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

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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.

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Acknowledgements

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

Funding

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

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Authors and Affiliations

  1. Division of Cardiology, Mitsui Memorial Hospital, 1 Kanda-Izumicho, Chiyoda-ku, Tokyo, 101-8643, Japan

    Jiro Aoki & Kengo Tanabe

  2. Department of Cardiology, Teikyo University Hospital, Tokyo, Japan

    Ken Kozuma

  3. Department of Advanced Cardiovascular Therapeutics, Osaka University Graduate School of Medicine, Osaka, Japan

    Masaki Awata

  4. Cardiovascular Center, Nagoya Daini Red Cross Hospital, Nagoya, Aichi, Japan

    Mamoru Nanasato

  5. Division of Cardiology, Hiroshima City Hospital, Hiroshima, Japan

    Nobuo Shiode

  6. Department of Cardiology, Tokyo Women’s Medical University, Tokyo, Japan

    Junichi Yamaguchi

  7. Abbott Vascular, Illinois, CA, USA

    Hajime Kusano & Hong Nie

  8. Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan

    Takeshi Kimura

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  1. Jiro Aoki
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  2. Ken Kozuma
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  3. Masaki Awata
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  5. Nobuo Shiode
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  10. Takeshi Kimura
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On behalf of XIEVCE V/PROMUS PMS Investigators

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Correspondence to Jiro Aoki.

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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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Aoki, J., Kozuma, K., Awata, M. et al. Five-year clinical outcomes of everolimus-eluting stents from the post marketing study of CoCr-EES (XIENCE V/PROMUS) in Japan. Cardiovasc Interv and Ther 34, 40–46 (2019). https://doi.org/10.1007/s12928-018-0515-z

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  • DOI: https://doi.org/10.1007/s12928-018-0515-z

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