medwireNews: The US-based Thrombolysis in Myocardial Infarction (TIMI) Study Group has developed a new atherothrombotic risk score for use specifically in people with type 2 diabetes, which they believe has the potential to inform clinical-decision making.
“A number of clinical risk tools are recommended to help estimate atherothrombotic risk in clinical practice,” David Berg (Brigham and Women’s Hospital, Boston, Massachusetts, USA) and colleagues acknowledge in the Journal of the American College of Cardiology, but “concerns have been raised about the performance of these widely used scores in patients with [type 2 diabetes].”
The risk score, which they have named the TIMI Risk Score for Atherothrombosis in Diabetes, identifies people with type 2 diabetes as being at low, intermediate, high, or very high risk for myocardial infarction (MI) or ischemic stroke at 3 years.
To develop the risk score they used data for 42,181 patients with type 2 diabetes who had participated in four large TIMI Group trials – splitting them into a derivation cohort (n=23,643) and a validation cohort (n=18,538).
The derivation cohort was used to find clinical variables that predicted the risk for having an MI or ischemic stroke, with 16 included in the final model.
Ten of these variables – age, sex, waist circumference, low-density lipoprotein cholesterol, systolic blood pressure, tobacco use, glycated hemoglobin, insulin use, estimated glomerular filtration rate, and the urine albumin-to-creatinine ratio – “apply to all patients with [type 2 diabetes],” say the researchers.
They add that the other six variables – coronary artery disease, peripheral artery disease, and a history of MI, ischemic stroke, percutaneous coronary intervention, and/or coronary artery bypass grafting – “reflect the extent of prior atherosclerotic disease” in those with known atherosclerotic cardiovascular disease.
The results showed that there was an eightfold gradient in MI or stroke rates between the top and bottom risk categories in both the derivation and validation cohorts. In the validation cohort, the cumulative incidences of predicted MI or ischemic stroke over 3 years according to the top and bottom risk categories were 14.9% versus 1.4%, a significant difference.
The researchers say the discrimination of their risk score compares “favorably” with existing risk scores such as the SMART Risk score, the UKPDS Cardiovascular Risk Engine, and the ADVANCE-Risk Score. Moreover, their risk score performs well for predicting MI and ischemic stroke risk as individual endpoints.
The risk score worked consistently in people with and without established atherosclerotic cardiovascular disease, demonstrating the score’s “value in both primary and secondary prevention,” the investigators point out.
They also applied the score to data from the DECLARE-TIMI 58 trial of dapagliflozin versus placebo and the FOURIER trial of evolocumab versus placebo to look at is clinical application for assessment of individual risk profiles. They found that patients in the high- and very high-risk groups had greater absolute reductions in the rates of MI and ischemic stroke with both dapagliflozin and evolocumab than those in the low- and intermediate-risk groups, at 2.1% versus 0.2% and 3.2% versus 1.0%, respectively.
In an editorial comment, Kent Brummel and Kim Eagle, both from the University of Michigan in Ann Arbor, USA, question if the new tool is “useful or more of the same?”
They suggest that “the cohorts used to derive and validate the risk score deserve scrutiny,” noting that the included patients in all four trials were “enriched for cardiovascular risk factors.” Moreover, they argue that the trial cohorts were not representative of the US population, as 20% of the patients included were non-White and just 35% were women. “This may limit generalizability,” they suggest.
However, Brummel and Eagle acknowledge its possible importance, saying if the risk score “stands up to wide-spread validation in nontrial cohorts,” it could “be incorporated in future guidelines to guide the care of patients with diabetes.”
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