Balloon-Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease: 9-Month Results from the BOLSTER Multicenter Study

PURPOSE: This study sought to assess the performance of the LIFESTREAM balloon-expandable covered stent for the treatment of iliac artery atherosclerotic lesions. METHODS: A total of 155 patients were treated in a prospective, single-arm study at 17 centers in the United States, Europe, and New Zealand. The primary endpoint was a composite of device- or procedure-related death or myocardial infarction (MI) over the course of 30 days, or target lesion revascularization (TLR), major amputation of the target limb, or re-stenosis through 9-months. Secondary endpoints included primary patency, TLR, sustained clinical success, quality of life, and major adverse events (MAE). RESULTS: At 9 months, the primary composite endpoint rate was 16.2% (93.5% confidence interval [CI]: 10.6%-23.2%), primary patency was 89.1% (95% CI: 82.6%-93.7%), and freedom from TLR was 96%. There was a cumulative clinical improvement of at least one Rutherford category from baseline to 9 months of 90.5% (95% CI: 84.3%-94.9%). Quality of life, assessed by using the Walking Impairment Questionnaire (WIQ), demonstrated a mean change in total score from baseline through 9 months of 32.1 ± 26.84; overall, improvements were noted from baseline in each WIQ category. Seven of one-hundred fifty patients (4.7%; 95% CI: 1.9%-9.4%) experienced MAEs, but none were determined to be related to device or procedure. CONCLUSIONS: The LIFESTREAM balloon-expandable covered stent provided satisfactory 9-month clinical outcomes including a low rate of target lesion revascularization for the treatment of stenotic and occlusive lesions of the iliac arteries.