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It is now emerging that, in patients who are at high risk for cardiovascular complications and in particular, those with diabetes, the occurrence of late restenosis and thrombosis after treatment of coronary artery disease with drug-eluting stents is higher than earlier reports have suggested. Encouraging clinical data of the Drug Coated Balloon warrant its investigation in these patients. Therefore, we aimed to evaluate the influence of diabetes on the safety and efficacy of the new treatment modality called MagicTouchTM SCB (Concept Medical Research Pvt. Ltd.) angioplasty in patients with coronary artery disease.
The Nanolutè registry is prospective and multicentre registry enrolling diabetic patients with coronary artery disease. We analysed the incidence of Major Adverse Cardiac Events (MACE) at 6 and 12 months. MACE was defined as composite of cardiac death, Target vessel myocardial infarction (TV-MI), and target lesion/vessel revascularization (TLR/TVR).
Total 163 patients with 176 lesions were treated with 197 MagicTouchTM SCB. 50.92% patients had stable angina. More than half of the patients had hypertension (65.64%). Acute coronary syndrome accounts for 47.85% of the patients. Majority of the lesions were situated in LAD (48.30%). Bail-out stenting was required in 7.98% patients and SCB alone therapy was implemented in 92.02% patients. Mean Balloon diameter and length were 2.72 ± 0.45 mm and 21.84 ± 6.65 mm respectively. 94.48% patients completed 6 months follow-up. Amongst them MACE of 2.60% was reported. 12 months follow-up was completed in 85.28% patients and the MACE was reported as 4.32%, mainly driven by TLR/TVR (3.60%) followed by cardiac death (0.72%).
MagicTouchTM SCB angioplasty is associated with favourable results when used for treating coronary lesions in diabetic patients. Good clinical outcomes at 6 months and 12 months were observed in this complex subgroup. Larger studies are needed to confirm these findings. Data with updated follow-up will be presented in conference.
CORONARY: Drug-Eluting Balloons and Local Drug Delivery