Paclitaxel Drug-eluting Tracheal Stent Could Reduce Granulation Tissue Formation in a Canine Model.
BACKGROUND
Currently available silicone and metallic stents for tracheal stenosis are associated with many problems. Granulation proliferation is one of the main complications. The present study aimed to evaluate the efficacy of paclitaxel drug-eluting tracheal stent in reducing granulation tissue formation in a canine model, as well as the pharmacokinetic features and safety profiles of the coated drug.


METHODS
Eight beagles were randomly divided into a control group (bare-metal stent group, n = 4) and an experimental group (paclitaxel-eluting stent group, n = 4). The observation period was 5 months. One beagle in both groups was sacrificed at the end of the 1st and 3rd months, respectively. The last two beagles in both groups were sacrificed at the end of 5th month. The proliferation of granulation tissue and changes in tracheal mucosa were compared between the two groups. Blood routine and liver and kidney function were monitored to evaluate the safety of the paclitaxel-eluting stent. The elution method and high-performance liquid chromatography were used to characterize the rate of in vivo release of paclitaxel from the stent.


RESULTS
Compared with the control group, the proliferation of granulation tissue in the experimental group was significantly reduced. The drug release of paclitaxel-eluting stent was the fastest in the 1st month after implantation (up to 70.9%). Then, the release slowed down gradually. By the 5th month, the release reached up to 98.5%. During the observation period, a high concentration of the drug in the trachea (in the stented and adjacent unstented areas) and lung tissue was not noted, and the blood test showed no side effect.


CONCLUSIONS
The paclitaxel-eluting stent could safely reduce the granulation tissue formation after stent implantation in vivo, suggesting that the paclitaxel-eluting tracheal stent might be considered for potential use in humans in the future.
Department of Respiratory, Beijing Tian Tan Hospital, Capital Medical University, Beijing 100069, China.
Ting
T
Wang
Department of Respiratory, Beijing Tian Tan Hospital, Capital Medical University, Beijing 100069, China.
Jie
J
Zhang
Department of Respiratory, Beijing Tian Tan Hospital, Capital Medical University, Beijing 100069, China.
Juan
J
Wang
Department of Respiratory, Beijing Tian Tan Hospital, Capital Medical University, Beijing 100069, China.
Ying-Hua
YH
Pei
Department of Respiratory, Beijing Tian Tan Hospital, Capital Medical University, Beijing 100069, China.
Xiao-Jian
XJ
Qiu
Department of Respiratory, Beijing Tian Tan Hospital, Capital Medical University, Beijing 100069, China.
Yu-Ling
YL
Wang
D000818:Animals; D001999:Bronchoscopy; D004195:Disease Models, Animal; D004285:Dogs; D054855:Drug-Eluting Stents; D006097:Granulation Tissue / Q000187:drug effects*; D008855:Microscopy, Electron, Scanning; D017239:Paclitaxel / Q000627:therapeutic use*; D014132:Trachea / Q000473:pathology*; D014135:Tracheal Stenosis / Q000188:drug therapy* / Q000601:surgery*
D017239:Paclitaxel