TY - JOUR
T1 - Twelve-Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries (TOBA II BTK)
AU - Geraghty, Patrick J.
AU - Adams, George L.
AU - Schmidt, Andrej
AU - Lichtenberg, Michael
AU - Wissgott, Christian
AU - Armstrong, Ehrin J.
AU - Hertting, Klaus
AU - Cardenas, Joseph
AU - Lichtenberg, Michael
AU - Wissgott, Christian
AU - Hertting, Klaus
AU - Armstrong, Ehrin
AU - Thieme, Marcus
AU - Ruzsa, Zoltan
AU - Staffa, Robert
AU - Golzar, Jaafer
AU - Brodmann, Marianne
AU - Holden, Andrew
AU - Shammas, Nicolas
AU - Ali, Vaqar
AU - Adams, George
AU - Carr, Jeffrey
AU - Bernardo, Nelson
AU - George, Jon
AU - Jain, Ashit
AU - Rundback, John
AU - Klein, Andrew
AU - Khan, Muhammad
AU - Ansel, Gary
AU - Das, Sundeep
AU - Soukas, Peter
AU - Walker, Craig
AU - Aggarwala, Gaurav
AU - Bose, Rahul
AU - Brechtel, Klaus
AU - Fisher, Bryan
AU - Kilaru, Sashi
AU - Merkley, Bela
AU - Attaran, Robert
AU - Chamberlin, Jack
AU - Davis, Thomas
AU - Delgado, Gabriel
AU - Dexter, David
AU - Kovach, Richard
AU - Rao, Siddhartha
AU - Schmidt, Andrej
AU - Silva, Michael
AU - Strickman, Neil
N1 - Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was funded by Intact Vascular, Inc.
Publisher Copyright:
© The Author(s) 2020.
PY - 2020/8/1
Y1 - 2020/8/1
N2 - Purpose: To report the 12-month safety and efficacy outcomes of the investigational device exemption trial evaluating an implantable below-the-knee (BTK) dissection repair device. Materials and Methods: The prospective, multicenter, single-arm Tack-Optimized Balloon Angioplasty (TOBA) II BTK study (ClinicalTrials.gov identifier NCT02942966) evaluated the Tack Endovascular System in the BTK arteries vs objective performance goals derived from a systematic review of BTK angioplasty literature. Patients presenting with Rutherford category 3–5 ischemia were eligible and were enrolled during the procedure if angioplasty resulted in dissection(s) of the BTK arteries. Between February 2017 and December 2018, the study enrolled 233 patients (mean age 74.4±10.0 years; 157 men). Most lesions (93.8%) were de novo; almost half (118/248, 47.6%) were total occlusions. Mean target lesion length was 80±49 mm. Moderate to severe calcium was present in 89 (35.8%) lesions. The 30-day primary safety endpoint was a composite of major adverse limb events (MALE) and all-cause perioperative death (POD). The primary efficacy endpoint was a composite of MALE at 6 months and 30-day POD. These safety and efficacy endpoints were assessed at 12 months as observational endpoints along with amputation-free survival (AFS), freedom from clinically-driven target lesion revascularization (CD-TLR), vessel patency, and changes from baseline in clinical and quality of life measures. Results: All patients had post-PTA dissection and received at least 1 Tack implant (range 1 to 16). The angiographic core laboratory noted successful resolution of 100% of the 341 treated dissections. At 12 months, 93.4% (170/182) of patients remained free of the composite endpoint of MALE + POD. Tacked segment patency was 81.3% and limb salvage was 96.8% at 12 months; freedom from CD-TLR and AFS were 83.1% and 89.3%, respectively. Sustained Rutherford category improvement was reported in 82.4% of evaluated patients, with 62.4% improving ≥3 categories (p<0.001). Ninety of 124 index wounds (72.5%) healed or improved. Conclusion: The Tack Endovascular System is safe and effective in the treatment of post-angioplasty BTK dissections. Twelve-month outcome data from the TOBA II BTK study demonstrate high rates of patency, limb salvage, and wound healing.
AB - Purpose: To report the 12-month safety and efficacy outcomes of the investigational device exemption trial evaluating an implantable below-the-knee (BTK) dissection repair device. Materials and Methods: The prospective, multicenter, single-arm Tack-Optimized Balloon Angioplasty (TOBA) II BTK study (ClinicalTrials.gov identifier NCT02942966) evaluated the Tack Endovascular System in the BTK arteries vs objective performance goals derived from a systematic review of BTK angioplasty literature. Patients presenting with Rutherford category 3–5 ischemia were eligible and were enrolled during the procedure if angioplasty resulted in dissection(s) of the BTK arteries. Between February 2017 and December 2018, the study enrolled 233 patients (mean age 74.4±10.0 years; 157 men). Most lesions (93.8%) were de novo; almost half (118/248, 47.6%) were total occlusions. Mean target lesion length was 80±49 mm. Moderate to severe calcium was present in 89 (35.8%) lesions. The 30-day primary safety endpoint was a composite of major adverse limb events (MALE) and all-cause perioperative death (POD). The primary efficacy endpoint was a composite of MALE at 6 months and 30-day POD. These safety and efficacy endpoints were assessed at 12 months as observational endpoints along with amputation-free survival (AFS), freedom from clinically-driven target lesion revascularization (CD-TLR), vessel patency, and changes from baseline in clinical and quality of life measures. Results: All patients had post-PTA dissection and received at least 1 Tack implant (range 1 to 16). The angiographic core laboratory noted successful resolution of 100% of the 341 treated dissections. At 12 months, 93.4% (170/182) of patients remained free of the composite endpoint of MALE + POD. Tacked segment patency was 81.3% and limb salvage was 96.8% at 12 months; freedom from CD-TLR and AFS were 83.1% and 89.3%, respectively. Sustained Rutherford category improvement was reported in 82.4% of evaluated patients, with 62.4% improving ≥3 categories (p<0.001). Ninety of 124 index wounds (72.5%) healed or improved. Conclusion: The Tack Endovascular System is safe and effective in the treatment of post-angioplasty BTK dissections. Twelve-month outcome data from the TOBA II BTK study demonstrate high rates of patency, limb salvage, and wound healing.
KW - balloon angioplasty
KW - chronic limb-threatening ischemia
KW - critical limb ischemia
KW - dissection
KW - endovascular revascularization
KW - infrapopliteal disease
KW - peripheral artery disease
KW - restenosis
UR - http://www.scopus.com/inward/record.url?scp=85090492466&partnerID=8YFLogxK
U2 - 10.1177/1526602820944402
DO - 10.1177/1526602820944402
M3 - Article
C2 - 35156451
AN - SCOPUS:85090492466
SN - 1526-6028
VL - 27
SP - 626
EP - 636
JO - Journal of Endovascular Therapy
JF - Journal of Endovascular Therapy
IS - 4
ER -