Ahmed Shahzaib, Ahmad Eeman, Ahmed Mushood, Ul Ain Hoor, Ahmed Raheel, Jain Hritvik, Harikrishna Arya, Ali Ashraf Danish, Ahmad Shoaib
Department of Medicine, Fatima Memorial Hospital College of Medicine and Dentistry, Lahore, Pakistan.
Rawalpindi Medical University, Rawalpindi, Pakistan.
Medicine (Baltimore). 2025 Apr 11;104(15):e42113. doi: 10.1097/MD.0000000000042113.
Paclitaxel is an antimicrotubular agent and is used to coat balloons and stents used in percutaneous coronary intervention. This study aims to provide a pooled comparison of paclitaxel-coated balloons (PCB) and paclitaxel-eluting stents (PES) in terms of their efficacy in treating restenosis and their associated safety outcomes.
We systematically searched PubMed, Scopus, Science Direct, and Clinicaltrials.gov from inception until August 2024 to evaluate the outcomes between PCB and PES for treating coronary in-stent restenosis. Studies were deemed eligible if they compared PCB with PES in patients with coronary in-stent restenosis. Pooled data were reported using risk ratio (RR) for dichotomous outcomes and mean difference for continuous outcomes, along with 95% confidence intervals (CI). This systematic review and meta-analysis was registered with International Prospective Register of Systematic Reviews (CRD42024543509).
734 patients across 4 trials were included in this analysis. Descriptive analysis showed high device success in both groups (99.6% for PCB vs 97.9% for PES), while restenosis occurred in 20.6% of PCB patients and 23.7% of PES patients. Myocardial infarction rates were 1.9% for PCB and 3.0% for PES, while mortality was observed in 1.6% and 3.6% of patients, respectively. No significant differences between PCB and PES were revealed in terms of recurrent binary restenosis rates (RR: 0.76; 95% CI: 0.19 to 2.99) or late lumen loss (mean difference: -0.02; 95% CI: -0.25 to 0.22). Device success rates (RR: 1.01; 95% CI: 0.91 to 1.13), the incidence of myocardial infarction (RR: 0.64; 95% CI: 0.24 to 1.69), and the incidence of death (RR: 0.48; 95% CI: 0.16 to 1.41) were also comparable between the 2 groups.
PCB provides a viable stent-free alternative to PES with comparable outcomes. Further studies, especially those focused on assessing patient-specific factors and lesion characteristics are required to guide optimal treatment selection.
紫杉醇是一种抗微管药物，用于涂覆经皮冠状动脉介入治疗中使用的球囊和支架。本研究旨在对紫杉醇涂层球囊（PCB）和紫杉醇洗脱支架（PES）在治疗再狭窄方面的疗效及其相关安全性结果进行汇总比较。
我们系统检索了从数据库建立至2024年8月的PubMed、Scopus、Science Direct和Clinicaltrials.gov，以评估PCB和PES治疗冠状动脉支架内再狭窄的结果。如果研究比较了冠状动脉支架内再狭窄患者的PCB和PES，则被认为符合纳入标准。汇总数据采用二分类结局的风险比（RR）和连续结局的均值差报告，并给出95%置信区间（CI）。本系统评价和荟萃分析已在国际前瞻性系统评价注册库（注册号：CRD42024543509）注册。
本分析纳入了4项试验中的734例患者。描述性分析显示两组的器械成功率均较高（PCB组为99.6%，PES组为97.9%），而PCB组20.6%的患者和PES组23.7%的患者发生了再狭窄。PCB组心肌梗死发生率为1.9%，PES组为3.0%，两组患者的死亡率分别为1.6%和3.6%。PCB和PES在复发性二分类再狭窄率（RR：0.76；95%CI：0.19至2.99）或晚期管腔丢失（均值差：-0.02；95%CI：-0.25至0.22）方面无显著差异。两组的器械成功率（RR：1.01；95%CI：0.91至1.13）、心肌梗死发生率（RR：0.64；95%CI：0.24至1.69）和死亡率（RR：0.48；95%CI：0.16至1.41）也相当。
PCB为PES提供了一种可行的无支架替代方案，疗效相当。需要进一步的研究，尤其是那些侧重于评估患者特异性因素和病变特征的研究，以指导最佳治疗选择。
