UNC REX Healthcare, Raleigh, NC, USA.
Clinic of Angiology, Karolinen-Hospital, Arnsberg, Germany.
J Endovasc Ther. 2023 Jun;30(3):393-400. doi: 10.1177/15266028221083462. Epub 2022 Mar 30.
To report 24 month safety and efficacy of the Tack Endovascular System for treatment of post-percutaneous transluminal angioplasty (PTA) infrapopliteal dissections in patients with critical limb-threatening ischemia (CLTI).
The Tack-Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) study was a prospective, multicenter, single-arm evaluation of the Tack Endovascular system for post-PTA infrapopliteal dissection repair. Patients with Rutherford Clinical Category (RC) 3 to 5 and a post-PTA dissection(s) of the BTK arteries were enrolled. The 30 day primary safety endpoint was a composite of major adverse limb events (MALE) and all-cause perioperative death (POD). The primary effectiveness endpoint was a composite of MALE at 6 months and 30 day POD. Outcomes were assessed as observational endpoints at 24 months.
Tack-Optimized Balloon Angioplasty II BTK enrolled 233 patients; all patients had a post-PTA dissection(s) and received ≥1 Tack implant (range, 1-16). Mean age was 74.4±10.0 years and 67.4% were men. Most patients had CLTI (RC 3: 16.3%; RC 4/5: 83.7%). Mean target lesion length was 80±49 mm. Moderate to severe calcium was present in 89 (35.8%) lesions and total occlusions were present in 118 (47.6%) lesions. Kaplan-Meier freedom from MALE at 24 months + POD at 30 days was 92.2% and 24 month freedom from clinically-driven target lesions revascularization was 73.6%. Kaplan-Meier target limb salvage was 95.7% and amputation-free survival was 75.4%. Improvements in functional status and quality of life were observed through 24 months.
The TOBA II BTK study demonstrated sustained safety and efficacy through 24 months in patients treated for post-PTA dissection(s) of BTK lesions.
ClinicalTrials.gov identifier NCT02942966.
报告 Tack 血管内系统治疗经皮腔内血管成形术（PTA）后下肢缺血性病变（CLI）患者的膝下（BTK）部位的腔内血管成形术后夹层的 24 个月安全性和疗效。
Tack-Optimized Balloon Angioplasty（TOBA）II 膝下 BTK 研究是对 Tack 血管内系统进行的一项前瞻性、多中心、单臂评价，用于治疗 PTA 后 BTK 动脉夹层。纳入了 Rutherford 临床分类（RC）3 至 5 级和 PTA 后 BTK 动脉夹层的患者。30 天的主要安全性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。主要有效性终点是 6 个月和 30 天 POD 的 MALE 复合终点。结果作为观察终点在 24 个月进行评估。
Tack-Optimized Balloon Angioplasty II BTK 共纳入 233 例患者；所有患者均有 PTA 后夹层，并接受了至少 1 个 Tack 植入物（范围 1-16 个）。平均年龄为 74.4±10.0 岁，67.4%为男性。大多数患者患有 CLI（RC 3：16.3%；RC 4/5：83.7%）。平均靶病变长度为 80±49mm。89 处病变（35.8%）有中度至重度钙化，118 处病变（47.6%）为完全闭塞。24 个月时，Kaplan-Meier 无 MALE 生存率+30 天时的 POD 为 92.2%，24 个月时的临床驱动的靶病变血运重建无复发生存率为 73.6%。Kaplan-Meier 目标肢体保肢率为 95.7%，保肢无截肢生存率为 75.4%。通过 24 个月观察到功能状态和生活质量的改善。
TOBA II BTK 研究表明，在治疗 BTK 病变 PTA 后夹层的患者中，24 个月时安全性和疗效持续。
ClinicalTrials.gov 标识符 NCT02942966。
