Recent publications on Residual Risk

In this analysis of the PreterAx and DiamicroN modified-release controlled evaluation (ADVANCE) trial and the ADVANCE-ON post-trial study, major peripheral artery disease (lower-extremity ulceration or amputation, and peripheral revascularization) increased the risk of all-cause mortality and cardiovascular events in patients with type 2 diabetes. In addition, lower-extremity ulceration or amputation was associated with an increased risk of severe retinopathy. These findings underline the close associations between macrovascular and microvascular risk in type 2 diabetes.
In this report, 11,140 type 2 diabetes patients were followed for a median of 5.0 (in-trial), 5.4 (post-trial), and 9.9 (overall) years. Overall, 516 (4.6%) patients had major peripheral arterial disease at baseline; 300 (2.7%) had lower-extremity chronic ulceration or amputation alone, 190 (1.7%) had peripheral revascularization alone, and 26 (0.2%) had both presentations. Over the follow-up period, 2265 (20.3%) died (all causes), 2166 (19.4%) had major cardiovascular events of whom 988 (8.9%) died, and 807 (7.2%) had major clinical microvascular events. Overall, major peripheral artery disease was associated with 35% (15-60%) increased risk of death (p = 0.0004), 47% (23-75%) increased risk of major cardiovascular events (p <0.0001), 75% (39-221%) increased risk of cardiovascular death (p < 0.0001), and 58% (19-209%) increased risk of myocardial infarction (p = 0.001). There was also a trend toward an association between baseline peripheral artery disease and risk of major clinical microvascular events [hazard ratio 1.31, 95% CI 0.96–1.78, p = 0.09], specifically diabetic retinopathy. In conclusion, these findings emphasize that type 2 diabetes patients with major peripheral artery disease have poor survival and cardiovascular outcomes and underline the need for routine screening for peripheral artery disease to improve prognosis.