Department of Thoracic and Vascular Surgery, Skåne University Hospital, Malmö, Sweden.
Department of Clinical Sciences, Faculty of Medicine, Lund University, Malmö, Sweden.
Vasc Endovascular Surg. 2023 Oct;57(7):706-716. doi: 10.1177/15385744231171746. Epub 2023 Apr 21.
Drug eluting stents (DES) might improve the results of stenting in the femoropopliteal (FP) segment, but randomized data between DES and BMS in the treatment of patients with chronic limb threatening ischemia (CLTI) is lacking. The aim of this study was to perform a randomized comparison, between DES and bare metal stent (BMS) implantation in a subgroup of CLTI patients with lesions in the superficial femoral artery (SFA) and the P1-P2 portion of the popliteal artery.
Patients presenting with CLTI scheduled for endovascular treatment of FP lesions were randomly assigned by blinded envelopes 1:1 in a single blinded, parallel group design to DES or BMS after lesion crossing. Primary endpoints were target lesion revascularization (TLR) at 12 and 24 months and primary patency at 12 and 24 months. Secondary endpoints were technical success (TS), clinical success, secondary patency at 12 and 24 months, limb salvage, serious adverse events (SAE) at 24 month and survival at five years.
A total of 48 CLTI patients and 49 limbs, were enrolled, 22 in the BMS group and 27 in the DES group. Demographics, comorbidities, and Rutherford class were similar in both treatment arms. The overall rate of total occlusions was 96% and the corresponding overall median lesion length was 240 mm. No patients were lost to follow up. No significant differences were detected between groups regarding TLR and primary patency. The overall primary patency at 12 and 24 months was 42.9% and 36.7% respectively and the overall freedom from TLR was 67.3% and 61.2% respectively. The results in the two groups were also similar regarding secondary outcomes.
This single centre, randomized study could not demonstrate superiority of DES compared to BMS when treating long FP lesions in patients with CLTI but was limited by insufficient patient inclusion.
药物洗脱支架（DES）可能会改善股腘（FP）段支架置入的结果，但在治疗慢性肢体威胁性缺血（CLTI）患者中，DES 和 bare metal stent（BMS）之间的随机数据仍然缺乏。本研究的目的是在患有股浅动脉（SFA）和腘动脉 P1-P2 段病变的 CLTI 患者亚组中，对 DES 和 BMS 植入进行随机比较。
对计划进行 FP 病变血管内治疗的 CLTI 患者，通过盲法信封随机分配 1:1 至 DES 或 BMS 组，在病变通过后进行治疗。主要终点是 12 个月和 24 个月时的靶病变血运重建（TLR）和 12 个月和 24 个月时的主要通畅率。次要终点是技术成功率（TS）、临床成功率、12 个月和 24 个月时的次要通畅率、肢体挽救率、24 个月时的严重不良事件（SAE）和 5 年生存率。
共纳入 48 例 CLTI 患者和 49 条肢体，其中 BMS 组 22 例，DES 组 27 例。两组患者的人口统计学、合并症和 Rutherford 分级相似。总闭塞率为 96%，相应的中位病变长度为 240mm。无患者失访。两组之间在 TLR 和主要通畅率方面无显著差异。12 个月和 24 个月的总通畅率分别为 42.9%和 36.7%，TLR 无事件率分别为 67.3%和 61.2%。两组的次要结局结果也相似。
本单中心随机研究未能证明在治疗 CLTI 患者的长 FP 病变时，DES 优于 BMS，但由于患者纳入数量不足，该研究受到限制。
