The COMPASS trial revealed that patients with stable atherosclerotic vascular disease tremendously benefit from 2.5 mg Xarelto twice daily, plus 100 mg aspirin once daily. This regimen was found to have not only reduced the risk of a second cardiovascular event (e.g., stroke, heart attack) but also reductions in major adverse limb events.
Peripheral Artery Disease (PAD)
An abnormal narrowing of arteries other than those that supply the heart or brain. When narrowing occurs in the heart, it is called coronary artery disease, and in the brain, it is called cerebrovascular disease. Peripheral artery disease most commonly affects the legs, but other arteries can be involved.
The most significant risk factor for PAD is cigarette smoking, but others include diabetes, high blood pressure, kidney problems, and high blood cholesterol. The most common underlying mechanism of PAD is atherosclerosis, especially in individuals over 40. Stable Atherosclerotic vascular disease is a disease in which the inside of an artery narrows due to a build-up of plaque.
PAD is highly prevalent, representing 12-14% of the general population. PAD affects 33% of diabetics over the age of 50 in America. It impacts 12-20% of Americans age 65 and up. An estimated 10 million Americans have PAD. Only 25% of PAD patients are undergoing treatment, the lack of which leads to fatalities in many cases.
For patients with stable atherosclerotic vascular disease, the patient’s treatment options can mean saving one’s life. The study was launched in 2013 and ends in 2021. A Phase III randomized controlled trial with over 27,395 patients, the study is sponsored by Bayer and the German company’s collaborators, including Janssen Research & Development LLC (a subsidiary of Johnson & Johnson) and Population Health Research Institute. The primary objectives of the study include the determination of 1) whether rivaroxaban (Xarelto) 2.5 mg twice daily (bid) plus aspirin 100 mg once daily (od) compared with aspirin 100mg od reduces the risk of a composite of myocardial infarction (heart attack), stroke, or cardiovascular death in patients with coronary artery disease (CAD) or periphery artery disease (PAD); and 2) whether rivaroxaban (Xarelto) 5mg compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in patients with CAD or PAD.
Trail Results to Date
Recently MD Magazine interviewed Dr. Deepak Bhatt on the importance of the COMPASS trial findings to date. Based on the positive COMPASS trial results, PAD patients now have a new treatment option: 2.5 mg Xarelto twice daily plus 100 mg aspirin once daily. The study findings reveal that the use of Xarelto plus aspirin reduces the risk of secondary cardiovascular events, with an additional benefit to those afflicted with limb ischemia (inadequate blood supply).
The secondary analysis Bhatt reported in the video interview revealed that this regimen lowers the incidence of vascular amputations in major adverse limb events (MALE) by 43%; a 58% reduction in total vascular amputations; peripheral vascular interventions by 24% and all peripheral vascular outcomes by 24%.
Follow the link below to source MD Magazine for the full interview.
Dr. Deepak Bhatt