Trial investigator Deepak Bhatt, MD, MPH, discusses how use of rivaroxaban in a clinical setting has changed as a result of the COMPASS trial.
While rivaroxaban (Xarelto) received its first US Food and Drug Administration (FDA) approval in 2011 for reduction of stroke risk and systemic embolism in patients with atrial fibrillation, results of the COMPASS trial has revolutionized use of the oral anticoagulant.
Results of the COMPASS trial, which were announced in 2017, revealed that 2.5 mg rivaroxaban twice daily combined with 100 mg aspirin had the ability to reduce major adverse cardiovascular events and major adverse limb events in patients with coronary or peripheral artery disease.
While the FDA subsequently approved rivaroxaban for the reduction of major cardiovascular events in October 2018, Deepak Bhatt, MD, MPH, executive director of Interventional Cardiovascular Programs at Brigham and Women's Hospital and professor of medicine at Harvard Medical School, cautions it is not a panacea for patients with CAD or PAD.
Bhatt, who was an investigator in the COMPASS trial, recently sat down with MD Magazine® to discuss how COMPASS results have changed the way cardiologists use rivaroxaban in a clinical setting.
MD Mag: How have the COMPASS results changed the way rivaroxaban is utilized in a clinical setting?
Bhatt: Now we've got a new treatment option post- the COMPASS trial for patients with peripheral artery disease — and, for that matter, even patients with stable coronary artery disease that are high ischemic risk and the approval of COMPASS or I should say the FDA approval of COMPASS results and labeling of rivaroxaban have really opened up the field in terms of patients that are eligible for this therapy. The label is actually rather broad. The trial included a broad array of patients with stable CAD and PAD — that I think is good for patients because there are a lot of options. I think it's also challenging for physicians because there are a lot of patients who are potentially eligible for this form of therapy and I think it probably makes sense to focus efforts on patients who are at highest ischemic risk, especially as physicians are becoming comfortable with using a low dose of a NOAC in patients with stable atherosclerosis.
Of course, we're using NOACs at a higher dose in atrial fibrillation and DVT — so there's a lot of experience out there, but here we're talking about a lower dose rivaroxaban 2.5 (mg) twice a day plus low-dose aspirin which in the US would be 81 mg a day and there is a bleeding risk we saw in COMPASS — a significant excess in major bleeding. Fortunately, we didn't see any significant excess in failure intracranial bleeding but still do need to be cautious and not use this therapy in patients who are high risk of bleeding, be cautious in patients who are older, and who have other risk factors for bleeding, but in patients who have a low risk of bleeding, haven't had bleeding problems on aspirin, but remain at high ischemic risk —there, I think the addition of rivaroxaban 2.5 mg twice a day could be really useful to reduce future events.