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Long-Term Outcomes of Patients With Mediastinal Radiation–Associated Coronary Artery Disease Undergoing Coronary Revascularization With Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting Systematic Review and Network Meta‐Analysis Comparing Bifurcation Techniques for Percutaneous Coronary Intervention Does pulsed field ablation regress over time? A quantitative temporal analysis of pulmonary vein isolation Current Status and Future Prospects of Transcatheter Mitral Valve Replacement: JACC State-of-the-Art Review Implications of the local hemodynamic forces on the formation and destabilization of neoatherosclerotic lesions Transseptal puncture versus patent foramen ovale or atrial septal defect access for left atrial appendage closure 2015 ACC/HRS/SCAI Left Atrial Appendage Occlusion Device Societal Overview Evolving insights into the role of local shear stress in late stent failure from neoatherosclerosis formation and plaque destabilization Management and outcomes of patients with left atrial appendage thrombus prior to percutaneous closure Alcohol consumption, cardiac biomarkers, and risk of atrial fibrillation and adverse outcomes
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FDA Updates Prescribing Information For Alirocumab

ACC News Story


The U.S. Food and Drug Administration (FDA) has updated prescribing information for alirocumab (Praluent) as of April 26, 2019. Specifically, the updated prescribing information states that "Praluent is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor antibody indicated:

  • to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. (1.1)
  • as adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol LDL-C. (1.2)"


The FDA update follows data from the ODYSSEY OUTCOMES trial assessing the effect of adding Praluent to maximally-tolerated statins on cardiovascular outcomes in 18,924 patients who had an acute coronary syndrome (ACS) within a year of enrolling in the trial. The original results were published in theNew England Journal of Medicinein November 2018, with a recent subgroup analysis presented at ACC.19. For complete drug label information visit the FDA's DailyMed website.

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