Policy Commentary The SHAPE Paradigm A Commentary

Atherosclerosis is a chronic immunoinflammatory disease trigerred by lipoprotein retention in the subendothelium and produces its most serious manifestations by triggering arterial thrombosis when the plaque ruptures or erodes.1 Atherothrombotic cardiovascular disease remains the leading cause of death in the West and is achieving similar dubious distinction in developing countries.2 Atherosclerosis begins at a young age, but it remains clinically silent for a long time and the majority of clinical manifestations occur later in life. Despite considerable progress, regrettably 50% of lifethreatening acute cardiovascular events occur in previously asymptomatic individuals. Identifying individuals at risk for future cardiovascular events affords an opportunity for risk reduction and thus remains a major imperative for healthcare professionals. In 2006 the SHAPE (Society for Heart Attack Prevention and Education) Task Force introduced an algorithm incorporating noninvasive screening for subclinical atherosclerosis to augment risk factor–based risk stratification in asymptomatic subjects between the ages of 45 to 75 in men and 55 to 75 in women, excluding those at very low risk or at high risk.3 In June 2009, the Texas Governor Rick Perry signed off on the Texas Heart Attack Prevention Bill introduced by Rep Rene Oliveira, mandating health-benefit plans to cover noninvasive screening for subclinical atherosclerosis. This bill grew out of the 2006 SHAPE Task Force guidelines and became effective September 1, 2009; an earlier version of the bill had been rejected in 2007. This generated a mixed reaction from healthcare professionals and others, much of which played out in the media. The critics argued that such an action is inappropriate because: (1) the SHAPE guidelines were created by an ad hoc group and had not been explicitly endorsed by the American College of Cardiology (ACC) or the American Heart Association (AHA), and (2) SHAPE guidelines are not based on randomized clinical trials.4,5