Cardiologists across the world expect the launch of a first biodegradable stent with less chances for thrombosis and restenosis soon if world's first study to evaluate safety and efficacy of a fully bio absorbable drug eluting stent is successful. Abbott Laboratories is conducting the clinical studies of the product for some time now.
The Biodegradable stents, the device to tackle blockage in arteries without the help of metals, are estimated to degrade within a month after the implant. The method, if found successful to avoid late stent thrombosis and restenosis in the patient, will be the most wanted system globally after the development of Drug Eluting Stent, according to eminent cardiologists.
In an Interventional Cardiology Summit 2007, conducted by India International Forum of Cardiology with exclusive sponsorship of Eurocor GmbH, the German based subsidiary of Banglore based Opto Circuits Ltd., cardiologists from various parts of the world added that more clinical trials and intense data collection is needed prior to its extensive use.
"At present, there is only one study by the Abbott Vascular on 30 patients is available on the method. We need more number of studies to know whether the strength of scaffolding is enough in the technology and whether you may undergo the same restenosis problem once the stent is degraded," Dr Brian Pinto, Cardiologist, Nanavati Hospital and the programme director of the summit said in a press conference.
"A paper on biodegradable stents will be presented at American College of Cardiology, in which the present situation and future of the method may come under discussion. It is an interesting development, but we should wait for adequate data," added Dr Nishit A Choksi, Cardiologist, Internal Medicine Doctor, and Interventional Cardiologist in Berkley, Michigan (MI). The method would be one step ahead to the current method of using biopolymer in Drug Eluting Stents to avoid problems later.
The ABSORB trial, conducted by Abbott Vascular, one of the world's leading vascular care businesses under Abbott Laboratories, is designed to assess safety and performance of its bio absorbable everolimus-eluting stent in the treatment of patients with single de novo, native coronary artery disease or untreated lesions. Everolimus has been shown to reduce tissue growth in the coronary vessels following stent implantation, according to company officials. The ABSORB trial is a prospective, non-randomized (open label) study and has been designed to enrol up to 60 patients in Belgium, Denmark, France, New Zealand, Poland and The Netherlands.
The summit also discussed about the use of Drug Eluting Stent (DES) instead of Bare Metal Stent (BMS). A group of experts argued that the DES are more prone to late stent thrombosis, which may lead to the sudden death of patient, while another group strongly recommended the use of DES instead of BMS.
"The late stent thrombosis, which will be anytime after six months after implantation of DES will not allow enough time for us to save the patient. Though prone to allow restenosis, BMS does not have such a high risk after six months. Even in the case of restenosis, BMS will allow time for us to save the patient, which leaves us in confusion on whether to use BMS or DES," said Eric Borges, consulting cardiologist and physician, Bombay Hospital.
Meanwhile, in the inaugural address of the summit, Dr Prof B K Goyal, director, Interventional Cardiology and Honorary Dean, Bombay Hospital and Medical Research Centre and an awardee of Padma Vibhushan, Padma Bhushan and Padma Sri, opined that the success of Drug Eluting Stent might lead to stabilisation to newer methods. "The DES leaves little concern over late thrombosis after the recent Swiss study. Much importance should be encouraged, as the facts show that the price of the cheapest BMS is twice the per capita income of an ordinary Indian," he said in his address. He opined that the insurance companies should come up with packages to increase the number of coronary artery treatment from 60 to 70 thousand last year to more than one billion in the coming years.