Three-year data from the XIENCE V® INDIA study: Safety and efficacy of XIENCE V® in 1000 real world Indian patients

Abstract

Background: Cardiovascular disease in Asia has reached epidemic proportions in recent years. Use of drug eluting stents in Asians has rapidly expanded with varying penetration rates across different countries. The XIENCE V® INDIA Study included ‘real world’ patients who underwent XIENCE V® stent implantation to assess short and intermediate term outcomes in Indian patients with diverse risk factors. Objective: To evaluate 3-year clinical outcomes in a cohort of ‘real world’ Indian patients with CAD being treated with XIENCE V® Everolimus Eluting Coronary Stent System. Methods: 1000 patients were enrolled from 18 sites in India between June 2008 and March 2009. Patients were included if their index procedures were completed using only XIENCE V®. There were no clinical or angiographic exclusions. An independent Clinical Events Committee adjudicated all endpoint-related events. The primary endpoint was stent thrombosis rate annually through to 3 years as defined by the Academic Research Consortium criteria. The co-primary endpoint was the composite rate of cardiac death and myocardial infarction at 1 year. Results: At 1-year the primary endpoint of definite/probable stent thrombosis rate was 0.51%. No additional very late stent thrombosis was reported through a 3-year follow up. The composite endpoint of cardiac death and any myocardial infarction was 1.9%, 2.7% and 3.1% at 1, 2 and 3 years respectively. Conclusion: Despite the high risk population of coronary artery disease, the use of XIENCE V® in 'real world' Indian patients was associated with very low clinical event rates upto three years of follow up.

Keywords

• Coronary artery disease
• Drug-eluting stent
• XIENCE V®
• Percutaneous coronary intervention
• XIENCE V® INDIA