1. 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.
- Author
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Kaul U, Patel TM, Zambahari R, Mullasari AS, Bahl VK, Stuteville M, Dorange C, Veldhof S, and Grube E
- Subjects
- Asia, Southeastern, China, Coronary Artery Disease mortality, Everolimus, Female, Follow-Up Studies, Humans, Immunosuppressive Agents adverse effects, India, Male, Middle Aged, Myocardial Infarction etiology, Myocardial Revascularization statistics & numerical data, Reoperation, Sirolimus administration & dosage, Sirolimus adverse effects, Thrombosis etiology, Treatment Outcome, Asian People, Coronary Artery Disease ethnology, Coronary Artery Disease therapy, Drug-Eluting Stents adverse effects, Immunosuppressive Agents administration & dosage, Sirolimus analogs & derivatives
- Abstract
Background: 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)., Methods and Results: 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., Conclusion: 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.
- Published
- 2011