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Coronary artery disease is a major cause of complications and death among patients with diabetes. We sought to assess the clinical performance of Magictouch Sirolimus coated balloon (Concept Medical Research Pvt Ltd, Surat, India) in diabetic patients with coronary artery disease.
The Nanolute registry is prospective, multi-centre, non-randomized, all-comers registry to evaluate the safety and performance of Magictouch sirolimus coated balloon (SCB) in patients under real world conditions with treatment according to standard of care. The Major study endpoint encompassed MACE (major adverse cardiac event) at 12 months. MACE is defined as composite of target lesion/vessel revascularization (TLR/TVR), target vessel myocardial infarction (TV-MI) and cardiac death.
Overall, 185 diabetic patients underwent percutaneous transluminal angioplasty with Magictouch sirolimus coated balloon. Total 198 coronary lesions among 185 patients were treated with 225 study devices. The study population was dominated by male patients (81.08%). Hypertension was present in 65.95% patients. Most of the lesions were located in left anterior descending (46.97%) followed by right coronary artery (24.75%) and left circumflex (22.22%). SCB alone strategy was employed in majority of the patients (90.81%) while additional stenting was performed in 9.19% patients. 171/185 (92.43%) patients completed 12 months follow up and MACE was reported as 4.09%. The rate was mainly propelled by TLR (3.51%) followed by cardiac death (0.58%) with no TV-MI reported. The low MACE rate was also confirmed for the subgroups at the 12 months follow-up: diabetics with small vessels (4.67%), diabetics with in-stent restenosis (3.30%) and diabetics with long lesions (1.85%).
The results observed in this “real world” population demonstrated a low MACE rate up to 12 months not only in the diabetic cohort but also in diabetic patients with complex lesions which have a higher risk of experiencing an adverse event.
CORONARY: Drug-Eluting Balloons and Local Drug Delivery