Antithrombotic therapy with low-dose rivaroxaban plus aspirin should be considered in low–bleeding risk patients with peripheral arterial disease who are at increased risk for ischemic and/or limb events, according to an analysis of the COMPASS trial published in Current Opinion in Cardiology.
, of the University of Toronto and his colleagues assessed the ramifications of COMPASS to vascular surgeons. They used two clinical case studies of patients with peripheral arterial disease (PAD) to illustrate differing considerations in care.
The(Cardiovascular Outcomes for People Using Anticoagulation Strategies) trial showed that low-dose rivaroxaban at 2.5 mg twice daily plus daily aspirin was superior to aspirin alone in reducing major adverse cardiovascular and cerebrovascular events, as well as major adverse limb events, among patients with stable atherosclerotic vascular disease, including those with PAD. However, the risk for major bleeding was higher with rivaroxaban plus aspirin and is a serious consideration for patient treatment.
In clinical case 1, used to illustrate the pertinence of COMPASS to patient care, Dr. Hussain and his colleagues detailed a 68-year-old man presenting with a 3-month history of intermittent claudication of bilateral calves at 10 minutes of brisk walking. His comorbidities include a MI with percutaneous coronary stenting 2 years ago, diabetes mellitus, hypertension, hyperlipidemia, and chronic obstructive pulmonary disease on the basis of prior smoking.
Clinical case 2 was a 70-year-old woman with a small gangrenous ulcer on the dorsal part of her first toe on the left foot. She has history of coronary artery disease with coronary artery bypass graft surgery 5 years prior, diabetes mellitus, mild chronic kidney disease, and hypertension. She underwent an uneventful lower extremity bypass using a prosthetic graft and had an uncomplicated postoperative course.
Both patients were on daily 81 mg aspirin.
In order to determine the appropriate care for these patients, the authors presented a flowchart of considerations regarding risk and benefits. Patients with symptomatic PAD who had no recent major bleeds, history of stroke, congestive heart failure, chronic kidney disease, frailty, or anemia were considered for rivaroxaban treatment, otherwise they were put on single antiplatelet therapy.
The investigators recommended that, if the patients were at high limb risk or high ischemic risk, they should be treated with either rivaroxaban plus aspirin or dual antiplatelet therapy (the latter if there was a recent MI or peripheral stenting). If the patients were not at risk, they were deemed eligible for either the rivaroxaban plus aspirin therapy or single antiplatelet therapy.
With regard to the clinical case studies, the authors discussed the rationale for putting both patients on the rivaroxaban plus aspirin therapy after an assessment of the risk/benefit profile for each patient based upon the above considerations. In both cases the bleeding risk was considered low; the ischemic risk in the first patient and the limb risk in the second patient was considered high. Although the second patient had chronic kidney disease, it was not considered severe enough to preclude such treatment.
“Future data from trials such as Vascular Outcomes Study of ASA Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization For Peripheral Artery Disease  will provide data with regards to the role of low-dose rivaroxaban plus aspirin following peripheral artery revascularization for PAD,” the researchers concluded.
Dr. Hussain reported having no conflicts; his coauthors reported receiving funding from various pharmaceutical companies, including Bayer, which was a sponsor of the original COMPASS trial.
SOURCE: Hussain MA et al. .