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Comparison of clinical outcomes of two different types of paclitaxel-coated balloons for treatment of patients with coronary in-stent restenosis

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Abstract

Drug-coated balloon (DCB) angioplasty has been shown to be a promising option for the treatment of coronary in-stent restenosis (ISR). We compared the clinical outcomes of patients with ISR who were treated with two commonly used paclitaxel-containing DCBs, the Pantera Lux (PL) and SeQuent Please (SP). A total of 491 patients with 507 ISR lesions [PL-DCB in 127 (26%) patients and SP-DCB in 364 (74%) patients] underwent DCB angioplasty for ISR lesions. The major adverse cardiac events (MACEs), including cardiac death, target lesion-related myocardial infarction, and target lesion revascularization, were assessed. There were no significant differences in each occurrence of MACE and cardiac death: 16 MACEs (61 per 1000 person-years) in the PL-DCB group and 55 (60 per 1000 person-years) MACEs in the SP-DCB group, log-rank p = 0.895, and three cardiac deaths (11 per 1000 person-years) in the PL-DCB group and ten cardiac deaths (11 per 1000 person-years) in the SP-DCB group, log-rank p = 0.849. Diabetes mellitus under insulin treatment [hazard ratio (HR) 2.71; 95% confidence interval (CI) 1.31–5.60; p = 0.007], chronic kidney disease (HR 1.99; 95% CI 1.01–3.92; p = 0.045), early-onset ISR (HR 1.99; 95% CI 1.18–3.36; p = 0.010), and recurrent ISR (HR 1.89; 95% CI 1.08–3.32; p = 0.026) were associated with the occurrence of MACE after DCB angioplasty. There was no significant difference of MACE between PL-DCB and SP-DCB treatment in patients with ISR. Patients with insulin-treated diabetes, chronic kidney disease, early-onset ISR, and recurrent ISR were at a higher risk of MACE after DCB angioplasty.

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Funding

This study was supported by a grant from the Korea Healthcare Technology Research and Development Project, Ministry for Health and Welfare, Republic of Korea (Nos. A085136 and HI15C1277), the Mid-Career Research Program through a NRF grant funded by the NEST, Republic of Korea (No. 2015R1A2A2A01002731), and the Cardiovascular Research Center, Seoul, Korea.

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Author notes

  1. Viet Phuong Thuy Nguyen and Choongki Kim contributed equally to this work.

Authors and Affiliations

  1. Division of Interventional Cardiology, Cho Ray Hospital, Ho Chi Minh City, Vietnam

    Viet Phuong Thuy Nguyen

  2. Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Republic of Korea

    Choongki Kim, Sung-Jin Hong, Chul-Min Ahn, Jung-Sun Kim, Byeong-Keuk Kim, Young-Guk Ko, Donghoon Choi, Yangsoo Jang & Myeong-Ki Hong

  3. Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea

    Chul-Min Ahn, Jung-Sun Kim, Byeong-Keuk Kim, Young-Guk Ko, Donghoon Choi, Yangsoo Jang & Myeong-Ki Hong

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  1. Viet Phuong Thuy Nguyen
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Nguyen, V.P.T., Kim, C., Hong, SJ. et al. Comparison of clinical outcomes of two different types of paclitaxel-coated balloons for treatment of patients with coronary in-stent restenosis. Heart Vessels 34, 1420–1428 (2019). https://doi.org/10.1007/s00380-019-01388-z

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