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 after angioplasty.

Materials 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 TOBA-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 postangioplasty dissection. The average total dissection lengths per patient were 37.3 mm in TOBA II, 39.6 mm in TOBA III, and 19.6 mm in TOBA II-BTK. Of the 383 patients who received an above-the-knee TOBA implant 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 below-the-knee TOBA implant 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 TOBA produces positive short- and long-term results while preserving future treatment options.