Outside researchers criticized a new cardiovascular disease risk calculator promoted by a top health association and warned that it could improperly render as many as 16 million people ineligible for medication largely because of the removal of race from the equation.
The experts outlined the criticism in a new study published in JAMA on Monday. They found that changes to the American Heart Association’s screening tool PREVENT , including removing race as a variable, could cause millions of patients to fall outside of the recommendation criteria for anti-high blood pressure and anti-cholesterol medication, which could lead to as many as 107,000 more heart attacks and strokes in the next 10 years.
To compare patient outcomes between the new PREVENT calculator and the original 2013 version, researchers utilized data from 7,700 patients, ages 30 to 79, to approximate the U.S. population.
Using the new risk calculator, only 67.5 million people would be recommended for anti-cholesterol medication, compared to 81.8 million people in the 2013 model. Likewise, only 72.7 million people would qualify for blood pressure medication, compared to 75.3 million people under the 2013 formula.
This is in part due to the removal of race from the 2023 calculator, a step the AHA took based on the idea that race is a social construct and an imprecise proxy variable for genetics, behaviors, or other factors that might lead to heart disease — including racism.
According to the Health and Human Services Office of Minority Health, black Americans are 30% more likely to die from a heart attack than white Americans. Black people are also 30% more likely to have high blood pressure than white people, but they are less likely to have it under control.
Black women are also 50% more likely to have high blood pressure than white women.
Lead study author Dr. James Diao, a researcher at Harvard University's Department of Biomedical Informatics who is also affiliated with Brigham and Women’s Hospital, said, surprisingly, black patients were not disproportionately represented in the increased number of heart attacks following the changes to the PREVENT calculator.
Diao said this is probably because black patients are less likely to use blood pressure and cholesterol medication even if they are eligible. In other words, with the old calculator, many black people were eligible for medication but did not take it. With the new calculator, those same people would not be eligible.
“We thought that if Black individuals became disproportionately less eligible for statins, they would be projected to have disproportionately more heart attacks and strokes, but our data did not reflect this expectation,” Diao said in a press release. “We think this may be because fewer Black Americans have access to these medications and to recommended care to begin with. That’s a clear case of two wrongs don’t make a right.”
Removing race is not the only difference from the 2013 model. The equation now takes into account several other variables, including kidney function, blood sugar levels, and urine protein.
The 2023 equation also takes into account a patient's ZIP code to reflect socioeconomic factors, such as access to fresh produce grocery stores as well as income. But this does not account for biological disposition to disease.
The study authors recommended the scientific community re-evaluate the medication eligibility for cholesterol and blood pressure drugs to reflect the changes to the PREVENT calculator.
“I would be concerned if we only change one side of this equation without reexamining the other side, which is the treatment threshold,” said Dr. Arjun Raj Manrai, a senior study author and assistant professor at Harvard Medical School .
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The authors stressed, however, that careful decisions should ultimately be made for each patient as an individual rather than solely relying upon a formula.
“The sort of nuanced decision-making that needs to occur at the physician’s office means that after a careful conversation, two people with the same estimated level of risk might end up on different treatment regimens,” Manrai said.
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