Treatment of really small vessel disease (less than 2.25mm) with placlitaxel drug-eluting balloon: 6-months angiographic and 1-year clinical outcomes of the Spanish multicenter registry

Backgroung: Small vessel disease (SMD) remains a major challenge to revascularization procedures, as coronary artery bypass grafting is limited by high rates of technical failure, and PCI is associated with an increased risk of restenosis. We sought to assess the efficacy and safety of a placlitaxel-eluting balloon (PEB) in patients with SMD. Methods and results: 103 patients with significant native coronary lesions in small vessel (mean reference diameter 1.95±0.32mm), treated by using a PEB without a contrast agent as a drug-carrier (3.0μg/m2 balloon surface area) were included in this prospective multicenter registry. In each case, after optimal plain balloon dilatation, a PEB was inflated for a minimum of 60 seconds. DAT was recommended at standard doses for at least 1 month. The only exclusion criteria were cardiogenic shock. Patients were 65±10 years old, 42% diabetic, 68% ACS as clinical presentation, 42% involved a bifurcated lesion and 74% had at least 2-vessel disease. The most frequent lesion treated was first diagonal (31). Angiograpic success was 93%. MACE rate at a median of 12 (8-13) months was 5.8% (2.9% cardiac death, 1.0% MI and 2.9% TLR). There was only 1 subacute occlusion event. In 2 centers, repeat angiography was performed in 84% (50% of the overall population); late loss was 0.34±0.23mm with a restenosis rate of 19.6% (10). Conclusion: In this real-world population, the use of this PEB for the treatment of really SMD provides excellent 1-year outcomes with only 2.9% TLR with a late loss of 0.34mm.