Background and Objectives Environmental and genetic data indicate that India contains a population at uniquely high risk for heart disease and diabetes when compared to other ethnicities. Past drug eluting stent trials have examined mainly populations of European heritage. The XIENCE V India single arm study provides an evaluation of the performance of the XIENCE V Everolimus Eluting Coronary Stent (EES) in India when used by physicians for treating patients at a range of hospitals from community to academic.
Methods Thousand patients were enrolled in this prospectve, open-label, multi-center, observational, single arm study from 18 sites in India between June 2008 and March 2009. The treatment strategy was determined by the investigator. Patients were enrolled after providing written informed consent and if the EES was the only type of stent received during the index procedure.
Results The patient population included 44% diabetics, 33% and 62% requiring medication for hypercholesterolemia and hypertension respectively. The mean pre-procedure percent diameter stenosis was 88% with 37% of lesions >=20 mm in length. The mean number of stents implanted per patient was 1.4. At 1 year follow-up the primary endpoint of cumulative stent thrombosis (ARC defined definite and probable) was 0.5%. The rate of the co-primary composite endpoint of cardiac death and any myocardial infarction was 1.9%. The rates of myocardial infarction and target lesion revascularisation were 1.3% and 1.2% respectively.
Conclusion Full 2 year clinical results of the XIENCE V India study will be presented.