A heart scan led to far fewer statin recommendations and much higher medication adherence, but a major trial could not prove the strategy was as protective as traditional risk scoring.
Who should start taking a statin before a heart attack or stroke ever happens? Doctors typically estimate that risk using factors such as cholesterol, blood pressure, smoking, and diabetes. A large clinical trial tested a more direct approach: looking for calcium buildup inside the heart’s arteries with a CT scan.
The scan-based strategy led to far fewer people being advised to start statins, yet after 4.2 years, major cardiovascular events occurred in 2.7% of participants in both groups. However, there was an important catch. Because fewer cardiovascular events occurred than researchers expected, the trial could not prove that the scan-based approach was no worse than traditional risk assessment.
The findings come from the CorCal Outcomes trial, which compared two ways of deciding who should start statins before experiencing a first major cardiovascular event. Statins are cholesterol-lowering medications that can reduce the risk of atherosclerotic cardiovascular disease, or ASCVD, which includes coronary artery disease and ischemic stroke.
“For far too many patients, the first symptom of ASCVD is a heart attack,” said Dr. Joseph B. Muhlestein of Intermountain Medical Center in Murray, Utah, principal investigator of the CorCal Outcomes trial. “Statins have been shown to be highly effective in the prevention of ASCVD; however, there is a major gap in risk assessment, statin initiation and statin persistence.”
That gap is important because some people who eventually experience a heart attack would not have appeared to be at high enough risk beforehand to qualify for statin treatment. Muhlestein noted that this can be particularly true for younger people.
Heart scans look directly for plaque
The trial tested whether looking directly for evidence of plaque in the coronary arteries could provide another way to guide treatment. Researchers compared the pooled cohort equations, or PCE, which estimate cardiovascular risk from traditional risk factors, with coronary artery calcium, or CAC, scoring.
A CAC scan uses computed tomography, or CT, to detect calcium deposits in the arteries that supply blood to the heart. The calcium is a sign of underlying coronary plaque, giving doctors a more direct look at atherosclerosis than a risk calculation alone.
The study included 5,772 participants registered with the Canyons and Desert regions of Intermountain Health Care in the United States. Their average age was 64, and 51% were women. None had known ASCVD, diabetes, or previous statin therapy.
Participants were randomly assigned to receive a recommendation about starting statins based either on their traditional PCE risk score or their CAC scan result. The study protocol determined the recommendation, but patients and their physicians made the final treatment decision.
Equal event rates did not prove equivalence
After 4.2 years of follow-up, major cardiovascular events occurred in 2.7% of participants in each group. The study counted death from any cause, heart attack, stroke, and procedures to restore blood flow through narrowed or blocked arteries as major cardiovascular events.
Seeing the same 2.7% event rate in both groups might seem to suggest that the two strategies worked equally well. Statistically, however, the researchers could not make that conclusion.
The trial was designed to determine whether CAC-based decision-making was noninferior, meaning it was not unacceptably worse than the traditional risk-score approach. The hazard ratio was 0.99, with a 95% confidence interval of 0.71 to 1.38, but the study did not meet its predefined threshold for demonstrating noninferiority.
One reason was that major cardiovascular events were less common than expected. With fewer events to compare, the study had less statistical power to determine whether the two approaches truly produced similar outcomes.
Fewer recommendations, much higher adherence
Even without a definitive answer on cardiovascular outcomes, the two strategies produced very different patterns in who was advised to take statins.
Participants in the traditional PCE group received recommendations to start statins more than three times as often as those whose recommendations were based on CAC scans.
Yet people advised to take statins based on their CAC results were much more likely to stay on the medication. Statin adherence was 62% in the CAC group compared with 23% among those who received a recommendation based on the traditional risk score.
“The power of the study to detect a difference was reduced by the lower-than-expected event rates, and we did not demonstrate noninferiority between the groups,” said Dr. Muhlestein, who concluded: “The study did provide important hypothesis-generating insights into the efficiency of statin initiation and adherence when decisions are based on CAC scoring. Taken together, our data could be used to plan an additional well-powered randomized trial comparing CAC with current risk factor-based algorithms.”
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2 Comments
And in my personal experience statins cause serious leg cramps far too frequently as well as increasing peripheral neuropathy in my legs, neither of which are pleasant and both of which stopped after I had stopped taking the prescribed statin for lowering cholesterol.
Any medical professional (doctors that is) wishing to comment?
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