For decades, the American Heart Association, the American College of Cardiology, and other guardians of conventional wisdom about heart disease have urged physicians to follow rigorous "evidence-based" protocols based on defining treatment targets for LDL cholesterol, and then focusing statin prescriptions to reach these goals.
Earlier this month, in a move that rattled the cardiology world, the same organizations published new guidelines insisting that doctors no longer need to measure LDL or other lipids, and that pretty much anybody who looks like they're at risk for CVD should automatically get a statin prescription.
The guidelines seem to suggest that for the vast majority of Americans, detailed lipid testing is unnecessary. The consensus among the expert committees now seems to be statins are so safe and effective, that physicians can prescribe them more or less empirically, based on guidance from a new online risk assessment calculator that takes into account basic risk factors like age, weight, family history, total cholesterol, blood pressure, diabetes status, and others.
I Feel Like a Number
Neil Stone, MD, professor of medicine at Northwestern University Feinberg School of Medicine, and chairman of the committee that wrote the new guidelines, believes the new recommendations have great practical value.
In a brief video posted on the AHA website, he states, "For the first time, the guidelines are focused on what matters most: what's going to reduce your risk of a heart attack or stroke based on the evidence that's accumulated. It's not focused on a number, it's focused on your risk. And it uses all your numbers to give you the best advice or improved outcomes."
Right out of the gate, though, the guidelines hit a major snag, when Drs. Paul Ridker and Nancy Cook—two well-respected researchers—reported that the online risk calculator over-estimates risk of heart attacks—and need for statins--by as much as 150%.
The Ridker-Cook report, which was picked up by mainstream media outlets worldwide, sent shock waves through the cardiology community, and prompted "behind-closed-doors" damage control sessions at the AHA's recent meeting in Dallas.
In the New York Times' coverage of the debacle, Dr. Steven Nissen, Chief of Cardiology at the Cleveland Clinic, and a reliable voice of reason on scientific and public policy matters, said that he used the calculator to assess the risk of a healthy 60-year-old, non-smoking, non-diabetic black man with no obvious heart risk factors---ie, total cholesterol of 150, HDL (aka "good cholesterol") of 45, blood pressure of 125 mmHg.
The calculator came to the conclusion that the man should be on a statin. "Something is terribly wrong," Dr. Nissen told the Times' Gina Kolata. If doctors follow the calculator, virtually every African American man over 65 would be put on a statin without question.
In an official statement on the American College of Cardiology's website, AHA president Mariell Jessup, MD, defended the new guidelines. "We stand behind our guidelines, the process that was used to create them and the degree to which they were rigorously reviewed by experts."
ACC's president, John Gordon Harold, MD, stressed however that no guidelines can replace clinical judgment, and that the main value of the new recommendations is to facilitate discussion between patients and practitioners on how best to prevent CVD, "based on the patient's personal health profile and their preferences." He added that a high score on the new calculator, "does not automatically mean a patient should be taking a statin drug."
The merit of the new guidelines—or lack thereof—will likely be debated for months to come. The timing of their release is certainly curious, though, coming as they did just a few months after the initial chaotic rollout of the Affordable Care Act.
Given that under healthcare reform, all payers---whether federal or private sector—will be looking for ways to cut costs, it is interesting that two major influencers on clinical practice are suddenly reversing a longstanding position on the role of lab tests in risk assessment.
Several months ago, LDL assessment was the paragon of evidence-based practice, as it had been for close to 20 years. Now, it is suddenly unnecessary. Think of the money saved if we just cut out all those millions of tests and just cut right to the statins.
There's no way to know whether the authors of the new statin guidelines were in any way influenced by healthcare reform, but the timing is too interesting to ignore.