TY - JOUR
T1 - Polymer-free sirolimus- and probucol-eluting stents versus durable polymer-based everolimus-eluting stents for percutaneous coronary revascularization
T2 - A prospective multicenter randomized clinical trial
AU - Ikuta, Akihiro
AU - Yajima, Junji
AU - Okazaki, Shinya
AU - Yonetsu, Taishi
AU - Ando, Jiro
AU - Takamisawa, Itaru
AU - Ito, Yoshiaki
AU - Saito, Shigeru
AU - Sakurada, Masami
AU - Yoshida, Yukihiko
AU - Ozaki, Yukio
AU - Amano, Tetsuya
AU - Fujii, Kenshi
AU - Shite, Junya
AU - Ono, Koh
AU - Nakamura, Shigeru
AU - Takaya, Tomofumi
AU - Hirohata, Atsushi
AU - Kishi, Koichi
AU - Ando, Kenji
AU - Kawasaki, Tomohiro
AU - Shibata, Yoshisato
AU - Kozuma, Ken
AU - Ikari, Yuji
AU - Ueno, Takafumi
AU - Muramatsu, Toshiya
AU - Hibi, Kiyoshi
AU - Morino, Yoshihiro
AU - Kadota, Kazushige
N1 - Publisher Copyright:
© 2025
PY - 2025/8
Y1 - 2025/8
N2 - Background: Owing to the advent of new generation drug-eluting stents, percutaneous coronary intervention (PCI) outcomes are improving. However, the polymers, which have been the most common type of coatings used in drug-eluting stents, have some issues. The study aim was to evaluate the clinical outcomes of patients undergoing PCI with polymer-free sirolimus- and probucol-eluting stents (NP023). Methods: This clinical trial was a prospective multicenter single-blind noninferiority randomized study performed at 22 hospitals in Japan. We randomly assigned patients in a 2:1 ratio to undergo PCI with either NP023 or durable polymer-based everolimus-eluting stents (control stents) with a 5-year follow-up. The primary outcome was freedom from target lesion failure (TLF) at 9 months, defined as patient-oriented composite of cardiac death, ischemia-driven target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization. The secondary outcome included adverse outcomes at 5 years following the index procedure. Results: Overall, 432 patients (463 lesions) were treated at 22 sites in Japan [mean age, 68 years; males, 345 (80 %); chronic coronary artery diseases, 322 (74.5 %)]. Of the participants, 91 % completed the 5-year follow-up. The Kaplan–Meier estimates of the percentages of patients who were free from TLF were 95.8 % and 97.3 % with NP023 and control stents, respectively (hazard ratio, 0.98; 95 % confidential interval, 0.80–1.21; p < 0.01 for noninferiority). At the 5-year follow-up, the secondary endpoint for safety was not different between the two groups. Conclusions: The results of this study showed similar outcomes for polymer-free sirolimus- and probucol-eluting stents and durable polymer-based everolimus-eluting stents regarding freedom from TLF at 9 months and other outcomes at 5 years among patients undergoing PCI.
AB - Background: Owing to the advent of new generation drug-eluting stents, percutaneous coronary intervention (PCI) outcomes are improving. However, the polymers, which have been the most common type of coatings used in drug-eluting stents, have some issues. The study aim was to evaluate the clinical outcomes of patients undergoing PCI with polymer-free sirolimus- and probucol-eluting stents (NP023). Methods: This clinical trial was a prospective multicenter single-blind noninferiority randomized study performed at 22 hospitals in Japan. We randomly assigned patients in a 2:1 ratio to undergo PCI with either NP023 or durable polymer-based everolimus-eluting stents (control stents) with a 5-year follow-up. The primary outcome was freedom from target lesion failure (TLF) at 9 months, defined as patient-oriented composite of cardiac death, ischemia-driven target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization. The secondary outcome included adverse outcomes at 5 years following the index procedure. Results: Overall, 432 patients (463 lesions) were treated at 22 sites in Japan [mean age, 68 years; males, 345 (80 %); chronic coronary artery diseases, 322 (74.5 %)]. Of the participants, 91 % completed the 5-year follow-up. The Kaplan–Meier estimates of the percentages of patients who were free from TLF were 95.8 % and 97.3 % with NP023 and control stents, respectively (hazard ratio, 0.98; 95 % confidential interval, 0.80–1.21; p < 0.01 for noninferiority). At the 5-year follow-up, the secondary endpoint for safety was not different between the two groups. Conclusions: The results of this study showed similar outcomes for polymer-free sirolimus- and probucol-eluting stents and durable polymer-based everolimus-eluting stents regarding freedom from TLF at 9 months and other outcomes at 5 years among patients undergoing PCI.
KW - Durable polymer-based everolimus-eluting stent
KW - Percutaneous coronary intervention
KW - Polymer-free sirolimus- and probucol-eluting stents
UR - https://www.scopus.com/pages/publications/85218999872
UR - https://www.scopus.com/pages/publications/85218999872#tab=citedBy
U2 - 10.1016/j.jjcc.2025.01.018
DO - 10.1016/j.jjcc.2025.01.018
M3 - Article
C2 - 39909305
AN - SCOPUS:85218999872
SN - 0914-5087
VL - 86
SP - 148
EP - 154
JO - Journal of cardiology
JF - Journal of cardiology
IS - 2
ER -