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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

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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.

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Authors and Affiliations

  1. Division of Cardiology, Akane Foundation Tsuchiya General Hospital, 3-30 Nakajima-cho, Naka-ku, Hiroshima, 730-8655, Japan

    Nobuo Shiode

  2. Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan

    Jiro Aoki & Kengo Tanabe

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

    Ken Kozuma

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

    Masaki Awata

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

    Mamoru Nanasato

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

    Junichi Yamaguchi

  7. Abbott Vascular, Santa Clara, 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. Nobuo Shiode
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  2. Ken Kozuma
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  3. Jiro Aoki
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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 Nobuo Shiode.

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Shiode, N., Kozuma, K., Aoki, J. et al. 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. Cardiovasc Interv and Ther 33, 313–320 (2018). https://doi.org/10.1007/s12928-017-0484-7

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  • DOI: https://doi.org/10.1007/s12928-017-0484-7

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