Evaluation of biodegradable paclitaxel-eluting nanofibre-covered metal stents for the treatment of benign cardia stricture in an experimental model.

ABSTRACT

BACKGROUND: Benign strictures at the cardia are troublesome for patients and often require repeated endoscopic treatments. Paclitaxel can reduce fibrosis. This study evaluated a biodegradable paclitaxel-eluting nanofibre-covered metal stent for the treatment of benign cardia stricture in vitro and in vivo. METHODS: Drug release was investigated in vitro at pH 7·4 and 4·0. Eighty dogs were divided randomly into four groups (each n = 20) controls (no stent), bare stent (retained for 1 week), and two drug-eluting stent (DES) groups with retention for either 1 week (DES-1w) or 4 weeks (DES-4w). Lower oesophageal sphincter pressure (LOSP) and 5-min barium height (5-mBH) were assessed before, immediately after stent deployment, at 1 week, and 1, 3 and 6 months later. Five dogs in each group were killed for histological examination at each follow-up point. RESULTS: Stent migration rates were similar (0 bare stent versus 2 DES; P = 0·548). The percentage and amount of paclitaxel released in vitro was higher at pH 4·0 than at pH 7·4. After 6 months, LOSP and 5-mBH were both improved in the DES-1w (P = 0·004 and P = 0·049) and DES-4w (both P < 0·001) groups compared with the bare-stent group, with better relief when the stent was retained for 4 weeks (P = 0·004 and P = 0·007). The DES was associated with a reduced peak inflammatory reaction and less scar formation compared with bare stents, especially when inserted for 4 weeks. CONCLUSION: The DES was more effective for the treatment of benign cardia stricture than bare stents in a canine model. Retention of the DES for 4 weeks led to a better clinical and pathological outcome than 1 week.