Two new analyses of data from the COMPASS trial show that Bayer and Janssen’s blood thinner Xarelto significant cut the amputation rate for patients with peripheral artery disease (PAD) and also a 23 percent reduction in deaths in patients with coronary artery disease (CAD).
Findings from the PAD analysis showed that Xarelto (rivaroxaban) 2.5mg twice daily, plus aspirin 100mg once daily substantially reduced the risk of major amputation by 70 percent and the risk of experiencing major adverse cardiovascular events (MACE), major adverse limb events (MALE) and major amputation by 31 percent compared with aspirin 100mg once daily alone.
Additional data for this treatment regimen in patients with PAD demonstrated a 28 percent relative risk reduction in the primary efficacy outcome of MACE, and a 46 percent reduction in MALE compared with aspirin 100mg once daily alone.
The firms also noted that bleeding rates were low, and while major bleeding was increased, there was no significant differences in fatal bleeding, non-fatal intracranial bleeding or bleeding into a critical organ between any of the treatment groups.
Also, the Xarelto regimen demonstrated an improvement in net clinical benefit - defined as the combined outcome of MACE, MALE and major amputation, balanced with fatal bleeding or symptomatic bleeding into a critical organ - in both patient populations compared with aspirin alone (28 percent in patients with PAD, and 23 percent in patients with CAD).
“A focus on PAD is well overdue and once licensed, we are optimistic that treatment would help save not only limbs but lives,” said Mr Andrew Garnham, consultant vascular Surgeon at the Royal Wolverhampton NHS Trust.
“Patients affected by PAD are at high risk of both heart attack and stroke, and the COMPASS data has huge implications for patients in the UK with PAD who face the very stark reality of limb amputations or cardiovascular complications.”
The results “provide UK clinicians with the first glimpse of how rivaroxaban could protect patients with PAD, once licensed in this indication,” added Dr Luis Felipe Graterol, UK medical director, Bayer.
Both analyses were published in The Lancet.
Bayer filed for approval of Xarelto in combination with aspirin to reduce the risk of cardiovascular events in patients with coronary or peripheral artery disease in Europe earlier this month.