Coordinated post-myocardial infarction care versus the PCSK9 modulator drug program: a comparative outcomes study
M Banach, M Kruk, B Kon, A Machnio, J Lewek, B Sosnowska, R Gil, A Bielecka-Dabrowa, M Galazka-SobotkaAbstract
Background
Despite effective and innovative contemporary therapies, survivors of acute myocardial infarction (AMI) remain at high risk for recurrent events and death. In Poland, two distinct nationwide pathways address this risk: KOS-Zawał, a multidisciplinary programme combining early cardiac rehabilitation, lifestyle counselling, and systematic follow-up, which has already demonstrated substantial efficacy, and the drug program B.101, a pharmacotherapy-centred pathway providing intensive combination lipid-lowering therapy with PCSK9 modulators for MI patients. Robust head-to-head data comparing these two effective strategies are lacking.
Purpose
To assess whether participation in the B.101 drug program favourably affects endpoints in post-MI patients compared to those participating in the KOS-Zawał program and not included in the drug program.
Methods
Patients who participated in the KOS-Zawał program between 2021-2024 and experienced an AMI during their program care period (within 30 days) were included. Similarly, patients who began the B.101 program under the "very high cardiovascular risk" branch between 2021–2024 were selected. Those who appeared in both investigated groups simultaneously were excluded from the defined population. Both groups were matched using propensity score matching (PSM) that was conducted in a 4:1 ratio (KOS-Zawał:B.101). The groups were compared in terms of endpoints: all-cause mortality, and the composite of death or AMI occurrence.
Results
The final dataset included 1,760 patients (n=352 in the B.101 group and n=1,408 in the KOS-Zawał group), comprising 1,200 men (68.2%) and 560 women, with a mean age of 60.6 years. Diabetes was diagnosed in 28% of patients, obesity in 6.5%, chronic kidney disease in 5.7%, and stroke or TIA in 4%. Based on logistic regression analysis over a follow-up of 2 years, there were no statistically significant differences for all-cause mortality or the composite endpoint (KOS-Zawał vs. B.101 program; OR=1.83, p=0.287, and OR=1.28, p=0.506). Based on the Cox proportional hazards model with a longer follow-up of 4.4 years, the KOS-Zawał comprehensive program, compared to the treatment of patients with PCSK9 modulators in the B101 program, was associated with a significantly higher risk of death (HR=3.28; 95%CI: 1.52–7.07) (Figure 1A) and the composite of death or recurrent acute myocardial infarction (HR=1.70; 95%CI: 1.10–2.63) (Figure 1B).
Conclusions
The B101 drug program, where patients are treated with intensive combination LLT including statins, ezetimibe, and PCSK9 inhibitors or inclisiran, is associated with a significant 70% lower risk of all-cause mortality and a 41% lower risk of death or recurrent AMI compared to patients included in the coordinated comprehensive post-MI care program. These findings suggest that, for optimal healthcare outcomes, the B.101 drug program should be made available to all patients enrolled in KOS-Zawał.Figure