Related Experiment Video
Updated: Jun 30, 2025
The Rabbit Model of Accelerated Atherosclerosis: A Methodological Perspective of the Iliac Artery Balloon Injury
Published on: October 3, 2017
Biological differences of three paclitaxel- and sirolimus-coated balloons on coronary lesions in a rabbit model
Kazuki Aihara1, Sho Torii1, Masatoshi Ito2
1Department of Cardiology, Tokai University School of Medicine, Isehara, Japan.
Background:
Drug-coated balloons (DCBs) are important treatment options for coronary artery disease; however, randomised controlled trials comparing various DCB technologies are sparse, and further investigations are needed.
Aims:
This preclinical study aimed to histologically and biologically compare the drug effects and safety of a low-dose paclitaxel-coated DCB (PCB; AGENT), a regular-dose PCB (SeQuent Please NEO) and a sirolimus-coated DCB (SCB; MagicTouch).
Methods:
The DCBs were inflated in the healthy iliac arteries of 18 rabbits, which were euthanised after 28 days. The treated iliac arteries and distal skeletal muscles were histopathologically evaluated, and drug concentrations were measured.
Results:
In the histopathological evaluation, the medial smooth muscle cell loss score regarding depth, an indicator of drug efficacy, was significantly higher with AGENT and SeQuent Please NEO than with MagicTouch (4.0 [3.6-4.0] vs 3.7 [3.7-4.0] vs 2.2 [2.0-2.4]), with significant differences in comparisons between AGENT and MagicTouch (p<0.01) and between SeQuent Please NEO and MagicTouch (p<0.01). AGENT and SeQuent Please NEO showed comparable drug concentrations in the treated artery (p=0.61). In contrast, the drug concentrations in distal skeletal muscles were the highest for MagicTouch, followed by SeQuent Please NEO and AGENT (28.07 [13.19-52.46] ng/mg vs 0.66 [0.22-3.76] ng/mg vs 0.25 [0.04-3.23] ng/mg, respectively).
Conclusions:
This study demonstrated that PCBs might have higher efficacy and lower drug concentrations in distal skeletal muscles than the MagicTouch SCB. The efficacy of the AGENT low-dose PCB and the SeQuent Please NEO regular-dose PCB was comparable.
Insights
Paclitaxel-coated balloons (PCBs) showed higher efficacy and lower drug concentrations in distal muscles compared to sirolimus-coated balloons (SCBs). Both low-dose and regular-dose PCBs demonstrated comparable effectiveness in this preclinical study.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Drug-coated balloons (DCBs) are crucial for managing coronary artery disease.
- Limited randomized controlled trials exist comparing different DCB technologies.
- Further research is needed to evaluate novel DCB devices.
Purpose of the Study:
- To histologically and biologically compare the drug effects and safety of two paclitaxel-coated balloons (PCBs) and one sirolimus-coated balloon (SCB).
- To assess the efficacy and safety profiles of a low-dose PCB (AGENT), a regular-dose PCB (SeQuent Please NEO), and a SCB (MagicTouch).
Main Methods:
- A preclinical study involving 18 rabbits with DCBs (AGENT, SeQuent Please NEO, MagicTouch) inflated in healthy iliac arteries.
- Animals were euthanized after 28 days for histopathological evaluation of treated iliac arteries and distal skeletal muscles.
- Drug concentrations were measured in arterial and muscle tissues.
Main Results:
- Paclitaxel-coated balloons (AGENT, SeQuent Please NEO) demonstrated significantly higher medial smooth muscle cell loss scores, indicating greater efficacy, compared to the sirolimus-coated balloon (MagicTouch).
- Drug concentrations in treated arteries were comparable between AGENT and SeQuent Please NEO.
- Distal skeletal muscle drug concentrations were substantially higher for MagicTouch compared to both AGENT and SeQuent Please NEO.
Conclusions:
- Paclitaxel-coated balloons (PCBs) may offer superior efficacy with reduced systemic drug exposure compared to the MagicTouch sirolimus-coated balloon (SCB).
- The efficacy of the low-dose AGENT PCB and the regular-dose SeQuent Please NEO PCB was found to be comparable.
- These findings support the potential of PCBs in improving treatment outcomes for coronary artery disease.
