Fundamentals. Background: Although we’ve had more than a decade of experience with implanting drug-eluting stents, (DES), the best treatment for restenosis on these devices remains unknown. The drug-eluting balloons are a promising alternative which avoid the possibility of a new layer of metal on the restenotic injury. This study compared the performance of these balls with the strategy of placing a new drug-eluting stent for the treatment of restenosis of a stent with sirolimus.
Methods and Results: We included 402 patients with sirolimus-stent restenosis, (restenosis lesions> 50%), and signs and /or symptoms of ischemia. These were randomized to: 1) conventional balloon angioplasty (POBA), 2) angioplasty using eluting Paclitaxel Sequent Please – B Braun Vascular (BEP) balloon, or 3) Taxus stent implantation. Approximately 65% of patients had focal restenosis. The primary endpoint was the percent diameter stenosis, (% DS), with angiographic follow-up at 8 months. The study was designed to demonstrate non-inferiority between the BEP and TAXUS groups and the superiority of the BEP and TAXUS groups over the POBA group. The DS% was 38% in the BEP group, 37.4% in the TAXUS group, (p = 0.007 for non-inferiority), and 54% in the POBA group, (p <0.001 for superiority). Binary restenosis occurred in 26.5% of the BEP group, 24% in the TAXUS group, (p = 0.61), and 56.7% in the POBA group. Culprit lesion revascularization rates were 22.1% in the BEP group, 13.5% in the TAXUS group, (p = 0.09), and 43.5% in the POBA group. There were no differences in hard clinical events between the groups.
Conclusions and comments: The drug-eluting balloon was not inferior to the Taxus stent and was superior to the conventional treatment of in-stent restenosis of a sirolimus. The results were consistent across the pre-specified subgroups, without any interaction with diabetic status or the restenosis pattern (focal or diffuse). This is the first randomized trial comparing drug-eluting balloons with drug-eluting stents in the treatment of DES restenosis.
Editorial Comment: The choice of the best therapeutic approach for the treatment of in-stent restenosis remains a problem to be solved. The drug eluting balloon has emerged as a valid alternative strategy and would prevent in-stent.
Robert Byrne.
2012-10-26
Original title: ISAR-DESIRE 3: A Prospective, Randomized Trial of Paclitaxel-Eluting Balloons vs. Paclitaxel-Eluting Stents vs. Balloon Angioplasty for Restenosis of “Limus”-Eluting Coronary Stents
