Biomarkers: A Challenging Conundrum in Cardiovascular Disease

Arteriosclerosis, Thrombosis, and Vascular Biology

Volumn 35, Issue 12, 2015, Pages 2491-2495

  Libby, Peter ^a   King, Kevin ^a,b  

^a HARVARD MEDICAL SCHOOL   (United States)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

Author keywords

Biological markers; clinical trial; laboratories; prognosis; risk assessment

Indexed keywords

BIOLOGICAL MARKER;

AMBULATORY CARE; ARTICLE; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CARDIOVASCULAR THERAPEUTIC DEVICE; CLINICAL EFFECTIVENESS; CLINICAL PRACTICE; CLINICAL TRIAL (TOPIC); DIAGNOSTIC VALUE; EMERGENCY CARE; HUMAN; MICROFLUIDICS; PATIENT CARE; PHYSICIAN; POINT OF CARE TESTING; PRIORITY JOURNAL; PROGNOSIS; TRANSLATIONAL RESEARCH; WEARABLE DEVICE; ANIMAL; CARDIOVASCULAR DISEASES; METABOLISM; PREDICTIVE VALUE; REPRODUCIBILITY; RISK FACTOR;

ANIMALS; BIOMARKERS; CARDIOVASCULAR DISEASES; HUMANS; PREDICTIVE VALUE OF TESTS; PROGNOSIS; REPRODUCIBILITY OF RESULTS; RISK FACTORS;

EID: 84948078116     PISSN: 10795642     EISSN: 15244636     Source Type: Journal    
DOI: 10.1161/ATVBAHA.115.305233     Document Type: Article

References (31)

1. Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther. 2001;69:89-95.
2. Varo N, Nuzzo R, Natal C, Libby P, Schönbeck U. Influence of pre-analytical and analytical factors on soluble CD40L measurements. Clin Sci (Lond). 2006;111:341-347. doi: 10.1042/CS20060047.
3. Melo SA, Luecke LB, Kahlert C, Fernandez AF, Gammon ST, Kaye J, LeBleu VS, Mittendorf EA, Weitz J, Rahbari N, Reissfelder C, Pilarsky C, Fraga MF, Piwnica-Worms D, Kalluri R. Glypican-1 identifies cancer exosomes and detects early pancreatic cancer. Nature. 2015;523:177-182. doi: 10.1038/nature14581.
4. Loyer X, Vion AC, Tedgui A, Boulanger CM. Microvesicles as cell-cell messengers in cardiovascular diseases. Circ Res. 2014;114:345-353. doi: 10.1161/CIRCRESAHA.113.300858.
5. Scheiermann C, Kunisaki Y, Frenette PS. Circadian control of the immune system. Nat Rev Immunol. 2013;13:190-198. doi: 10.1038/nri3386.
6. Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled Ann Intern Med. 1996;125:605-613.
7. Libby P, Gerszten RE, Ridker PM. Biomarkers, proteomics, metabolomics, and personalized medicine. In: Mann DL, Zipes DP, Libby P, Bonow RO, eds. Braunwald's Heart Disease: A Textbook of Cardiovascular Medicine, 10th ed. Philadelphia: Elsevier Saunders; 2014:84-93.
8. Ioannidis JP, Panagiotou OA. Comparison of effect sizes associated with biomarkers reported in highly cited individual articles and in subsequent meta-analyses. JAMA. 2011;305:2200-2210. doi: 10.1001/jama.2011.713.
9. Anitschkow N, Chalatow S. On experimental cholesterin steatosis and its significance in the origin of some pathological processes (1913). Arteriosclerosis. 1983;3:178-182.
10. Steinberg D. In celebration of the 100th anniversary of the lipid hypothesis of atherosclerosis. J Lipid Res. 2013;54:2946-2949. doi: 10.1194/jlr. R043414.
11. Morgan TM, Krumholz HM, Lifton RP, Spertus JA. Nonvalidation of reported genetic risk factors for acute coronary syndrome in a large-scale replication study. JAMA. 2007;297:1551-1561. doi: 10.1001/jama.297.14.1551.
12. Musunuru K, Strong A, Frank-Kamenetsky M, Lee NE, Ahfeldt T, Sachs KV, Li X, Li H, Kuperwasser N, Ruda VM, Pirruccello JP, Muchmore B, Prokunina-Olsson L, Hall JL, Schadt EE, Morales CR, Lund-Katz S, Phillips MC, Wong J, Cantley W, Racie T, Ejebe KG, Orho-Melander M, Melander O, Koteliansky V, Fitzgerald K, Krauss RM, Cowan CA, Kathiresan S, Rader DJ. From noncoding variant to phenotype via SORT1 at the 1p13 cholesterol locus. Nature. 2010;466:714-719. doi: 10.1038/nature09266.
13. Cohen JC, Boerwinkle E, Mosley TH Jr, Hobbs HH. Sequence variations in PCSK9, low LDL, and protection against coronary heart disease. N Engl J Med. 2006;354:1264-1272. doi: 10.1056/NEJMoa054013.
14. Ference BA, Yoo W, Alesh I, Mahajan N, Mirowska KK, Mewada A, Kahn J, Afonso L, Williams KA Sr, Flack JM. Effect of long-term exposure to lower low-density lipoprotein cholesterol beginning early in life on the risk of coronary heart disease: a Mendelian randomization analysis. J Am Coll Cardiol. 2012;60:2631-2639. doi: 10.1016/j.jacc.2012.09.017.
15. Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, MacFadyen JG, Nordestgaard BG, Shepherd J, Willerson JT, Glynn RJ; JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008;359:2195-2207. doi: 10.1056/NEJMoa0807646.
16. Puntmann VO. How-to guide on biomarkers: biomarker definitions, validation and applications with examples from cardiovascular disease. Postgrad Med J. 2009;85:538-545. doi: 10.1136/pgmj.2008.073759.
17. Apple FS, Collinson PO; IFCC Task Force on Clinical Applications of Cardiac Biomarkers. Analytical characteristics of high-sensitivity cardiac troponin assays. Clin Chem. 2012;58:54-61. doi: 10.1373/clinchem.2011.165795.
18. Ridker PM, Cook NR. Statins: new American guidelines for prevention of cardiovascular disease. Lancet. 2013;382:1762-1765. doi: 10.1016/S0140-6736(13)62388-0.
19. Ridker PM, Buring JE, Rifai N, Cook NR. Development and validation of improved algorithms for the assessment of global cardiovascular risk in women: the Reynolds Risk Score. JAMA. 2007;297:611-619. doi: 10.1001/jama.297.6.611.
20. Cook NR, Paynter NP, Eaton CB, Manson JE, Martin LW, Robinson JG, Rossouw JE, Wassertheil-Smoller S, Ridker PM. Comparison of the Framingham and Reynolds Risk scores for global cardiovascular risk prediction in the multiethnic Women's Health Initiative. Circulation. 2012;125:1748-1756, S1-11. doi: 10.1161/CIRCULATIONAHA.111.075929.
21. Everett BM, Brooks MM, Vlachos HE, Chaitman BR, Frye RL, Bhatt DL; BARI 2D Study Group. Troponin and Cardiac Events in Stable Ischemic Heart Disease and Diabetes. N Engl J Med. 2015;373:610-620. doi: 10.1056/NEJMoa1415921.
22. Nadir MA, Rekhraj S, Wei L, Lim TK, Davidson J, MacDonald TM, Lang CC, Dow E, Struthers AD. Improving the primary prevention of cardiovascular events by using biomarkers to identify individuals with silent heart disease. J Am Coll Cardiol. 2012;60:960-968. doi: 10.1016/j. jacc.2012.04.049.
23. Emerging Risk Factors C, Di Angelantonio E, Gao P, et al. Glycated hemoglobin measurement and prediction of cardiovascular disease. JAMA. 2014;311:1225-1233. doi: 10.1001/jama.2014.1873.
24. Joseph L, Robinson JG. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition and the future of lipid lowering therapy. Prog Cardiovasc Dis. 2015;58:19-31. doi: 10.1016/j.pcad.2015.04.004.
25. Center for Drug Evaluation and Research. Guidance for industry diabetes mellitus: evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes, 2008. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071627.pdf.
26. Goodsaid F, Frueh F. Biomarker qualification pilot process at the US Food and Drug Administration. AAPS J. 2007;9:E105-E108. doi: 10.1208/aapsj0901010.
27. Težak Z, Kondratovich MV and Mansfield E. US FDA and personalized medicine: in vitro diagnostic regulatory perspective. Per Med. 2010;7:517-530.
28. Christodoulides N, Floriano PN, Sanchez X, et al. Programmable bionanochip technology for the diagnosis of cardiovascular disease at the point of care. MDCVJ. 2012;8:6-12.
29. Barrett PM, Topol EJ. Pharmacogenetics: Point-of-care genetic testing-a new frontier explored. Nat Rev Cardiol. 2012;9:315-316. doi: 10.1038/nrcardio.2012.63.
30. Chin CD, Linder V, Sia SK. Commercialization of microfluidic point-ofcare diagnostic devices. Lab Chip. 2012;12:2118-2134. doi: 10.1039/c2lc21204h.
31. Ferguson BS, Hoggarth DA, Maliniak D, Ploense K, White RJ, Woodward N, Hsieh K, Bonham AJ, Eisenstein M, Kippin TE, Plaxco KW, Soh HT. Real-time, aptamer-based tracking of circulating therapeutic agents in living animals. Sci Transl Med. 2013;5:213-165. doi: 10.1126/scitranslmed.3007095.