Clinical trial shows superiority of one drug eluting stent over another in patients with diabetes

Prof Dr Upendra Kaul, presents data as a ‘late breaking research’ at the gathering of interventional cardiologists at TCT conference in San Francisco, US

Prof Dr Upendra Kaul, Dean and 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 demonstrates 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 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 ‘Trans catheter Cardiovascular Therapeutics’ (TCT), only 12 exceptional trials got selected. The clinical trial with an acronym ‘Tuxedo India’ presented by Kaul was one of them and showcased the cutting-edge research work in India.

The TCT is an important educational meeting specialising in interventional cardiovascular medicine. TCT has been the centre 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 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 Upendra Kaul supported by his team headed by Priyadarshini Arambam, Senior Manager, Clinical Research operations, Fortis Heathcare.

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.

The study and its results were covered 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).