ABSTRACT
We report the initial human evaluation of the novel BioMimeTM sirolimus-eluting stent (SES) (MerilLife Sciences Pvt. Ltd., Gujarat, India) with an ultra-thin stent platform (65 μm) and a biodegradable polymerfor the treatment of de novo coronary lesions.Methods and results: The meriT-1 trial was a prospective, non-randomised, single-arm, single-centre,first-in-human evaluation of the safety, feasibility and performance of the BioMime SES. Lesion criteriaincluded non-occlusive stenosis ≤19 mm in length located in native coronary vessels. Clinical follow-up (FU)was performed at 1, 8 and 12 months; all patients were assigned for angiographic FU at eight months. A totalof 30 patients (30 lesions) were enrolled between March 2009 and February 2010. Mean age was 49.9 years,30% were diabetics, and 36.7% had previous myocardial infarction (MI). Baseline median [25%, 75% interquartilerange] lesion length, reference diameter and % diameter stenosis were 15.51 mm [12.74, 20.27],2.94 mm [2.71, 3.34], and 80.5% [67.0%, 90.7%], respectively. Overall, there was one stent implanted perlesion and procedural success was 100%. At eight-month angiographic FU (26/30), median in-stent latelumen loss was 0.15 mm [0.09, 0.33]; also, there were no cases of binary restenosis within the treated segment.Clinical FU at 12 months (100%) demonstrated absence of MACE (cardiac death, MI and target lesionrevascularisation) and stent thrombosis (ST).Conclusions: The novel BioMime SES demonstrated excellent performance in single coronary lesionsincluding high procedural success and efficacy, as demonstrated by the relatively low late lumen loss (a surrogateof neointimal hyperplasia) at eight-month angiographic FU. Overall, there were no safety concerns inthis preliminary evaluation including absence of MACE or ST up to 12 months.