Abstract
BackgroundDrug coated balloons (DCB) with paclitaxel (Ptx) dose of 2–3.5 μg/mm2 balloon surface inhibit restenosis with different effectiveness and duration of success. A clinical dose finding study is not known for any of the currently marketed products. The aim of the present preclinical trial was to investigate a novel DCB coated with 6 μg Ptx/mm2 in a porcine model.Methods and resultsThe current study investigated a DCB with a novel, modified iopromide based matrix with 6 μg Ptx/mm2. Drug transfer to the vessel wall of peripheral arteries was compared with a dose of 3 μg Ptx/mm2 and two fully overlapping DCB with 3 μg Ptx/mm2, each.Ptx concentration in the vessel wall after drug transfer was about twice as high for balloons with 6 μg/mm2 (1957±1472 μg/g) and two overlapping DCB with 3 μg Ptx/mm2, each (1287±619 μg/g) compared to a single balloon with 3 μg Ptx/mm2, (787±738 μg/g), with statistical significant differences for 1x6 μg/mm2 vs. 1x3 μg/mm2 (p = 0.017) but not for 2x3 μg/mm2 vs. 1x3 μg/mm2 (p = 0.184) and 1x6 μg/mm2 vs. 2x3 μg/mm2 (p = 0.178). The proportion of residual Ptx on balloon after treatment was similar for all groups between 6±1% and 10±3% of dose on balloon.ConclusionThe dose of 6 μg Ptx/mm2 was successfully as well as reproducibly coated on conventional balloon catheters. Increased Ptx on balloons resulted in increased drug concentration in the vessel wall. A single balloon with 6 μg Ptx/mm2 seems to provide double dose compared to 3 μg Ptx/mm2, facilitates the procedure, and may reduce medico-economic cost compared to the use of two standard DCB.
Highlights
Vascular diseases such as atherosclerosis and its secondary diseases are the cause of many serious conditions in middle and old age and the leading cause of death in western countries [1]
Drug transfer to the vessel wall of peripheral arteries was compared with a dose of 3 μg Ptx/mm2 and two fully overlapping drug coated balloons (DCB) with 3 μg Ptx/mm2, each
Increased Ptx on balloons resulted in increased drug concentration in the vessel wall
Summary
Vascular diseases such as atherosclerosis and its secondary diseases are the cause of many serious conditions in middle and old age and the leading cause of death in western countries [1]. Endovascular treatment of vascular diseases (e.g. balloon angioplasty, atherectomy and/or stent implantation) has become established in many indications and offers immediately effective and less invasive alternatives [3]. This applies to the treatment of arterial occlusive disease in coronary and peripheral arteries. In this case, drug-coated medical devices (stents and/or balloon catheters) have led to an improvement in the durability of interventions, reducing the need to repeat treatments leading to substantial cost savings or to carry out more invasive measures [3]. Even after treatment with DCB with 3.5 μg/mm there are therapy failures that do not respond to treatment or where the treatment effect such as prevention of restenosis of the treated vessel does not last long
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