Clinical outcomes in real-world patients with acute myocardial infarction receiving XIENCE V® everolimus-eluting stents: One-year results from the XIENCE v USA study

Krishnankutty Sudhir, James B. Hermiller, Srihari S. Naidu, Timothy D Henry, Vivian W. Mao, Weiying Zhao, Joanne M. Ferguson, Jin Wang, Lalitha Jonnavithula, Charles A. Simonton, David R. Rutledge, Mitchell W. Krucoff

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Abstract

Objectives The objective of this analysis was to evaluate the safety and effectiveness of XIENCE V in acute myocardial infarction (AMI). Background The XIENCE V® Everolimus-eluting coronary stent was superior to the TAXUS® paclitaxel-eluting stent in angiographic and clinical outcomes in the SPIRIT II, III, and IV randomized controlled trials, but patients with AMI were excluded. Methods XIENCE V USA is a large, prospective, multicenter, real-world single-arm postmarket surveillance trial. Consecutive patients undergoing PCI with XIENCE V were enrolled. For this analysis, clinical outcomes in 673 patients presenting with AMI (STEMI, n = 125) were as compared to patients without AMI (n = 3528) at 1 year. Results At 1 year, ARC-defined stent thrombosis (ST) rates were 1.08% in AMI vs. 0.85% in the non-AMI group (P = 0.4987). The late ST (30 days-1 year) rates were 0.31% vs. 0.47% (AMI vs. non-AMI, P = 0.7551). Rates of target lesion revascularization (TLR) were 4.1% vs. 4.6% (P = 0.6104), and rates of target lesion failure (TLF) were 9.1% vs. 8.5%, (P = 0.5964). With the historical WHO definition of MI, 1 year TLF rates were 7.0% vs. 6.7% (P = 0.8001). Improvements in quality of life, angina frequency, angina stability, and physical limitations occurred at 6 months (each P < 0.0001) and were sustained at 1 year in both groups. There were no significant differences in clinical outcomes between STEMI and non-STEMI patients. Conclusions At 1 year, AMI patients treated with XIENCE V had low rates of ST, TLR, and TLF, similar to non-AMI patients. Marked improvements in patients' health status in this subgroup were also demonstrated.

Original languageEnglish (US)
Pages (from-to)E385-E394
JournalCatheterization and Cardiovascular Interventions
Volume82
Issue number4
DOIs
StatePublished - Oct 1 2013

Keywords

  • drug eluting stent
  • everolimus
  • major adverse cardiac events
  • stent

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    Sudhir, K., Hermiller, J. B., Naidu, S. S., Henry, T. D., Mao, V. W., Zhao, W., Ferguson, J. M., Wang, J., Jonnavithula, L., Simonton, C. A., Rutledge, D. R., & Krucoff, M. W. (2013). Clinical outcomes in real-world patients with acute myocardial infarction receiving XIENCE V® everolimus-eluting stents: One-year results from the XIENCE v USA study. Catheterization and Cardiovascular Interventions, 82(4), E385-E394. https://doi.org/10.1002/ccd.24749