Department of Diagnostic Imaging, Molecular Imaging, Interventional Radiology, Radiotherapy, and Nuclear Medicine, "IRCCS Policlinico di Tor Vergata," Rome, Italy.
J Endovasc Ther. 2013 Dec;20(6):805-14. doi: 10.1583/13-4308MR.1.
To compare the safety and efficacy of laser debulking (LD) and drug-eluting balloon (DEB) angioplasty to treatment with DEB angioplasty alone in patients affected by critical limb ischemia (CLI) and superficial femoral artery (SFA) chronic stent occlusion in a prospective, randomized study.
Among 448 CLI patients treated from December 2009 to March 2011, 48 patients (39 men; mean age 72.7±7.8 years) with chronic SFA in-stent occlusion were randomly assigned to treatment using LD+DEB (n=24) or DEB angioplasty alone (n=24). Patency at 12 months was the primary outcome measure; secondary outcomes were target lesion revascularization (TLR) and clinical success at 12 months.
In the LD+DEB group, the patency rates at 6 and 12 months (91.7% and 66.7%, respectively) were significantly higher (p=0.01) than in the DEB only patients (58.3% and 37.5%, respectively). TLR at 12 months was 16.7% in the LD+DEB group and 50% in the DEB only group (p=0.01). Two (8%) patients needed major amputations in the LD+DEB group vs. 11 (46%) in the DEB only group at 12 months (p=0.003).
In this small initial experience, combined treatment with LD and DEB angioplasty is correlated with better outcomes in CLI patients with occluded SFA stents.
在一项前瞻性、随机研究中，比较激光斑块切除术（LD）和药物洗脱球囊（DEB）血管成形术与单纯 DEB 血管成形术治疗伴有严重肢体缺血（CLI）和股浅动脉（SFA）慢性支架内闭塞的患者的安全性和疗效。
在 2009 年 12 月至 2011 年 3 月期间治疗的 448 例 CLI 患者中，48 例（39 名男性；平均年龄 72.7±7.8 岁）慢性 SFA 支架内闭塞患者被随机分为 LD+DEB 治疗组（n=24）或单纯 DEB 血管成形术治疗组（n=24）。12 个月时的通畅率是主要观察终点；次要终点是 12 个月时的目标病变血运重建（TLR）和临床成功。
在 LD+DEB 组，6 个月和 12 个月时的通畅率（分别为 91.7%和 66.7%）明显更高（p=0.01），而单纯 DEB 血管成形术组分别为 58.3%和 37.5%。LD+DEB 组 12 个月时的 TLR 为 16.7%，而单纯 DEB 血管成形术组为 50%（p=0.01）。LD+DEB 组有 2 例（8%）患者在 12 个月时需要进行主要截肢，而单纯 DEB 血管成形术组有 11 例（46%）（p=0.003）。
在这项初步的小型研究中，联合应用 LD 和 DEB 血管成形术治疗 SFA 支架内闭塞的 CLI 患者，其结果更好。
