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Sustained Low Clinical Event Rates in Real-World Patients Receiving Everolimus-Eluting Coronary Stent System from a Large, Prospective, Condition of Approval Study: 2-Year Clinical Outcomes from the XIENCE V® USA Study.
- Source :
- Journal of Interventional Cardiology; Dec2012, Vol. 25 Issue 6, p565-575, 11p, 6 Charts, 1 Graph
- Publication Year :
- 2012
-
Abstract
- Objectives: This 2-year follow-up of the XIENCE V<superscript>®</superscript> USA study examines both the long-term safety and effectiveness of the everolimus-eluting coronary stent system (EECSS) in real-world patients. Background: The safety and effectiveness of EECSS at 1 year in real-world clinical settings have been demonstrated in XIENCE V<superscript>®</superscript> USA trial with low rates of target lesion revascularization (TLR), cardiac death, myocardial infarction (MI), and stent thrombosis (ST). Data on whether efficacy is maintained after 1 year and the event rate of very late stent thrombosis (VLST) between 1 and 2 years have not yet been reported. Methods: XIENCE V<superscript>®</superscript> USA is a prospective, multicenter, single-arm, FDA required condition of approval study designed to examine the safety and effectiveness of EECSS in an all-inclusive, consecutively enrolled population from real-world clinical settings. Clinical end-point events, including ST, cardiac death, MI, and revascularization were adjudicated by an independent Clinical Events Committee. Results: Four thousand eight hundred and seventy-three (96.4%) out of 5,054 participants (1,875 standard-risk; 3,059 extended-risk) reached 2-year follow-up. The 2-year rate of Academic Research Consortium (ARC)-defined definite and probable ST was 0.96% (95% CI 0.70-1.28) in the overall population and 0.34% (95% CI 0.12-0.74) and 1.33% (95% CI 0.95-1.81) in the standard-risk and extended-risk cohorts, respectively. The rate of VLST was 0.06% in the overall population, 0.0% in the standard-risk, and 0.10% in the extended-risk cohorts. The 2-year composite rate of cardiac death and ARC-defined MI was 8.9% (95% CI 8.08-9.70) in the overall population and 5.6% (95% CI 4.61-6.78) and 10.8% (95% CI 9.71-11.94) in the standard-risk and extended-risk cohorts, respectively. Conclusion: Low event rates observed at 1 year were maintained through 2 years. Despite the increased number of patients who discontinued dual antiplatelet therapy by 2 years, the ST rate remained consistently low, and <1% at 2 years due to low VLST occurrence. These results demonstrate continued safety and effectiveness of the XIENCE V<superscript>®</superscript> everolimus-eluting stent in a highly complex, real-world patient population through 2 years. (J Interven Cardiol 2012;25:565-575) [ABSTRACT FROM AUTHOR]
- Subjects :
- CORONARY artery surgery
SURGICAL stents
MYOCARDIAL infarction
HEART diseases
Subjects
Details
- Language :
- English
- ISSN :
- 08964327
- Volume :
- 25
- Issue :
- 6
- Database :
- Complementary Index
- Journal :
- Journal of Interventional Cardiology
- Publication Type :
- Academic Journal
- Accession number :
- 84307709
- Full Text :
- https://doi.org/10.1111/j.1540-8183.2012.00766.x