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We sought to investigate the clinical outcomes after the treatment of Magic Touch Sirolimus Coated Balloon (SCB, Concept Medical Research Pvt Ltd, Surat, India) in patients with lesions located in small coronary arteries.
The all comers, multicentre Nanolute registry enrolled patients with lesions located in coronary vessels with reference vessel diameter (RVD) ≤ 2.75 mm. We conducted the analysis at 12 months with the pre-specified study endpoints of MACE (major adverse cardiac events) which is composed by target lesion/vessel revascularization (TLR/TVR), target vessel myocardial infarction (TV-MI) and cardiac death.
A total of 190 patients with 198 lesions were treated with 211 SCB. 38.95% patients presented with diabetes mellitus and 43.68% patients with hypertension. Additional stenting was performed only in 5.26% of the patients. The mean diameter and length of the balloons were 2.33±0.26 mm and 21.80±7.25 mm respectively. To this day, 12-month follow up is available for 83% of the patients, and MACE occurred in 3.80% of the patients. The MACE was mainly propelled by TLR/TVR (3.16%) followed by cardiac death (0.63%). We conducted additional analysis of the clinical outcomes in patients with very small vessel (RVD <2.5 mm) disease. A total of 98 patients were included in this sub analysis. The analysis revealed a MACE rate of 2.44% patients at 12 months.
Twelve-month clinical results after treatment of SCB demonstrated low rates of MACE in this small vessel cohort of the NANOLUTE' registry, hence showing an adequate efficacy and safety in this setting. The results are also encouraging in patients with very small vessels. Adequately powered studies in a western countries population are ongoing.
CORONARY: Drug-Eluting Balloons and Local Drug Delivery