Abstract
Objectives
The TOBA (Tack Optimized Balloon Angioplasty) II trial is a prospective, single-arm, multicenter study that investigated Tack treatment for patients with dissection after angioplasty in the superficial femoral artery and/or proximal popliteal artery. The Tack device is a nitinol-based, short (6 mm), stent-like implant with low outward force that can be deployed in a targeted fashion to treat vascular dissection. TOBA II primary results through 12 months have been published previously. This report provides follow-up safety and efficacy results through 24 months (RC).
Methods
The TOBA II trial enrolled 213 patients with Rutherford classification 2 to 4 and a de novo or non-stented restenotic lesion in the superficial femoral artery and/or proximal popliteal artery who developed a dissection of any grade after treatment with plain balloon or drug-coated balloon (DCB) angioplasty. Participants were followed for 30 days, 6 months, 12 months, 24 months, and 36 months following the procedure. Evaluations included clinically driven target lesion revascularization (CD-TLR), ankle-brachial index, Rutherford classification, peripheral artery questionnaire, quality of life assessed by the EQ-5D-3L, and the Walking Impairment Questionnaire.
Results
At enrollment, mean age was 68.2 ± 9.1 years, 70.9% were male, and 95.8% of patients were categorized as RC 2 or 3. The distribution of balloon types in the study were standard balloons: 42.3%; and drug-coated balloons: 57.7%. At 24-month follow-up, 167 patients (78.4%) had available data. The overall survival rate at 24 months was 95.4% and there were no major amputations during this time. After 24 months of follow-up, the Kaplan–Meier freedom from CD-TLR was 77.7%. Rutherford classification, ankle-brachial index, and quality of life were significantly improved compared with baseline through 24 months.
Conclusions
The TOBA II 24-month data demonstrate durable intermediate-term outcomes with the use of the Tack Endovascular System. Tack deployment was a safe and effective therapeutic option for dissection repair following angioplasty.
Get full access to this article
View all access options for this article.
References
Supplementary Material
Please find the following supplemental material available below.
For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.
For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.
