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) is proposed as 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.
See also: Novel Biomarkers in Risk Assessment and Management of Cardiovascular Disease
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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. Medical Policy Reference Manual. (12.2017). Measurement of lipoprotein-associated phospholipase A2 in the assessment of cardiovascular risk (2.04.32). Retrieved April 2, 2018 from BlueWeb. (43 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.
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.
Palmetto Government Benefits Administrators (2018, February) Local Coverage Determination (LCD): MolDX: Biomarkers in Cardiovascular Risk Assessment (L36129) Retrieved April 2, 2018 from https://www.cms.gov.
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: 5/10/2018
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