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Vascular stent safe, effective in challenging long lesions
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HOLLYWOOD, Fla. — The Tigris Vascular Stent demonstrated safety and efficacy at 2 years, with no evidence of stent fracture, in patients with symptomatic peripheral artery disease with long atherosclerotic lesions in the superficial femoral or proximal popliteal arteries.
Thomas Zeller, MD, PhD, head physician in the department of angiology at Universitäts Herzzentrum, Bad Krozingen, Germany, presented the completed 2-year results of the investigational device exemption (IDE) study of the Tigris Vascular Stent (W.L. Gore and Associates).
The study enrolled patients with de novo and restenostic atherosclerotic lesions ( 24 cm) in the superficial femoral or proximal popliteal arteries who were randomly assigned in a 3:1 fashion to treatment with the Tigris stent (n = 197; 28% women) or LifeStent Vascular Stent (Bard Peripheral Vascular; n = 70; control group; 30% women). Total stented length was 129 mm in the Tigris group and 148.7 mm in the LifeStent group. The study was conducted at 36 international sites.
“[The Tigris stent] met the study endpoints and demonstrated safety and efficacy. [The results show] excellent efficacy compared to what was considered the benchmark at the time,” the LifeStent, Zeller said at the International Symposium of Endovascular Therapy.
The Tigris stent was approved by the FDA in August 2016 for treatment of PAD.
According to data reported by Zeller, the primary safety endpoint, freedom from 30-day major adverse events, was 99.5% with the Tigris stent vs. 100% with the LifeStent. The primary efficacy endpoint, Kaplan-Meier-estimated 360-day primary patency, was 63.1% with the Tigris stent vs. 66.4% with the LifeStent.
“It is interesting to see what there was almost no drop in primary patency between 1 and 2 years, slightly in favor of the Tigris stent at 2 years compared to the LifeStent,” he said.
Avoidance of stent fracture is important in challenging long lesions such as those treated in this study. The stent fracture was “notably high” at 1- and 2-year follow-up with the LifeStent, he noted, with a rate of 27.1% and 32.7%, respectively. “Every third LifeStent fractured in the control cohort,” he said. At 2 years, most stent fractures were grade 4 (misaligned) or grade 5 (transaxial-spiral). No stent fractures occurred in the Tigris stent group (0% at both follow-up periods).
Both groups demonstrated similar success: procedural, 99.5% with Tigris and 100% with LifeStent; technical, 99.5% with Tigris and 97.1% with LifeStent.
Zeller also noted that, as expected, patients receiving both devices showed notable improvement in quality-of-life metrics including Rutherford classification, ankle-brachial index, Peripheral Artery Questionnaire and EuroQOL five dimensions questionnaire (EQ-5D).
The Tigris stent was designed to meet the challenges of the superficial femoral and proximal popliteal arteries. The stent is designed to naturally conform and allow vessel movement; maximize flexibility while minimizing risk for fracture; and allow axial compression while resisting stent elongation, according to Zeller.
Both the Tigris and LifeStent devices demonstrated minimal elongation by comparison of pre- and postprocedure angiograms, he said. Percent elongation was 0.03% with the Tigris group vs. 0.12% with the LifeStent.
To further compare the two stents, Zeller referenced data from RESILIENT, the IDE trial for LifeStent. He noted that patients treated with the LifeStent in the current study had a 92% longer average lesion length than in RESILIENT, had more than twice as many chronic total occlusions, and were 20% more likely to have moderate or severely calcified lesions.
“We are dealing here with a challenging, real-world, long-lesion study. It is one of the first studies comparing, head to head, an established device with a newer device,” he said.
Zeller concluded that “this stent could be particularly useful for high-flexion areas, and could be a good combination device for drug-coated balloons where provisional stenting might be indicated.” – by Katie Kalvaitis
Reference:
Zeller T. Concurrent Session VI: Late-Breaking Trials and Hot Topics. Presented at: International Symposium on Endovascular Therapy; Feb. 4-8, 2017; Hollywood, Fla.
Disclosure: Zeller reports financial ties with 480 Biomedical, Abbott Vascular, Bard Peripheral Vascular, Biotronik, Boston Scientific, Cook Medical, Cordis Corp., Medtronic, Spectranetics, Straub Medical, Terumo, TriReme, Veryan, Volcano and W.L. Gore and Associates.