A review of the latest clinical trial data and medical advances from the European Society of Cardiology Congress in Barcelona.
Rivaroxaban plus aspirin improves survival and reduces stroke and heart attack in patients with stable coronary or peripheral artery disease, according to results from the COMPASS trial presented at the ESC.
Aspirin is the single most widely used treatment to prevent strokes and heart attacks, but is only modestly effective. Published in the NEJM, the COMPASS trial tested two possible ways to improve on aspirin, by using the combination of rivaroxaban and aspirin, or by using rivaroxaban alone, to protect against heart attack and stroke in patients with stable coronary or peripheral artery disease.
The trial randomised 27,395 patients from 33 countries in North America, South America, Asia, Western Europe, Eastern Europe, South Africa and Australia. The treatments tested were rivaroxaban 2.5mg twice daily plus aspirin 100mg once daily and rivaroxaban 5mg twice daily, each of which were compared to standard therapy with aspirin 100mg once daily. The primary endpoint was a composite of cardiovascular death, stroke or myocardial infarction.
On 6 February 2017, the Data Safety Monitoring Board recommended that the rivaroxaban and aspirin arms be stopped because of a clear superiority of the combination of rivaroxaban and aspirin over aspirin alone.
The results indicate that the addition of rivaroxaban to aspirin, compared with aspirin alone, reduced cardiovascular death, stroke, or heart attack by 24%, and improved survival by 18%. Rivaroxaban 5mg twice daily was not superior to aspirin alone. The addition of rivaroxaban to aspirin increased bleeding, and the most common site of bleeding was in the stomach or lower bowel. There was no significant increase in fatal or brain bleeding.