Clinical efficacy of endovascular therapy for patients with critical limb ischemia attributable to pure isolated infrapopliteal lesions.

BACKGROUND: Prognosis of endovascular therapy (EVT) for isolated infrapopliteal lesions has not been adequately studied. We investigated and risk-stratified long-term prognosis after EVT for critical limb ischemia (CLI) attributable to isolated infrapopliteal lesions.

METHODS: Between March 2004 and October 2010, 884 patients (1057 limbs) with CLI attributable to isolated infrapopliteal lesions who underwent EVT with angioplasty alone were enrolled. Outcome measures were freedom from major adverse limb events with perioperative death (MALE+POD) and amputation-free survival. Cox proportional hazards models were used to assess independent predictors for these outcomes.

RESULTS: Freedom from MALE+POD was 82 ± 1% and 74 ± 2% at 1 and 5 years, respectively. Risk factors associated with MALE+POD were age ≥80 years (adjusted hazard ratio [HR], 0.4; P < .001), nonambulatory status (HR, 2.0; P < .001), albumin <3.0 g/dL (HR, 1.4; P < .0001), Rutherford 6 (HR, 2.2; P < .001), C-reactive protein ≥3.0 mg/dL (HR, 2.1; P < .001), and below-the-ankle disease (HR, 2.0; P < .001). One- and 5-year amputation-free survival was 71 ± 2% and 38 ± 3%, respectively. Risk factors associated with major amputation/mortality were nonambulatory status (adjusted HR, 2.1; P < .001), body mass index <18.5 kg/m(2) (HR, 1.4; P = .02), albumin <3.0 g/dL (HR, 1.8; P < .0001), end-stage renal disease (HR, 1.4; P = .004), ejection fraction <50% (HR, 1.6; P < .001), Rutherford 6 (HR, 1.9; P < .001), C-reactive protein ≥3.0 mg/dL (HR, 1.7; P < .0001), and below-the-ankle disease (HR, 1.8; P < .001). In patients with more than four risk factors, both end points at 1 year were below the 71% suggested efficacy objective performance goal.

CONCLUSIONS: Long-term clinical outcomes were acceptable after EVT for patients with CLI due to pure isolated infrapopliteal lesion. Risk stratification by baseline characteristics is useful in estimating long-term prognosis.