ISAR-DESIRE 3 did not show that paclitaxel-eluting balloon may be useful for treating restenosis of a sirolimus–eluting stent. This study tests the safety and efficacy of a paclitaxel-eluting balloon versus a paclitaxel-eluting stent in cases of in-stent drug-eluting restenosis.
We included 220 patients with in-stent restenosis of a drug-eluting stent ball randomized at a 1:1 ratio to receive paclitaxel or a paclitaxel-eluting stent. There was a clinical follow-up after 1 year. We observed a higher minimum luminal diameter in patients who received the stent (2.39 ± 0.37 mm vs. 2.56 ± 0.44 mm, p=0.002); however, this difference did not translate into any event during the follow-up.
Conclusion: This study shows that treatment of in-stent drug-eluting restenosis can be made with a paclitaxel-eluting balloon with a safety and efficacy similar to that of the paclitaxel-eluting stent.
Run-lin Gao
2013-05-23
Original title: A prospective, multicentre, randomised trial of paclitaxel-eluting balloon versus paclitazel-eluting stent for treatment of DES in-stent restenosis: 9-months angiographic and clinical results.