Predicting major adverse limb events in individuals with type 2 diabetes: Insights from the EXSCEL trial.

Autor: Weissler EH; Division of Vascular Surgery, Duke University School of Medicine, Durham, NC, USA., Clare RM; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA., Lokhnygina Y; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA., Buse JB; Division of Endocrinology, University of North Carolina School of Medicine, Chapel Hill, NC, USA., Goodman SG; Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada.; Department of Medicine, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada., Katona B; BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA., Iqbal N; BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA., Pagidipati NJ; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.; Division of Cardiology, Duke University School of Medicine, Durham, NC, USA., Sattar N; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK., Holman RR; Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK., Hernandez AF; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.; Division of Cardiology, Duke University School of Medicine, Durham, NC, USA., Mentz RJ; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.; Division of Cardiology, Duke University School of Medicine, Durham, NC, USA., Patel MR; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.; Division of Cardiology, Duke University School of Medicine, Durham, NC, USA., Jones WS; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.; Division of Cardiology, Duke University School of Medicine, Durham, NC, USA.
Jazyk: angličtina
Zdroj: Diabetic medicine : a journal of the British Diabetic Association [Diabet Med] 2021 Oct; Vol. 38 (10), pp. e14552. Date of Electronic Publication: 2021 Mar 18.
DOI: 10.1111/dme.14552
Abstrakt: Aims: Although models exist to predict amputation among people with type 2 diabetes with foot ulceration or infection, we aimed to develop a prediction model for a broader range of major adverse limb events (MALE)-including gangrene, revascularization and amputation-among individuals with type 2 diabetes.
Methods: In a post-hoc analysis of data from the Exenatide Study of Cardiovascular Event Lowering (EXSCEL) trial, we compared participants who experienced MALE with those who did not. A multivariable model was constructed and translated into a risk score.
Results: 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) (HR adj 4.83, 95% CI: 3.94-5.92), prior foot ulcer (HR adj 2.16, 95% CI: 1.63-2.87), prior amputation (HR adj 2.00, 95% CI: 1.53-2.64), current smoking (HR adj 2.00, 95% CI: 1.54-2.61), insulin use (HR adj 1.86, 95% CI: 1.52-2.27), coronary artery disease (HR adj 1.67, 95% CI: 1.38-2.03) and male sex (HR adj 1.64, 95% CI: 1.31-2.06). 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 (95% CI: 0.803-0.841).
Conclusions: 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. 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.
(© 2021 Diabetes UK.)
Databáze: MEDLINE
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