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

Viet Phuong Thuy Nguyen, Choongki Kim, Sung Jin Hong, Chul Min Ahn, Jung Sun Kim, Byeong Keuk Kim, Young Guk Ko, Donghoon Choi, Yangsoo Jang, Myeong Ki Hong

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)1420-1428
Number of pages9
JournalHeart and Vessels
Volume34
Issue number9
DOIs
Publication statusPublished - 2019 Sep 13

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Paclitaxel
Stents
Pharmaceutical Preparations
Balloon Angioplasty
Therapeutics
Confidence Intervals
Chronic Renal Insufficiency
Insulin
Diabetes Mellitus
Myocardial Infarction

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Nguyen, Viet Phuong Thuy ; Kim, Choongki ; Hong, Sung Jin ; Ahn, Chul Min ; Kim, Jung Sun ; Kim, Byeong Keuk ; Ko, Young Guk ; Choi, Donghoon ; Jang, Yangsoo ; Hong, Myeong Ki. / Comparison of clinical outcomes of two different types of paclitaxel-coated balloons for treatment of patients with coronary in-stent restenosis. In: Heart and Vessels. 2019 ; Vol. 34, No. 9. pp. 1420-1428.
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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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Comparison of clinical outcomes of two different types of paclitaxel-coated balloons for treatment of patients with coronary in-stent restenosis. / Nguyen, Viet Phuong Thuy; Kim, Choongki; Hong, Sung Jin; Ahn, Chul Min; Kim, Jung Sun; Kim, Byeong Keuk; Ko, Young Guk; Choi, Donghoon; Jang, Yangsoo; Hong, Myeong Ki.

In: Heart and Vessels, Vol. 34, No. 9, 13.09.2019, p. 1420-1428.

Research output: Contribution to journalArticle

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T1 - Comparison of clinical outcomes of two different types of paclitaxel-coated balloons for treatment of patients with coronary in-stent restenosis

AU - Nguyen, Viet Phuong Thuy

AU - Kim, Choongki

AU - Hong, Sung Jin

AU - Ahn, Chul Min

AU - Kim, Jung Sun

AU - Kim, Byeong Keuk

AU - Ko, Young Guk

AU - Choi, Donghoon

AU - Jang, Yangsoo

AU - Hong, Myeong Ki

PY - 2019/9/13

Y1 - 2019/9/13

N2 - 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.

AB - 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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