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Safety of six-month dual antiplatelet therapy after second-generation drug-eluting stent implantation: OPTIMA-C Randomised Clinical Trial and OCT Substudy Non-obstructive High-Risk Plaques Increase the Risk of Future Culprit Lesions Comparable to Obstructive Plaques Without High-Risk Features: The ICONIC Study Surgery Does Not Improve Survival in Patients With Isolated Severe Tricuspid Regurgitation Rationale and design of the comParIson Of sacubitril/valsartaN versus Enalapril on Effect on nt-pRo-bnp in patients stabilized from an acute Heart Failure episode (PIONEER-HF) trial Cost-Effectiveness of Different Durations of Dual-Antiplatelet Use After Percutaneous Coronary Intervention A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation in patients with systolic heart failure: rationale, design, and baseline patient characteristics. Prognostic implication of lipidomics in patients with coronary total occlusion undergoing PCI Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials 6-Month Versus 12-Month Dual-Antiplatelet Therapy Following Long Everolimus-Eluting Stent Implantation: The IVUS-XPL Randomized Clinical Trial Plaque composition by intravascular ultrasound and distal embolization after percutaneous coronary intervention

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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.