J M Abadal1, Esther Vazquez2, Miguel Morales3, Arturo Toro3, Manuel Quintana2, Miguel Araujo2. 1. Vascular and Interventional Radiology Department, Hospital Universitario Severo Ochoa, 28911, Leganes, Madrid, Spain. jmabadal@yahoo.es. 2. Vascular Surgery Department, Hospital Universitario Severo Ochoa, Madrid, Spain. 3. Vascular and Interventional Radiology Department, Hospital Universitario Severo Ochoa, 28911, Leganes, Madrid, Spain.
Abstract
PURPOSE: The aim of the study was to evaluate the pharmacokinetics and tissue absorption of 2 paclitaxel (PTX) drug-coated balloons (DCB) using different drug loads in a porcine-injured iliac artery model. MATERIALS AND METHODS: Twenty-eight pigs were randomized into 2 groups. In group B1, angioplasty was performed with a 1.0 µg/mm(2) DCB with PTX and in group B3, with a 3.0 µg/mm(2) DCB with PTX. An overstretched model of the iliac artery was used for angioplasty under fluoroscopy. Blood and vessel wall PTX were measured with liquid-chromatography mass spectrometry at 1, 5, 30 min, 1, 7, and 28 days. Remaining drug in the balloon was analyzed. RESULTS: Mean PTX in blood was significantly higher in the group B3 0.269 ± 0.085 µg/ml compared with the B1 0.218 ± 0.085 µg/ml; p = 0.01. Peak blood PTX concentration was detected at 1 min, and PTX was undetectable 24 h post-angioplasty. There were no statistically significant differences in the mean arterial wall concentration from the treated iliac artery between group-B1 (15.24 ± 21.29 ng/mg) and B3 (15.68 ± 16.33 ng/mg), or in the PTX wall concentration measured at different time points. Mean remaining drug in assayed balloons was lower for group-B1 and represented 8 % of the initial dose. CONCLUSIONS: Blood PTX was higher when using 3.0 µg/mm(2) DCB, with a peak drug concentration at 1-min, although the drug was undetectable at 24 h, independently of the loading dose. This study demonstrates no difference in arterial wall uptake of a low dose DCB (1.0 µg/mm(2)), when compared to a common dose DCB (3.0 µg/mm(2)) suggesting that the dose of drug in the DCB could be reduced obtaining a similar clinical effect.
PURPOSE: The aim of the study was to evaluate the pharmacokinetics and tissue absorption of 2 paclitaxel (PTX) drug-coated balloons (DCB) using different drug loads in a porcine-injured iliac artery model. MATERIALS AND METHODS: Twenty-eight pigs were randomized into 2 groups. In group B1, angioplasty was performed with a 1.0 µg/mm(2) DCB with PTX and in group B3, with a 3.0 µg/mm(2) DCB with PTX. An overstretched model of the iliac artery was used for angioplasty under fluoroscopy. Blood and vessel wall PTX were measured with liquid-chromatography mass spectrometry at 1, 5, 30 min, 1, 7, and 28 days. Remaining drug in the balloon was analyzed. RESULTS: Mean PTX in blood was significantly higher in the group B3 0.269 ± 0.085 µg/ml compared with the B1 0.218 ± 0.085 µg/ml; p = 0.01. Peak blood PTX concentration was detected at 1 min, and PTX was undetectable 24 h post-angioplasty. There were no statistically significant differences in the mean arterial wall concentration from the treated iliac artery between group-B1 (15.24 ± 21.29 ng/mg) and B3 (15.68 ± 16.33 ng/mg), or in the PTX wall concentration measured at different time points. Mean remaining drug in assayed balloons was lower for group-B1 and represented 8 % of the initial dose. CONCLUSIONS: Blood PTX was higher when using 3.0 µg/mm(2) DCB, with a peak drug concentration at 1-min, although the drug was undetectable at 24 h, independently of the loading dose. This study demonstrates no difference in arterial wall uptake of a low dose DCB (1.0 µg/mm(2)), when compared to a common dose DCB (3.0 µg/mm(2)) suggesting that the dose of drug in the DCB could be reduced obtaining a similar clinical effect.