The impact of coronary calcification on angiographic and 3-year clinical outcomes of everolimus-eluting stents: results
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ORIGINAL ARTICLE
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 Shiode1 · Ken Kozuma3 · Jiro Aoki2 · Masaki Awata4 · Mamoru Nanasato5 · Kengo Tanabe2 · Junichi Yamaguchi6 · Hajime Kusano7 · Hong Nie7 · Takeshi Kimura8 · On behalf of XIEVCE V/Promus PMS Investigators
Received: 13 February 2017 / Accepted: 13 July 2017 © Japanese Association of Cardiovascular Intervention and Therapeutics 2017
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 ischemicdriven 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, IDTLR 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 nondialysis 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.
* Nobuo Shiode [email protected]
Clinical Trial registration https://clinicaltrials.gov/ct2/ show/NCT01086228.
1
Division of Cardiology, Akane Foundation Tsuchiya General Hospital, 3‑30 Nakajima‑cho, Naka‑ku, Hiroshima 730‑8655, Japan
Keywords Coronary calcification · Everolimus-eluting stent · Dialysis
2
Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan
3
Department of Cardiology, Teikyo University Hospital, Tokyo, Japan
Introduction
4
Department of Advanced Cardiovascular Therapeutics, Osaka University Graduate School of Medicine, Osaka, Japan
5
Cardiovascular Center, Nagoya Daini Red Cross Hospital, Aichi, Japan
6
Department of Cardiology, Tokyo Women’s Medical University, Tokyo, Japan
7
Abbott Vascular, Santa Clara, CA, USA
8
Department of Cardiovascular Medicine, Kyoto University Graduate School of
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