Lipoprotein-Associated Phospholipase in the Assessment of Cardiovascular Risk
Lipoprotein-associated phospholipase A2 (Lp-PLA2), also known as platelet-activating factor acetylhydrolase, is a vascular inflammatory enzyme that hydrolyzes phospholipids and is primarily associated with low density lipoproteins. Lp-PLA2 (i.e., PLAC ® Test) may be a biomarker of coronary artery disease and has been proposed as an adjunct to conventional risk assessment in individuals to determine who might benefit from specific risk-reducing interventions such as pharmacological therapies and behavior modification strategies.
Measurement of lipoprotein-associated phospholipase A2 (Lp-PLA2) in the assessment of cardiovascular risk is considered investigational.
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Direct evidence for improved health outcomes with the use of Lp-PLA2 in clinical practice is lacking. Changes to an individual’s health management that would occur as a result of obtaining Lp-PLA2 levels in practice are not well-defined. The evidence is insufficient to determine the effects of the technology on health outcomes.
American Association of Clinical Endocrinologists / American College of Endocrinology (2017). Guidelines for management of dyslipidemia and prevention of cardiovascular disease. Retrieved April 2, 2018 from https://www.aace.com.
American College of Cardiology/American Heart Association (2013) 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk. Retrieved March 14, 2017 from: http://circ.ahajournals.org.
BlueCross BlueShield Association. Evidence Positioning System. (1.2019). Measurement of lipoprotein-associated phospholipase A2 in the assessment of cardiovascular risk (2.04.32). Retrieved February 12, 2019 from http://www.evidencepositioningsystem.com . (42 articles and/or guidelines reviewed)
Cai, A., Li, G., Chen, J., Li, X., Li, L., & Zhou, Y. (2015). Increased serum level of Lp-PLA2 is independently associated with the severity of coronary artery diseases: a cross-sectional study of Chinese population. BMC Cardiovascular Disorders, 15 (14), DOI 10.1186/s12872-015-0001-9. (Level 3 evidence)
Celik, O., Ozturk, D., Akin, F., Satilmis, S., Yalcin, A., Erturk, M., et al. (2015). Evaluation of lipoprotein-associated phospholipase A2 and plaque burden/composition in young adults. Coronary Artery Disease, 26 (3), 266-271. Abstract retrieved June 6, 2016 from PubMed database.
CMS.gov: Centers for Medicare & Medicaid Services, Palmetto GBA. (2018, February) MolDX: Biomarkers in Cardiovascular Risk Assessment (LCD ID L36129) Retrieved April 2, 2018 from https://www.cms.gov.
Li, D., Zhao, L., Yu, J., Zhang, W., Du, R., Liu, X., et. al. (2017, February) Lipoprotein-associated phospholipase A2 in coronary heart disease: Review and meta-analysis. Clinica Chimica Acta; 465:22-29. Abstract retrieved March 14, 2017 from PubMed database.
U.S. Food and Drug Administration. (2005, June). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K050523. Retrieved September 26, 2008 from http://www.accessdata.fda.gov.
U.S. Food and Drug Administration. (2014, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K141575. Retrieved June 6, 2016 from http://www.accessdata.fda.gov.
Ueshima, H., Kadowaki, T., Hisamatsu, T., Fujiyoshi, A., Miura, K., Ohkubo, T., et al. (2016). Lipoprotein-associated phospholipase A2 is related to risk of subclinical atherosclerosis but is not supported by Mendelian randomization analysis in a general Japanese population. Atherosclerosis, 246, 141-147. Abstract retrieved June 6, 2016 from PubMed database.
ORIGINAL EFFECTIVE DATE: 2/8/2009
MOST RECENT REVIEW DATE: 4/11/2019
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