Gore's Tigris Stent Meets Safety and Efficacy Endpoints at 24 Months in Long SFA Lesions

September 21, 2016—John Laird, MD, presented 24-month results from the TIGRIS 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.

The TIGRIS trial is a prospective, multicenter, noninferiority, randomized controlled clinical study designed to evaluate the Tigris stent (Gore & Associates). The Tigris stent has a dual-component design that aims to allow natural movement and conformation to the vessel, maximize flexibility while minimizing risk of fracture, and allow axial compression while resisting stent elongation.

At VIVA 16, Dr. Laird reported that patients in TIGRIS were enrolled at 33 sites in the United States and three in Europe. Patients were enrolled on an intention-to-treat basis (n = 274) and per protocol (n = 267), then randomized 3:1 to treatment with either the Tigris stent or LifeStent (Bard Peripheral Vascular, Inc.).

The mean pretreatment lesion lengths were 107.6 ± 68.6 mm and 117.9 ± 75.4 mm in the Tigris and LifeStent arms, respectively (P = .292). The total stented length was 129 ± 73.3 mm in the Tigris arm and 148.7 ± 75.4 mm in the LifeStent arm (P = .057). In the Tigris arm and LifeStent arm, respectively, 51.1% and 62.9% of lesions required implantation of one stent for coverage, 28.1% and 31.4% required two, 18.4% and 5.7% required three, 2% and 0% required four stents. Occlusive disease accounted for 42.1% of lesions treated with Tigris and 37.1% with LifeStent.

The Kaplan-Meier estimates that 24-month primary patency and freedom from target lesion revascularization rates are 63% and 76.6% for the Tigris stent versus 67.4% and 80.6% for LifeStent, respectively. There were no stent fractures observed at 24-month follow-up with the Tigris stent, whereas the LifeStent stent fracture rate was 28.8%, with the majority being grades 3 to 5.

The TIGRIS investigators concluded that this challenging, head-to-head, real-world, long lesion trial met its endpoints and demonstrated the Tigris device’s safety and efficacy. The novel design of the Tigris stent matches the demands of high-flexion areas, stated Dr. Laird at VIVA 16.