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Raising the Evidentiary Bar for Guideline Recommendations for TAVR: JACC Review Topic of the Week Coronary plaque redistribution after stent implantation is determined by lipid composition: A NIRS-IVUS analysis Quality of Life after Everolimus-Eluting Stents or Bypass Surgery for Treatment of Left Main Disease Ticagrelor Monotherapy Versus Dual-Antiplatelet Therapy After PCI: An Individual Patient-Level Meta-Analysis Successful bailout stenting strategy against lethal coronary dissection involving left main bifurcation Intravascular Ultrasound Parameters Associated With Stent Thrombosis After Drug-Eluting Stent Deployment Criteria for Iron Deficiency in Patients With Heart Failure Contribution of stent underexpansion to recurrence after sirolimus-eluting stent implantation for in-stent restenosis The impact of intravascular ultrasound guidance during drug eluting stent implantation on angiographic outcomes Comparison of inhospital mortality, length of hospitalization, costs, and vascular complications of percutaneous coronary interventions guided by ultrasound versus angiography
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FDA Updates Prescribing Information For Alirocumab

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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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