June 25, 2020

Twelve-Month Results of Tack Optimized Balloon Angioplasty in Below-the-Knee Arteries (TOBA II BTK)

VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, presents the data summary below in conjunction with our Late-Breaking Clinical Trials Livestream on June 25, 2020.

Presenter: Patrick Geraghty, MD

Objective
Post-angioplasty dissection following below-the-knee (BTK) percutaneous transluminal angioplasty (PTA) is associated with restenosis and early re-intervention. We investigated use of a BTK dissection repair implant.

Methods
Prospective, single arm, multi-center study evaluating the safety and efficacy of the Tack Endovascular System® for post-PTA dissection repair of BTK arteries. Primary safety and efficacy endpoints at 6 months were met. 12-month endpoints include freedom from MALE + POD, patency, freedom from target lesion revascularization (TLR), target limb salvage and amputation-free survival.

Results
233 patients were enrolled with post-PTA dissection: 50.2% (117/233) Rutherford Category (RC) 5, 33.5% (78/233) RC 4, and 16.3% (38/233) RC 3. Treated lesion length was 154±110mm and 47.6% (118/248) of lesions were total occlusions. Freedom from MALE at 12 months + POD was 93.4% (170/182) in all patients and 91.9% (136/148) in patients with RC 4/5 at baseline. Kaplan-Meier (KM) Tacked segment patency was 81.3% freedom from TLR was 83.1% at 12 months. KM target limb salvage 96.1% and amputation free survival was 89.0% for patients with baseline CLTI. TBI at 12 months was 0.61±0.28, compared to pretreatment 0.43±0.23 (p<0.0001). Sustained improvement seen in Rutherford class at 12 months in 82.4% (146/177) of patients, with 62.4% (107/177) improving ≥3 classes (p<0.0001). In CLTI enrollees, 79.8% (114/143) were improved at 12 months, with 70.7% (101/143) improved ≥ 3 classes (p<0.0001). Healing or improvement was reported in 72.5% (90/124) of evaluable index wounds. No Tack implant migration or fracture was evident on radiographs at 12 months.

Conclusion
The Tack Endovascular System® is the first implant approved in the United States for repair of post-PTA dissection in the BTK arteries. Twelve-month data demonstrates sustained high rates of patency, limb salvage, and wound healing in CLTI patients.

About VIVA Physicians
VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, strives to be the premier educator in the field. Our team of specialists in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery is driven by the passion to advance the field and improve patient outcomes. Educational events presented by VIVA Physicians have a distinct spirit of collegiality attained by synergizing collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide. To learn more about VIVA Physicians, visit www.vivaphysicians.org.

SOURCE VIVA Physicians

For further information: press@vivaphysicians.org