Guidelines designed to lower the risk of atherosclerotic cardiovascular disease continue to spark controversy many months after their publication, primarily over two flash points: abandonment of cholesterol goals and the use of a new risk estimator. Some physicians welcome the changes and some abhor them. Others say it is time to step back and look at the bigger picture.
Third time was not the charm
The din of clanking forks and coffee cups had died down by the time Neil J. Stone, MD, took over the podium. He faced a ballroom of about 150 physicians, one third of whom minutes before had responded “hate them” to a question about their opinion of the American Heart Association/American College of Cardiology (AHA/ACC) guidelines. The guidelines were designed to help clinicians treat patients whose blood cholesterol may put them at risk of atherosclerotic cardiovascular disease-related events. “I have a tough task,” he acknowledged.
The dinner presentation had been scheduled midway through the ACC’s March scientific session in Washington, D.C., as an educational evening on lipids management. Stone, chair of the expert panel that published the prevention guidelines in November 2013, used the opportunity to clarify what the authors perceived as misinterpretations of the recommendations. The new guidelines had come under fire before the ink was dry for a risk assessment tool that critics said either underestimated or overestimated at-risk patients. Some physicians also voiced disappointment over recommendations based on accumulated findings from randomized controlled clinical trials and not other types of studies and expert opinion.
Trial data did not support the use of LDL targets in patients with high cholesterol, the expert panel determined, which was a tectonic shift from the Adult Treatment Panel III (ATP III) guidelines that had been the beacon in care for about a decade. In his presentation, Stone explained at three different times the need to get a lipid panel periodically to gauge response and adherence to statin treatment. One in five attendees still responded that the guidelines did not recommend cholesterol testing in an on-site poll.
“We have learned that we need to continue to repeat simple messages that reflect the guidelines,” says Stone, a cardiologist at Northwestern Memorial Hospital and a professor at Northwestern University Feinberg School of Medicine in Chicago. “We need to repeat simply our justification and we need to correct if people have mistakenly assumed what we said when actually we have not said it.”
The guidelines focus on patients in four different groups who are most likely to benefit from primary or secondary prevention treatment (Circulation online Nov. 12, 2013). They call for intensive or moderate statin therapy in patients with clinical atherosclerotic cardiovascular disease; with LDL cholesterol levels of 190 mg/dL or higher; with diabetes if they are between the ages of 40 and 75 (the age groups represented in trials); and those between 40 and 75 without diabetes but with LDL cholesterol levels between 70 and 189 with a 10-year risk of 7.5 percent or higher. The recommendations also include safety considerations, other strategies such as biomarker tests to help guide treatment decisions and discussions with patients before starting treatment.
“The strength of our guideline is that it is not an opinion-generated guideline,” Stone says. “It was based on as close adherence to the accumulated evidence as possible.”
Ta-ta to targets
The 2004 revised ATP III, in which Stone is a co-author, set treatment goals of less than 100 mg/dL in high-risk patients and less than 70 mg/dL in very high-risk patients (Circulation 2004;110:227-239). The new guidelines propose a “lowest is best” approach for LDL cholesterol without targets, a switch that some researchers who have studied the statistical underpinnings of cholesterol guidelines cheered.
“They should be commended on getting rid of the LDL targets,” says Rodney A. Hayward, MD, co-director of the Center for Practice Management and Outcomes Research at the Ann Arbor Veterans Affairs Healthcare System and a professor in the internal medicine department at the University of Michigan in Ann Arbor. “It was a brave move and it was the right move.”
For about a decade, Hayward and colleagues have been questioning the benefit of the use of cholesterol goals for treating at-risk patients. Their review of the evidence in ATP III and similar guidelines