Abstract 18272: Placlitaxel Eluting Balloon for the Treatment of in-Stent Restenosis (49% DES): 6 Months Outcomes of the Spanish Multicenter Registry
Backgroung: Even in the drug-eluting stent (DES) treatment of in-stent restenosis (ISR) is limited by high rates of restenosis. Moreover stent-in-stent approach involves 2 or more layers of metal in a native coronary artery that implies a potential higher risk of stent thrombosis. We wolud like to assess the efficacy and safety of a new placlitaxel-coated, drug-eluting balloon (DEB) in the treatment of these lesions.
Methods: 115 patients and 120 in-stent restenosis lesions, treated by using a new paclitaxel-eluting balloon (3.0μg/m2 balloon surface area) were included in this prospective multicenter (11 Spanish center) registry. In each case, after optimal dilatation using conventional balloon angioplasty, a DEB was inflated for a minimum of 60 seconds. Clinical follow-up was planned at 1, 6 and 12 months with repeat angiography at 6–8 months in 50%. DAT was recommended at standard doses for at least 1 month. The only exclusion criteria were acute MI and cardiogenic shock.
Results: Patients were 65.3±10 years old, 35% diabetic, 50% previous MI, 51% presented as ACS. 48% ISR in small vessel (<2.5mm) or involving bifurcated lesions. 48% DES-ISR. The most frequent angio ISR pattern was focal 59% (IC-focal body 36%). Angiographic success was 96% (in 4% of lesions a BMS was implanted because acute recoil and/or > type B dissection). At 6 months (follow-up (FU) completed in 80 patients) there was only 11% MACE (3.0% MI, 4.5% cardiac death, 8% TLR). There were no definite thombotic events. By bivariate analysis, the most frequent ISR pattern, IC focal body, was associated with better outcomes at 6-months FU compared with the other patterns (focal-margin and diffuse patterns) (0 vs 21.2% MACE; p=0.04). Finally, when ISR of bifurcated lesions was associated with worse outcomes at 6 months FU (4.5 vs 23% MACE; p=0.03).
Conclusions: In this real-world multicenter registry, treatment of ISR with the use of this new paclitaxel-eluting balloon, provides excellent mid-term results with only 8% TLR at 6 months, especially in ISR pattern IC (0% MACE). ISR of bifurcated lesions was associated with worse outcomes.
- © 2010 by American Heart Association, Inc.