The findings of the research were presented at the trans-catheter cardiovascular therapeutics (TCT) conference in San Francisco, US
Prof Upendra Kaul, Dean & Executive Director, Cardiology and Academics & Research Department, Fortis Escorts Heart Institute and Fortis Flt Lt Rajan Dhall Hospital presented research that clearly demonstrated the superiority of everolimus eluting stents over Paclitaxel eluting stents, in diabetics. This single blind randomised clinical trial was conducted at 46 Indian centres. The study was conceived and executed by Fortis Escorts Heart Institute, New Delhi, India and put to rest a decade old medical controversy on the comparative superiority of the stents in diabetics.
The findings of the research was presented at the prestigious trans-catheter cardiovascular therapeutics (TCT), a renowned educational meeting specialising in interventional cardiovascular medicine. These findings are expected to enable doctors to provide an informed view to their patients and help to improve outcomes, especially in the case of diabetic patients.
The trial was conducted on Paclitaxel – eluting versus everolimus – eluting stents in patients with diabetes mellitus and coronary artery disease. Among the 350 trials conducted globally and submitted to the TCT only 12 exceptional trials got selected. The clinical trial with an acronym ‘Tuxedo India’ presented by Dr Kaul was one of them and showcased the research work in India being coordinated and executed by Fortis Escorts Heart Institute, in New Delhi.
The study conclusively showed that the everolimus eluting stents are superior to Paclitaxel eluting stents in diabetic patients including those requiring insulin therapies. This randomised study carried out on 1830 subjects was conducted in 46 Indian hospitals. The research project was conceived and executed by the Academics and Research department of Fortis Escorts Heart Institute, Fortis Healthcare under the leadership of Prof Kaul supported by his team headed by Priyadarshini Arambam, Senior Manager.
The study and its results were covered widely by the US medical press, C Michael Gibson for clinicaltrialresults.org, Dr Ron Waksman for cardiotube.net and www.crtonline.org and Kim A Eagle of American College of Cardiology, NEJM reporters etc. In addition the study has also been published online in the New England Journal of Medicine (NEJM).
The implications of this trial are that it supports scientifically the widespread use of limus-based drug eluting stents even in diabetic patients including those requiring insulin. This is because these studies used first generation stents which TUXEDO-India study has shown are inferior to everolimus eluting stents.
“India offers a very lucrative environment for clinical trials. It has a large English educated young population including scientists and researchers. India also offers significant cost advantage as compared to developed and other emerging economies, 40-60 per cent lower than in developed countries and around 10-20 per cent lower than emerging economies. Indian companies have already proven its capabilities in discovering and developing and are highly capable in research and development particularly in drug discovery. The recently revised guidelines for clinical research in India provide an enlightened framework and make the process more transparent. We as stakeholders need to make sure that there is absolute clarity about the new guidelines, with efficiency in execution so that crucial clinical trials can go on smoothly,” said Dr Kaul.
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