Research progress on the safety of paclitaxel drug-loaded devices
10.3760/cma.j.cn112139-20241224-00587
- VernacularTitle:紫杉醇载药器械安全性的研究进展
- Author:
Zihan ZHANG
1
;
Jian HE
;
Peng JIANG
;
Yongpan CUI
;
Jianfeng SUN
;
Jiang XIONG
;
Fei MEI
Author Information
1. 三峡大学第一临床医学院 宜昌市中心人民医院血管外科 缺血性心血管病湖北省重点实验室 湖北省缺血性心血管疾病临床医学研究中心，宜昌 443003
- Publication Type:Journal Article
- Keywords:
Arteriosclerosis obliterans;
Lower extremity;
Paclitaxel-coated balloon;
Paclitaxel-eluting stent;
Paclitaxel;
Safety;
Mortality.
- From:
Chinese Journal of Surgery
2025;63(7):637-641
- CountryChina
- Language:Chinese
-
Abstract:
In endovascular treatment of peripheral arterial disease, paclitaxel-coated device (PCD) have been widely used to reduce vascular restenosis, yet their safety remains controversial. Some scholars have suggested that PCD might increase long-term mortality, sparking widespread concern and debate. In recent years, a number of studies have provided support for the safety of PCD, believing that PCD have advantages in terms of re-intervention, patency rate, and reduction of amputation risk, and do not increase the risk of death. There is no direct relationship between the paclitaxel dose and mortality. Overall, the safety controversy primarily stems from methodological limitations in early studies. The latest research has provided safety evidence for their clinical application. However, further investigations are required to define the boundary conditions for their long-term safety, elucidate variations in responses across different patient populations, and clarify paclitaxel′s mechanisms of action in vivo. Such efforts will facilitate optimal balancing of therapeutic efficacy and safety in clinical applications.
