Sbarzaglia Paolo, Galli Mattia, Tenti Elena, Sangiorgi Diego, Lunetto Maria Letizia, Russo Paolo, Liso Armando, Pernice Vincenzo, Micari Antonio, Castriota Fausto
Cardiovascular Department, Maria Cecilia Hospital, GVM Care & Research, Cotignola, Ravenna, 48033, Italy.
Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, 04100, Italy.
Vasc Health Risk Manag. 2025 Apr 10;21:239-250. doi: 10.2147/VHRM.S510121. eCollection 2025.
The clinical performance of drug-coated balloons (DCBs) for the treatment of femoro-popliteal lesions may depend on the specific device used. There is limited evidence on the clinical safety and efficacy of the paclitaxel-coated device Stellarex for the treatment of long (>180 mm) femoro-popliteal lesions.
This is a single arm, prospective, open label, observational study including symptomatic patients with long femoro-popliteal lesions undergoing endovascular revascularization with Stellarex DCB. The primary endpoints were the safety and efficacy of the DCB over time. Secondary endpoints were represented by functional outcomes.
Ninety-five patients (median age 72, lesion length 250 mm) were included. At 6 months after the procedure, 61% of patients were asymptomatic as defined by the Rutherford classification, decreasing over time (57% at 12 months, 56% at 24 months, 44% at 36 months). Walking Impairment Questionnaire showed a remarkable improvement at 6 months, with a decreasing trend over time. When single components were analysed, better performances were observed for distance and climbing scores throughout the study period, while speed returned to baseline levels after 24 months. EQ5D Questionnaire showed a statistically significant improvement throughout the study period (with a decreasing trend over time, as seen for Rutherford classification and Walking Impairment Questionnaire). During the 36-months follow-up, 9% of patients died, with previous limb amputation being an independent predictor of mortality (HR = 7.4, p = 0.013). One-year primary patency was 76.5%, with no significant difference compared to the reference rate of 80% (p = 0.810). Primary patency defined as PSVR ≤2.4 (peak systolic velocity ratio) was maintained over time (median survival time free from PSVR >2.4 was not assessable as it exceeded the 36 months of follow-up).
In our sample, Stellarex showed to be safe and effective and it was associated with an event rate comparable to other devices reported in literature.
药物涂层球囊（DCB）治疗股腘动脉病变的临床效果可能取决于所使用的具体器械。关于紫杉醇涂层器械Stellarex治疗长（>180mm）股腘动脉病变的临床安全性和有效性的证据有限。
这是一项单臂、前瞻性、开放标签的观察性研究，纳入有症状的长股腘动脉病变患者，采用Stellarex DCB进行血管内血运重建。主要终点是DCB随时间的安全性和有效性。次要终点由功能结局表示。
纳入95例患者（中位年龄72岁，病变长度250mm）。术后6个月，61%的患者根据卢瑟福分类法无症状，随时间下降（12个月时为57%，24个月时为56%，36个月时为44%）。步行障碍问卷显示6个月时有显著改善，随时间呈下降趋势。当分析单个成分时，在整个研究期间，距离和攀爬分数表现更好，而速度在24个月后恢复到基线水平。EQ5D问卷显示在整个研究期间有统计学显著改善（随时间呈下降趋势，与卢瑟福分类法和步行障碍问卷情况相同）。在36个月的随访期间，9%的患者死亡，既往肢体截肢是死亡的独立预测因素（HR = 7.4，p = 0.013）。一年的初级通畅率为76.5%，与80%的参考率相比无显著差异（p = 0.810）。定义为PSVR≤2.4（收缩期峰值速度比）的初级通畅率随时间维持（由于超过36个月的随访时间，无法评估无PSVR>2.4的中位生存时间）。
在我们的样本中，Stellarex显示出安全有效，且其事件发生率与文献中报道的其他器械相当。
