Brodmann Marianne, Wissgott Christian, Brechtel Klaus, Nikol Sigrid, Zeller Thomas, Lichtenberg Michael, Blessing Erwin, Gray William
Division of Angiology, Medical University Graz, Graz, Austria.
Institute for Diagnostic and Interventional Radiology, Westküstenklinikum Heide, Heide, Germany.
J Vasc Surg. 2020 Nov;72(5):1636-1647.e1. doi: 10.1016/j.jvs.2020.01.078. Epub 2020 May 12.
The Tack Endovascular System (Intact Vascular, Wayne, Pa) combines low-metallic content with focal delivery to seal areas of dissection associated with balloon angioplasty. The device system is designed to treat vascular dissections in the superficial femoral and proximal popliteal arteries. Tack implants exert low radial force and are associated with minimal metal burden, which reduces the mechanical stress on the arterial wall in treating dissections after balloon angioplasty. This study investigated the safety and effectiveness of the Tack Endovascular System in patients with dissections after drug-coated balloon (DCB) angioplasty.
The Tack Optimized Balloon Angioplasty III (TOBA III) study is a prospective, multicenter, single-arm study in which patients who underwent percutaneous transluminal angioplasty with the Medtronic IN.PACT Admiral DCB (Medtronic, Dublin, Ireland) and experienced dissection after angioplasty were treated with Tack implants. The primary end points were freedom from major adverse events at 30 days and primary patency at 12 months.
A total of 201 patients were enrolled in the trial, 169 with standard-length lesions (≥20 mm and ≤150 mm) and 32 with long-length lesions (>150 mm and ≤250 mm). Safety and effectiveness results were favorable compared with historical benchmarks at 12 months in the standard-lesion cohort. Notably, patients in the standard-lesion cohort experienced 95.0% primary patency, 97.5% freedom from clinically driven target lesion revascularization, 100% freedom from amputation, and 100% survival at 12 months (P < .0001). Primary patency in long-lesion patients was 89.3%, freedom from clinically driven target lesion revascularization was 96.8%, and freedom from amputation was 100% at 12 months. Device success was achieved in 95.8% (182/190) and 97.7% (43/44) of devices deployed into standard-lesion and long-lesion patients, respectively. Procedural success was 99.4% (168/169) and 100% (44/44) in the standard-lesion and long-lesion cohorts, respectively, with only one bailout stent placed in the entire population.
The Tack Endovascular System is a safe and effective treatment option for patients with dissections after angioplasty in the superficial femoral and proximal popliteal arteries, with high patency, low rates of secondary intervention, and low incidence of bailout stenting when it is used in combination with DCB.
Tack血管内系统（Intact Vascular公司，宾夕法尼亚州韦恩市）将低金属含量与局部递送相结合，以封闭与球囊血管成形术相关的夹层区域。该设备系统旨在治疗股浅动脉和腘动脉近端的血管夹层。Tack植入物施加的径向力较低，且金属负荷最小，这减少了球囊血管成形术后治疗夹层时动脉壁上的机械应力。本研究调查了Tack血管内系统在药物涂层球囊（DCB）血管成形术后夹层患者中的安全性和有效性。
Tack优化球囊血管成形术III（TOBA III）研究是一项前瞻性、多中心、单臂研究，其中接受美敦力IN.PACT Admiral DCB（美敦力，爱尔兰都柏林）经皮腔内血管成形术且血管成形术后出现夹层的患者接受Tack植入物治疗。主要终点是30天时无主要不良事件以及12个月时的原发性通畅率。
共有201例患者纳入试验，169例为标准长度病变（≥20mm且≤150mm），32例为长长度病变（>150mm且≤250mm）。与标准病变队列12个月时的历史基准相比，安全性和有效性结果良好。值得注意的是，标准病变队列中的患者在12个月时原发性通畅率为95.0%，临床驱动的靶病变血运重建率为97.5%，截肢率为100%，生存率为100%（P <.0001）。长病变患者在12个月时的原发性通畅率为89.3%，临床驱动的靶病变血运重建率为96.8%，截肢率为100%。分别有95.8%（182/190）和97.7%（43/44）的植入标准病变和长病变患者的器械获得成功。标准病变和长病变队列中的手术成功率分别为99.4%（168/169）和100%（44/44），整个人群中仅置入了一枚补救支架。
Tack血管内系统是股浅动脉和腘动脉近端血管成形术后夹层患者的一种安全有效的治疗选择，与DCB联合使用时具有高通畅率、低二次干预率和低补救支架置入率。
