Analysis of IN.PACT DEEP trial on the association between changes in perfusion from pre- to postrevascularization and clinical outcomes in critical limb ischemia

Drug-eluting balloons (DEB) may reduce infrapopliteal restenosis and reintervention rates versus percutaneous transluminal angioplasty (PTA) and improve wound healing/limb preservation.

Critical limb ischemia (CLI) continues to be a major cause of vascular-related morbidity and mortality in the United States.

Arteriographic lesions of diabetic subjects with critical limb ischemia (CLI) and ischemic foot ulcer were reviewed retrospectively, to provide new criteria for stratification of these patients on the basis of their vascular involvement. In 417 consecutive CLI diabetic subjects with ischemic foot ulcer undergoing lower limb angiography, lesions were defined as stenosis or occlusion, localization, and length ( 10 cm). In a subgroup of 389 subjects, foot arteries also were evaluated. Patients then were categorized into 7 classes of progressive vascular involvement based on angiographic findings. Of the 2893 found lesions (55% occlusions) 1% were in the iliac arteries, whereas 74% were in below-the-knee (BTK) arteries. Sixty-six % of all BTK lesions were occlusions, and 50% were occlusions >10 cm (p<0.001 vs proximal segments). Occlusions of all BTK were present in 28% of patients, although there was patency of at least one foot artery in 55% of patients. The morphologic Class 4 (two arteries occluded and multiple stenoses of tibial/peroneal and/or femoral/popliteal vessels) was the most common (36%). An inverse correlation between morphologic class and TcPO2 was observed (r=-0.187, p=0.003). In CLI diabetic subjects with ischemic foot ulcer, the vascular involvement is extremely diffuse and particularly severe in tibial arteries, with high prevalence of long occlusions. A new morphologic categorization of these patients is proposed.