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The aim of this study was to evaluate the safety and efficacy of Magictouch Sirolimus coated balloon (Concept Medical Research Pvt Ltd, Surat, India) in patients with in-stent restenosis in coronary vessels.
The Nanolute study is a prospective, non-randomized, multi-centre, interventional study evaluating the investigational device Magictouch Sirolimus coated balloon for the treatment of coronary in-stent restenosis. MACE (major adverse cardiac event) was the main study endpoint assessed at scheduled 12 months or any clinically driven follow-up before that point of time. MACE was comprised of target lesion/vessel revascularization (TLR/TVR), target vessel myocardial infarction (TV-MI) and cardiac death.
All 187 patients with coronary in-stent restenosis were enrolled in the present study. Total 227 investigational devices were employed to treat 199 lesions among 187 patients. Half of the patients (52.41%) had diabetes mellitus and 49.73% patients had hypertension. Coronary in-stent restenotic lesions were categorized according to Mehran’s classification. The lesions were classified as: Focal (58.79%), diffuse intra-stent (20.10%), diffuse proliferative (8.54%), diffuse total occlusion (9.05%) and unknown (3.52%). Most of the ISR lesions were due to restenosis of DES (79.4%) followed by BMS (11.06%), bioresorbable vascular scaffold (1.01%) and graft (1.51%). The incidence of MACE was 5.92% in 169/187 (90.37%) at 12 months clinical follow up. The MACE was mainly driven by TLR/TVR (5.33%) followed by TV-MI (0.59%) with no death reported. We conducted an additional analysis of clinical performance of Magictouch sirolimus coated balloon in DES-ISR. There were total 158 patients with DES-ISR in the current study. The MACE was reported as 5.97% among them at 12 months.
Treatment of coronary ISR with MagicTouch sirolimus coated balloon is safe and effective resulting in reduced rate of repeat revascularization during 12 months follow-up. The low MACE rate in patients with DES-ISR after the treatment Magictouch sirolimus coated balloon supports its performance in this setting.
CORONARY: Drug-Eluting Balloons and Local Drug Delivery