One-year prospective quality-of-life outcomes in patients treated with angioplasty for symptomatic peripheral arterial disease.

BACKGROUND: Despite lower reported patency rates than open bypass, percutaneous transluminal angioplasty (PTA) may result in symptom relief, limb salvage, maintenance of ambulation and independent living, and overall improved quality of life. The goal of this study was to prospectively assess quality of life and functional outcomes after angioplasty and stenting in patients with chronic leg ischemia.

METHODS: From August to December 2002, 84 patients with 118 chronically ischemic limbs underwent PTA with or without stenting as part of an ongoing prospective project performed to examine management of symptomatic peripheral arterial disease. All patients completed a preprocedure health questionnaire (Short Form 36) to provide adequate baseline data. Each patient was followed up every 3 months after treatment for 1 year to determine traditional outcomes of arterial patency, limb salvage, survival and amputation-free survival, and functional outcomes assessed according to improvement in quality of life, maintenance of ambulatory status, and maintenance of independent living status. The entire cohort was analyzed, as were subgroups of patients with lifestyle-limiting claudication and those with critical limb ischemia. Outcomes were analyzed by using Kaplan-Meier life-table analysis, the log-rank test for survival curves, and the one-sample t test. A Cox proportional hazard model was used to determine whether presentation and level of disease were independent predictors of outcome.

RESULTS: Of the 84 patients, 54 (64.3%) were treated for claudication (34 aortoiliac occlusive disease and 20 infrainguinal disease), and 30 (35.7%) were treated for critical limb ischemia (11 aortoiliac occlusive disease and 19 infrainguinal disease). One-year results for the 54 patients with claudication were as follows: primary patency, 78.5%; limb salvage, 100%; amputation-free survival, 96.3%; survival, 96.3%; maintenance of ambulation status, 100%; and maintenance of independence, 100%. There was statistical improvement in all physical function categories, including physical function (29.4 +/- 8.9 vs 37.1 +/- 11.3; P < .0001), role-physical (32.5 +/- 11.3 vs 39.5 +/- 13.0; P = .0001), bodily pain (35.8 +/- 8.5 vs 42.9 +/- 10.9; P < .0001), and aggregate physical scoring (31.1 +/- 9.7 vs 38.1 +/- 11.5; P < .0001). One-year results for the 30 patients with critical limb ischemia were as follows: primary patency, 35.2%; limb salvage, 77.2%; amputation-free survival, 50.0%; survival, 60.0%; maintenance of ambulation status, 75.8%; and maintenance of independence, 92.8%. There was statistical improvement in bodily pain resolution (35.3 +/- 12.0 vs 46.6 +/- 12.0; P = .0009). Cox models with hazard ratios (HRs) revealed that presentation was a significant predictor for outcomes of primary patency (HR, 4.2; P= .0002), secondary patency (HR, 6.0; P < .0001), limb salvage (HR, 20.2; P = .0047), survival (HR, 10.9; P = .0002), and amputation-free survival (HR, 11.2; P < .0001). Conversely, the level of disease was predictive of outcome only for primary patency (HR, 1.8; P = .00289).

CONCLUSIONS: Despite inferior reconstruction patency rates when compared with the historical results of open bypass, PTA provides excellent functional outcomes with good patient satisfaction, especially for treating claudication. These findings support a more liberal use of PTA intervention for patients with vasculogenic claudication.