Six-Month COPPER BTK Cohort Results Presented for the Occlusion Perfusion Catheter

November 7, 2018—The 6-month interim results from the COPPER below-the-knee (BTK) Cohort were presented by Pradeep K. Nair, MD, at VIVA 2018, the Vascular Interventional Advances annual conference held November 5–8 in Las Vegas, Nevada. The study is investigating the utilization of the Occlusion perfusion catheter (OPC, Advanced Catheter Therapies) to administer antiproliferative medications for peripheral artery disease (PAD). The study's objective was to assess the safety and efficacy of paclitaxel administration using the OPC drug-delivery catheter for the prevention of restenosis in infrapopliteal de novo and restenotic lesions.

Thirty-five patients were enrolled in this prospective, nonrandomized, open-label, multicenter registry of the novel delivery catheter delivering liquid paclitaxel after atherectomy and percutaneous transluminal angioplasty. Average lesion length was 111.9 ± 80.4 mm and a diameter stenosis of 93.7% ± 8.81%.

The primary efficacy endpoint at 6 months is defined as freedom from clinically driven target lesion revascularization (CD-TLR) and target lesion patency as evaluated by duplex Doppler ultrasound.

The primary safety endpoint at 1 month is freedom from major adverse events, defined as target limb-related death, major amputation in the target limb, or TLR.

Dr. Nair reported that all patients tolerated the procedure well, with no reports of adverse procedural events. Thirty-one patients have completed 1-month follow-up, 28 patients have completed 3-month follow-up, and 21 patients have completed 6-month follow-up. All subjects are expected to return for 6-month follow-up by January 2019.

In all follow-up cases, only one (4% of 24 patients) CD-TLR has been observed. Primary patency at 6 months was 85.7% in 21 patients. Additionally, no patients have experienced major adverse events through 1-month follow-up.

The feasibility and initial efficacy of this device are encouraging for this new technique, with the potential as an alternative approach for infrapopliteal revascularization. In particular, the ability to treat very long or multiple lesions with a single device provides a more economical option. The safety profile in this small-cohort study is particularly favorable in view of recent concerns regarding adverse events with DCBs for BTK applications, concluded Dr. Nair at VIVA 2018.