Patients with stable atherosclerotic vascular disease who were assigned to rivaroxaban (2.5 mg twice daily) plus aspirin had better cardiovascular outcomes, but more major bleeding events, than patients taking aspirin alone. Researchers presented the results of the COMPASS trial in two separate presentations on Aug. 27 at the ESC Congress 2017 in Barcelona.

The double-blind trial randomized 27,395 participants with stable atherosclerotic vascular disease to rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg once daily). The primary outcome was a composite of cardiovascular death, stroke or myocardial infarction. The study was stopped for superiority of the rivaroxaban-plus-aspirin group after a mean follow-up of 23 months.

Overall results published in the New England Journal of Medicine showed the primary outcome occurred in fewer patients in the rivaroxaban-plus-aspirin group (379 patients) compared to the aspirin-alone group (496 patients). However, major bleeding events occurred in more patients in the rivaroxaban-plus-aspirin group (288 patients vs. 170 patients). Researchers noted no significant difference in intracranial or fatal bleeding between the two groups. Patients in the rivaroxaban-alone group did not experience better cardiovascular outcomes than those in the aspirin-only group, but did experience more major bleeding.

A deeper look at results in 7, 470 patients with peripheral artery disease, one-third of whom were current smokers and 44 percent of whom had diabetes, showed low-dose rivaroxaban plus aspirin reduced major adverse cardiovascular events, as well as limb-threatening ischemia, including amputation, by a combined total of 30 percent. This finding was consistent with the overall results from COMPASS. Rivaroxaban alone, compared to aspirin alone, did not reduce major adverse cardiovascular events, but did reduce major adverse limb events. However, researchers noted no significant difference when combining cardiovascular and limb events together. Rivaroxaban plus aspirin did increase the risk of major bleeding, but not the risk of fatal or critical organ bleeding. Most major bleedings were reversible.

Sonia Anand, MD, PhD, professor of medicine at McMaster University in Hamilton, Canada, who led the PAD component of the COMPASS trial said: “This is an important advance for patients with PAD. Until now, we have only had aspirin which is modestly effective. To now have a therapy that reduces major cardiovascular events and major adverse limb events by one third is going to be a great benefit for these high-risk patients.”

“This trial represents an important step forward in thrombocardiology, and it is likely to change practice guidelines. But is it the end of clinical investigation in this area? Probably not,” said Eugene Braunwald, MD, MACC, in a related editorial comment.

Keywords: ESC Congress, ESC2017, Aspirin, Peripheral Arterial Disease, Myocardial Infarction, Hemorrhage, Atherosclerosis, Diabetes Mellitus, Amputation, Stroke

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