03 - Optimizing Dissection Repair: Pooled Subanalysis from the Tack Optimized Balloon Angioplasty (TOBA) Studies
Purpose: Dissection after angioplasty with plain balloon (POBA) or drug-coated balloon is known to negatively impact short and long-term outcomes in above and below-the-knee lesions. The Tack Optimized Balloon Angioplasty (TOBA) studies investigate dissection repair with the Tack endovascular system in the femoropopliteal (TOBA II and TOBA III) and infrapopliteal (TOBA II BTK) arteries following angioplasty.
Material and Methods: The primary and secondary endpoints of the TOBA II, TOBA III, and TOBA II BTK studies were previously met and reported in peer-reviewed literature. In the present subanalysis, the three studies were pooled and clinically driven target lesion revascularization (CD-TLR) patterns of Tack-repaired lesions were assessed.
Results: In total, TOBA II (N = 213), TOBA III (N = 201), and TOBA II BTK (N = 233) enrolled 647 patients. Each patient had at least one core-lab adjudicated post-angioplasty dissection. The average total dissection length per patient was 37.3mm in TOBA II, 39.6mm in TOBA III, and 19.6mm in TOBA II-BTK. Of the 383 patients who received a Tack implant above-the-knee in the TOBA II and TOBA III studies, 37 (9.7%) required a CD-TLR. The primary revascularization modality was stent (32%), followed by POBA (29%), atherectomy (22%), thrombectomy (15%), and bypass (2%). Of the 233 patients who received a Tack implant below-the-knee in the TOBA II BTK study, 39 (16.9%) required a CD-TLR. The primary revascularization modality was POBA (56%), followed by atherectomy (19%), stent (15%), thrombectomy (5%), bypass (3%), and unknown (2%).
Conclusions: The pooled analysis from three TOBA studies demonstrates very low rates of CD-TLR and bail-out stenting, with restenosis patterns that appear much less complex than in-stent restenosis. Dissection repair with Tack produces positive short- and long-term results while preserving future treatment options.