Practice Update - ESC Congress 2017

Rivaroxaban + Aspirin Is Shown to Improve Outcomes in Patients With Stable Cardiovascular Disease – COMPASS Trial

rivaroxaban and aspirin arms be stopped because of clear superiority of the com- bination of rivaroxaban and aspirin over aspirin alone. The results indicated that the addition of rivaroxaban to aspirin, compared with aspirin alone, reduced cardiovascular death, stroke, and heart attack by 24%, and improved survival by 18%. Rivaroxaban 5 mg twice daily was not superior to aspirin alone. The addition of rivaroxaban to aspirin increased bleeding, the most common site of which was the stomach or lower bowel. No significant increase in fatal or brain bleeding was observed. “Recent trials in other diseases have demonstrated substantial benefits of using low doses of a combination of drugs. This concept is now further sup- ported by the results of COMPASS,” the authors concluded. Co-investigator Stuart Connolly, MD, also of McMaster University, suggested that the increase in bleeding should be consid- ered in the context of the overall findings. He added that the results showed a clear net benefit for patients, as highlighted by the 18% reduction in mortality.

Rivaroxaban + aspirin has been shown to improve survival and reduce stroke and heart attack in patients with stable coronary or peripheral artery disease. This conclusion, based on results of the prematurely halted Cardiovascular OutcoMes for People using Anticoagulation StrategieS (COMPASS) trial, was presented at the 2017 European Society of Cardiology (ESC) Congress, from August 26–30.

Dr. John Eikelboom

J ohn Eikelboom, MBBS, of McMaster University, Hamilton, Ontario, Canada, explained that one-third of the 55 million deaths in the world each year are from cardiovascular causes. Patients with known coronary or periph- eral artery disease are at risk of death, stroke and heart attack. Aspirin is the single most widely used treatment to prevent strokes and heart attacks but is only modestly effective. John Eikelboom, MBBS, of McMaster University, Hamilton, Ontario, Canada, the study’s lead author and colleagues noted in an accompanying publication that “despite the use of effective secondary prevention strategies, 5 to 10% of patients with cardiovascular disease have recurrent events each year. They add that long-term treatment with a vitamin K antagonist, alone or in combination with aspirin, is superior to aspirin for secondary preven- tion after acute myocardial infarction but is associated with more bleeding, including intracranial bleeding. “Thus, anticoagula- tion has generally not been recommended for patients in this context.” In the Anti-Xa Therapy to Lower cardio- vascular events in Addition to Standard therapy in subjects with Acute Coronary Syndrome ACS 2–Thrombolysis In Myocardial Infarction 51 (ATLAS ACS 2-TIMI 51) trial involving patients with acute coro- nary syndrome receiving standardmedical therapy, rivaroxaban 2.5 or 5.0 mg twice daily reduced the risk of a composite of cardiovascular death, myocardial infarction, or stroke vs placebo, with a mortality ben- efit seen at the lower dose. As expected, major bleeding was increased. The COMPASS trial set out to evaluate two possible ways to improve the protection by aspirin against heart attack and stroke

in patients with stable coronary or periph- eral artery disease: 1. The combination of rivaroxaban and aspirin 2. Rivaroxaban alone The trial randomized 27,395 patients from 33 countries in North America, South America, Asia, Western Europe, Eastern Europe, South Africa, and Australia. Rivaroxaban 2.5 mg twice daily + aspirin 100 mg once daily and rivaroxaban 5 mg twice daily were both compared with standard therapy with aspirin 100 mg once daily. The primary endpoint was a composite of cardiovascular death, stroke, or myocardial infarction. In February 2017, the Data Safety Monitoring Board recommended that the

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