Frank Bunch1, Craig Walker2, Elias Kassab3, Jeffrey Carr4. 1. Cardiology Associates, Interventional Cardiologist and Peripheral Interventionalist, 188 Hospital Drive, Suite 100, Fairhope, AL, 36532. 2. Cardiovascular Institute of the South, President and Founder, Interventional Cardiologist and Peripheral Interventionalist, 225 Dunn Street, Houma, LA, 70360. 3. Michigan Outpatient Vascular Institute, Interventional Cardiologist and Peripheral Interventionalist, 5500 Auto Club Drive, Dearborn, MI, 48126. 4. Cardiovascular Associates of East Texas, Interventional Cardiologist and Peripheral Interventionalist, 1783 Troup Hwy, Tyler, TX, 75701.
Abstract
OBJECTIVE: The objective of this study was to assess the feasibility, safety and initial efficacy of paclitaxel administration using a novel drug delivery catheter for the prevention of restenosis in infrapopliteal de novo and restenotic lesions. BACKGROUND: Restenosis continues to be a great challenge after percutaneous revascularization procedures for peripheral arterial disease, particularly for below-the-knee applications. METHODS: A prospective, multicenter first-in-human registry of a novel delivery catheter delivering liquid paclitaxel was conducted in 10 patients. The primary efficacy endpoint at 6 months was freedom from clinically driven target lesion revascularization (CD-TLR) and the primary safety endpoint at 1, 3, and 6 months were thrombosis, major amputation in the target limb and target limb related death. RESULTS: All patients tolerated the procedure well with no reports of adverse procedural events. Twelve (n = 12) lesions in ten patients were treated with a mean lesion length of 83.3 ± 49.2 mm, with the lesion length range of 30mm to 182 mm. At 6-month follow-up, the rate of CD-TLR was 30% (3 of 10 patients). Zero patients (0 out of 10) demonstrated thrombosis, major amputation in the target limb and target limb related death at the 1, 3, and 6 month follow-up intervals. CONCLUSIONS: This first in-human experience obtained in a multicenter study of real-world de novo and restenotic lesions demonstrates a favorable safety and efficacy profile at 6 months. Randomized comparison to current drug coated balloons should be performed to further validate this approach and positive experience.
OBJECTIVE: The objective of this study was to assess the feasibility, safety and initial efficacy of paclitaxel administration using a novel drug delivery catheter for the prevention of restenosis in infrapopliteal de novo and restenotic lesions. BACKGROUND:Restenosis continues to be a great challenge after percutaneous revascularization procedures for peripheral arterial disease, particularly for below-the-knee applications. METHODS: A prospective, multicenter first-in-human registry of a novel delivery catheter delivering liquid paclitaxel was conducted in 10 patients. The primary efficacy endpoint at 6 months was freedom from clinically driven target lesion revascularization (CD-TLR) and the primary safety endpoint at 1, 3, and 6 months were thrombosis, major amputation in the target limb and target limb related death. RESULTS: All patients tolerated the procedure well with no reports of adverse procedural events. Twelve (n = 12) lesions in ten patients were treated with a mean lesion length of 83.3 ± 49.2 mm, with the lesion length range of 30mm to 182 mm. At 6-month follow-up, the rate of CD-TLR was 30% (3 of 10 patients). Zero patients (0 out of 10) demonstrated thrombosis, major amputation in the target limb and target limb related death at the 1, 3, and 6 month follow-up intervals. CONCLUSIONS: This first in-human experience obtained in a multicenter study of real-world de novo and restenotic lesions demonstrates a favorable safety and efficacy profile at 6 months. Randomized comparison to current drug coated balloons should be performed to further validate this approach and positive experience.
Authors: Frank Bunch; Pradeep Nair; Gaurav Aggarwala; Eric Dippel; Elias Kassab; Muhammad A Khan; Christopher LeCroy; John M McClure; Thaddeus Tolleson; Craig Walker Journal: Catheter Cardiovasc Interv Date: 2020-02-04 Impact factor: 2.692