BOLSTER Data Presented for Bard's LifeStream Balloon-Expandable Covered Stent

September 21, 2016—John Laird, MD, presented 9-month data from the BOLSTER trial during the third Late-Breaking Trials session at VIVA 16, the 14th annual Vascular InterVentional Advances meeting, which is sponsored by VIVA Physicians, Inc. and held September 18–22, 2016 at the Wynn Las Vegas in Las Vegas, Nevada.

BOLSTER is a prospective multicenter study of the LifeStream balloon-expandable covered stent (Bard Peripheral Vascular, Inc.) with 17 enrollment sites in the United States, Europe, and New Zealand. Independent core labs analyzed the imaging studies, and a clinical events committee adjudicated major adverse events.

The LifeStream is composed of an electropolished, 316-L stainless steel balloon-expandable stent encapsulated between two layers of expanded polytetrafluoroethylene. It is premounted on a noncompliant balloon on a 0.035-inch guidewire-compatible delivery catheter. Radiopaque markers on the balloon shaft indicate the ends of the covered stent.

At VIVA 16, Dr. Laird reported that in BOLSTER, the LifeStream covered stent was successfully deployed in 98.3% of cases, with an acute procedural success rate of 97.4%. At 9 months, 11.6% of evaluated patients met the primary composite endpoint (device- and/or procedure-related death or myocardial infarction through 30 days or any target lesion revascularization, major limb amputation, or restenosis), which was significantly less than the historical performance goal (19.5%; P = .01). 

The primary patency rate (proportional-based analysis) was 89.1%, and the rate of freedom from target lesion revascularization was 96.7% at 270 days. There was one major amputation.

The BOLSTER trial is ongoing, with duplex ultrasound imaging follow-up to continue through 3 years, advised Dr. Laird at VIVA 16.