Evaluation of the XIENCE V everolimus eluting coronary stent system in the Asian population of the SPIRIT V single arm study. 2-year clinical follow-up data
Kaul, U.; Patel, T.M.; Zambahari, R.; Mullasari, A.S.; Bahl, V.K.; Stuteville, M.; Dorange, C.éc.; Veldhof, S.; Grube, E.
Indian Heart Journal 63(5): 402-408
2011
ISSN/ISBN: 0019-4832 PMID: 23550416 Document Number: 656052
Asian patients have a uniquely high risk for heart disease compared to other ethnicities. Past drug eluting stent trials have examined mainly populations of European heritage. As a significant proportion of the real world population in the SPIRIT V single arm study is Asian, the study provides insight into how this population responds to stenting with the XIENCE V Everolimus Eluting Coronary Stent (EES). 2,700 patients were enrolled at 93 sites in Europe, Asia Pacific and Canada between November 2006 and November 2007. 698 (26%) patients were recruited from Asian sites in India, China, Hong Kong, Malaysia, Singapore and Thailand. De novo coronary artery lesions of all patients were to be treated with up to 4 planned EES. Up to 2 year follow-up, major adverse cardiac events, myocardial infarction and target lesion revascularization rates were lower in the Asian subgroup than in the non-Asian subgroup. These results were mainly driven by better clinical outcomes in the Indian population. All populations showed similar low stent thrombosis rates. These findings demonstrate the safety and efficacy of the EES when used in a real-world Asian population, known to be at higher risk for heart disease.