Clot Chronicles: Rivaroxaban’s New FDA Approval

Hello. This is Dr. Sam Goldhaber. I am president of NATF and today on the Clot Chronicles, we are going to talk about the COMPASS trial and the new FDA approval of a very low dose of rivaroxaban, also known as Xarelto, for the prevention of recurrent coronary artery disease, stroke, or peripheral artery disease in patients who have suffered prior coronary events or peripheral arterial disease diagnostic problems.

The new dose of rivaroxaban that has been approved is 2.5 mg twice daily in combination with a baby aspirin once daily. There were remarkable results in the COMPASS trial, which was a global randomized control trial with almost 30,000 patients. This combination of the anticoagulant rivaroxaban in tiny doses plus a baby aspirin led to a remarkable reduction in heart attack, stroke, and limb loss. It’s really surprising that such a tiny dose of an anticoagulant can make such a big difference in combination with aspirin.

Now, just to give you some perspective, our dose of rivaroxaban for stroke prevention in atrial fibrillation is 20 mg once daily. Whereas, in the COMPASS trial and this new indication for rivaroxaban, the dose is 2.5 mg twice daily plus a baby aspirin. The new regimen, combining low dose anticoagulation and low dose aspirin, was compared against aspirin alone. There was roughly a 25 percent reduction in cardiovascular mortality, heart attack, and stroke in the patients who received combined anticoagulation plus aspirin compared with aspirin alone.

I think this is a great breakthrough, not only for patients with coronary artery disease, but especially for patients with peripheral arterial disease, for which there has been no new effective medication to prevent cardiovascular events in more than 30 years.

I think what we’ll have to do now is make sure NATF does its mission of patient education, family education, and healthcare provider education, and also advocates for patients to make sure they can get the approval from their insurance companies to allow the doctors and other healthcare providers to prescribe this new, very effective preventive regimen.

This is Dr. Sam Goldhaber, signing off for the Clot Chronicles.

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