药物涂层球囊在Supera支架治疗下肢动脉闭塞病变中的附加价值

Additional Value of Drug-Coated Balloon in Supera Stent Treatment for Occlusive Lesions of Lower Limb Arteries

目的:评估药物涂层球囊能否进一步提高Supera支架在复杂股腘动脉闭塞病变中的治疗效果。方法:收集2019年1月至2022年10月期间接受Supera支架治疗的下肢动脉疾病患者资料,根据是否联合使用DCB,将所有患者分为观察组和对照组,观察组为Supera支架联合使用DCB治疗(n = 59),对照组为单纯使用Supera支架治疗(n = 97),比较两组患者的一期通畅率,技术成功率,临床成功率,死亡率和再干预率等。结果:平均随访时间为36.5 ± 10.1个月。两组患者基线特征相似,无明显统计学差异。观察组和对照组分别有74.1%和68.0%的患者累及腘动脉(P > 0.05),观察组技术成功率为96.6%,对照组为93.8% (P > 0.05),观察组12个月时的一期通畅率为81.4%,对照组为84.5%,两组无统计学差异(P > 0.05)。两组患者死亡率、卢瑟福分级改变也无明显统计学差异(P > 0.05),观察组有6.8%的患者接受了再干预,低于对照组的10.3%,但在统计学上两组差别无意义(P > 0.05)。结论:Supera支架联合DCB的治疗策略是安全的,但较单独使用Supera支架策略并未表现出明显优势。还需要进一步的研究来在更大的患者队列中证实这些结果。

Objective: To evaluate whether drug-coated balloon can further improve the efficacy of Supera stent in the treatment of complex femoral and popliteal artery occlusion. Methods: The data of patients with arterial disease of lower extremities treated with Supera stent from January 2019 to October 2022 were collected. According to the combination of DCB, all patients were divided into observa-tion group and control group. The observation group was treated with Supera stent combined with DCB (n = 59), and the control group was treated with Supera stent alone (n = 97). The primary pa-tency rate, technical success rate, clinical success rate, mortality and re-intervention rate were compared between the two groups. Results: The mean follow-up time was 36.5 ± 10.1 months. The baseline characteristics of the two groups were similar, and there was no significant statistical dif-ference. 74.1% and 68.0% of the patients in the observation group and the control group involved the popliteal artery respectively (P > 0.05). The technical success rate was 96.6% in the observation group and 93.8% in the control group (P > 0.05). The primary patency rate was 81.4% in the ob-servation group and 84.5% in the control group. There was no statistical difference between the two groups (P > 0.05). There was no significant difference in mortality and Rutherford classification between the two groups (P > 0.05). 6.8% of the patients in the observation group received re-intervention, which was lower than 10.3% in the control group, but there was no significant dif-ference between the two groups (P > 0.05). Conclusion: The strategy of Supera stent combined with DCB is safe, but it does not show obvious advantage over the strategy of Supera stent alone. Further studies are needed to confirm these results in a larger cohort of patients.