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ABS20191020_0002
Drug-Eluting Balloons
Clinical Efficacy and Safety of Sirolimus Drug Coated Balloon in a Real-World Single-Center Registry of South-East Asian Patients
Zin Mar Mar Than1, Jinhyun Lee1, Deanna Khoo2, Jason Kwok Kong Loh1, Fahim Jafary1, Paul JL Ong3, Hee Hwa Ho1
Tan Tock Seng Hospital, Singapore1, Ttsh, Singapore2, Heart Specialist International, Singapore3
Background:
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.
Methods:
Between July 2018 to January 2019, 123 patients (69% male, mean age 62.4 ¡¾ 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.
Results:
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 ¡¾ 0.5 mm and average length of 26.5 ¡¾ 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%).
Conclusion:
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. 
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