Polymer-free sirolimus- and probucol-eluting stents versus durable polymer-based everolimus-eluting stents for percutaneous coronary revascularization: A prospective multicenter randomized clinical trial.
Fuente:
PubMed
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Artículo científico |
| Language: | en |
| Published: |
Journal of cardiology
2025
|
| Subjects: | |
| Online Access: | |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1868266247433486336 |
|---|---|
| author | Ikuta, Akihiro Yajima, Junji Okazaki, Shinya Yonetsu, Taishi Ando, Jiro Takamisawa, Itaru Ito, Yoshiaki Saito, Shigeru Sakurada, Masami Yoshida, Yukihiko Ozaki, Yukio Amano, Tetsuya Fujii, Kenshi Shite, Junya Ono, Koh Nakamura, Shigeru Takaya, Tomofumi Hirohata, Atsushi Kishi, Koichi Ando, Kenji Kawasaki, Tomohiro Shibata, Yoshisato Kozuma, Ken Ikari, Yuji Ueno, Takafumi Muramatsu, Toshiya Hibi, Kiyoshi Morino, Yoshihiro Kadota, Kazushige |
| author_facet | Ikuta, Akihiro Yajima, Junji Okazaki, Shinya Yonetsu, Taishi Ando, Jiro Takamisawa, Itaru Ito, Yoshiaki Saito, Shigeru Sakurada, Masami Yoshida, Yukihiko Ozaki, Yukio Amano, Tetsuya Fujii, Kenshi Shite, Junya Ono, Koh Nakamura, Shigeru Takaya, Tomofumi Hirohata, Atsushi Kishi, Koichi Ando, Kenji Kawasaki, Tomohiro Shibata, Yoshisato Kozuma, Ken Ikari, Yuji Ueno, Takafumi Muramatsu, Toshiya Hibi, Kiyoshi Morino, Yoshihiro Kadota, Kazushige Ikuta, Akihiro Yajima, Junji Okazaki, Shinya Yonetsu, Taishi Ando, Jiro Takamisawa, Itaru Ito, Yoshiaki Saito, Shigeru Sakurada, Masami Yoshida, Yukihiko Ozaki, Yukio Amano, Tetsuya Fujii, Kenshi Shite, Junya Ono, Koh Nakamura, Shigeru Takaya, Tomofumi Hirohata, Atsushi Kishi, Koichi Ando, Kenji Kawasaki, Tomohiro Shibata, Yoshisato Kozuma, Ken Ikari, Yuji Ueno, Takafumi Muramatsu, Toshiya Hibi, Kiyoshi Morino, Yoshihiro Kadota, Kazushige |
| collection | PubMed - marine biology |
| contents | Polymer-free sirolimus- and probucol-eluting stents versus durable polymer-based everolimus-eluting stents for percutaneous coronary revascularization: A prospective multicenter randomized clinical trial. Ikuta, Akihiro Yajima, Junji Okazaki, Shinya Yonetsu, Taishi Ando, Jiro Takamisawa, Itaru Ito, Yoshiaki Saito, Shigeru Sakurada, Masami Yoshida, Yukihiko Ozaki, Yukio Amano, Tetsuya Fujii, Kenshi Shite, Junya Ono, Koh Nakamura, Shigeru Takaya, Tomofumi Hirohata, Atsushi Kishi, Koichi Ando, Kenji Kawasaki, Tomohiro Shibata, Yoshisato Kozuma, Ken Ikari, Yuji Ueno, Takafumi Muramatsu, Toshiya Hibi, Kiyoshi Morino, Yoshihiro Kadota, Kazushige Humans Drug-Eluting Stents Probucol Male Everolimus Female Aged Percutaneous Coronary Intervention Prospective Studies Sirolimus Single-Blind Method Polymers Middle Aged Treatment Outcome Coronary Artery Disease Follow-Up Studies 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). 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. 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 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. |
| format | Artículo científico |
| id | pubmed_39909305 |
| institution | PubMed |
| language | en |
| publishDate | 2025 |
| publisher | Journal of cardiology |
| record_format | pubmed |
| spellingShingle | Polymer-free sirolimus- and probucol-eluting stents versus durable polymer-based everolimus-eluting stents for percutaneous coronary revascularization: A prospective multicenter randomized clinical trial. Ikuta, Akihiro Yajima, Junji Okazaki, Shinya Yonetsu, Taishi Ando, Jiro Takamisawa, Itaru Ito, Yoshiaki Saito, Shigeru Sakurada, Masami Yoshida, Yukihiko Ozaki, Yukio Amano, Tetsuya Fujii, Kenshi Shite, Junya Ono, Koh Nakamura, Shigeru Takaya, Tomofumi Hirohata, Atsushi Kishi, Koichi Ando, Kenji Kawasaki, Tomohiro Shibata, Yoshisato Kozuma, Ken Ikari, Yuji Ueno, Takafumi Muramatsu, Toshiya Hibi, Kiyoshi Morino, Yoshihiro Kadota, Kazushige Humans Drug-Eluting Stents Probucol Male Everolimus Female Aged Percutaneous Coronary Intervention Prospective Studies Sirolimus Single-Blind Method Polymers Middle Aged Treatment Outcome Coronary Artery Disease Follow-Up Studies Polymer-free sirolimus- and probucol-eluting stents versus durable polymer-based everolimus-eluting stents for percutaneous coronary revascularization: A prospective multicenter randomized clinical trial. Ikuta, Akihiro Yajima, Junji Okazaki, Shinya Yonetsu, Taishi Ando, Jiro Takamisawa, Itaru Ito, Yoshiaki Saito, Shigeru Sakurada, Masami Yoshida, Yukihiko Ozaki, Yukio Amano, Tetsuya Fujii, Kenshi Shite, Junya Ono, Koh Nakamura, Shigeru Takaya, Tomofumi Hirohata, Atsushi Kishi, Koichi Ando, Kenji Kawasaki, Tomohiro Shibata, Yoshisato Kozuma, Ken Ikari, Yuji Ueno, Takafumi Muramatsu, Toshiya Hibi, Kiyoshi Morino, Yoshihiro Kadota, Kazushige Humans Drug-Eluting Stents Probucol Male Everolimus Female Aged Percutaneous Coronary Intervention Prospective Studies Sirolimus Single-Blind Method Polymers Middle Aged Treatment Outcome Coronary Artery Disease Follow-Up Studies 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). 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. 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 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. |
| 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. |
| topic | Humans Drug-Eluting Stents Probucol Male Everolimus Female Aged Percutaneous Coronary Intervention Prospective Studies Sirolimus Single-Blind Method Polymers Middle Aged Treatment Outcome Coronary Artery Disease Follow-Up Studies |
| url | https://pubmed.ncbi.nlm.nih.gov/39909305/ |