Impact of hemodialysis on clinical and angiographic outcomes in in-stent restenotic lesions following optical coherence tomography-guided drug-coated balloon treatment View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2020-10-13

AUTHORS

Jiro Aoki, Gaku Nakazawa, Kenji Ando, Shigeru Nakamura, Tetsuya Tobaru, Masami Sakurada, Hisayuki Okada, Kiyoshi Hibi, Kan Zen, Akihiro Ikuta, Kenshi Fujii, Maoto Habara, Junya Ako, Taku Asano, Shunsuke Ozaki, Tetsuya Fusazaki, Ken Kozuma

ABSTRACT

Hemodialysis (HD) is associated with a high in-stent restenosis (ISR) rate even in the second-generation era. Drug-coated balloons (DCB) generally provide excellent clinical outcomes in patients with ISR lesions. Nonetheless, safety and efficacy of DCB for ISR lesions in HD patients are largely unknown. A total of 17 centers across Japan participated in this study. Patients were eligible for the study if ISR lesions were treated with DCB. Enrolled patients were divided into 2 groups (HD and non-HD groups). Angiographic, OCT, and clinical outcomes were compared between the HD and the non-HD groups. A total of 210 patients were enrolled (36 patients in the HD group, and 174 patients in the non-HD group). At 8 months, the binary restenosis rate was significantly higher (26.3% versus 11.3%, p = 0.02) and in-segment late loss was significantly higher (0.49 ± 0.61 mm versus 0.23 ± 0.33 mm, p = 0.02) in the HD group than the non-HD group. In the OCT analyses, change of minimum stent area between post- and pre-procedure was significantly smaller in the HD group compared to the non-HD group (0.08 ± 0.95 mm2 versus 0.68 ± 1.07 mm2, p = 0.004). Target vessel failure (TVF) rate at 2 years was significantly different between the 2 groups (25.0% in the HD group and 12.1% in the non-HD group, p = 0.04). In the multivariate analysis, HD was a significant predictor for TVF (Hazard ratio 5.81, 95% CI 1.28–26.4, p = 0.02). Clinical and angiographic outcomes following OCT-guided DCB treatment in ISR lesions were significantly worse in HD patients compared to non-HD patients.Clinical Trial Registration Information: https://clinicaltrials.gov/ct2/show/NCT02300454 More... »

PAGES

429-435

References to SciGraph publications

Journal

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s12928-020-00718-7

DOI

http://dx.doi.org/10.1007/s12928-020-00718-7

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1131656164

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/33048289


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16 schema:description Hemodialysis (HD) is associated with a high in-stent restenosis (ISR) rate even in the second-generation era. Drug-coated balloons (DCB) generally provide excellent clinical outcomes in patients with ISR lesions. Nonetheless, safety and efficacy of DCB for ISR lesions in HD patients are largely unknown. A total of 17 centers across Japan participated in this study. Patients were eligible for the study if ISR lesions were treated with DCB. Enrolled patients were divided into 2 groups (HD and non-HD groups). Angiographic, OCT, and clinical outcomes were compared between the HD and the non-HD groups. A total of 210 patients were enrolled (36 patients in the HD group, and 174 patients in the non-HD group). At 8 months, the binary restenosis rate was significantly higher (26.3% versus 11.3%, p = 0.02) and in-segment late loss was significantly higher (0.49 ± 0.61 mm versus 0.23 ± 0.33 mm, p = 0.02) in the HD group than the non-HD group. In the OCT analyses, change of minimum stent area between post- and pre-procedure was significantly smaller in the HD group compared to the non-HD group (0.08 ± 0.95 mm2 versus 0.68 ± 1.07 mm2, p = 0.004). Target vessel failure (TVF) rate at 2 years was significantly different between the 2 groups (25.0% in the HD group and 12.1% in the non-HD group, p = 0.04). In the multivariate analysis, HD was a significant predictor for TVF (Hazard ratio 5.81, 95% CI 1.28–26.4, p = 0.02). Clinical and angiographic outcomes following OCT-guided DCB treatment in ISR lesions were significantly worse in HD patients compared to non-HD patients.Clinical Trial Registration Information: https://clinicaltrials.gov/ct2/show/NCT02300454
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23 HD group
24 HD patients
25 ISR lesions
26 Japan
27 OCT analysis
28 TVF
29 analysis
30 angiographic
31 angiographic outcomes
32 area
33 balloon
34 balloon treatment
35 binary restenosis rate
36 center
37 changes
38 clinical outcomes
39 drug-coated balloon (DCB) treatment
40 drug-coated balloons
41 efficacy
42 efficacy of DCB
43 era
44 excellent clinical outcomes
45 failure rate
46 group
47 hemodialysis
48 impact
49 impact of hemodialysis
50 late loss
51 lesions
52 loss
53 minimum stent area
54 months
55 multivariate analysis
56 non-HD group
57 non-HD patients
58 outcomes
59 patients
60 post
61 predictors
62 rate
63 restenosis rate
64 restenotic lesions
65 safety
66 segment late loss
67 significant predictors
68 stent area
69 stent restenosis rate
70 stent restenotic lesions
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72 total
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74 years
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