Interventional Cardiology
Figure 12: BioMime Scanning Electron Microscopy Endothelialisation
Mid-segment open cell area Edge segment closed cell area
calculated via QCA. Secondary end-points will be MACE at one year and device-related serious adverse events until 12 months, and angiographic stent thrombosis (acute, sub-acute and late). Angiographic and device success and procedural success will be additional parameters in the secondary point. The trial is now under way and no adverse events related to device usage have been reported.32
Insights and Conclusions
revascularisation (TLR). Zero per cent MACE was noted at six-month clinical follow-up. No cases of death (cardiac or non-cardiac), MI (Q-wave or non-Q-wave) or ischaemia-driven TLR were reported.31
All
of the patients will now be entering eight-month angiographic and intravascular ultrasound (IVUS) follow-up to understand the stent’s qualitative coronary angiography (QCA) parameters of late lumen loss and volumetric obstruction. The RAndomized study with the sirolimus coated Bx VELocity balloon (RAVEL) study reported a MACE rate of 5.8% in the Cypher arm at one-year follow-up11
and, so far, with 0% MACE in BioMime-stented patients, the results are encouraging.
In a larger multicentre, non-randomised all-comers study known as the MeriT-1 trial, BioMime is being studied in 250 patients in a real-world scenario; the only exclusion criteria are saphenous vein grafts (SVGs), acute MIs, left main disease and a left ventricular ejection fraction (LVEF)
Primary safety and efficacy end-points are defined as MACE, which is a composite of death, MI (Q-wave and non-Q-wave), emergent CABG and clinically driven TLR. In-stent and in-segment late loss will be
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10. Agostoni P, Biondi-Zoccai GGL, Gasparini GL, et al., Eur Heart J, 2005;26:881–9.
11. Morice MC, Serruys PW, Sousa JE, et al., N Engl J Med, 2002;346:1773–80.
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14. Serruys PW, Eu Heart J, 2002;23:757–59. 15. Moses JW, Leon MB, Popma JJ, et al., N Engl J Med, 2003;350:221–31.
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22. Serruys PW, Morice MC, Fajadet J, et al., J Am Coll Cardiol,
First-generation DES were linked with late stent thrombosis and were created on bulky stent platforms with questionable deliverability and polymer biocompatibility. BioMime SES is a fresh approach to the design of DES, keeping in mind that the DES should endothelialise in a few months. Hence, all of the ingredients that allow for optimal endothelialisation have been incorporated in BioMime development. The stent (CE-marked) is cobalt–chromium, with ultra-low strut thickness (65µm), variable strut width and a novel geometry involving an intelligent hybrid of open and closed cells, which allows for morphology-mediated expansion of the stent while retaining high radial strength and conformability. The drug employed is sirolimus, which is an ideal choice considering that it acts on the common final pathway of cell division cycle without an exceptional risk of necrosis induction. The BioPoly is a co-polymer combination of the well-known biodegradable polymers PLLA and PLGA, which are non-inflammatory and allow for a 2µm stable coating. The resultant SES has drug elution kinetics of 30 days and a polymer degradation that is short and well documented.
BioMime has been found to be safe and efficacious in pre-clinical models and in the primary safety and efficacy study. Notable is the 0% rate of MACE at six months. Data from a large multicentric trial involving 250 real-world patients will further establish its credibility in routine clinical practice. Hence, based on the available pre-clinical and initial clinical reports, it can be predicted that this third-generation DES has adapted from the learning curve of the past DES and will set a path for the biomimicry concept in DES design for future. n
2010;55:1093–1101.
23. Pfisterer M, Brunner-La Roca H, Buser P, et al., J Am Coll Cardiol, 2006;48:2584–91.
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29. Kastrati A, et al., Circulation, 2001;103:2816–21. 30. Kastrati A, Pache J, Mehilli J, et al., J Am Coll Cardiol, 2003;41:1283–8.
31. Dr Sameer Dani, presented during India LIVE 2010, New Delhi, India. Unpublished data.
32. Dr Ashok Seth, presented during India LIVE 2010, New Delhi, India. Unpublished data.
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