FDA News

Rivaroxaban approved to prevent CV events in CAD, PAD

Kelley Branch

Janssen announced that the FDA has approved its factor Xa inhibitor rivaroxaban for reduction of risk for major adverse CV events in patients with chronic CAD or peripheral artery disease.

Rivaroxaban (Xarelto, Janssen/Bayer) is the first factor Xa inhibitor to be approved for this indication, Janssen stated in a press release. The drug was already approved for reduction of stroke/systemic embolism risk in patients with nonvalvular atrial fibrillation and for treatment and prevention of recurrence of blood clots in patients with venous thromboembolism.

“The regimen is broadly applicable given the consistency of effect through various trial subgroups,” Kelley Branch, MD, MSc, FACC, FSCCT, associate professor in cardiology at the University of Washington, Seattle, told Cardiology Today. “This supports the more than 20-year-old data that thrombin inhibition has benefit in CAD, but it also goes further for PAD, which does not benefit from vitamin K antagonists.”

The approval was based on the results of the COMPASS trial, in which, as Cardiology Today previously reported, rivaroxaban 2.5 mg twice daily plus aspirin was associated with a 24% reduction in major adverse CV events, defined as CV death, MI and stroke in patients with chronic CAD or PAD compared with aspirin alone. The results were driven by a 42% reduction in stroke, a 22% reduction in CV death and a 14% reduction in MI, according to the release.

“COMPASS steers us in a new direction toward preventing cardiovascular complications in chronic CAD and PAD,” Branch told Cardiology Today. “Given the therapeutic benefits in PAD and CAD patients, the vascular protective combination of low-dose rivaroxaban with aspirin saves lives while reducing cardiovascular complications from head to toe.”

It is now up to doctors to determine which patients will most benefit from this indication of rivaroxaban, Branch said in an interview.

“The patients at highest risk, such as those with polyvascular disease — combination CAD, PAD and/or cerebrovascular disease — PAD, heart failure with ejection fraction > 30%, diabetes and/or decreased renal function seemed to have higher risk overall and may be a reasonable population to target first,” he said. “However, there was a consistent benefit in lower-risk CAD, PAD and cerebrovascular disease COMPASS populations, so the combination treatment should be considered in these patients with as well.”

The European Commission granted approval to rivaroxaban for the same indication in August, according to the release. – by Erik Swain

For more information:

Kelley Branch, MD, MSc, FACC, FSCCT, can be reached at kbranch@u.washington.edu.

Disclosure: Branch reports he serves on advisory boards for Bayer and Janssen, receives research support from Bayer and was the U.S. national leader for the COMPASS trial.

Kelley Branch

Janssen announced that the FDA has approved its factor Xa inhibitor rivaroxaban for reduction of risk for major adverse CV events in patients with chronic CAD or peripheral artery disease.

Rivaroxaban (Xarelto, Janssen/Bayer) is the first factor Xa inhibitor to be approved for this indication, Janssen stated in a press release. The drug was already approved for reduction of stroke/systemic embolism risk in patients with nonvalvular atrial fibrillation and for treatment and prevention of recurrence of blood clots in patients with venous thromboembolism.

“The regimen is broadly applicable given the consistency of effect through various trial subgroups,” Kelley Branch, MD, MSc, FACC, FSCCT, associate professor in cardiology at the University of Washington, Seattle, told Cardiology Today. “This supports the more than 20-year-old data that thrombin inhibition has benefit in CAD, but it also goes further for PAD, which does not benefit from vitamin K antagonists.”

The approval was based on the results of the COMPASS trial, in which, as Cardiology Today previously reported, rivaroxaban 2.5 mg twice daily plus aspirin was associated with a 24% reduction in major adverse CV events, defined as CV death, MI and stroke in patients with chronic CAD or PAD compared with aspirin alone. The results were driven by a 42% reduction in stroke, a 22% reduction in CV death and a 14% reduction in MI, according to the release.

“COMPASS steers us in a new direction toward preventing cardiovascular complications in chronic CAD and PAD,” Branch told Cardiology Today. “Given the therapeutic benefits in PAD and CAD patients, the vascular protective combination of low-dose rivaroxaban with aspirin saves lives while reducing cardiovascular complications from head to toe.”

It is now up to doctors to determine which patients will most benefit from this indication of rivaroxaban, Branch said in an interview.

“The patients at highest risk, such as those with polyvascular disease — combination CAD, PAD and/or cerebrovascular disease — PAD, heart failure with ejection fraction > 30%, diabetes and/or decreased renal function seemed to have higher risk overall and may be a reasonable population to target first,” he said. “However, there was a consistent benefit in lower-risk CAD, PAD and cerebrovascular disease COMPASS populations, so the combination treatment should be considered in these patients with as well.”

The European Commission granted approval to rivaroxaban for the same indication in August, according to the release. – by Erik Swain

For more information:

Kelley Branch, MD, MSc, FACC, FSCCT, can be reached at kbranch@u.washington.edu.

Disclosure: Branch reports he serves on advisory boards for Bayer and Janssen, receives research support from Bayer and was the U.S. national leader for the COMPASS trial.