Treatment of infrapopliteal post‐PTA dissection with tack implants: 12‐month results from the TOBA‐BTK study

OBJECTIVES: The Tack implant is designed for focal, minimal metal management of dissections. This study evaluated Tacks for treating postpercutaneous transluminal angioplasty (PTA) dissection in patients with below‐the‐knee (BTK) arterial occlusive disease. BACKGROUND: PTA is the most commonly used endovascular treatment for patients with occlusive disease of the BTK vessels. Post‐PTA dissection is a significant clinical problem that results in poor outcomes, but currently there are limited treatment options for managing dissections. METHODS: This prospective, single‐arm study evaluated patients with CLI and BTK lesions; 11.4% were Rutherford category (RC) 4 and 88.6% were RC 5. BTK occlusive disease was treated with standard PTA and post‐PTA dissections were treated with Tack placement. The primary safety endpoint was a composite of major adverse limb events (MALE) and perioperative death (POD) at 30 days. Other endpoints included: device success; procedure success (vessel patency in the absence of MALE); freedom from clinically driven target lesion revascularization (CD‐TLR); primary patency; and changes in RC. Data through 12 months are presented. RESULTS: Thirty‐two of 35 (91.4%) patients had post‐PTA dissection and successful deployment of Tacks. Procedural success was achieved in 34/35 (97.1%) patients with no MALEs at 30 days. The 12‐month patency rate was 78.4% by vessel, 77.4% by patient, and freedom from CD‐TLR was 93.5%. Significant (P < .0001) improvement from baseline was observed in RC (75% of patients improved 4 or 5 steps). CONCLUSION: Tack implant treatment of post‐PTA dissection was safe and effective for treatment of BTK dissections and resulted in reasonable 12‐month patency and low rates of CD‐TLR.