Treatment of Chronic SFA In-Stent Occlusion With Combined Laser Atherectomy and Drug-Eluting Balloon Angioplasty in Patients With Critical Limb Ischemia: A Single-Center, Prospective, Randomized Study

医学 血管成形术 严重肢体缺血 气球 动脉切除术 闭塞 外科 支架 血运重建 再狭窄 单中心 腘动脉 前瞻性队列研究 内科学 心肌梗塞
作者
Roberto Gandini,Costantino Del Giudice,Stefano Merolla,Daniele Morosetti,Enrico Pampana,Giovanni Simonetti
出处
期刊:Journal of Endovascular Therapy [SAGE Publishing]
卷期号:20 (6): 805-814 被引量:95
标识
DOI:10.1583/13-4308mr.1
摘要

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.
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