Abstract 18235: Treatment of Small Vessel Disease (<2.5mm) With a Placlitaxel Eluting Balloon: 6 Months Outcomes of the Spanish Multicenter Registry
Backgroung: Independently of the type of percutaneous coronary intervention (balloon angioplasty and/or stenting with BMS/DES): coronary vessel size (small) is a strong predictor for restenosis following angioplasty, representing a challenging problem even in the DES era. We sought to assess the efficacy and safety of a new placlitaxel-coated, drug-eluting balloon (DEB) in patients with small vessel disease.
Methods: 89 patients and 91 de novo significant native coronary lesions in small vessel (<2.5mm), 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 66±10 years old, 38% diabetic, 58% ACS as clinical presentation, 30% had LVEF <50%, 40% involved a bifurcated lesion and 30% had 3-vessel disease. The most frequent lesion treated was first diagonal (30%). In 49% of patients an stent was implanted outside the target lesion (40% DES). Angiograpic success was 92% (in 8% of lesions a BMS was implanted because of significant recoil and/or more than type B dissection). At 1 month (follow-up completed in all the patients) there were no adverse avent (MACE). At 6 months (follow-up completed in 69 patients) there was only 2.2% MACE (1 MI, 0 cardiac deaths, 1 TLR). There was no subacute thrombosis or occlusion. At 6 months, angiographic follow-up was completed in 30 patients, reference diameter was 1.9±0.3 with a late loss of 0.23 mm and a binary restenosis of 13.3 (4).
Conclusions: In this real-worl population with multivesel disease, the use of this new paclitaxel-eluting balloon for the treatment of really small vessel disease and in combination in 40% of cases with DES in other coronary vessels, provides excellent acute angiographic results and mid term outcomes with only 2.2% TLR, late loss of 0.23 an binary angiographic restenosis of 13% at 6 months.
- © 2010 by American Heart Association, Inc.