Center of Vascular Medicine, Angiology and Vascular Surgery, Park Hospital Leipzig, Strümpellstrasse 41, Leipzig,Germany.
J Am Coll Cardiol. 2011 Sep 6;58(11):1105-9. doi: 10.1016/j.jacc.2011.05.034.
The purpose of this study was to investigate the efficacy of drug-eluting balloons (DEBs) in the treatment of long infrapopliteal lesions with regard to the short-term restenosis rate and midterm clinical result.
Restenosis rates of long-segment tibial artery disease are very high. Recently, a restenosis rate of 69% at 3 months after standard balloon angioplasty was demonstrated.
Infrapopliteal angioplasty was performed with a paclitaxel-eluting balloon (In.Pact Amphirion, Medtronic, Minneapolis, Minnesota). Clinical and angiographic follow-up was performed at 3 months to detect binary restenosis, and further clinical assessment was performed over a 12-month period thereafter.
In 104 patients, 109 limbs were treated for critical limb ischemia (82.6%) or severe claudication (17.4%). Mean lesion length of the arteries treated was 176 ± 88 mm. Angiography studied in 84 treated arteries at 3 months showed a restenosis in 27.4% (19.1% had restenosis of more than 50%, and 8.3% were totally occluded) and usually occurred focally. Only in 9.5% of all angiographically followed up arteries was the entire treated segment restenosed or reoccluded. During a follow-up period of 378 ± 65 days, 1 patient was lost and 17 died. Of the 91 limbs remaining in the analysis, clinical improvement was present in 83 (91.2%). Complete wound healing occurred in 74.2%, whereas major amputation occurred in 4 patients, resulting in limb salvage of 95.6% for patients with critical limb ischemia.
The early restenosis rate of long-segment infrapopliteal disease is significantly lower after treatment with DEBs compared with historical data using uncoated balloons. Randomized trials are required to show whether this difference will lead to improvement in clinical outcomes.
本研究旨在探讨药物洗脱球囊（DEB）治疗长段下肢动脉病变的疗效，主要关注短期再狭窄率和中期临床结果。
长段胫骨动脉疾病的再狭窄率非常高。最近，标准球囊血管成形术后 3 个月的再狭窄率为 69%。
采用紫杉醇洗脱球囊（In.Pact Amphirion，美敦力，明尼苏达州明尼阿波利斯）进行下肢动脉血管成形术。在 3 个月时进行临床和血管造影随访，以检测二元再狭窄，并在此后 12 个月进行进一步的临床评估。
在 104 例患者中，109 条肢体因严重肢体缺血（82.6%）或严重跛行（17.4%）接受治疗。治疗动脉的平均病变长度为 176±88mm。84 条治疗动脉的 3 个月血管造影显示，再狭窄率为 27.4%（19.1%再狭窄超过 50%，8.3%完全闭塞），通常呈局灶性。只有在 9.5%的所有接受血管造影随访的动脉中，整个治疗节段出现再狭窄或再闭塞。在 378±65 天的随访期间，1 例患者失访，17 例患者死亡。在分析中仍有 91 条肢体，83 条（91.2%）肢体临床改善。74.2%完全愈合伤口，4 例患者发生主要截肢，严重肢体缺血患者的保肢率为 95.6%。
与使用未涂层球囊的历史数据相比，DEB 治疗长段下肢动脉病变的早期再狭窄率明显降低。需要进行随机试验以证明这种差异是否会导致临床结局的改善。
