USA: A risk score may identify patients with type 2 diabetes (T2D) at high risk for major adverse limb events (MALE) including those without a history of peripheral artery disease (PAD), according to a recent study in the journal Diabetic Medicine. MALE included gangrene, revascularization and amputation.
Models that predict amputation in people with T2D with foot ulceration or infection do exist, E. Hope Weissler, Duke University School of Medicine, Durham, NC, USA, and colleagues aimed to develop a predictuon model for a broader range of MALE among people with type 2 diabetes.
For this purpose, the researchers analyzed post hoc data from the Exenatide Study of Cardiovascular Event Lowering (EXSCEL) trial. They compared participants who experienced MALE with those who did not. A multivariable model was constructed and translated into a risk score.
Participants were monitored for adverse events for the duration of the trial and a 90-day, post-trial follow-up period. Outcomes were assessed at clinical care visits at 1 week, 2 months, 6 months and every 6 months thereafter for the duration of the trial.
Key findings of the study include:
Among the 14,752 participants with type 2 diabetes in EXSCEL, 3.6% experienced MALE.
Characteristics associated with increased risk of MALE were peripheral artery disease (PAD) (HRadj 4.83), prior foot ulcer (HRadj 2.16), prior amputation (HRadj 2.00), current smoking (HRadj 2.00), insulin use (HRadj 1.86), coronary artery disease (HRadj 1.67) and male sex (HRadj 1.64).
Cerebrovascular disease, former smoking, age, glycated haemoglobin, race and neuropathy were also associated significantly with MALE after adjustment.
A risk score ranging from 6 to 96 points was constructed, with a C‐statistic of 0.822.
"The majority of MALE occurred among participants with PAD, but participants without a history of PAD also experienced MALE. A risk score with good performance was generated," wrote the authors. "Although it requires validation in an external dataset, this risk score may be valuable in identifying patients requiring more intensive care and closer follow‐up."
Reference:
The study titled, "Predicting major adverse limb events in individuals with type 2 diabetes: Insights from the EXSCEL trial," is published in the journal Diabetic Medicine.
DOI: https://onlinelibrary.wiley.com/doi/abs/10.1111/dme.14552