Author + information
- Ricardo A. Costa1,
- Alexandre Abizaid2,
- Sameer Dani3,
- Hasit Joshi4,
- Gurpreet S. Wander5,
- Suhas Hardas6,
- Suresh Vijan7,
- Thomas Alexander8,
- Sunita Abraham9,
- Manjunath N. Cholenahally10,
- Prabhakar Shetty11,
- Upendra Kaul12 and
- Ashok Seth13
The novel BioMime drug-eluting stent (Meril Life Sciences Pvt. Ltd., Gujarat, India) incorporates a L605 cobalt-chromium metallic platform that combines ultra-thin struts (65μm) with hybrid cell design and a bioabsorbable co-polymer (PLLA/PLGA) formulation (2μm thickness) which carries and releases sirolimus in a dosage of 1.25μg per mm2 of stent surface area. Our objective was to report the angiographic findings of the BioMime sirolimus-eluting stents (SES) tested in the meriT-1 and -2 clinical trials.
280 pts with 385 de novo lesions located in native vessels were prospectively enrolled in 2 non-randomized studies in India, including the first-in-man, single center meriT-1 trial (30 patients/lesions) and the subsequent multicenter meriT-2 trial (250 pts/355 lesions). Angiographic follow-up was assigned at 8 months. QCA analysis was performed at an independent angiographic core lab.
LAD was the target vessel in 47%, 16.4% had significant calcium, 78.4% were eccentric, 4.9% had ulcer and pre-TIMI flow 3 was found in 87.5%. Most lesions were classified as highly complex (type B2/C in 74.8%). Predilatation was performed in 91%, the study stent was implanted in 100%, an additional study stent was implanted in 6%, and 60% had postdilatation; also, final TIMI 3 flow was achieved in 99.5%. QCA results are shown in the Table. Binary restenosis was found in 5.7% (4.5% in-stent) including focal pattern (type-I) in most cases (4.8%).
|- Lesion length, mm||13.17 [8.97, 18.73]|
|- Reference diameter, mm||2.73 [2.43, 2.99]|
|- MLD, mm||0.74 [0.44, 1.02]|
|- %DS||72.2 [61.8, 83.8]|
|Postprocedure (in-stent analysis)|
|- MLD, mm||2.60 [2.31, 2.88]|
|- %DS||7.4 [4.7, 11.6]|
|- Acute gain, mm||1.88 [1.49, 2.24]|
|Follow-up at 8 months (in-stent analysis)||N=335 (87%)|
|- MLD, mm||2.40 [2.05, 2.71]|
|- %DS||11.8 [7.4, 19.2]|
|- Late lumen loss, mm||0.12 [0.05, 0.30]|
In this subanalysis of the combined meriT-1 and -2 trials, the novel BioMime SES demonstrated efficacy in the treatment of complex de novo coronary lesions, as demonstrated by the relatively low median in-stent late lumen loss (a surrogate of neointimal hyperplasia) at 8-month angiographic follow-up (87%). In addition, in-stent binary restenosis was low (<5%) and associated with focal pattern in the majority of cases.