Background: In the DES era, the best strategy to treat 001 bifurcated lesions remains unanswered. This is the first prospective registry assessing the efficacy and safety of second generation of drug-eluting balloon (DEB) (EurocorGm), (3.0mg/m2 balloon surface area), in patients with 001 bifurcated lesions placed in secondary branches Methods: After 2.7 years, 51 patients with 001 bifurcated lesion and clinical evidence of myocardial ischemia related to the target lesion were prospectively included in this multicenter (8 centers) registry. After optimal dilatation, a PEB was inflated for a minimum of 45 seconds. Left main bifurcated lesions, severe calcification and cardiogenic shock, were the only exclusion criteria. In 2 eligible patients after regular balloon pre-dilatation the DEB could not be used and patients were excluded of the registry. Results: Patients were 62AE12 years old, 42% diabetic, 56% ACS as clinical presentation. The most frequent lesion treated was first diagonal (41%). Radial approach was done in most cases (84%). Pre-dilatation was done in all the cases, with cutting balloon in 59%. Angiographic success was 90% (by protocol in 10% of lesions a BMS was implanted because of significant acute recoil (3) or coronary dissection more that type B (2)). At 1 month (follow-up completed in all the patients) there was no adverse event (MACE). At a mean of 11.2 AE 2.2 months (12 months completed in 81% of patients) there was 14.2% cumulative non-hierarchical MACE (1 MI, 0 cardiac deaths, 7 TLR). There was no thrombosis or occlusion. In 4 selected centers at a mean of 7.2 AE 1.1 months, angiographic follow-up was completed in 31/36 (86%) patients; reference diameter was 2.2 AE 0.3 mm with a binary restenosis of (6) 19.3%. Conclusions: We report the first registry assessing 001 bifurcated lesion placed in small vessels (2.2mm). This is a rare type of coronary lesion (inclusion period of 2.7 years) that was observed in a relative young and diabetic population. In this complex setting, second generation of PEB is a safe strategy, technically easier and it seems to be effective at mid-term follow up with a 14% MACE at 1 year.
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