Real-world data: ARNI more effective in reducing adverse outcomes in HFrEF than RAAS blockade

Real-world Comparison Between ARNI and RAS Blockade in Patients With HFrEF

Presented at the ESC Heart Failure 2023 by: Byungsu Yoo, MD, PhD - Wonju, South Korea

Introduction and methods

Previously, the PARADIGM-HF trial showed that sacubitril/valsartan was superior to enalapril in reducing HF hospitalization and CV and all-cause mortality in patients with HFrEF. However, real-world evidence does have its advantages over data derived from RCTs, such as rapid access to data and information on medication adherence.

In the observational PARADE-HF (Comparative Effectiveness Between ARNI and ACE Inhibitor/ARB Medication in Patient With HFrEF) study, the effect of treatment with ARNI versus traditional RAAS blockade on 1-year mortality and any hospitalization was compared in HFrEF patients using the Korean National Health Insurance Database, a nationwide real-world database containing drug prescription and claims data. Using 1:1 propensity score matching, 13,483 HFrEF patients receiving an ARNI and an equal number of patients receiving traditional RAAS blockade were included.

The primary endpoint was a composite outcome of all-cause mortality or any hospitalization at 1 year. Secondary endpoints were the individual components of the primary endpoint.

Main results

• The primary endpoint occurred in 4726 patients (49.1%) in the ARNI group and 5525 patients (64.1%) in the RAAS blockade group (HR: 0.78; 95%CI: 0.75–0.81; P<0.001).
• The risks of all-cause mortality (HR: 0.86; 95%CI: 0.78–0.94; P<0.001) and any hospitalization (HR: 0.77; 95%CI: 0.74–0.80; P<0.001) were also lower in the ARNI group compared with the RAAS blockade group.
• Subgroup analyses showed the treatment effect of ARNI on the primary endpoint was consistent across most, predefined, subgroups.
• In patients with a proportion of days covered (PDC) ≥80%, the risk of the primary endpoint was lower in the ARNI group compared with the RAAS blockade group (HR: 0.75; 95%CI: 0.72–0.78; P<0.001). This risk reduction was, however, not observed in patients with lower medication adherence (i.e., PDC <80%) (HR: 0.95; 95%CI: 0.85–1.05; P=0.313; P for interaction<0.001).
• Interaction by PDC status was also observed for the risk of any hospitalization (P for interaction<0.001) but not for risk of all-cause mortality (P for interaction=0.584).

Conclusion

In a real-world, Korean cohort of 26,966 HFrEF patients, ARNI was more effective in reducing the 1-year risk of all-cause mortality or any hospitalization than traditional RAAS blockade. The beneficial effect of ARNI was more pronounced in patients with good medication adherence (i.e., PDC ≥80%).

- Our reporting is based on the information provided at the ESC Heart Failure 2023 -