Polymer-free sirolimus- and probucol-eluting stents versus durable polymer-based everolimus-eluting stents for percutaneous coronary revascularization: A prospective multicenter randomized clinical trial.
{"title":"Polymer-free sirolimus- and probucol-eluting stents versus durable polymer-based everolimus-eluting stents for percutaneous coronary revascularization: A prospective multicenter randomized clinical trial.","authors":"Akihiro Ikuta, Junji Yajima, Shinya Okazaki, Taishi Yonetsu, Jiro Ando, Itaru Takamisawa, Yoshiaki Ito, Shigeru Saito, Masami Sakurada, Yukihiko Yoshida, Yukio Ozaki, Tetsuya Amano, Kenshi Fujii, Junya Shite, Koh Ono, Shigeru Nakamura, Tomofumi Takaya, Atsushi Hirohata, Koichi Kishi, Kenji Ando, Tomohiro Kawasaki, Yoshisato Shibata, Ken Kozuma, Yuji Ikari, Takafumi Ueno, Toshiya Muramatsu, Kiyoshi Hibi, Yoshihiro Morino, Kazushige Kadota","doi":"10.1016/j.jjcc.2025.01.018","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":15223,"journal":{"name":"Journal of cardiology","volume":" ","pages":""},"PeriodicalIF":2.5000,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of cardiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jjcc.2025.01.018","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍：
The official journal of the Japanese College of Cardiology is an international, English language, peer-reviewed journal publishing the latest findings in cardiovascular medicine. Journal of Cardiology (JC) aims to publish the highest-quality material covering original basic and clinical research on all aspects of cardiovascular disease. Topics covered include ischemic heart disease, cardiomyopathy, valvular heart disease, vascular disease, hypertension, arrhythmia, congenital heart disease, pharmacological and non-pharmacological treatment, new diagnostic techniques, and cardiovascular imaging. JC also publishes a selection of review articles, clinical trials, short communications, and important messages and letters to the editor.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
