Patterns of artery disease in 450 patients undergoing revascularization for critical limb ischemia: Implications for clinical trial design

Objective: The pattern and distribution of arterial occlusions and stenoses in patients with critical limb ischemia presenting at two academic medical centers was described. Methods: From January 1998 to December 2006, 450 consecutive critical limb ischemia patients who underwent arteriography and infrainguinal revascularization at the University of Colorado Health Sciences Center or Southern Illinois University were retrospectively evaluated. Demographics, clinical morbidities, and Fontaine stage were recorded. The arterial tree was categorized into three groups: the aorta and iliac arteries (A-I); the common femoral, superficial femoral, and profunda femoral arteries (Fem); and the popliteal and tibial arteries (Pop-Tib). Arterial segments within groups were categorized as subcritical stenoses (patent or <50% stenoses), critical stenoses (single or multiple >50% stenoses), or occluded (segmental occlusions of any length). Patients with diabetes mellitus, end-stage renal disease, and Fontaine stage (III vs IV) were analyzed for differing disease patterns according to their chart history. Results: Occlusive disease was present in 5% in all arterial segments (A-I + Fem + Pop-Tib), in 1% in the A-I + Fem group, in 2% in the A-I + Pop-Tib group, in 3% in A-I group, in 4% in the Fem group, in 30% in the Fem + Pop-Tib group, and in 55% in the Pop-Tib group. Descriptive comparisons among subgroups demonstrated a 61% to 69% prevalence of popliteal and tibial occlusive patterns in patients with diabetes mellitus, end-stage renal disease, and Fontaine stage IV. Furthermore, 65% of patients with Pop-Tib occlusions had associated critical stenoses in the proximal arterial groups. Conclusion: More than half of critical limb ischemia patients undergoing infrainguinal revascularization have arterial occlusions in the popliteal or tibial arterial segments, or both, with associated critical stenoses in the femoral arterial segments, which is even greater in the subgroups with diabetes mellitus, end-stage renal disease, and Fontaine stage IV. Knowledge of such occlusive patterns is important for the development of novel infrainguinal endovascular and angiogenesis therapies for critical limb ischemia.