Objectives

The aim of this study was to evaluate the Tack Endovascular System (Intact Vascular, Wayne, Pennsylvania) for treating dissections following angioplasty in the superficial femoral artery and/or proximal popliteal artery.

Background

Dissection after angioplasty of femoropopliteal arteries with either a plain balloon or a drug-coated balloon (DCB) can negatively affect both short- and long-term outcomes.

Methods

TOBA (Tack Optimized Balloon Angioplasty) II is a prospective, single-arm, multicenter study enrolling 213 patients, all with dissection following angioplasty. Eligibility included Rutherford classification 2 to 4 with a de novo or nonstented restenotic lesion in the superficial femoral artery or proximal popliteal artery undergoing plain balloon or DCB angioplasty. Following dilation, lesions with <30% residual stenosis and presence of ≥1 dissection were enrolled. The 12-month efficacy endpoint was primary patency (freedom from duplex-derived binary restenosis and clinically driven target lesion revascularization.

Results

Patients’ mean age was 68 ± 9 years, and 43.2% had diabetes. Twenty-three percent of lesions were chronic total occlusions, and ∼60% had moderate to severe calcium. The mean lesion length was 74.3 ± 40.6 mm. Severe dissection (grade ≥C) was present in 69.4%. By operator choice, 57.7% of patients underwent DCB angioplasty. Most (92.1%) dissections resolved completely, and only 1 bailout stent was required. There were no 30-day major adverse events. The 12-month efficacy endpoint was met, with Kaplan-Meier primary patency and freedom from clinically driven target lesion revascularization of 79.3% and 86.5%, respectively. At 12 months, there were no device fractures or clinically significant migrations, and significant improvements were noted in Rutherford category, ankle-brachial index, and quality of life.

Conclusions

TOBA II demonstrated the safety and efficacy of the Tack Endovascular System for focal dissection repair following standard and DCB angioplasty.

中文翻译：

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使用Tack血管内系统治疗股pop动脉成形术后解剖：TOBA II研究的12个月结果。

目标

这项研究的目的是评估Tack血管内系统（Intact Vascular，韦恩，宾夕法尼亚州），用于治疗股浅动脉和/或近端pop动脉的血管成形术后的解剖。

背景

股pop动脉血管成形术后使用普通球囊或药物涂层球囊（DCB）进行解剖可能会对短期和长期结局产生负面影响。

方法

TOBA（Tack优化的球囊血管成形术）II是一项前瞻性，单臂，多中心研究，招募了213例患者，所有患者均在血管成形术后进行了解剖。符合条件的卢瑟福（Rutherford）分类2到4，在进行了平气囊或DCB血管成形术的浅表股动脉或pop部近端动脉中有新生或无支架的再狭窄病变。扩张后，纳入残余狭窄<30％且解剖≥1的病变。12个月的疗效终点是主要通畅（无双源性二元再狭窄和临床驱动的靶病变血运重建）。

结果

患者的平均年龄为68±9岁，其中43.2％为糖尿病。23％的病变为慢性完全阻塞，约60％的钙为中度至重度钙。平均病变长度为74.3±40.6mm。严重解剖（≥C级）的发生率为69.4％。根据操作员的选择，57.7％的患者接受了DCB血管成形术。大多数解剖（92.1％）完全解决，仅需要1个救助支架。没有30天的重大不良事件。达到了12个月的疗效终点，Kaplan-Meier的主要通畅性和不受临床驱动的目标病变血运重建的自由度分别为79.3％和86.5％。在12个月时，没有出现器械骨折或临床上明显的迁移，卢瑟福类别，踝臂指数和生活质量得到了显着改善。

结论

TOBA II证明了Tack血管内系统在遵循标准和DCB血管成形术进行局灶性夹层修复中的安全性和有效性。