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Eligibility for PCSK9 inhibitors based on the 2019 ESC/EAS and 2018 ACC/AHA guidelines
Konstantinos C Koskinas1, Baris Gencer2, David Nanchen3
1Department of Cardiology, University Hospital Bern, Switzerland.
Insights
New lipid guidelines impact eligibility for proprotein convertase subtilisin/kexin-9 inhibitors (PCSK9i) in acute coronary syndrome patients. The ESC/EAS guidelines identify significantly more patients as eligible for PCSK9i compared to ACC/AHA guidelines.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Guidelines
Background:
- Recent updates to lipid management guidelines from ACC/AHA (2018) and ESC/EAS (2019) have revised recommendations for proprotein convertase subtilisin/kexin-9 inhibitors (PCSK9i).
- PCSK9 inhibitors represent a significant advancement in lipid-lowering therapy, particularly for high-risk cardiovascular patients.
Purpose of the Study:
- To evaluate the potential eligibility for PCSK9i treatment in patients following an acute coronary syndrome (ACS) based on the latest ACC/AHA and ESC/EAS guidelines.
- To compare the proportion of ACS patients eligible for PCSK9i under the different guideline criteria.
Main Methods:
- Analysis of a prospective Swiss cohort of 2521 patients hospitalized for ACS.
- Modeling of statin intensification and ezetimibe effects on low-density lipoprotein-cholesterol (LDL-C) levels.
- Assessment of PCSK9i eligibility at one year post-ACS using ESC/EAS (LDL-C < 1.4 mmol/l) and ACC/AHA (LDL-C < 1.8 mmol/l in very high-risk patients) criteria.
Main Results:
- At one year, 37.5% of patients had LDL-C < 1.8 mmol/l and 15.7% had LDL-C < 1.4 mmol/l.
- After modeling intensified statin and ezetimibe therapy, LDL-C levels < 1.8 mmol/l and < 1.4 mmol/l were achieved in 76.1% and 49% of patients, respectively.
- Eligibility for PCSK9i was 51% based on ESC/EAS criteria versus 14% based on ACC/AHA criteria.
Conclusions:
- The 2019 ESC/EAS guidelines identify a substantially larger proportion of post-ACS patients as eligible for PCSK9i treatment compared to the 2018 ACC/AHA guidelines.
- Intensification of statin and ezetimibe therapy significantly increases the number of patients achieving target LDL-C levels, influencing PCSK9i eligibility.
- Guideline differences have a major impact on identifying patients who could benefit from PCSK9 inhibitors after an acute coronary syndrome.
Aims:
The 2018 American College of Cardiology (ACC)/American Heart Association (AHA) and 2019 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) lipid guidelines recently updated their recommendations regarding proprotein convertase subtilisin/kexin-9 inhibitors (PCSK9i). We assessed the potential eligibility for PCSK9i according to the new guidelines in patients with acute coronary syndromes.
Methods And Results:
We analysed a contemporary, prospective Swiss cohort of patients hospitalised for acute coronary syndromes. We modelled a statin intensification effect and an incremental ezetimibe effect on low-density lipoprotein-cholesterol levels among patients who were not on high-intensity statins or ezetimibe. One year after the index acute coronary syndrome event, treatment eligibility for PCSK9i was defined as low-density lipoprotein-cholesterol of 1.4 mmol/l or greater according to ESC/EAS guidelines. For ACC/AHA guidelines, treatment eligibility was defined as low-density lipoprotein-cholesterol of 1.8 mmol/l or greater in the presence of very high-risk atherosclerotic cardiovascular disease, defined by multiple major atherosclerotic cardiovascular disease events and/or high-risk conditions. Of 2521 patients, 93.2% were treated with statins (53% high-intensity statins) and 7.3% with ezetimibe at 1 year, and 54.9% had very high-risk atherosclerotic cardiovascular disease. Low-density lipoprotein-cholesterol levels less than 1.8 mmol/l and less than 1.4 mmol/l at 1 year were observed in 37.5% and 15.7% of patients, respectively. After modelling the statin intensification and ezetimibe effects, these numbers increased to 76.1% and 49%, respectively. The proportion of patients eligible for PCSK9i was 51% according to ESC/EAS criteria versus 14% according to ACC/AHA criteria.
Conclusions:
In this analysis, the 2019 ESC/EAS guidelines rendered half of all post-acute coronary syndrome patients potentially eligible for PCSK9i treatment, as compared to a three-fold lower eligibility rate based on the 2018 ACC/AHA guidelines.
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