Nine-Month BOLSTER Data Published for BD's LifeStream Covered Stent in Iliac Artery
April 8, 2019—Nine-month findings from the BOLSTER study, which sought to assess the performance of the LifeStream balloon-expandable covered stent (BD Interventional) for the treatment of iliac artery atherosclerotic lesions were published by John R. Laird, MD, et al in Journal of Vascular and Interventional Radiology (JVIR).
The BOLSTER investigators concluded in JVIR, "The LifeStream device provided satisfactory 9-month clinical outcomes including a low rate of target lesion revascularization (TLR) for the treatment of stenotic and occlusive lesions of the iliac arteries."
The study was composed of 155 patients who were treated in a prospective, single-arm study at 17 centers in the United States, Europe, and New Zealand.
As summarized in JVIR, the primary endpoint was a composite of device- or procedure-related death or myocardial infarction (MI) at 30 days, or a 9-month rate of TLR, major amputation of the target limb, or restenosis. Secondary endpoints included primary patency, TLR, sustained clinical success, quality of life, and major adverse events (MAE).
The BOLSTER investigators reported the following in JVIR:
- Thirty-day primary endpoint composite rate of 16.2% (93.5% confidence interval [CI], 10.6%–23.2%)
- Primary patency rate of 89.1% (95% CI, 82.6%–93.7%)
- Freedom from TLR rate of 96%
- A cumulative clinical improvement of at least one Rutherford category from baseline to 9 months of 90.5% (95% CI, 84.3%–94.9%)
- An improvement in the quality of life from baseline, assessed by a mean change in the Walking Impairment Questionnaire (WIQ) total score of 32.1 ± 26.84 with improvements noted in each WIQ category
- Of 150 patients, seven (4.7%; 95% CI, 1.9%–9.4%) experienced MAEs, but none were determined to be related to device or procedure
The 9-month BOLSTER data were presented at VIVA 16, the 14th annual Vascular InterVentional Advances meeting, sponsored by VIVA Physicians, Inc. and held in September 2016 at the Wynn Las Vegas in Las Vegas, Nevada.