Treating Post-Angioplasty Dissection in the Femoropopliteal Arteries Using the Tack Endovascular System: 12-Month Results From the TOBA II Study

Abstract

Objectives: The aim of this study was to evaluate the Tack Endovascular System (Intact Vascular, Wayne, Pennsylvania) for treating dissections following angioplasty in the superficial femoral artery and/or proximal popliteal artery.

Background: Dissection after angioplasty of femoropopliteal arteries with either a plain balloon or a drug-coated balloon (DCB) can negatively affect both short- and long-term outcomes.

Methods: TOBA (Tack Optimized Balloon Angioplasty) II is a prospective, single-arm, multicenter study enrolling 213 patients, all with dissection following angioplasty. Eligibility included Rutherford classification 2 to 4 with a de novo or nonstented restenotic lesion in the superficial femoral artery or proximal popliteal artery undergoing plain balloon or DCB angioplasty. Following dilation, lesions with <30% residual stenosis and presence of ≥1 dissection were enrolled. The 12-month efficacy endpoint was primary patency (freedom from duplex-derived binary restenosis and clinically driven target lesion revascularization.

Results: Patients' mean age was 68 ± 9 years, and 43.2% had diabetes. Twenty-three percent of lesions were chronic total occlusions, and ∼60% had moderate to severe calcium. The mean lesion length was 74.3 ± 40.6 mm. Severe dissection (grade ≥C) was present in 69.4%. By operator choice, 57.7% of patients underwent DCB angioplasty. Most (92.1%) dissections resolved completely, and only 1 bailout stent was required. There were no 30-day major adverse events. The 12-month efficacy endpoint was met, with Kaplan-Meier primary patency and freedom from clinically driven target lesion revascularization of 79.3% and 86.5%, respectively. At 12 months, there were no device fractures or clinically significant migrations, and significant improvements were noted in Rutherford category, ankle-brachial index, and quality of life.

Conclusions: TOBA II demonstrated the safety and efficacy of the Tack Endovascular System for focal dissection repair following standard and DCB angioplasty.

Keywords: angioplasty; dissection; femoropopliteal artery; peripheral artery disease.