Abstract
Introduction The current use of lipid lowering therapies and the eligibility for proprotein convertase subtilisin/kexin-9 (PCSK9) inhibitors of patients surviving a myocardial infarction (MI) is poorly known. Methods Using the data from two contemporary, nationwide, prospective, real-world registries of patients with stable coronary artery disease, we sought to describe the lipid lowering therapies prescribed by cardiologists in patients with a prior MI and the resulting eligibility for PCSK9 inhibitors according to the European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) and the Italian regulatory agency (Agenzia Italiana del Farmaco; AIFA) criteria. The study cohort was stratified according to the following low-density lipoprotein cholesterol (LDL-C) levels at the time of enrolment: <70 mg/dl; 70–99 mg/dl and ≥100 mg/dl. Results Among the 3074 post-MI patients with LDL-C levels available, a target level of LDL-C < 70 mg/dl was present in 1186 (38.6%), while 1150 (37.4%) had LDL-C levels ranging from 70 to 99 mg/dl and the remaining 738 (24.0%) an LDL-C ≥ 100 mg/dl. A statin was prescribed more frequently in post-MI patients with LDL-C levels <70 mg/dl (97.1%) compared to the other LDL-C groups (p < 0.0001). A low dose of statin was prescribed in 9.3%, while a high dose in 61.4% of patients. Statin plus ezetimibe association therapy was used in less than 18% of cases. In the overall cohort, 293 (9.8%) and 450 (22.2%) resulted eligible for PCSK9 inhibitors, according to ESC/EAS and AIFA criteria, respectively. Conclusions Post-MI patients are undertreated with conventional lipid lowering therapies. A minority of post-MI patients would be eligible to PCSK9 inhibitors according to ESC/EAS guidelines and Italian regulatory agency criteria.
Highlights
Long-term prognosis of patients a er a myocardial infarction (MI) has considerably improved, the residual risk of these patients remains high with a recurrence rate of ischemic fatal and nonfatal events of 20–30% within 3 years [1]
Several secondary prevention trials [2, 3] have consistently demonstrated a direct correlation between low-density lipoprotein cholesterol (LDL-C) levels achieved during lipid-lowering therapies and the risk of atherosclerotic cardiovascular disease (ASCVD)
Analyses of large real-world database might be useful in order to provide this information, which is pivotal to estimate the subsequent budget impact associated with the widespread adoption of these therapies and to evaluate the proportion of high risk ASCVD patients not reaching the recommended LDL-C targets who are deprived of benefit and improved outcomes by lack of use of proprotein convertase subtilisin/kexin-9 (PCSK9) inhibitors
Summary
Long-term prognosis of patients a er a myocardial infarction (MI) has considerably improved, the residual risk of these patients remains high with a recurrence rate of ischemic fatal and nonfatal events of 20–30% within 3 years [1]. Analyses of large real-world database might be useful in order to provide this information, which is pivotal to estimate the subsequent budget impact associated with the widespread adoption of these therapies and to evaluate the proportion of high risk ASCVD patients not reaching the recommended LDL-C targets who are deprived of benefit and improved outcomes by lack of use of PCSK9 inhibitors. All patients included into the analysis were evaluated for PCSK9 inhibitor eligibility using the ESC/EAS clinical guidance recommendations [15] and the criteria released by the Italian regulatory agency AIFA. Analyses were performed with SAS system so ware, version 9.4
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