Reduction in Adverse Events with Rivaroxaban Plus Aspirin

Rivaroxaban, in conjunction with aspirin, has been shown to reduce major adverse cardiovascular and limb events by about one-third in peripheral artery disease (PAD) patients, according to results from the COMPASS trial.

Presented at the European Society of Cardiology (ESC) Congress, the trial showed a 28% reduction of cardiovascular death, stroke, or heart attack, and a 46% reduction in limb-threatening ischemia (including amputation).

“This is an important advance for patients with peripheral artery disease,” Sonia Anand (pictured), MD, PhD, FRCP, a professor of medicine at McMaster University in Canada, said in a statement. “Until now we have only had aspirin which is modestly effective. To now have a therapy that reduces major adverse cardiovascular events and major adverse limb events by one-third is going to be a great benefit for these high-risk patients.”

The COMPASS trial consisted of an international patient population of 7470 patients with PAD of the lower extremities and carotid artery disease and tested 2 study arms: rivaroxaban alone and rivaroxaban in combination with aspirin. Of the total subject population, one-third were smokers and 44% had diabetes, 2 of the biggest risk factors for PAD.

With consideration for both endpoints of cardiovascular death, stroke, or heart attack and limb-threatening ischemia, the combination therapy reduced major adverse events by 31%. Rivaroxaban alone reduced only adverse limb events, having no reduction for major adverse cardiovascular events.

“PAD patients have a threefold risk of heart attack and stroke, and there is no antithrombotic therapy which reduces both cardiovascular and limb events,” Salim Yusuf, MD, Chair of the COMPASS Steering Committee and director of the Population Health Research Institute at McMaster University, said. “Use of low dose rivaroxaban and aspirin appears to be the right combination at the right dose to lower rates of cardiovascular and limb events in this high-risk population.”

The combination therapy did reportedly increase the risk of major bleeding, but not the risk of fatal or critical organ bleeding. Most of the major bleeding events were deemed reversible.

The results indicated that at 21 months of treatment, for every 1000 PAD patients, 2.5 mg rivaroxaban twice daily plus aspirin can prevent 27 patients from having a major cardiovascular event, at the cost of 12 major, but treatable, bleeds. These benefits were attained with secondary prevention therapies being used in conjunction.

PAD affects an estimated 200 million people around the world and patients are at increased risk of heart attack, stroke, and death from cardiovascular problems, as well as limb-threatening ischemia and amputation. Currently, aspirin is the standard antithrombotic therapy, but it is only modestly effective when used alone.

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