Local paclitaxel delivery as a treatment of persistent, recurrent in-stent restenosis -- safety assessment

Abstract

Introduction: In-stent restenosis still remains a serious clinical problem. Local intramural drug delivery (LDD -- Local Drug Delivery) seems to be an interesting alternative to drug-eluting stents (DES).

Aim: The aim of the study was to assess the safety and effectiveness of local intramural paclitaxel administration in the treatment of recurrent in-stent restenosis (ISR).

Methods: Five patients were enrolled in the study (3 men, mean age 50+/-7 years) with at least a second episode of ISR within the same stent. Percutaneous coronary angioplasty was performed on a total of 11 vessel segments. Remedy delivery catheters (Boston Scientific) were used for balloon angioplasty. Inflation pressure was calibrated to obtain a balloon/vessel lumen ratio of 1.1:1. Then the pressure was lowered to 3 atmospheres and 100 microg of paclitaxel diluted in 2 ml of 0.9% NaCl was given over 60 seconds under the pressure of 2-3 atmospheres. This dose was used for each 10 mm of lesions. Control coronary angiography was performed six months after the procedure.

Results: In all patients effective target vessel revascularisation was achieved. No adverse events were observed in the periprocedural period or during the 6-month follow-up period. Control angiography revealed ISR in three segments (27.2%) and in-stent late lumen loss of 0.21+/-0.93 mm.

Conclusions: Local intramural paclitaxel delivery is a safe and effective method of ISR treatment. The optimal paclitaxel dose should be established in further studies.