Center for Vascular Medicine, Park Hospital Leipzig, Germany.
J Endovasc Ther. 2012 Aug;19(4):467-75. doi: 10.1583/12-3832R.1.
To evaluate the efficacy and safety of endovascular brachytherapy with liquid beta-emitting rhenium-188 (Re-188) in patients with long-segment in-stent stenosis in the femoropopliteal segment.
From July 2009 to April 2011, 90 consecutive patients (59 men; mean age 68.3±10.3 years, range 43-86) with symptomatic in-stent stenosis/occlusion (24.6-cm mean lesion length) of the femoropopliteal segment underwent angioplasty and subsequent endovascular brachytherapy. The liquid beta-emitting Re-188 was applied to the target lesion within an angioplasty balloon using a dose of 13 Gy at a depth of 2 mm into the vessel wall. Clinical and angiographic follow-up data were collected up to 2 years. The main study endpoints were the 6- and 12-month primary patency rates defined as <50% in-stent stenosis as detected by duplex ultrasound. Clinical endpoints were the cumulative rates of death, amputation, and bypass surgery, as well as improvement in the Rutherford category and the ankle-brachial index. Results were correlated with patient and lesion characteristics.
Primary technical success was achieved in all patients, with 1 early stent thrombosis, but no other complications related to the irradiation. Eighty-eight patients reached the 6-month and 82 the 12-month examinations; the primary patency was 95.2% and 79.8%, respectively. In-stent stenosis occurred in 9 patients, while 10 patients had reocclusion of the treated segment. During follow-up, there were 2 late acute thrombotic occlusions, both after discontinuation of clopidogrel. The clinical status improved in 67.0% and 62.2% of the patients after 6 and 12 months, respectively. No patient, lesion, or procedure variables were predictive of restenosis after EVBT.
EVBT with liquid beta-emitting Re-188 was safe and effective in preventing restenosis in long-segment femoropopliteal ISS.
评估腔内近距离放射治疗应用液体β放射性核素 188 铼（Re-188）治疗股腘段长节段支架内再狭窄的疗效和安全性。
2009 年 7 月至 2011 年 4 月，90 例连续患者（59 例男性；平均年龄 68.3±10.3 岁，范围 43-86 岁）因股腘段支架内再狭窄/闭塞（平均病变长度 24.6cm）而接受血管成形术和随后的腔内近距离放射治疗。将液体β放射性核素 188 应用于血管成形术球囊内的靶病变，球囊内液体放射性核素的剂量为 13Gy，深度为 2mm 进入血管壁。收集了长达 2 年的临床和血管造影随访数据。主要研究终点是 6 个月和 12 个月的主要通畅率，定义为超声检查发现支架内狭窄<50%。临床终点是死亡率、截肢率和旁路手术率，以及 Rutherford 分类和踝肱指数的改善。结果与患者和病变特征相关。
所有患者均达到了初始技术成功，1 例早期支架血栓形成，但无其他与照射相关的并发症。88 例患者完成了 6 个月和 12 个月的检查；6 个月和 12 个月的主要通畅率分别为 95.2%和 79.8%。9 例患者发生支架内狭窄，10 例患者治疗段再闭塞。随访期间，2 例迟发性急性血栓闭塞均发生在停用氯吡格雷后。6 个月和 12 个月后，分别有 67.0%和 62.2%的患者临床状况得到改善。EVBT 后，无患者、病变或手术变量可预测再狭窄。
腔内近距离放射治疗应用液体β放射性核素 188 治疗股腘段长节段支架内再狭窄是安全有效的，可预防再狭窄。
