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Treatment of In-Stent Restenosis (ISR) remains challenging, and the optimal treatment option is still unclear. We sought to assess the safety and efficacy of Sirolimus Coated Balloon (SCB) MagicTouchTM in patients with ISR in native coronary vessels.
This was a prospective, multi-center registry enrolling patients from the real world. The primary endpoint of the study was Major adverse cardiac events (MACE) defined as composite of Cardiac Death, Target vessel myocardial infarction (TV-MI) and Target lesion revascularization (TLR)/Target vessel revascularization (TVR) at 6 months and procedural success defined as technical and angiographic success in the absence of MACE at hospital discharge. The secondary endpoint was MACE at 12 months.
A total of 167 patients with ISR in coronary vessels were included in the analysis. Almost half of the patients had Diabetes (53.89%). 50.90% patients presented with Hypertension and 58.08 % patients had a history of MI. According to Mehran’s classification lesions reported were focal (62.78%), diffuse intra-stent (18.33%), diffuse proliferative (8.33%), diffuse total occlusion (8.33%) and unknown (2.22%). The majority of the patients presented with as DES-ISR (80.56%). The occurrence of MACE at 6 months was reported as 4.24 % in 98.8% patients who completed 6 months follow-up. Procedural success was achieved in 99.4% of the patients. 91.62% patients completed 12 months follow-up and MACE rate was 5.88%, composite of TLR/TVR (5.23%), TV-MI (0.65%) and no death reported at 12 months.
Safety and efficacy of Sirolimus Coated Balloon MagicTouchTM have proven in a cohort of ISR patients as low incidence of MACE was observed at 6 and 12 months follow-up.