New Cholesterol Guidelines and CV Risk Calculator: Controversy Clarified

Controversy at AHA: New Cholesterol Guidelines

Clyde W. Yancy, MD, MSc: Hi. I'm Clyde Yancy here in Dallas, Texas, at the American Heart Association (AHA) Scientific Sessions, and I'm joined by 2 esteemed colleagues: Jennifer Robinson from the University of Iowa, a member of the Department of Medicine and the Department of Epidemiology, and Bob Harrington, Chair of Medicine, Stanford University.

We are here to have a discussion about what may have been the most controversial topic at these AHA scientific sessions: a discussion about last week's release of the prevention guidelines on blood cholesterol treatment,^[1] with a unique focus on the change in paradigm, exposing more patients to statin therapy, and the 4 categories that are deemed to be most likely to benefit from therapy -- one of which is ≥ 7.5% risk over 10 years, which has become the lightning rod for discussions here. Can we truly estimate that 7.5% risk?

I want to begin by making certain that our readers hear us all endorse the notion that regardless of how the furor settles, what is most important is launching an initiative that allows us to identify patients at risk and treat them with proven effective strategies, with the ultimate goal being to reduce the burden of heart disease. Jennifer, would you be in complete agreement about that?

Jennifer G. Robinson, MD: AbsoluteIy, and I will refer readers to our title, which is "The Treatment of Blood Cholesterol to Reduce Atherosclerotic Risk in Adults." It's about reducing heart attacks and strokes and deaths from those conditions.

Anatomy of the Process

Dr. Yancy: This ought to be about the big picture, correct?

Robert A. Harrington, MD: It's about the big picture, and the guideline authors who have been talking throughout these meetings have said it well -- which is that it is no longer just about numbers, it's about calculating risk and then starting a discussion with your patient about how to lower that risk.

Dr. Yancy: I don't want to dismiss the criticism, because we have a transparent community. We invite critiques because that is how we keep ourselves accountable and get to the next level. Before we address some of the critiques, Jennifer, you had the privilege of sitting on that committee.

Dr. Robinson: I was the Vice-Chair. We were convened in 2008 and have worked diligently since then to develop an evidence-based set of guidelines.

Dr. Yancy: Let me personally congratulate you and the other committee members for the job you have done. What is the history?

Dr. Robinson: We were convened in 2008 by the National Heart, Lung, and Blood Institute (NHLBI) as a panel of experts that included all sorts of experts, such as family practitioners; we tried to involve a broad range of people. We used the model that is now advocated by the Institute of Medicine (IOM) for state-of-the-art guidelines, which is to have a series of critical questions. Then you define a priori the inclusion and exclusion criteria for the trials that are involved. We limited ourselves to randomized controlled trials. We did not consider epidemiologic evidence or observational studies.

Dr. Yancy: Let's pause on that for a moment. Bob, you and I have been involved in the American College of Cardiology (ACC) guideline process for years. Typically in the ACC/AHA guideline construct, we start with a set of recommendations and then seek evidence to support those recommendations. This is a very different process.

Dr. Harrington: This is a much more rigorous process, and it is the one recommended by the ORION statement (Guidelines for transparent reporting of Outbreak Reports and Intervention studies Of Nosocomial infection). It includes the notion that you will provide an evidence review a priori, something also advocated by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Investigators.^[2]

We have used it in the past for the American College of Chest Physicians thrombosis guidelines. It is very difficult to do. It is very rigorous. It's very expensive. It takes the guideline to a level of quality that many of our guidelines don't quite get to.

Dr. Yancy: But it may restrict the global nature of the guidelines because the evidence comes first. The ACC and the AHA are going in that direction without question, but it does make this process different. It may be important for our readers to understand that from a process standpoint, this is a very different sort of exercise.

Dr. Robinson: We developed the inclusion and exclusion criteria, but the systematic review was retrieved by an independent contractor. We advised them and asked, for example, "Why is this study missing?" But we had to consider all of the evidence, and maybe there were some factors that we as experts wouldn't have brought to the table in making the guidelines.

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Cite this: Clyde W. Yancy, Robert A. Harrington, Jennifer G. Robinson. New Cholesterol Guidelines and CV Risk Calculator: Controversy Clarified - Medscape - Jan 29, 2014.