Poor Predictive Value of High-Sensitivity C-Reactive Protein Indicates Need for Reassessment

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Abstract
Inflammation appears to be an integral part of the process of atherosclerosis that leads to coronary artery disease (CAD) and acute ischemic syndromes (1)(2). Data indicate that high-sensitivity C-reactive protein (hs-CRP) and other inflammatory markers are associated with atherosclerosis and that hs-CRP decreases with statin treatment (3)(4). These are important findings that support the inflammatory disease hypothesis. Moreover, it was suggested that hs-CRP could be used to assess risk of CAD for clinical purposes (5), and several hs-CRP assays are commercially available (6). In this Journal, Rifai and Ridker (7) suggested an algorithm for assessing risk of CAD based on hs-CRP in conjunction with the ratio of HDL-cholesterol to total cholesterol. The algorithm was later modified to use hs-CRP cutoffs of 3 mg/L in conjunction with the LDL-cholesterol (LDLC) concentration or the Framingham 10-year risk assessment (8). Several editorials that have accompanied reports on hs-CRP cautioned that use of this test for clinical purposes was premature (9)(10)(11)(12). In spite of these warnings, an American Heart Association/CDC Scientific Statement (13) recommended the use of this test to enhance risk evaluation in certain population groups, although they noted that the benefits of this strategy or any treatment based on it remain uncertain. The clinical recommendations of others argued for even wider use of the test, suggesting that it should be an adjunct for initial screening for global risk assessment in conjunction with conventional lipid testing (8). We contend that because of its poor predictive value, until its use is better demonstrated, hs-CRP should not be recommended for defining risk. As discussed below, our argument is based …