Background:Although self-expanding drug-eluting stents (DES) have recently shown superior outcomes for superficial femoral artery (SFA) lesions, optimal sizing of DES diameter in SFA intervention is unclear.

Methods and Results:A total of 40 de novo SFA lesions were randomized 1:1 to receive self-expanding DES with either a 1-mm or 2-mm larger diameter than the reference vessel diameter. Follow-up optical coherence tomography (OCT) was scheduled 6 months after DES implantation to evaluate the vascular response to the stents. Volume index (VI) was defined as volume divided by stent length. The primary endpoint was neointimal VI at 6 months. Baseline reference vessel diameter was similar between the 1-mm larger diameter group and the 2-mm larger diameter group (5.0±0.8 mm vs. 4.7±0.9 mm, P=0.35). Stent diameter was 6.3±0.6 mm in the 1-mm larger group and 7.1±0.6 mm in the 2-mm larger group (P<0.0001), and stent to reference vessel diameter ratio (SV ratio) was 1.3±0.2 and 1.5±0.2 (P<0.0001), respectively. At 6-month, neointimal VI was greater in the 2-mm larger diameter group (5.5±1.5 mm²vs. 9.6±3.4 mm², P<0.001). The correlation analysis revealed that degree of neointimal VI was positively correlated with SV ratio (r=0.43, P<0.01).

Conclusions:Implantation of self-expanding DES with a considerably high SV ratio resulted in neointimal hyperplasia in SFA lesions.

背景：尽管自膨式药物洗脱支架 (DES) 最近在股浅动脉 (SFA) 病变方面显示出优异的结果，但 SFA 干预中 DES 直径的最佳尺寸尚不清楚。

方法和结果：总共 40 个新的 SFA 病灶按 1:1 的比例随机接受直径比参考血管直径大 1 毫米或 2 毫米的自膨式 DES。在 DES 植入后 6 个月安排随访光学相干断层扫描 (OCT)，以评估血管对支架的反应。体积指数 (VI) 定义为体积除以支架长度。主要终点是 6 个月时的新内膜 VI。1 毫米大直径组和 2 毫米大直径组的基线参考血管直径相似（5.0±0.8 毫米与 4.7±0.9 毫米，P=0.35）。支架直径在 1 毫米大组中为 6.3±0.6 毫米，在 2 毫米大组中为 7.1±0.6 毫米（P<0.0001），支架与参考血管直径比（SV 比）为 1.3±0.2 和 1.5±分别为 0.2 (P<0.0001)。6 个月时，²对 9.6±3.4 mm ²，P<0.001)。相关性分析显示，新生内膜VI程度与SV比呈正相关（r=0.43，P<0.01）。

结论：植入具有相当高 SV 比的自膨式 DES 导致 SFA 病变中的新生内膜增生。