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Clinical outcomes in real-world patients with bifurcation lesions receiving Xience V everolimus-eluting stents: Four-year results from the Xience V USA study.

Publication ,  Journal Article
Hermiller, JB; Applegate, RJ; Baird, C; Butler, MM; Rutledge, D; Wang, J; Kakarala, K; Krucoff, MW; Sudhir, K
Published in: Catheter Cardiovasc Interv
July 2016

BACKGROUND: The Xience V USA Study demonstrated safety and efficacy of the XIENCE V(®) everolimus-eluting stent (EES) in a large, prospective study of a real-world, unselected patient population. There is limited long-term data regarding EES performance in high risk patients with bifurcation lesions (BIF). The objective of this analysis was to evaluate the long-term safety and effectiveness of EES in patients with BIF from the XIENCE V USA study. METHODS: The Xience V USA Study was a single arm, prospective, multicenter, real-world study (n = 5,054) undergoing PCI with EES. Baseline data and clinical outcomes at 4 years were evaluated in the subgroup of patients with ≥ 1 BIF who did not undergo a staged procedure. Co-primary endpoints were ARC definite/probable stent thrombosis and a composite of cardiac death and ARC-defined myocardial infarction (MI). Endpoints were adjudicated by an independent CEC. RESULTS: Of 4,768 patients who did not undergo a staged procedure, there were 511 (10.7%) patients with BIF and 4,257 (89.3%) patients without BIF. Follow-up data was available in 4,459 patients (466 BIF, 3,993 non-BIF). Through binary outcome analysis, at 1 year the overall definite/probable stent thrombosis rates were higher in the BIF group (1.84% vs. 0.76%, P = 0.03). However, at 4 years, the difference in cumulative rates of ARC definite/probable stent thrombosis (BIF 2.3% vs. non-BIF 1.4%, P = 0.13) remained the same as that at 1 year, with no incremental definite/probable stent thrombosis in BIF patients from 2-4 years. The 4-year rates of composite cardiac death and MI were 13.5% for BIF vs. 14.1% for non-BIF (P = 0.78). At 4 years, target lesion failure (19.1% vs. 18.3%, P = 0.66) and ischemia driven-target lesion revascularization (10.2% vs. 10.1%, P = 0.89) were comparable between the two groups. CONCLUSIONS: This subgroup analysis of BIF lesions in a real world population receiving EES demonstrates continued low rates of clinical outcomes in the BIF subgroup at 4 years with no incremental stent thrombosis increase in BIF patients from 2 to 4 years. © 2015 Wiley Periodicals, Inc.

Duke Scholars

Published In

Catheter Cardiovasc Interv

DOI

EISSN

1522-726X

Publication Date

July 2016

Volume

88

Issue

1

Start / End Page

62 / 70

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Time Factors
  • Risk Factors
  • Prosthesis Design
  • Prospective Studies
  • Product Surveillance, Postmarketing
  • Percutaneous Coronary Intervention
  • Myocardial Infarction
  • Middle Aged
 

Citation

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Hermiller, J. B., Applegate, R. J., Baird, C., Butler, M. M., Rutledge, D., Wang, J., … Sudhir, K. (2016). Clinical outcomes in real-world patients with bifurcation lesions receiving Xience V everolimus-eluting stents: Four-year results from the Xience V USA study. Catheter Cardiovasc Interv, 88(1), 62–70. https://doi.org/10.1002/ccd.26217
Hermiller, James B., Robert J. Applegate, Colleen Baird, Michael M. Butler, David Rutledge, Jin Wang, Kalyan Kakarala, Mitchell W. Krucoff, and Krishnankutty Sudhir. “Clinical outcomes in real-world patients with bifurcation lesions receiving Xience V everolimus-eluting stents: Four-year results from the Xience V USA study.Catheter Cardiovasc Interv 88, no. 1 (July 2016): 62–70. https://doi.org/10.1002/ccd.26217.
Hermiller JB, Applegate RJ, Baird C, Butler MM, Rutledge D, Wang J, et al. Clinical outcomes in real-world patients with bifurcation lesions receiving Xience V everolimus-eluting stents: Four-year results from the Xience V USA study. Catheter Cardiovasc Interv. 2016 Jul;88(1):62–70.
Hermiller, James B., et al. “Clinical outcomes in real-world patients with bifurcation lesions receiving Xience V everolimus-eluting stents: Four-year results from the Xience V USA study.Catheter Cardiovasc Interv, vol. 88, no. 1, July 2016, pp. 62–70. Pubmed, doi:10.1002/ccd.26217.
Hermiller JB, Applegate RJ, Baird C, Butler MM, Rutledge D, Wang J, Kakarala K, Krucoff MW, Sudhir K. Clinical outcomes in real-world patients with bifurcation lesions receiving Xience V everolimus-eluting stents: Four-year results from the Xience V USA study. Catheter Cardiovasc Interv. 2016 Jul;88(1):62–70.
Journal cover image

Published In

Catheter Cardiovasc Interv

DOI

EISSN

1522-726X

Publication Date

July 2016

Volume

88

Issue

1

Start / End Page

62 / 70

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Time Factors
  • Risk Factors
  • Prosthesis Design
  • Prospective Studies
  • Product Surveillance, Postmarketing
  • Percutaneous Coronary Intervention
  • Myocardial Infarction
  • Middle Aged