Deepak Bhatt, MD: Safety Profile of Rivaroxaban from COMPASS Trial

For patients with stable atherosclerotic vascular disease, treatments and therapies that aid in the prevention of secondary events, such as stroke, cardiovascular death, or myocardial infarction can mean the difference between life and death. 



With the overwhelmingly positive results of the COMPASS trial, patients with peripheral artery disease now have an additional treatment option — in the form of 2.5 mg rivaroxaban (Xarelto) twice daily plus 100 mg aspirin once daily — that has been found to not only reduce risk of a second cardiovascular event but also reductions in major adverse limb events. 


After initial results of the COMPASS trial, which enrolled 27,395 participants, revealed that use of rivaroxaban plus aspirin reduced the risk of secondary cardiovascular event inpatients an additional analyses was performed to assess the impact on limb ischemia.

In the secondary analysis, investigators assessed outcomes in 6391 patients with lower extremity peripheral artery disease. A total of 128 patients experienced an incident of major adverse limb events (MALE) during the course of the COMPASS trial. Investigators noted that, compared with aspirin alone, rivaroxaban plus aspirin lowered the incidence of MALE by 43%, total vascular amputations by 58%, peripheral vascular interventions by 24%, and all peripheral vascular outcomes by 24%. 





To find out more about the results of secondary analysis, MD Magazine sat down with COMPASS investigator Deepak Bhatt, MD, MPH, executive director of Interventional Cardiovascular Programs at Brigham and Women's Hospital and professor of medicine at Harvard Medical School, to discuss how this data can be used by cardiologists in a clinical setting.

MD Mag: Can you discuss the safety profile established within the COMPASS trial?

Bhatt: One of the really exciting findings from the COMPASS trial was a significant reduction in peripheral ischemic events — including, importantly, amputations which were significantly reduced and that's an endpoint that's been very difficult to reduce patients with advanced peripheral artery disease or a challenging cohort to treat because they have such high rates of peripheral ischemic events, but also coronary ischemic events and also cerebral vascular events.

As it turns out in this trial — COMPASS — there was a very profound reduction in all those ischemic events including amputations in patients with peripheral artery disease. So, right now, options that are used in patients with PAD include aspirin alone clopidogrel alone sometimes a combination of aspirin and clopidogrel but now we have another option for patients with PAD that's evidence based and, in fact, the FDA has approved use of low-dose rivaroxaban 2.5 mg twice a day in addition to low-dose aspirin for such patients.