E-Science Station

Drug coated balloon (DCB) is a therapeutic option for treatment of obstructive coronary lesions in percutaneous coronary intervention(PCI) as there are limitations with drug-eluting stents. We evaluated the clinical efficacy and safety of a novel sirolimus DCB (Magic Touch, Concept Medical Inc, USA) in our cohort of South-East Asian patients in real world clinical practice and report on the clinical outcomes.

Between July 2018 to January 2019, 123 patients (69% male, mean age 62.4 ± 10.3 years) with a total of 129 coronary lesions were treated with sirolimus DCB. The primary endpoint was major adverse cardiac events (MACE) at 9 months follow-up i.e. a composite of cardiovascular death, myocardial infarction (MI) and target lesion revascularization (TLR). Secondary endpoint included individual components of MACE.

The majority of patients presented with acute coronary syndrome (65%). The most common indication for the use of DCB was small vessel disease (76%) followed by in-stent restenosis (ISR) (10%), bifurcation lesions(3%) and others (11%). Diabetes mellitus was present in 37% of patients and 39%of patients had prior PCI. DCB-only PCI was used as primary therapy (58% of patients) and as part of hybrid PCI strategy in 42% of patients. 4.1% of patients required bail-out stenting after DCB angioplasty and there was no acute vessel closure. An average of 1.2 + 0.4 DCB were used per patient, with mean DCB diameter of 2.1 ± 0.5 mm and average length of 26.5 ± 13.5 mm. “Ultra-small” 1.5mm sirolimus DCB was used in 24% of patients. At 9 months follow-up, 8.9% of patients developed MACE. MACE was mainly driven by TLR (6.2%) followed by MI (5.4%) and cardiovascular death (1.8%).

Our preliminary experience with sirolimus DCB demonstrated rates of  > 5% of 9-month MACE and TLR in our cohort of South-East Asian patients. Longer follow-up in a larger cohort of patients is needed to confirm our preliminary findings.