Rivaroxaban (Xarelto) at a unique low dose of 2.5 mg twice daily, in combination with 100 mg daily aspirin, has been listed on the PBS for the prevention of major cardiovascular events in high-risk patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD).

The listing is supported by evidence from the 2017 COMPASS study which found the combination significantly reduced major cardiovascular events compared to aspirin alone (HR 0.76; p<0.001).

The study also found that rivaroxaban plus aspirin reduced mortality rates compared to aspirin alone (HR 0.82; p=0.01).

“The risk of the composite net-clinical-benefit outcome of cardiovascular death, stroke, myocardial infarction, fatal bleeding, or symptomatic bleeding into a critical organ was lower with rivaroxaban plus aspirin than with aspirin alone.” the study authors said.

The COMPASS study of more than 27,000 participants was terminated early because of the consistent difference in the primary efficacy outcome in favour of the low-dose rivaroxaban plus aspirin.

Cardiologist Associate Professor John Amerena told the limbic that clinicians were aware of the benefits of the combination but hadn’t had the opportunity to use it due to delays getting the low dose DOAC through the regulatory process.

“Low dose rivaroxaban wasn’t available. We couldn’t use it even if we wanted to.”

However now it was available and listed on the PBS, he expected it would be taken up for the benefit it offered over and above conventional therapy such as aspirin and a statin.

“The group that will particularly benefit from the people already on the best therapy available is the percentage of those who go on to have a second heart attack,” he said.

“That’s a group in particular where there is a treatment failure with conventional therapy and we need to add in something extra.”

“The only limitation is polypharmacy in that a lot of patients are already on three, four or five drugs and then we are going to say add in something else. Some people won’t mind that but some will say they don’t want to take so many pills.”

Professor Amerena, director of the Geelong Cardiology Research Unit,  said nothing else before the combination had been shown to have any influence on major limb events in PAD.

“This is something proven effective for preventing events in the leg such as amputation, revascularisation, etc.”