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The usage of Sirolimus Coated Balloon (SCB) in in-stent restenosis, small vessel disease and bifurcation lesions showed good clinical results. DCB in Acute Coronary Syndrome (ACS) provides the opportunity for highly concentrated, rapid local drug release and avoidance of sustained drug-polymer effects on the vessel wall. If the culprit lesion is only briefly exposed to the anti-proliferative drug, theoretically endothelial healing and function should not be affected. But there are few data about SCB in ACS. We aim to evaluate safety and efficacy of MagicTouchTM SCB (Concept Medical Research Pvt., Ltd. Gujarat, India) in patients with ACS.
This is a multi-centre, prospective registry were enrolled real world patients with ACS. All patients were followed up at 1, 6 and 12 months for evaluation of Major Adverse Cardiac Event (MACE). The clinical endpoints was MACE, defined as composite of cardiac death, Target vesselmyocardial infarction (TV-MI) and target lesion/vessel revascularization (TLR/TVR) at 6 months and 12 months.
Total 169 patients with 181 lesions were treated with 193 MagicTouchTM SCB. Mean age of the patients is 59.52±9.57 years. Majority of the patients presented unstable Angina (65.68%), followed by ST elevation myocardial infarction (22.49%) and non-ST elevation myocardial infarction (11.83%). Most coronary lesions were located in LAD (46.96%). Bail-out stenting was required in 6.51% patients. In most cases SCB alone therapy was employed (93.49%). In 6 months follow-up was available for 94.67% patients. The overall incidence of TLR/TVR and TV-MI were 4.38% and 0.63% respectively. Total 83.43% patients completed 12 months follow-up and the reported MACE was 6.38%, mainly driven by TLR/TVR (5.67%) followed by TV-MI (0.71%).
Percutaneous Coronary Intervention with MagicTouchTM SCB in real world patients with ACS is effective, with low MACE rate, including TLR/TVR at 12 months follow-up. More number of studies is required to further elucidate the role of this technology in the patients with ACS. Data with updated follow-up will be presented in conference.
CORONARY: Drug-Eluting Balloons and Local Drug Delivery