Geraghty Patrick J, Adams George L, Schmidt Andrej, Lichtenberg Michael, Wissgott Christian, Armstrong Ehrin J, Hertting Klaus
Vascular Surgery, Washington University, St Louis, MO, USA.
North Carolina Heart and Vascular, Rex Hospital, Raleigh, NC, USA.
J Endovasc Ther. 2020 Aug;27(4):626-636. doi: 10.1177/1526602820944402.
To report the 12-month safety and efficacy outcomes of the investigational device exemption trial evaluating an implantable below-the-knee (BTK) dissection repair device. The prospective, multicenter, single-arm Tack-Optimized Balloon Angioplasty (TOBA) II BTK study ( identifier NCT02942966) evaluated the Tack Endovascular System in the BTK arteries vs objective performance goals derived from a systematic review of BTK angioplasty literature. Patients presenting with Rutherford category 3-5 ischemia were eligible and were enrolled during the procedure if angioplasty resulted in dissection(s) of the BTK arteries. Between February 2017 and December 2018, the study enrolled 233 patients (mean age 74.4±10.0 years; 157 men). Most lesions (93.8%) were de novo; almost half (118/248, 47.6%) were total occlusions. Mean target lesion length was 80±49 mm. Moderate to severe calcium was present in 89 (35.8%) lesions. The 30-day primary safety endpoint was a composite of major adverse limb events (MALE) and all-cause perioperative death (POD). The primary efficacy endpoint was a composite of MALE at 6 months and 30-day POD. These safety and efficacy endpoints were assessed at 12 months as observational endpoints along with amputation-free survival (AFS), freedom from clinically-driven target lesion revascularization (CD-TLR), vessel patency, and changes from baseline in clinical and quality of life measures. All patients had post-PTA dissection and received at least 1 Tack implant (range 1 to 16). The angiographic core laboratory noted successful resolution of 100% of the 341 treated dissections. At 12 months, 93.4% (170/182) of patients remained free of the composite endpoint of MALE + POD. Tacked segment patency was 81.3% and limb salvage was 96.8% at 12 months; freedom from CD-TLR and AFS were 83.1% and 89.3%, respectively. Sustained Rutherford category improvement was reported in 82.4% of evaluated patients, with 62.4% improving ≥3 categories (p<0.001). Ninety of 124 index wounds (72.5%) healed or improved. The Tack Endovascular System is safe and effective in the treatment of post-angioplasty BTK dissections. Twelve-month outcome data from the TOBA II BTK study demonstrate high rates of patency, limb salvage, and wound healing.
报告评估一种可植入式膝下（BTK）夹层修复装置的研究性器械豁免试验的12个月安全性和有效性结果。前瞻性、多中心、单臂优化球囊血管成形术（TOBA）II BTK研究（标识符NCT02942966）评估了BTK动脉中的Tack血管内系统与源自BTK血管成形术文献系统评价的客观性能目标。出现卢瑟福3 - 5级缺血的患者符合条件，若血管成形术导致BTK动脉夹层，则在手术过程中纳入研究。2017年2月至2018年12月期间，该研究纳入了233例患者（平均年龄74.4±10.0岁；157例男性）。大多数病变（93.8%）为新发；几乎一半（118/248，47.6%）为完全闭塞。平均靶病变长度为80±49毫米。89处（35.8%）病变存在中度至重度钙化。30天主要安全终点是主要不良肢体事件（MALE）和全因围手术期死亡（POD）的复合终点。主要疗效终点是6个月时的MALE和30天POD的复合终点。这些安全性和有效性终点在12个月时作为观察性终点进行评估，同时评估无截肢生存（AFS）、免于临床驱动的靶病变血运重建（CD-TLR）、血管通畅情况以及临床和生活质量指标相对于基线的变化。所有患者均有经皮腔内血管成形术后夹层，并接受了至少1枚Tack植入物（范围为1至16枚）。血管造影核心实验室指出，341处治疗的夹层中有100%成功解决。在12个月时，93.4%（170/182）的患者未出现MALE + POD复合终点。12个月时，Tack植入段通畅率为81.3%，肢体挽救率为96.8%；免于CD-TLR和AFS分别为83.1%和89.3%。82.4%的评估患者报告卢瑟福分级持续改善，其中62.4%改善≥3级（p<0.001）。124处索引伤口中有90处（72.5%）愈合或改善。Tack血管内系统在治疗血管成形术后BTK夹层方面安全有效。TOBA II BTK研究的12个月结果数据显示通畅率、肢体挽救率和伤口愈合率很高。
