Prospective Evaluation of the TIGRIS Vascular Stent Within a Modern Treatment Algorithm

Abstract

Purpose: To prospectively evaluate the safety and efficacy of the TIGRIS Vascular Stent in the superficial femoral artery (SFA) and proximal popliteal artery within a treatment algorithm that reserved stent usage for more challenging patients. Materials and Methods: This prospective, single-center study enrolled 97 patients (mean age 68.7 years; 66 men) who were treated for 100 de novo or nonstented restenotic femoropopliteal lesions (≥70% stenosis) and had recoil or dissection after plain balloon predilation. The average lesion length was 5.6±2.3 cm (maximum 8 cm per protocol). The composite primary efficacy outcome was 12-month primary patency, defined as a peak systolic velocity ratio ≤2.5 at the stented target lesion on duplex ultrasound, and no clinically-driven reintervention within the stented segment. The primary safety outcome was freedom from device- and procedure-related target vessel revascularization, target limb major amputation (above the metatarsals), or death through 30 days. Secondary outcomes included secondary patency, clinically-driven target lesion revascularization (TLR), Rutherford category change relative to baseline, and binary restenosis of the target lesion. Results: All devices were successfully implanted with no device-related complications at the time of implant or within the 30-day postimplant window. The average stented length was 7.0±2.5 cm; no stent elongation was observed during deployment. One patient was lost to follow-up before 12 months and another died of an unrelated cause, leaving 95 patients (98 lesions) available for 12-month follow-up and 77 patients/lesions for the 24-month preliminary analysis. The binary primary and secondary patency rates at 12 months were 92.9% and 100%. The binary freedom from TLR was 94.9%. At 24 months, the Kaplan-Meier estimate of primary patency was 90.0%. Conclusion: This prospective study demonstrated that the TIGRIS Vascular Stent is a safe and effective device in a modern treatment algorithm that reserved bare stent use for postangioplasty dissection or recoil in distal femoropopliteal arteries.

Commentary: Endovascular Peripheral Artery Disease Treatment: “Leaving Nothing Behind”?

“…Werner and colleagues placed the TIGRIS stent only in the vascular segment more exposed to mechanical stress, 9,10 such as the proximal superficial femoral artery (69%) and popliteal artery (31%), while in the other studies, stent deployments were more widespread across the femoropopliteal segment. In this setting, Werner et al 6 were able to achieve 90.0% primary patency, 88.6% freedom from target lesion revascularization, and 100% secondary patency at 12 months. These findings were superior to all other studies presented in the literature, 7,8,11,12 although all the aforementioned considerations should be taken into account.…”

“…Comparing the stenoses treated by Werner et al 6 with other reports on the TIGRIS stent, the lesion length was at the lower end of the range (from 43.1±27.8 mm to 17.2±10.5 cm) 7,8 and less severely calcified; in fact, calcification described as severe was seen in 12% (12/100) of Werner’s cohort vs 51.6% (16/31) 8 and 22.2% (42/189) 7 in the other studies. Werner and colleagues placed the TIGRIS stent only in the vascular segment more exposed to mechanical stress, 9,10 such as the proximal superficial femoral artery (69%) and popliteal artery (31%), while in the other studies, stent deployments were more widespread across the femoropopliteal segment.…”

“…Moreover, Werner et al 6 observed no device-related adverse events, but 6 procedure-related complications included 3 pseudoaneurysms, 2 hematomas, and 1 distal plaque embolization. This finding is absolutely in line with the other studies on TIGRIS deployment.…”

“…An article by Werner et al 6 in the October 2019 issue of the JEVT is notable for its evaluation of bailout stenting. In a prospective, single-center, open-label study, the authors evaluated the TIGRIS stent in a cohort of patients who had recoil or dissection after plain balloon predilation.…”