• Bullfrog Micro-Infusion Device Shows Robust 6-Month Outcomes in Below-the-Knee Arteries

    Adventitial delivery of temsirolimus using the Bullfrog Micro-Infusion Device in below-the-knee (BTK) arteries was achieved with robust outcomes at 6 months, according to data from the TANGO trial presented Sunday at the TCT Connect virtual conference,

    Percutaneous endovascular intervention using drug-coated balloons (DCB) of infrapopliteal arteries lack robust long-term data. There have been concerns regarding luminal application of the drug and penetration of heavy tissue and plaque burden.

    The TANGO (Temsirolimus Adventitial Delivery to Improve Angiographic Outcomes Below the Knee) trial sought to assess the safety and efficacy of the Bullfrog Micro-Infusion Device’s adventitial deposition of two escalating doses of temsirolimus in BTK arteries in reducing neointimal hyperplasia and target lesion failure as assessed angiographically.

    The Bullfrog Micro-Infusion device delivers temsirolimus with dose control and an unlimited payload with the ability to inject multiple times without changing balloons. Temsirolimus offers an improved pharmaceutical profile compared to sirolimus, said Ehrin Armstrong, MD, of the Rocky Mountain Regional VA Medical Center, Denver, who presented results from the study Sunday TCT Connect.

    The TANGO trial was a randomized, multicenter, dose-escalation trial of 61 patients with BTK disease. Patients were randomized in a 2-to-1 fashion to either treatment with one of two doses of temsirolimus or control (normal saline). The primary endpoint was 6-month angiographic transverse view area loss (TVAL). The secondary endpoint was a composite of clinically relevant target lesion failure (CR-TLF), ischemia-driven major amputation and clinically relevant target lesion occlusion at 6 months.

    Patients in the treatment arms saw a 22.3% decrease in the primary endpoint of TVAL (46% vs. 24%; difference, 22.3%; 95% confidence interval [CI], 2.2% to 42.3%) in patients with TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC) class B-D lesions (lesions that have less evidence to support percutaneous treatment). With regard to the secondary outcome, patients in the treatment arm saw a 39.2% increase in freedom from clinically relevant target lesion failure (31.0% vs. 70.2%; 95% CI, 7.1% to 71.4%).

    “Drug delivery is here to stay, and we need this quality of science to get the right answers for our patients and without this rigor of science we are not going to get this right,” Armstrong concluded.

    This trial was supported by the National Heart, Lung, and Blood Institute.

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