Department of Thoracic and Vascular Surgery, Ghent University Hospital, 2C2 De Pintelaan 185, 9000 Ghent, Belgium.
Cardiovasc Intervent Radiol. 2010 Apr;33(2):260-9. doi: 10.1007/s00270-009-9765-6. Epub 2009 Dec 3.
Excellent results with small stents in coronary arteries have led endovascular therapists to their use in infrapopliteal vessels. However, to date no level I evidence exists to recommend primary stenting over infrapopliteal angioplasty alone. The aim of this randomized single-center trial was to compare their 1-year outcome. A total of 38 limbs in 35 patients with critical limb ischemia were randomized to angioplasty (22 pts) or primary stenting (16 pts). Target lesions were infrapopliteal occluded (36) or stenotic (20) lesions ranging from <2 to >15 cm in length. The mean age was 72 years. At 12 months, there was no statistical difference in survival (angioplasty, 69.3%; primary stenting, 74.7%), in limb salvage (angioplasty, 90%; primary stenting, 91.7%), or in primary and secondary patency (angioplasty, 66 and 79.5%; primary stenting, 56 and 64%) between the groups Renal insufficiency was the only significant negative predicting factor for limb salvage in both groups. In conclusion, the 1-year results for both groups were broadly similar. Stenting has its place in infrapopliteal angioplasty if the procedure is jeopardized by a dissection or recoil, but our results do not support primary stenting in all cases.
经皮腔内血管成形术治疗冠状动脉疾病取得了良好的效果，这促使腔内治疗师将其应用于治疗小腿动脉疾病。然而，目前尚无一级证据推荐在治疗小腿动脉疾病时首选支架置入术而非单纯经皮腔内血管成形术。本随机单中心试验旨在比较这两种治疗方法的 1 年疗效。共有 35 例严重肢体缺血患者的 38 条肢体被随机分为血管成形术组（22 例）和直接支架置入术组（16 例）。靶病变为小腿动脉闭塞（36 例）或狭窄（20 例）病变，长度<2-15cm 不等。平均年龄为 72 岁。12 个月时，两组患者的生存率（血管成形术组为 69.3%，直接支架置入术组为 74.7%）、保肢率（血管成形术组为 90%，直接支架置入术组为 91.7%）或一期和二期通畅率（血管成形术组为 66%和 79.5%，直接支架置入术组为 56%和 64%）均无统计学差异。肾功能不全是两组患者保肢率的唯一显著负预测因素。总之，两组患者的 1 年结果大致相似。如果介入过程中出现夹层或回缩，支架置入术可作为经皮腔内血管成形术的一种补充治疗手段，但我们的结果并不支持所有情况下都首选支架置入术。
