Randomized Indian Clinical Trial Executed by Fortis Escorts Heart Institute Shows Superiority of one Drug Eluting Sent Over Another in Patients With Diabetes Mellitus

NEW DELHI, October 15, 2015 /PRNewswire/ --

Professor Dr Upendra Kaul, Presents Data as a 'Late Breaking Research' at the Largest Gathering of Interventional Cardiologists at 'Trans catheter Cardiovascular Therapeutics' (TCT) Conference in San Francisco, USA 

- Puts Decade old Controversy to Rest 

- Places India on the Global map in Clinical Research 

Prof. Upendra Kaul, Dean & Executive Director, Cardiology and Academics & Research Department, Fortis Escorts Heart Institute and Fortis Flt. Lt. Rajan Dhall Hospital presented a path-breaking 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 centers. 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 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), Dr. Kaul has been publicly honoured by one of the largest and most prestigious global congregations of eminent cardiologists.

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 TCT is the world's largest and most important educational meeting specializing in interventional cardiovascular medicine. TCT has been the center of cutting-edge educational content, showcasing the latest advances in current therapies and clinical research over the past 25 years. The symposium is designed for interventional cardiologists, radiologists, clinical cardiologists, basic scientists, vascular medicine specialists, cardiac and vascular surgeons, nurse practitioners, Cath lab technicians and other healthcare professionals with a special interest in interventional and vascular medicine.

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 http://www.clinicaltrialresults.org , Dr. Ron Waksman for http://www.cardiotube.netand http://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% lower than in developed countries and around 10-20% 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.

About Fortis Escorts Heart Institute 

Fortis Escorts Heart Institute (FEHI), Delhi, a pioneer and centre of excellence in cardiac care is celebrating its 28^th year of path-breaking work and service to the numerous of heart patients, who have benefitted from treatment, at this outstanding facility. Armed with clinical expertise and cutting-edge medical technology, the hospital has set enviable benchmarks in Heart transplants, Cardiac Bypass Surgery, Minimally Invasive Surgery, Interventional Cardiology, Non-invasive Cardiology, Pediatric Cardiology and Pediatric Cardiac Surgery. Till date, FEHI has successfully completed over 2 lakh Coronary Angiographies, over 1 lakh Cardiac Surgeries and almost 65,000 Coronary Angioplasties, in addition to several life-saving procedures. The hospital also performed India's first Trans Catheter Aortic Valve Implantation (TAVI) and Bioresorable Vascular Scaffold (BVS); Asia Pacific's first Directional Atherectomy, Angioscopy, Drug Eluting Stenting, etc. Over the years, FEHI has cloned a Heart Care Network of 19 hospitals and Heart Command Centers in India and abroad. It has also launched the revolutionary e-ICU program, enabling remote and timely access to critical care. Fortis Escorts Heart Institute has won numerous awards and accolades - 'Best Cardiology Hospital in the private sector' at the ICICI Lombard & CNBC TV18 India Healthcare Awards for 2015. 

About Fortis Healthcare Limited  

Fortis Healthcare Limited is a leading integrated healthcare delivery service provider in India. The healthcare verticals of the company primarily comprise hospitals, diagnostics and day care specialty facilities. Currently, the company operates its healthcare delivery services in India, Dubai, Mauritius and Sri Lanka with 54 healthcare facilities (including projects under development), approximately 10,000 potential beds and 266 diagnostic centres. 

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