The Tack-Optimized Balloon Angioplasty (TOBA) II Below-the-Knee Trial: 36-Month Results

PURPOSE: To report the 36-month results of the Tack-Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) study for repair of post-percutaneous transluminal angioplasty (PTA) dissection(s) of the infrapopliteal arteries. MATERIALS AND METHODS: TOBA II BTK is a prospective, multicenter, single-arm evaluation of the Tack Endovascular System (Intact Vascular, Inc., now a part of Philips Image Guided Therapy Corporation) for post-PTA BTK dissection repair. Patients with Rutherford category 3 to 5 and a post-PTA dissection(s) of the mid/distal popliteal, tibial, and/or peroneal arteries were enrolled. The primary safety endpoint was a composite of major adverse limb events (MALE) and all-cause perioperative death (POD) at 30 days. The primary effectiveness endpoint was a composite of MALE at 6 months and 30-day POD. Outcomes are reported through 36 months. RESULTS: TOBA II BTK enrolled 233 patients with 301 post-PTA dissection(s); all patients received 1 or more Tack im-plant(s) (range, 1-16). Mean age was 74.4 ± 10.0 years and 67.4% were men. Most patients had critical limb-threatening ischemia (83.7%). Kaplan-Meier freedom from MALE at 36 months + POD at 30 days was 91.6%. Freedom from clinically driven-target lesion revascularization (CD-TLR) was 69.6%. High rates of target limb salvage (TLS; 95.0%) and amputation-free survival (AFS; 64.7%) were also reported. Improvements in quality of life (QoL), mobility, and Rutherford category were sustained through 36 months. CONCLUSIONS: The Tack Endovascular System for infrapopliteal dissection repair demonstrates durable freedom from MALE + POD and CD-TLR and high rates of TLS and AFS through 36 months. Improvements were also sustained in QoL, mobility, and Rutherford category.