Head-to-Head Comparison of 2 Paclitaxel-Coated Balloons for Femoropopliteal Lesions.

BACKGROUND: There is a scarcity of published head-to-head comparisons between different paclitaxel-coated angioplasty balloons. More prospective safety data to support the health care economic reimbursement processes are needed. OBJECTIVES: The aim of this study was to report the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) (Biotronik AG) for the treatment of symptomatic peripheral artery disease caused by stenosis, restenosis, or occlusion of the femoral and/or popliteal arteries. METHODS: A total of 302 patients were randomized 1:1 and assigned to the Passeo-18 Lux DCB (study device) group or the IN.PACT Admiral DCB (control device, Medtronic Vascular) group for testing of noninferiority. The primary efficacy endpoint was freedom from clinically driven target lesion revascularization at 12 months. The primary safety endpoint was a composite of freedom from device-/procedure-related death through 30 days postindex procedure, major target limb amputation, and clinically driven target vessel revascularization at 12 months. RESULTS: At 12 months, 130 of 134 patients in the IN.PACT Admiral group had freedom from clinically driven target lesion revascularization (97.0%) compared with 137 of 141 patients in the Passeo-18 Lux group (97.2%). The primary safety endpoint showed 96.3% in the control group vs 95.7% in the study device group. The null hypothesis of inferiority on both efficacy and safety was rejected. The Kaplan-Meier estimate of primary patency at 1 year was 88.7% in the control arm vs 91.5% in the study device arm. CONCLUSIONS: The Passeo-18 Lux and the IN.PACT Admiral DCBs demonstrate comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions.

Qualitative risk assessment of homogeneity, stability, and residual concentrations of antimicrobials in medicated feed and drinking water in pig rearing.

BACKGROUND: Despite the common use of oral group treatment in pig rearing, the magnitude of the factors influencing the homogeneity and stability of antimicrobial drugs in medicated feed and medicated drinking water are largely unknown, as well as the residual concentrations of the drugs after the end of the treatment. RESULTS: This study presents a qualitative risk assessment to estimate the magnitude of the risks for reduced homogeneity and stability, and increased residual concentrations of antimicrobial drugs in medicated feed and drinking water on the farm. Risk assessment was done using a questionnaire and farm visits (n = 52), combined with a second questionnaire, and concentrations of amoxicillin and doxycycline measured in medicated feed and water samples, each collected on 10 farms. For medicated feed, the duration of storage in the silo did not show to influence the concentration levels in a consistent trend, while the treatment duration had a low to negligible effect. A moderate to high risk was found caused by human error when preparing the medicated feed on the farm. Purchased medicated feed greatly reduces the risk of human error and drugs remain stable during the duration of treatment, while the risk of residual concentrations after the end of the treatment was estimated to be low to moderate. The feed intake variability was identified as a moderate to high risk factor. For medicated drinking water, the type of dosing pump, age of pre-solution, and human errors during the preparation of the pre-solution present a moderate to high risk on homogeneity and stability. Precipitation of the active substance in the absence of a stirrer in a drinking water tank was shown to be a low to moderate risk factor for residues after treatment. Waterline length had a weak correlation with the concentrations of the antimicrobials, while a moderate to high influence was detected for the water intake by the pigs. CONCLUSIONS: A considerable variation in drug concentration in both medicated feed and medicated drinking water was detected depending on their preparation. Therefore, it is important to know which factors influence the homogeneity and stability, and the residual concentrations after treatment.

Methodology of the BIOPACT RCT, a Multi-center, Randomized, Non-inferiority Trial Evaluating Safety and Efficacy of Passeo-18 Lux Drug-Coated Balloon (DCB) of Biotronik Compared to the Medtronic IN.PACT Admiral DCB in the Treatment of Subjects with Lesions of the Femoropopliteal Artery.

PURPOSE: Although effectiveness and safety of many different paclitaxel coated balloons in the treatment of peripheral arterial disease (PAD) are extensively studied, there is a lack of direct head-to-head comparison studies. To meet this need and to avoid potential "class-effects", the BIOPACT was set up. The purpose is to demonstrate the safety and efficacy of the Passeo-18 Lux DCB (Biotronik) for treatment of patients with symptomatic PAD due to femoropopliteal lesions. METHODS: 302 patients are randomized in a 1:1 manner to treatment with either the Passeo-18 Lux DCB or the IN.PACT Admiral DCB (Medtronic) for testing of a formal non-inferiority hypothesis. The participants will be followed for 5 years. The primary efficacy endpoint is freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months, defined as any re-intervention at the target lesion due to symptoms, drop of ankle brachial index (ABI) > 20% or > 0.15 compared to post-procedural ABI. Primary safety endpoint is a composite of freedom from device/procedure-related death through 30 days post-index procedure, freedom from major target limb amputation and clinically-driven target vessel revascularization (CD-TVR) through 12 months post-index procedure. Secondary endpoints can be found at clinicaltrials.gov, ID NCT03884257. DISCUSSION: As full enrolment was reached by the beginning of September, the investigators expect complete analysis of the primary endpoints by the end of 2022; Meanwhile preliminary results will be disclosed during 2022. As in terms of randomized head-to-head efficacy and safety analysis, this study on paclitaxel coated balloons may provide additional information to clinicians and healthcare providers. Trial registration ClinicalTrials.gov ID: NCT03884257 LEVEL OF EVIDENCE: Level 2, Randomized trial.

Stability, Homogeneity and Carry-Over of Amoxicillin, Doxycycline, Florfenicol and Flubendazole in Medicated Feed and Drinking Water on 24 Pig Farms.

The vast majority of medicines in pig rearing are administered via oral group medication through medicated feed and drinking water. However, relevant on-farm factors affecting the concentration of these drugs in feed and drinking water, such as the homogeneity, stability, and cross-contamination, are largely unknown. To characterize these factors, samples of medicated feed and drinking water were taken on 24 Belgian pig farms during treatment and 2 days thereafter, as well as at different on-farm sampling sites from production to feeding troughs or drinking nipples. The samples contained amoxicillin, doxycycline, florfenicol, or flubendazole. Additionally, a questionnaire was completed. In contrast to the results of medicated feed, results of medicated water showed a large between-farm variation in antimicrobial drug concentration. The therapeutic concentration range was only met in 2 out of 11 farms using medicated feed, and in 3 out of 13 farms using medicated water. Medicated feed concentrations were often below the therapeutic concentration range mentioned in the Summary of Product Characteristics, while drinking water concentrations were just as often above as they were below the advised target concentration range. Drug residues measured 2 days after the end of therapy with both feed and water medication rarely exceeded 1% of the lowest therapeutic concentration. This study demonstrates that recommendations on good clinical practices for oral group medication in the pig industry are highly needed.

Oral group medication in pig production: characterising medicated feed and drinking water systems.

Despite common use of oral group medication in pig rearing, the homogeneity, stability and carry-over of frequently used medicinal products in feed and drinking water are largely unknown. Therefore, a field study was performed on 52 Belgian pig farms, characterising preparation and administration of medicinal products via these systems, and farmers' user experiences with medicated feed and medicated drinking water. The study showed that medicated drinking water is more commonly used than medicated feed, since 90.4 per cent of the farms sometimes use medicated drinking water and 69.2 per cent of the farms sometimes use medicated feed. The drinking water quality is evaluated at least once a year on only 30.7 per cent of the farms. Separate pipelines for medicated and non-medicated circuits were not present in any of the farms using medicated feed and in 27.7 per cent of the farms using medicated drinking water. With drinking water medication, 63.5 per cent of the farmers reported encountering practical problems, often related to solubility issues and precipitation of the active compounds. In contrast, medicated feed is bought ready-to-use from the feed manufacturer in 68.2 per cent of the cases, thus reducing the number of practical problems experienced by the farmer. This study shows room for improvement of oral group treatment, developing appropriate pharmaceutical formulations for drinking water medication, quality control of drinking water, using separate pipeline circuits, and cleaning and disinfecting protocols.