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


OBJECTIVE
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.
Oddział Ostrych Zespołów Wieńcowych, Górnoślaskie Centrum Medyczne, ul. Ziołowa 45, 40-635 Katowice, Poland.
Paweł
P
Buszman
Aleksander
A
Zurakowski
Agata
A
Gruszka
Iwona
I
Szkróbka
Ewa
E
Peszek-Przybyła
Kazimierz
K
Radwan
Krzysztof
K
Milewski
Zenon
Z
Barteczko
Michał
M
Tendera
D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D019917:Blood Vessel Prosthesis Implantation; D020099:Coated Materials, Biocompatible; D023903:Coronary Restenosis / Q000188:drug therapy* / Q000209:etiology / Q000628:therapy; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D015552:Injections, Intralesional / Q000379:methods; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D012008:Recurrence; D015607:Stents / Q000009:adverse effects; D016896:Treatment Outcome
D020099:Coated Materials, Biocompatible; D017239:Paclitaxel