Clinical Efficacy and Safety of SeQuent Please Paclitaxel-Eluting Balloon in a Real-World Single-Center Registry of South-East Asian Patients()()

BACKGROUND: Drug eluting balloon (DEB) is a new therapeutic option for treatment of obstructive coronary lesions in percutaneous coronary intervention (PCI). There is limited data on the safety and efficacy of DEB in Asian patients in contemporary clinical registries. We evaluated the clinical efficacy and safety of SeQuent Please paclitaxel-eluting balloon in our cohort of South-East Asian patients in real world clinical practice. METHODS: Between January 2010 to November 2012, 320 patients (76% male, mean age 61.3 ± 11.2 years) with a total of 337 coronary lesions were treated with SeQuent Please drug-eluting balloon (DEB). The primary endpoint was major adverse cardiac events (MACE) ie a composite of cardiovascular death, target vessel related myocardial infarction (MI) and target lesion revascularization (TLR) at 9 months follow-up. RESULTS: The majority of patients presented with acute coronary syndrome (76%).The most common indication for the use of DEB was small vessel disease (54%) followed by instent restenosis (21%), bifurcation lesions (6%) and others (19%). An average of 1.23 ± 0.5 DEB were used per patient, with mean DEB diameter of 2.6 ± 0.6 mm and average total length of 24.0 ± 11.1 mm. At 9 months follow-up, 5.3% of patients developed MACE. MACE was mainly driven by TLR(4%) followed by target vessel related myocardial infarction (2.6%) and cardiovascular death (1%). CONCLUSION: SeQuent Please DEB was a safe and effective treatment modality in our cohort of South-East Asian patients with a low incidence of MACE observed at 9 months follow-up.