Sirolimus for below the knee lesions: Mid-term results of SiroBTK study
Sirolimus for below the knee lesions: Mid-term results of SiroBTK study
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DOI：
10.1002/ccd.20893
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发表时间：
2006-11-01
影响因子：
2.3
通讯作者：
Roquebert, Pierre O.
中科院分区：
文献类型：
--
作者：
Commeau, Philippe;Barragan, Paul;Roquebert, Pierre O.
目的：评估西罗莫司洗脱支架（SES）治疗不适合手术的严重间歇性跛行和严重肢体缺血伴“膝下”病变的安全性和有效性。背景资料：有限的已发表证据表明，药物洗脱支架可显著改善膝下病变的治疗。研究方法：采用SES治疗了30例患有严重间歇性跛行或严重肢体缺血（CLI）、Rutherford分类3-6级和膝下动脉多支血管疾病（>= 2支血管）的连续患者。使用106个SES治疗了62条动脉。平均年龄为73.9岁，77%的患者为男性，36%为糖尿病患者。主要终点是短期（1个月）和中期（7.7个月）的临床改善和溃疡愈合。次要终点为主要血管通畅率（血管造影或多普勒评估）。所有患者均接受氯吡格雷（每日75 mg）或噻氯匹定（每日150 mg）治疗2个月或更长时间。结果：所有患者均获得血管造影和手术成功。7个月时（7.7 +/- 5.8），1例患者需要截肢1个脚趾，另1例患者需要截肢1个中足。100%的患者获得保肢。其他事件包括：2例与CLI无关的心源性死亡、1例中风伴偏瘫、1例初始再灌注综合征、1例对侧CLI和3例复发性同侧跛行病例。所有存活患者的中期临床改善率为97%（58条动脉中有56条动脉通畅）。结论：SES治疗“膝下”病变可能为CLI患者提供一种替代治疗方法。(C)2006 Wiley-Liss，Inc.
Objectives: To assess the safety and efficacy of sirolimus-eluting stents (SESs) in the treatment of severe intermittent claudication and critical limb ischaemia with "below-the-knee" lesions, unsuitable for surgery. Background: Limited published evidence suggests that drug-eluting stents may offer significant improvements in the treatment of infrapopliteal lesions. Methods: Thirty consecutive patients with either severe intermittent claudication or critical limb ischemia (CLI), category 3-6 of Rutherford classification, and multivessel disease of infrapopliteal arteries (>= 2 vessels) were treated with SES. Sixty-two arteries were treated with 106 SES. Mean age was 73.9 years, 77% of patients were male and 36% diabetic. The primary endpoint was clinical improvement and healing of ulcers at short term (1 month) and mid term (7.7 months). The secondary endpoint was primary vessel patency rate (angiographic or duplex assessment). All patients received clopidogrel (75 mg daily) or ticlopidine (150 mg daily) for 2 months or longer. Results: Angiographic and procedural success was achieved in all patients. At 7 months (7.7 +/- 5.8), it was necessary to amputate 1 toe in one patient and 1 mid-foot in another. Limb salvage was obtained in 100% of patients. Other events were: two cardiac deaths unrelated to CLI, one stroke with hemiparesia, one initial reperfusion syndrome, one contralateral CLI, and three recurrent homolateral claudication cases. All surviving patients had a mid-term clinical improvement with 97% of primary patency (56 patent arteries on 58 arteries). Conclusion: Treatment of "below-the-knee" lesions with SES may provide an alternative treatment for patients with CLI. (C) 2006 Wiley-Liss, Inc.