Interventional Cardiology
Moving Towards Biomimicry – The Development of the Novel BioMime™ Sirolimus-eluting Coronary Stent System
Ashok Seth Chairman, Chief Cardiologist, and Chairman, Cardiology Council, Fortis Group of Hospitals, Escorts Heart Institute and Research Centre, New Delhi
Abstract
Since the first reported use of percutaneous transluminal coronary angioplasty (PTCA), advances in the interventional cardiology arena have been fast-paced. Within the last 10 years, these developments have been exponential. Developers and clinicians are fast adapting from the learning curve awarded by the time-course of drug-eluting stent (DES) evolution. The BioMime™ sirolimus-eluting coronary stent is a new step towards a biomimicry concept. The stent is built on an ultra-low strut thickness (65µm) cobalt–chromium stent platform using an intelligent hybrid of close and open cells allowing for morphology-mediated expansion, and employs a well-known antiproliferative – sirolimus – that elutes from a biodegradable co-polymer formulation in 30 days and ensures high coating integrity and a low coating thickness of 2µm. The resultant stent demonstrated almost 100% endothelialisation at 30 days in pre-clinical models and 0% major adverse cardiac events (MACE) at six months in the primary efficacy and safety clinical study.
Keywords Drug-eluting stents, morphology-mediated expansion, sirolimus, stent thrombosis, restenosis
Disclosure: Ashok Seth is the principal investigator for the MeriT-1 trial and otherwise has no financial involvement with Meril Life Sciences Pvt. Ltd. Received: 14 April 2010 Accepted: 1 June 2010 Citation: European Cardiology, 2010:6(2):78–82 Correspondence: Ashok Seth, Chairman and Chief Cardiologist, Chairman, Cardiology Council, Fortis Group of Hospitals, Escorts Heart Institute & Research Centre, Okhla Road, New Delhi 110025, India. E:
ashok.seth@
fortishealthcare.com
Support: The publication of this article was funded by Meril Life Sciences Pvt. Ltd. The views and opinions expressed are those of the authors and not necessarily those of Meril Life Sciences Pvt. Ltd.
“I do not know what I may appear to the world, but to myself I seem to have been only like a boy playing on the sea-shore, diverting myself in now and then finding a smoother pebble or a prettier shell than ordinary, whilst the great ocean of truth lay all undiscovered before me.” Sir Isaac Newton
Advances in Percutaneous Coronary Intervention – An Overview
Over the last 10 years, the interventional cardiology field has evolved tremendously.1
From the ground-breaking work of
Frossmann in the 1960s to Andreas Gruentzig’s successful procedure with a percutaneous transluminal coronary angioplasty (PTCA) balloon catheter in 1977, the application of devices used to open up clogged coronary arteries has expanded manifold.1 As soon as PTCA balloon angioplasty became popular, problems surrounding the use of the plain old balloon angioplasty (POBA) technique emerged in the form of dissections and abrupt vessel closures.2
These issues were soon tackled using metal scaffolding designed by Palmaz-Schatz and others and soon the concerns surrounding the POBA technique were virtually eliminated by stenting.3,4 However, while stenting emerged as a sound technique to hold dissected vessel flaps and thus the expanded vessel, it caused injury and thus gave rise to a ubiquitous problem known as
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restenosis, the exuberance of neointimal proliferation, which again in-turn threatened to narrow or close down the vessel in the mid- term period. While restenosis remained the Achilles’ heel of interventional cardiology for a while, stent thrombosis also emerged as an important safety parameter that threatened the success of the procedure.5
On a parallel front, this development saw the rise of antiplatelet therapy in the form of aspirin, ticlopidine and then clopidogrel, which arrested the thrombosis issue.6–10
Two novel forms of treatment for
curbing restenosis came into existence. The first treatment was brachytherapy, but this was quickly abandoned due to its technological problems, and the second treatment was releasing an antiproliferative agent at the site of stent implantation that would work in situ and have control over restenosis. This came to be known as drug-eluting stent (DES) therapy. Soon, DES therapy caught on to the fast developmental pace and, today, more than 5 million PTCAs and stenting procedures are performed worldwide. More than 70% of stents are DES.
The efficacy of DES brought a high degree of treatment satisfaction and, worldwide, interventional cardiologists observed that perhaps an era of complete control over neointimal proliferation had arrived.11–13 Event-free survival similar/superior to that achieved by coronary artery bypass graft surgery14
(CABG) was also observed. © TOUCH BRIEFINGS 2010
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