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Medtronic's second generation DES rated high for long-term safety, efficacy
Our Bureau, Bangalore | Thursday, October 19, 2006, 08:00 Hrs  [IST]

The demand for drug eluting stents (DES) is on the rise and that has brought down the open heart surgery rates to two per cent in the US. In the hospitals of the west, stents are preferred to open heart surgery because it is minimally invasive, helps faster recovery and saves loss of time from work. But in India, despite the prevalence of heart diseases, usage of stents is still not widespread. The cost factor is a major deterrent. A major reason for this is poor medical insurance coverage in the country unlike the US where such procedures are included in health coverage.

A typical stent insertion in India would cost Rs 1 lakh or $2,000 and an open heart surgery is around Rs 1.50 lakh. It is the economies of scale which drives the Indian healthcare unlike the US, Dr Govindaraju Subramani, Interventional Cardiologist, Oshkosh, Wisconsin told Pharmabiz in an in a telephonic interview.

Dr Subramani who is currently in India, has been making presentations to cardiologists on the safety aspects in the usage of DES. "Preference for DES over bare-metal stent (BMS) is primarily because it brings down the risk of artery re-blockage (restenosis) and thus reduces the need for repeat intervention from about 25 per cent to less than 10 per cent".

Drug-coated stents have been implanted worldwide in almost 6 million patients since its introduction in 2000. The World Congress of Cardiology (WCC) in Barcelona in September 2006 highlighted concerns about the clinical results of first generation DES.

"Now patient need not panic as all DES are not the same. The DES is proving to provide distinct patient benefits over BMS. Different drugs, polymers and stent platforms have produced varied clinical outcomes and there is a clear indication that DES' clearly reduce restenosis rates and repeat procedures over BMS recipients. However there are variations in safety, efficacy and deliverability outcomes from one stent to the next," he explained.

Elements contributing to safety include the product (stent technology), procedure (stent deployment and placement) and post procedure anti-platlet therapy. Patient compliance to anti-platelet therapy post angioplasty is critical as major post surgery problems can be avoided if right drugs are used.

Making the right choice for a safe DES thus has become very critical. This is where Medtronic's Endeavour, a second generation DES surpasses from first generation version in three critical aspects. It uses a proven non-inflammatory phosphorylcholine polymer, PC technology, which allows for full endothelialization. Its non-cytotoxic drug, zotarolimus (ABT-578) is completely absorbed into the vessel wall in 28 days. The Cobalt Chromium, modular stent platform provides outstanding delivery and side branch access.

Studies have indicated that with Endeavour II, there has been only 6.5 per cent target lesion revascularization (TLR), 0.5 per cent Stent Thrombosis with no thrombosis after 10 days and lower composite death.

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