Late angiographic and clinical outcomes of the novel BioMime™ sirolimus-eluting coronary stent with ultra-thin cobalt-chromium platform and biodegradable polymer for the treatment of diseased coronary vessels: results from the prospective, multicentre meriT-2 clinical trial

Ashok Seth, Alexandre Abizaid, et al

Compared to first-generation drug-eluting coronary stents (DES), new-generation DES have attempted to improve safety, deliverability and overall performance, while maintaining efficacy by preventing neointimal hyperplasia (NIH), restenosis, and therefore the need for target lesion revascularisation (TLR) over a period of time in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI)1-3. In general, low-profile metallic stents, polymer-based drug carriers with enhanced bio-inertness (whether durable or biodegradable), and potent yet safe pharmacological agents from the “limus” family have commonly been incorporated into novel DES technologies4-11. The CE (Conformité Européenne) mark-approved BioMime™ sirolimus-eluting coronary stent system (Meril Life Sciences Pvt. Ltd., Gujarat, India) is a novel DES system which incorporates an advanced ultrathin stent platform covered with a biodegradable polymer, which releases sirolimus as the antiproliferative drug to the vessel wall. In the first clinical evaluation, the BioMime sirolimus-eluting coronary stent (SES) demonstrated safety and efficacy in inhibiting NIH in a relatively small sample of patients with single de novo, noncomplex coronary lesions treated at a single institution11. However, the results of the BioMime stent in a larger “real-life” population with complex coronary lesions have not been studied. We therefore assessed the performance and late angiographic and clinical outcomes of the BioMime SES in the treatment of a relatively large series of patients with obstructive coronary artery disease with very few exclusions at multiple clinical sites.