Current treatment to prevent heart attack and stroke commonly consists of low-dose aspirin therapy. The COMPASS (Cardiovascular OutcoMes for People using Anticoagulation Strategies) trial looked at what happened if patients added a low dose of the drug rivaroxaban to their daily aspirin regime.
- Risk of cardiovascular death, stroke or heart attack dropped by 24 percent.
- Limb-threatening ischemia, including amputation, dropped by 46 percent.
- Survival rates increased by 18 percent.
“This information gives us another avenue in treating heart and peripheral artery disease,” said Dr. DP Suresh, Principal Investigator for the study at St. Elizabeth and Medical Director for Heart and Vascular Services. “Within five years it could be the new standard of care.”
COMPASS Trial Details
The COMPASS trial tested whether adding a low dose of the drug rivaroxaban to a once-daily aspirin would more effectively treat cardiovascular disease than the current treatment of aspirin alone. The trial included more than 27,000 people from 33 countries.
Treatments tested were:
- 2.5 mg of rivaroxaban twice a day plus 100 mg of aspirin once a day.
- 5 mg of rivaroxaban twice daily with no aspirin.
- 100 mg of aspirin a day.
After 23 months, the trial ended earlier than scheduled because researchers found adding rivaroxaban to aspirin was clearly superior to taking only rivaroxaban or aspirin.
Risks of Adding Rivaroxaban
The most serious side effect of adding rivaroxaban to an aspirin regime is an increased risk of bleeding, most commonly in the stomach or lower intestine. However, there was no increase in fatal or brain bleeding. Most major bleedings were reversible. “The benefit that adding rivaroxaban brings to treatment far outweighs the increased risk of bleeding,” said Dr. Suresh.
The Food and Drug Administration is currently monitoring patients in Europe and Asia who are adding low-dose rivaroxaban to their daily aspirin therapy. Although rivaroxaban is approved for use in other applications, it has not yet been approved in a low dose for use with cardiovascular peripheral artery disease. Approval is expected within the next year, according to Dr. Suresh.
“This could be life changing for many people with PAD and heart disease,” said Dr. Suresh. “We already have good data for treating heart disease. It is very tough to move the needle but this study does that. The potential benefits are overwhelmingly positive.”