Prof. Upendra Kaul, dean and executive director, cardiology and academics & research department, Fortis Escorts Heart Institute and Fortis Flt. Lt. Rajan Dhall Hospital presented a pathbreaking research that clearly demonstrated the superiority of everolimus eluting stents over paclitaxel eluting stents, in diabetics. This single blind randomized clinical trial was conducted at 46 Indian centres.

The study which was conceived and executed by Fortis Escorts Heart Institute, New Delhi, India had put to rest a decade old medical controversy on the comparative superiority of the stents in diabetics.

The randomized, single blind clinical trial has also placed India and Fortis, firmly on the global map for clinical research. With the findings of this research being presented as a “late breaking trial” at the prestigious Trans-catheter Cardiovascular Therapeutics (TCT) conference in San Francisco, USA, Dr. Kaul has been publicly honoured by one of the largest and most prestigious global congregations of eminent cardiologists. The TCT is the world’s largest and most important educational meeting specializing in interventional cardiovascular medicine.

In recent times India has emerged as the capital for diabetes with a large population effected by this insidious disease. These findings will 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 cutting edge research work in India being coordinated and executed by Fortis Escorts Heart Institute, in New Delhi, a very well-known premier institution for the treatment of heart diseases in this part of the world.

The study conclusively showed that the everolimus eluting stents are superior to paclitaxel eluting stents in diabetic patients including those requiring insulin therapies. This randomized 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 Upendra Kaul supported by his team headed by Ms 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 on line in the New England Journal of Medicine (NEJM), an international journal considered the top medical journal with the highest impact factor. The publication came immediately on line after the presentation of Prof Kaul.

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.

This Tuxedo India trial and the astounding results represent the leap we have taken to get India back on the global map as a safe, logical and efficient clinical trials hub.