Treatment of Small Vessel Disease With the Paclitaxel Drug‐Eluting Balloon: 6‐Month Angiographic and 1‐Year Clinical Outcomes of the Spanish Multicenter Registry

Background Small vessel disease (SMD) remains a major challenge because of the increased risk of restenosis. We sought to assess the efficacy and safety of a paclitaxel‐eluting balloon (PEB) in patients with SMD. Methods and Results One‐hundred and four patients with native coronary lesions in small vessels treated by using a PEB were included in this prospective multicenter registry. In each case, after regular balloon dilatation, a larger PEB was inflated for a minimum of 45–60 seconds. Patients were 65 ± 10 years old, 43% diabetic, and 58% presented acutely. Angiographic success was 93% (7% bailout BMS implantation due to coronary dissection). The rate of major adverse cardiac events (MACE) at 12 months was 4.8% (1.9% cardiac death, 1.0% MI, and 2.9% TLR). One definite stent thrombosis was reported at 6 months in a patient with bailout BMS implantation. At 7 months, late loss was 0.31 ± 0.2 mm. Bail‐out BMS after DEB use, was an independent predictor of MACE, HR 18.74, 95%CI (2.58–135.84) and TLR, HR 30.99, 95%CI (2.79–344.07). Conclusion The use of this PEB for the treatment of SMD provides excellent 1‐year outcomes with only 4.8% MACE. The need for a bailout BMS was a strong predictor of MACE and TLR. (J Interven Cardiol 2015;28:430–438)