalysis of the COMPASS Randomized Clinical Trial
There is a high risk of major vascular events in patients with symptomatic lower extremity peripheral artery disease (LE-PAD). There are fewer known clinical features of symptomatic LE-PAD to predict major vascular events. It is also unclear whether low-dose rivaroxaban and aspirin are beneficial for patients at high-risk. Kaplovitch and collogues (2021) conducted the study titled “Rivaroxaban and Aspirin in Patients with Symptomatic Lower Extremity Peripheral Artery Disease A Subanalysis of the COMPASS Randomized Clinical Trial” published in the journal “JAMA Cardiology”. The summary is below.
Objectives:
To measure the risk of major vascular events.
To investigate the treatment outcome of low-dose rivaroxaban and aspirin in symptomatic LE-PAD patients as per clinical presentation and comorbidities.
Method:
A sub-analysis of a previously reported subgroup of patients with symptomatic LE-PAD was conducted. The participants were enrolled between March 2013 to January 2020 in a large, double-blind, placebo-controlled randomized clinical trial in 602 centres. Data analysis was conducted between May 2016 to June 2020. Study intervention included a combination of low-dose rivaroxaban and aspirin compared with aspirin alone. Primary outcomes included 30-month incidence risk of major adverse limb events (MALE) including major vascular amputation, bleeding, myocardial infarction, stroke, and cardiovascular death (MACE).
Findings:
Study shows that the patients with prior amputation, previous revascularization surgery, or severe symptoms of PAD have a higher risk of 30-month incidence of MACE or MALE, including amputation. Additionally, rivaroxaban and aspirin compared with aspirin alone have shown to have a substantial absolute risk reduction in these patients. On treatment with rivaroxaban and aspirin, there was a similar effect in LE-PAD patients with at least one high-risk comorbidity, including diabetes, polyvascular disease, heart failure, or kidney insufficiency.
The study suggests that half of the symptomatic LE-PAD patients have a previous amputation, high-risk limb presentation of Fontaine III or IV symptoms, or previous lower limb revascularization, whereas, four of five patients are at high-risk comorbidities of polyvascular disease, heart failure, diabetes, or kidney insufficiency.
Limitations:
Patients in the COMPASS trial was well treated for ischemic risk reduction, this might have affected the study findings to estimate the effect of combination rivaroxaban and aspirin in clinical practice. As the beneficial clinical outcome is been shown to increase over time, the follow-up duration of patients in COMPASS may have affected the result.
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