Department of Cardiology, Sapporo Heart Center, Sapporo, Japan -
Department of Cardiology, Sapporo Heart Center, Sapporo, Japan.
J Cardiovasc Surg (Torino). 2023 Aug;64(4):422-429. doi: 10.23736/S0021-9509.23.12500-6. Epub 2023 Mar 10.
The Misago iliac stent has not been compared with other stents. This study aimed to evaluate the 2-year clinical outcomes between the Misago stent and other self-expandable nitinol stents for symptomatic chronic aortoiliac disease.
This retrospective, single-center observational study enrolled 138 patients (180 limbs; Rutherford classification, between categories 2 and 6) treated with a Misago stent (N.=41) or self-expandable nitinol stent (N.=97) between January 2019 and December 2019. The primary endpoint was patency for up to 2 years. The secondary endpoints were technical success, procedure-related complications, freedom from target lesion revascularization, overall survival, and freedom from major adverse limb events. Multivariate Cox proportional hazards analysis was used to investigate predictors of restenosis.
The mean follow-up duration was 710±201 days. The 2-year primary patency rate was comparable between the groups (Misago, 89.6% and self-expandable nitinol stent, 91.0%, P=0.883). The technical success rate was 100% in both groups, and procedure-related complications were equivalent between the groups (1.7% and 2.4%, respectively; P=0.773). Freedom from target lesion revascularization was not significantly different between the groups (97.6% and 94.4%, respectively; P=0.890). The overall survival rate and freedom from major adverse limb events were not significantly different between the groups (77.2% and 70.8%, respectively, P=0.209; 66.9% and 58.4%, respectively, P=0.149). Statin therapy was positively associated with primary patency.
The Misago stent for aortoiliac lesions demonstrated comparable and acceptable clinical results of safety and efficacy for up to 2 years compared with other self-expandable stents. Statin use predicted the prevention of patency loss.
Misago 髂动脉支架尚未与其他支架进行比较。本研究旨在评估Misago 支架与其他自膨式镍钛合金支架治疗症状性慢性主髂动脉疾病的 2 年临床结果。
这是一项回顾性、单中心观察性研究，共纳入 138 例（180 条肢体；Rutherford 分级 2 级至 6 级）患者，分别接受 Misago 支架（n=41）或自膨式镍钛合金支架（n=97）治疗，治疗时间为 2019 年 1 月至 2019 年 12 月。主要终点为 2 年内通畅率。次要终点为技术成功率、与手术相关的并发症、免于靶病变血运重建、总生存率和免于重大不良肢体事件。多变量 Cox 比例风险分析用于探讨再狭窄的预测因素。
平均随访时间为 710±201 天。两组 2 年原发性通畅率无显著差异（Misago 支架组为 89.6%，自膨式镍钛合金支架组为 91.0%，P=0.883）。两组技术成功率均为 100%，与手术相关的并发症发生率无显著差异（分别为 1.7%和 2.4%，P=0.773）。免于靶病变血运重建率无显著差异（分别为 97.6%和 94.4%，P=0.890）。两组总生存率和免于重大不良肢体事件发生率无显著差异（分别为 77.2%和 70.8%，P=0.209；分别为 66.9%和 58.4%，P=0.149）。他汀类药物治疗与原发性通畅率呈正相关。
Misago 支架治疗主髂动脉病变，在 2 年的安全性和有效性方面与其他自膨式支架相当，可作为一种选择。他汀类药物的使用可预测通畅率的降低。
