Original title: ISAR DESIRE 3: Drug-eluting balloon is best option for restenosis of limus-eluting stents Reference: Dr Robert Byrne. TCT 2012. Miami, Fl.
The first of the ISAR DESIRE trials showed that drug-eluting stents (DES) were the best strategy for treating restenosis of a bare metal stent, the second ISAR DESIRE trial tested the hypothesis of changing or not the drug for Cypher restenosis. Today, because of the newly developed paclitaxel-eluting balloons, a third ISAR DESIRE test was needed.
The ISAR DESIRE 3 was designed to answer the question of what is the best strategy to treat restenosis of sirolimus-eluting DES. The trial included 402 patients with stenosis > 50% from a limus DES group, (everolimus, sirolimus or zotarolimus), plus signs or symptoms of ischemia and randomized to paclitaxel-eluting balloon, (SeQuent Please B Braun Vascular, Melsungen, Germany), paclitaxel eluting stent, (Taxus Boston Scientific, Natick, MA), or conventional balloon angioplasty. Left main coronary artery (LMCA) injury was excluded, as well as myocardial infarction and cardiogenic shock. The angiographic 6-8 month follow-up showed restenosis of at least 50% (binary restenosis), of 26.5% for paclitaxel-eluting balloons, 24% (p = 0.61) for Taxus and 56.7% for conventional balloon. Target revascularization lesion was 22.1% for the paclitaxel eluting balloon, 13.5% (p = 0.09) for Taxus and 43.5% for the conventional balloon. In the safety analysis, there were no differences in death, myocardial infarction or lesion thrombosis among the 3 groups.
Conclusion:
The paclitaxel-eluting balloon was not inferior to Taxus, and both were superior to a conventional balloon when treating a sirolimus-eluting DES restenosis.
Commentary:
The DES restenosis has reached a plateau despite the new generations and while it is still relatively uncommon, it remains a problem. After the many studies done on the subject, this completely changes the strategy with the advantage of not having a new layer of struts in the lesion or shortening dual antiplatelet therapy times.
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