February 1, 2011Investigative Radiology
Dose Response to Paclitaxel-Coated Balloon Catheters in the Porcine Coronary Overstretch and Stent Implantation Model
Key result
Paclitaxel-coated balloons using iopromide or urea matrices reduced neointimal area compared to uncoated controls (e.g., 2.0 vs 6.8 mm2 at 3 μg/mm2 dose) in a porcine coronary model.
Why the study?
Do paclitaxel-coated balloon catheters reduce neointimal proliferation in a porcine coronary overstretch model?
Structured PICO
Do paclitaxel-coated balloon catheters reduce neointimal proliferation in a porcine coronary overstretch model?
P
Population
Porcine coronary overstretch and stent implantation model (swine)
I
Intervention
Paclitaxel-coated balloon catheters (iopromide-matrix and urea-matrix formulations) at doses ranging from 1 to 9 μg/mm2 and 3 overlapping applications of 3 times the regular dose (3 μg/mm2)
C
Comparator
Uncoated control balloons
O
Outcome
Neointimal proliferation (neointimal area on cross sections) at 4 weekssurrogate
Main Result
Absolute Event Rate: 2% vs 6.8%
In a porcine model, paclitaxel-coated balloons effectively reduced neointimal proliferation at doses as low as 1 μg/mm2, with thrombotic events occurring only at intentionally excessive overlapping doses.
Authors
Discussion
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Implication
Supports preclinical efficacy of paclitaxel-coated balloons; leaves open translation to human coronary interventions.
Cite This Study
Kelsch et al. (2011) studied Coronary overstretch and stent implantation. Paclitaxel-coated balloon catheters (iopromide-matrix and urea-matrix) vs. Uncoated control was evaluated on Neointimal area on cross sections. Paclitaxel-coated balloons using iopromide or urea matrices reduced neointimal area compared to uncoated controls (e.g., 2.0 vs 6.8 mm2 at 3 μg/mm2 dose) in a porcine coronary model.