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In-stent Restenosis (ISR) after stent implantation remains a frequent problem in coronary interventional therapy. Although Drug-Eluting Stent (DES) significantly reduces the rates of restenosis and Target Lesion Revascularization (TLR), the increasing use of DES in complex patients and lesions with high restenotic potentials has resulted in double-digit restenosis rates. In recent years, the local delivery of an anti-proliferative drug from Drug Coated Balloon has emerged as a potential alternative for the treatment of ISR. However, its role in the management of ISR has not been comprehensively established. Therefore we aimed to assess the safety and efficacy of MagicTouchTM SCB (Concept Medical Research Pvt. Ltd, Gujarat, India) in patients undergoing percutaneous coronary intervention for ISR.
In this multi-centre, prospective registry, patients with ISR were enrolled. All lesions were adequately pre-dilated before using SCB. Endpoints of interest was Major Adverse Cardiac Events (MACE) defined as composite of cardiac death, Target Vessel Myocardial Infarction (TV-MI) and Target Lesion/Vessel Revascularization (TLR/TVR) at 6 and 12 months.
Total 164 patients with 178 lesions were treated with 202 MagicTouchTM SCB. Mean age of the patients is 60.15±9.21 years. More than half of the patients (52.44%) presented with stable angina. 53.66% patients were diabetic and 50% patients were hypertensive. Mean length and diameter of the device were 22.06 ± 6.66 mm and 2.89 ± 0.39 mm. Majority of the coronary lesions were located in LAD (46.63%). Bail-out stenting was required in 7.32% patients. In most of the cases, SCB alone therapy was employed (92.68%). 6 months follow-up was available for 93.90% patients. The overall incidence of MACE at 6 months was 4.55%. Total 82.93% patients completed 12 months follow-up and the reported MACE was 6.62%, mainly driven by TLR/TVR (5.88%) followed by TV-MI (0.65%).
MagicTouchTM SCB in real world patients with ISR is found to be safe and efficacious, with low incidence of MACE at 12 months. Data with updated follow-up will be presented at the conference.
CORONARY: Drug-Eluting Balloons and Local Drug Delivery