On June 6, 2018, Bayer announced the results of a subgroup analysis from the COMPASS trial in patients with coronary artery disease (CAD) and peripheral artery disease (PAD), with or without concomitant heart failure. The subgroup analysis demonstrated that in CAD and PAD patients with mild-to-moderate heart failure, rivaroxaban at an arterial dose of 2.5 mg twice daily combined with aspirin 100 mg once daily significantly reduced the risk of the primary composite endpoint (myocardial infarction, stroke, and cardiovascular death) and significantly improved clinical net benefit by 31%.[i]。
The incidence of bleeding was consistent with that of the overall study population, and patients with heart failure had a lower incidence of bleeding compared to those without heart failure. The data were presented on May 28, 2018, at the Heart Failure 2018 Congress held in Vienna, Austria.
Heart failure is the fastest-growing cardiovascular disease, with over 60 million patients worldwide, resulting in substantial morbidity, mortality, and economic burden. Furthermore, coronary artery disease is the leading cause of heart failure, with nearly 65% of heart failure patients diagnosed with coronary artery disease as the underlying etiology.[ii]. More importantly, it has been confirmed that heart failure leads to coronary artery disease in patients[ii]A 50% increase in 5-year mortality post-diagnosis. Additionally, heart failure is the leading cause of hospitalization among individuals aged 65 and older.
“The COMPASS trial has already provided robust evidence for the use of rivaroxaban in patients with coronary artery disease or peripheral artery disease, and we are now seeing highly promising data in those with concomitant mild-to-moderate heart failure,” said Martin van Eickels, Therapeutic Area Medical Director at Bayer. “Despite optimized management according to guidelines, morbidity and mortality rates among patients with heart failure remain high. We will continue to explore additional therapeutic options for this patient population.”
The COMPASS study enrolled a total of 27,395 patients with coronary artery disease or peripheral artery disease, including 5,902 patients with concomitant mild-to-moderate heart failure. Among patients with heart failure, the incidence of the primary endpoint was 5.5% in the rivaroxaban combination therapy group (rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily) and 7.9% in the aspirin monotherapy group (aspirin 100 mg once daily), representing an absolute risk reduction of 2.4%, equivalent to one patient benefiting for every 42 patients treated. Among patients without heart failure, the incidence of the primary endpoint was 3.8% in the rivaroxaban combination therapy group and 4.7% in the aspirin monotherapy group.
Clinical net benefit is a metric that comprehensively evaluates the incidence rates of primary endpoint events and major bleeding events. The clinical net benefit in patients with heart failure was consistent with that in patients without heart failure and with the overall population, and the absolute risk reduction was greater in patients with heart failure than in those without. Among patients with mild-to-moderate heart failure, the absolute risk reduction was 2.4% in the rivaroxaban combination therapy group compared with the aspirin monotherapy group, whereas it was 0.8% in patients without heart failure.
References:
[i] Branch K. Rivaroxaban Plus Aspirin In Patients With And Without Heart Failure And Chronic Coronary or Peripheral Artery Disease: The COMPASS Trial. Presentation at Heart Failure Congress 2018.
[ii] Gheorghiade M, Sopko G, De Luca L et al. Navigating the Crossroads of Coronary Artery Disease and Heart Failure. Circulation 2006;114:1202–1213.