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Rivaxoraban/aspirin reduces risk of MACE in CAD and/or PAD patients with heart failure: Results of a COMPASS sub-study

Heart Failure

Kelley Branch.jpgDr. Kelley Branch

Among patients with stable coronary artery disease (CAD) and/or peripheral artery disease (PAD), those with heart failure are at a higher risk of major adverse cardiovascular events (MACE) and derive a greater absolute benefit from rivaroxaban plus aspirin than those without heart failure. Yesterday, Doctor Kelley Branch (University of Washington, Seattle, Washington, USA) reported these findings from a sub-study of the large randomised, multicentre, multinational COMPASS trial (LBT25).

“The COMPASS trial, investigating secondary cardiovascular event prevention in over 27,000 patients with stable CAD and/or PAD, demonstrated practice-changing results,1” says Dr Branch. “A combination of rivaroxaban and aspirin significantly reduced the risk of MACE, defined as cardiovascular death, stroke or myocardial infarction, compared with standard aspirin monotherapy, and the trial was halted early due to the overwhelming efficacy of this approach. We wanted to look more closely at the data to see what the situation was for the 22% of patients (over 5,000) who had a history of heart failure,” says Dr. Branch. The median follow-up was 1.9 years (23 months). “The risk of MACE was higher among patients with heart failure than among those without heart failure, in both the rivaroxaban/aspirin combination and aspirin monotherapy arms,” explains Dr. Branch. “Also, while the rivaroxaban/aspirin combination reduced risk compared with aspirin in both groups, the absolute risk reduction was greater in patients with heart failure.”

“The absolute risk reduction in MACE achieved with rivaroxaban plus aspirin compared with aspirin was more than doubled in patients with heart failure (2.4%) compared with those without heart failure (1.0%).“

Absolute risk increases in major bleeding with rivaroxaban/aspirin compared with aspirin were reported in 0.7% and 1.4% of patients with and without heart failure, respectively. “For the net clinical benefit of rivaroxaban/aspirin compared with aspirin—which was based on a combination of MACE, fatal bleeding and bleeding into a critical organ—absolute risk reductions of 2.4% and 0.8% were seen in patients with and without heart failure, respectively. This translates into a smaller number needed to treat of 42 for patients with heart failure compared to 125 for patients without,” says Dr. Branch. What can we draw from these findings? Dr. Branch cautions that, as with all subgroup analyses, care should be taken not to overinterpret the findings. “However, the results do suggest that a combination of heart failure with CAD and/or PAD may be a useful marker for identifying patients who not only have a greater risk of MACE but who are also likely to derive a larger degree of absolute benefit from rivaroxaban/aspirin, compared with those without heart failure,” says Dr. Branch. “The results from other studies looking at rivaroxaban/aspirin in patients with CAD and heart failure, such as the COMMANDER HF trial in patients with heart failure with reduced ejection fraction (<35%), should give further insight into the benefit of the combination in patients with these diseases.”

1. Eikelboom JW, et al. N Engl J Med 2017;377:1319–1330.