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Eligibility for PCSK9 inhibitors according to ESC/EAS and ACC recommendations after acute coronary syndromes

Session Lipid-lowering therapy: old faces and new issues

Speaker Doctor Konstantinos Koskinas

Event : ESC Congress 2017

  • Topic : preventive cardiology
  • Sub-topic : Lipids
  • Session type : Moderated Posters

Authors : KC Koskinas (Bern,CH), B Gencer (Geneva,CH), L Raeber (Bern,CH), A Karagiannis (Bern,CH), D Nanchen (Lausanne,CH), D Carballo (Geneva,CH), S Carballo (Geneva,CH), R Klingenberg (Zurich,CH), D Heg (Bern,CH), C Matter (Zurich,CH), TF Luscher (Zurich,CH), N Rodondi (Bern,CH), S Windecker (Bern,CH), F Mach (Geneva,CH)

K.C. Koskinas1 , B. Gencer2 , L. Raeber1 , A. Karagiannis1 , D. Nanchen3 , D. Carballo2 , S. Carballo2 , R. Klingenberg4 , D. Heg5 , C. Matter4 , T.F. Luscher4 , N. Rodondi6 , S. Windecker1 , F. Mach2 , 1Bern University Hospital, Cardiology - Bern - Switzerland , 2Geneva University Hospitals, Cardiology - Geneva - Switzerland , 3University of Lausanne, Department of Ambulatory Care and Community Medicine - Lausanne - Switzerland , 4University Heart Center, Department of Cardiology - Zurich - Switzerland , 5Institute of Social and Preventive Medicine, University of Bern - Bern - Switzerland , 6University Hospital of Bern, Department of General Internal Medicine, - Bern - Switzerland ,

Prevention - Lipids

European Heart Journal ( 2017 ) 38 ( Supplement ), 29

Background: PCSK9 inhibitors have emerged as a promising treatment option for management of dyslipidemia. The European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) and the American College of Cardiology (ACC) have issued recommendations regarding the use of PCSK9 inhibitors in selected patients. Treatment eligibility rates according to these recommendations in real-world clinical practice remain unknown.

Purpose: To assess in a contemporary, real-world setting the eligibility for PCSK9 inhibitors after acute coronary syndromes (ACS) according to ESC/EAS vs. ACC recommendations.

Methods: We analysed a prospective Swiss cohort of 2,023 patients hospitalized for ACS between 2009 and 2014. Patients received optimal secondary prevention treatment. One year after enrollment, eligibility for PCSK9 inhibitor treatment was defined according to the ESC/EAS vs. ACC criteria on the basis of on-treatment levels of low-density lipoprotein cholesterol (LDL-C); achieved reduction in LDL-C; and high-risk clinical characteristics (rapid disease progression or comorbidities). Familial hypercholesterolemia (FH) was defined using the Dutch Lipid Clinic Network criteria. Because treatment with ezetimibe on top of maximally tolerated statin is included in both the ESC/EAS and ACC eligibility algorithms, we modelled a fixed relative reduction of 24% in LDL-C levels at one year in all patients not treated with ezetimibe.

Results: At one year, 94.3% of patients were treated with statin (55.3% with high-intensity statin) and 5.8% with ezetimibe. Mean LDL-C levels were 2.19±0.86 mmol/l at one year, and 35.8% of patients had LDL-C levels <1.8 mmol/l. After simulating the LDL-C-lowering effect of ezetimibe, the proportion of patients who would be eligible for PCSK9 inhibitor treatment at one year was 2.7% according to ESC/EAS criteria vs. 13.4% based on ACC criteria. Respective rates without modelling the ezetimibe effect would be 10.6% vs. 31.4%. In multivariable analysis, predictors of treatment eligibility with PCSK9 inhibitors included probable/definite FH (OR 3.38, 95% CI 1.70–6.72 for ESC/EAC criteria and 3.99, 95% CI 2.82–5.64 for ACC criteria; p<0.001) and non-attendance to a cardiac rehabilitation program after hospital discharge (OR 0.31, 95% CI 0.16–0.60 for ESC/EAS criteria and OR 0.48, 95% CI 0.34–0.66 for ACC criteria; p<0.001).

Conclusions: In this sizable cohort of ACS patients receiving contemporary secondary-prevention treatment for one year, recommendations made by the ACC would lead to five times higher eligibility rates for PCSK9 inhibitor treatment compared with the ESC/EAS statement. EligibilIty rates would increase substantially without the incremental LDL-C-lowering effect by ezetimibe. Coupled with findings of large outcomes trials, these observations may have implications for guiding clinical decision-making and enhancing cost-effectiveness analyses with regard to rational use of PCSK9 inhibitors.

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