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Cardiovascular Intervention and Therapeutics

, Volume 34, Issue 1, pp 40–46 | Cite as

Five-year clinical outcomes of everolimus-eluting stents from the post marketing study of CoCr-EES (XIENCE V/PROMUS) in Japan

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

Abstract

The Cobalt Chromium Everolimus-Eluting Stent (CoCr-EES) Post Marketing Surveillance (PMS) Japan study is a prospective multicenter registry designed to evaluate the safety and efficacy of XIENCE V/PROMUS everolimus-eluting stents in routine clinical practice at 47 centers representative of the clinical environment in Japan. We enrolled 2010 consecutive patients (2649 lesions) who underwent percutaneous coronary intervention using CoCr-EES. Clinical outcomes were evaluated through 5 years. Mean age was 68.8 years, 41.9% had diabetes, 4.9% received hemodialysis. Five-year clinical follow up was available for 1704 (84.8%) patients. Major adverse cardiovascular events (MACE) occurred in 10.7% of patients, including cardiac death (3.8%), myocardial infarction (1.8%), and clinically driven target lesion revascularization (TLR) (6.0%). Beyond 1 year, annual incidence of clinically driven TLR was 0.5–0.8%. Definite or probable stent thrombosis occurred in 9 (0.5%) patients at 5 years. After 1 year, definite stent thrombosis occurred in only 1 patient. Significant predictors for MACE were dialysis (ODDs ratio 4.58, 95% CI 2.75–7.64), prior cardiac intervention (ODDs ratio 2.47, 95% CI 1.75–3.49), total stent length (ODDs ratio 1.01, 95% CI 1.01–1.02), and number of diseased vessels (ODDs ratio 1.66, 95% CI 1.08–2.55). Five-year clinical outcomes from the CoCr-EES PMS Japan study demonstrated a low incidence of clinical events in the daily practice up to 5 years.

Clinical Trial Registration Information: https://clinicaltrials.gov/ct2/show/NCT01086228.

Keywords

Everolimus Stent Restenosis Thrombosis 

Notes

Acknowledgements

The authors thank the members of the cardiac catheterization laboratory and clinical research coordinators at the participating centers.

Funding source

The XIENCE V/PROMUS PMS was sponsored and funded by Abbott Vascular (ClinicalTrials.gov ID: NCT01086228).

Compliance with ethical standards

Conflict of interest

Ken Kozuma and Kengo Tanabe receive remuneration from Abbott Vascular, Kusano Hajime is an employee of Abbott Vascular and has stocks of Abbott Vascular, Hong Nie is an employee of Abbott Vascular, and Takeshi Kimura receives research and scholar funds from Abbott Vascular. Others have no disclosure related to this manuscript.

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Copyright information

© Japanese Association of Cardiovascular Intervention and Therapeutics 2018

Authors and Affiliations

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

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