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Cardiovascular Intervention and Therapeutics

, Volume 33, Issue 4, pp 313–320 | Cite as

The impact of coronary calcification on angiographic and 3-year clinical outcomes of everolimus-eluting stents: results of a XIENCE V/PROMUS post-marketing surveillance study

  • Nobuo Shiode
  • Ken Kozuma
  • Jiro Aoki
  • Masaki Awata
  • Mamoru Nanasato
  • Kengo Tanabe
  • Junichi Yamaguchi
  • Hajime Kusano
  • Hong Nie
  • Takeshi Kimura
  • On behalf of XIEVCE V/Promus PMS Investigators
Original Article
  • 108 Downloads

Abstract

Coronary calcification (CCA) is one of the independent predictors for major adverse cardiac events (MACEs) in coronary intervention. Post-marketing surveillance study Japan is a prospective registry designed to evaluate the safety and efficacy of the everolimus-eluting stent (EES, XIENCE V/PROMUS Stent) in routine clinical practice at 47 centers. In this study, 1848 lesions (1546 patients) were assessed using quantitative coronary angiography. In these 1546 patients, renal function data were unknown in 26 patients. Three patients in 70 patients with dialysis and 56 patients in 1450 patients with no dialysis were excluded, because they had multiple lesions with mixed calcification lesions. We evaluated the effects of CCA on 8-month angiographic and 3-year clinical outcomes in dialysis and non-dialysis patients. Moderate-to-severe (Ca group) and none-to-mild CCA (non-Ca group) were observed in 33 lesions (30 patients) and 48 lesions (37 patients) in dialysis patients, and these were observed in 306 lesions (286 patients) and 1303 lesions (1108 patients) in non-dialysis patients, respectively. In non-dialysis patients, the ischemic-driven target lesion revascularization (ID-TLR) and MACE rate over the 3 years were significantly higher in the Ca group than in the non-Ca group (5.8 vs. 3.1%, p = 0.025 and 10.0 vs. 5.0%, p = 0.0011). In dialysis patients, ID-TLR and MACE rates were high in both groups (14.3 vs. 17.9%, p = 0.85 and 17.5 vs. 36.1%, p = 0.16). In non-dialysis patients, 8-month angiographic and 3-year clinical outcomes were worse in the Ca group. However, in dialysis patients, both outcomes were worse regardless of CCA.

Clinical Trial registration https://clinicaltrials.gov/ct2/show/NCT01086228.

Keywords

Coronary calcification Everolimus-eluting stent Dialysis 

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Copyright information

© Japanese Association of Cardiovascular Intervention and Therapeutics 2017

Authors and Affiliations

  • Nobuo Shiode
    • 1
  • Ken Kozuma
    • 3
  • Jiro Aoki
    • 2
  • Masaki Awata
    • 4
  • Mamoru Nanasato
    • 5
  • Kengo Tanabe
    • 2
  • Junichi Yamaguchi
    • 6
  • Hajime Kusano
    • 7
  • Hong Nie
    • 7
  • Takeshi Kimura
    • 8
  • On behalf of XIEVCE V/Promus PMS Investigators
  1. 1.Division of CardiologyAkane Foundation Tsuchiya General HospitalHiroshimaJapan
  2. 2.Division of CardiologyMitsui Memorial HospitalTokyoJapan
  3. 3.Department of CardiologyTeikyo University HospitalTokyoJapan
  4. 4.Department of Advanced Cardiovascular TherapeuticsOsaka University Graduate School of MedicineOsakaJapan
  5. 5.Cardiovascular CenterNagoya Daini Red Cross HospitalAichiJapan
  6. 6.Department of CardiologyTokyo Women’s Medical UniversityTokyoJapan
  7. 7.Abbott VascularSanta ClaraUSA
  8. 8.Department of Cardiovascular MedicineKyoto University Graduate School of MedicineKyotoJapan

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