Author + information
- Received April 11, 2019
- Revision received July 29, 2019
- Accepted August 6, 2019
- Published online December 2, 2019.
- William A. Gray, MDa,∗ (, )
- Joseph A. Cardenas, MDb,
- Marianne Brodmann, MDc,
- Martin Werner, MDd,
- Nelson I. Bernardo, MDe,
- Jon C. George, MDf and
- Alexandra Lansky, MDg
- aLankenau Heart Institute, Wynnewood, Pennsylvania
- bYuma Cardiology Associates, Yuma Regional Medical Center, Yuma, Arizona
- cDivision of Angiology, Medical University Graz, Graz, Austria
- dDepartment of Angiology, Hanusch Hospital, Vienna, Austria
- eMedStar Washington Hospital Center, Washington, District of Columbia
- fEinstein Medical Center, Philadelphia, Pennsylvania
- gYale Cardiovascular Research Group, New Haven, Connecticut
- ↵∗Address for correspondence:
Dr. William A. Gray, Lankenau Heart Pavilion, 100 East Lancaster Avenue, Wynnewood, Pennsylvania 19096.
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.
This study was funded by Intact Vascular. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 11, 2019.
- Revision received July 29, 2019.
- Accepted August 6, 2019.
- 2019 The Authors