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Clinical outcomes in real-world patients with small vessel disease treated with XIENCE V® everolimus-eluting stents: one year results from the XIENCE V® USA condition of approval post-market study.

Publication ,  Journal Article
Hermiller, JB; Rutledge, DR; Mao, VW; Zhao, W; Wang, J; Gruberg, L; Lombardi, W; Sharma, SK; Krucoff, MW
Published in: Catheter Cardiovasc Interv
July 1, 2014

OBJECTIVES: The purpose of this study was to evaluate the 1-year clinical outcomes of more complex XIENCE V USA real-world patients with small versus nonsmall vessel lesions. BACKGROUND: Patients with small vessel lesions undergoing coronary stent placement are at higher risk of major adverse cardiac events. Improved safety and efficacy of XIENCE V everolimus eluting stents (EES) have been previously demonstrated in selected low-risk small vessel populations in randomized clinical trials. METHODS: The XIENCE V USA study was a condition of approval, single-arm study in unselected real-world patients. Baseline and 1-year clinical outcomes were compared between XIENCE V USA patients who received a single 2.5 mm stent (small vessel group, N = 838) and patients implanted with a single >2.5 mm stent (non-small vessel group, N = 2,015). Mean reference vessel diameter was 2.55 ± 0.36 and 3.25 ± 0.46 mm in the small and non-small vessel groups, respectively (P < 0.001). RESULTS: Small vessel group had more females, presented with a higher rate of diabetes, and had more complex lesion characteristics. The definite or probable ST rates analyzed using Kaplan-Meier method were low and not significantly different between the groups at 0.37 and 0.40% for the small and nonsmall vessel group (P = 0.88), respectively. The composite rate of cardiac death or MI was comparable at 4.5% for the small and 5.1% for the non-small vessel 1 groups (P = 0.57). The 1-year target lesion revascularization rate was also comparable in the small vessel group (3.8% vs. 3.0%, P = 0.35). CONCLUSIONS: Despite gender difference, higher prevalence of diabetes and more complex lesions in the small vessel groups, the 1-year clinical outcomes were similar in both small and nonsmall vessel groups. These results demonstrate the therapeutic benefit of XIENCE V EES in a real-world all inclusive patient population with small vessel disease.

Duke Scholars

Published In

Catheter Cardiovasc Interv

DOI

EISSN

1522-726X

Publication Date

July 1, 2014

Volume

84

Issue

1

Start / End Page

7 / 16

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Sirolimus
  • Prosthesis Design
  • Prospective Studies
  • Product Surveillance, Postmarketing
  • Myocardial Revascularization
  • Middle Aged
  • Male
  • Immunosuppressive Agents
  • Humans
 

Citation

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Hermiller, J. B., Rutledge, D. R., Mao, V. W., Zhao, W., Wang, J., Gruberg, L., … Krucoff, M. W. (2014). Clinical outcomes in real-world patients with small vessel disease treated with XIENCE V® everolimus-eluting stents: one year results from the XIENCE V® USA condition of approval post-market study. Catheter Cardiovasc Interv, 84(1), 7–16. https://doi.org/10.1002/ccd.25325
Hermiller, James B., David R. Rutledge, Vivian W. Mao, Weiying Zhao, Jin Wang, Luis Gruberg, William Lombardi, Samin K. Sharma, and Mitchell W. Krucoff. “Clinical outcomes in real-world patients with small vessel disease treated with XIENCE V® everolimus-eluting stents: one year results from the XIENCE V® USA condition of approval post-market study.Catheter Cardiovasc Interv 84, no. 1 (July 1, 2014): 7–16. https://doi.org/10.1002/ccd.25325.
Hermiller JB, Rutledge DR, Mao VW, Zhao W, Wang J, Gruberg L, Lombardi W, Sharma SK, Krucoff MW. Clinical outcomes in real-world patients with small vessel disease treated with XIENCE V® everolimus-eluting stents: one year results from the XIENCE V® USA condition of approval post-market study. Catheter Cardiovasc Interv. 2014 Jul 1;84(1):7–16.
Journal cover image

Published In

Catheter Cardiovasc Interv

DOI

EISSN

1522-726X

Publication Date

July 1, 2014

Volume

84

Issue

1

Start / End Page

7 / 16

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Sirolimus
  • Prosthesis Design
  • Prospective Studies
  • Product Surveillance, Postmarketing
  • Myocardial Revascularization
  • Middle Aged
  • Male
  • Immunosuppressive Agents
  • Humans