Author + information
- Erlon de Abreu-Silva1,
- RICARDO COSTA2,
- SAMEER DANI3,
- Mirela Lima1,
- HASIT JOSHI4,
- JAY SHAH3,
- RASHMIT PANDYA4 and
- Alexandre Abizaid5
Despite the marked efficacy of first generation drug-eluting stents (DES) on reducing neointimal hyperplasia (NIH), restenosis, and the need for repeat target lesion revascularization (TLR) compared to bare metal stents, concerns regarding deliverability, efficacy, and long-term safety,led to the development of new DES technologies. The BioMime™ device (Meril Life Sciences Pvt. Ltd., Gujarat, India) is a novel DES system that incorporates an ultra-thin stent platform (0,0026″ strut thickness), a biodegradable polymer and sirolimus. We report the initial human evaluation of the BioMime™ stent for the treatment of diseased coronary vessels.
The meriT-1 trial was a prospective, non-randomized, single-arm, single center first-in-man evaluation of the safety, feasibility and performance of the novel BioMime™ SES for the treatment of coronary lesions. Lesion criteria were single de novo stenosis 50-99% located in native vessels 2.5-3.5mm in diameter and ≤19mm in length. Left main and bifurcation lesions, in-stent restenosis, thrombus and total occlusion were excluded. Clinical follow-up (FU) at 1-8-12 and 24 months, and all patients were assigned to 8-month angiographic FU. Primary endpoint was in-stent late lumen loss (LLL) at 8 months. MACE (major adverse cardiac events) was defined as cardiac death, MI and ischemia-driven TLR.
A total of 30 patients/lesions. Mean age 49.9 years, 30% diabetics, and 43% had previous MI. By angiographic analysis, baseline median lesion length, reference diameter and % diameter stenosis: 15.51mm [12.74;20.27], 2.94mm [2.71;3.33], and 80.5 [67.0;90.7], respectively. Overall, 30 stents implanted (1 stent/lesion). Angiographic success(residual stenosis <20% + final TIMI flow grade 3) and procedural success (angiographic success without MACE in index hospitalization) were 100%. At 8 months FU (26/30), in-stent LLL was 0.15mm [0.09;0.33]; with no binary restenosis. Clinical FU at 12 months (30/30) showed no MACE or stent thrombosis.
In this first-in-human evaluation the novel BioMime™ SES had excellent performance with high procedural success and efficacy on inhibiting NIH at 8 months. There were no MACE or stent thrombosis up to 1 year.
- 2012 American College of Cardiology Foundation